 1 Antibiotics
 2 Acetaminophen
 3 Aspirin
 4 DRUG DOSAGE FORMS and Dosage measurments
 5 Drug Interactions - Self Medicating
 6 Pharmacies in Thailand
 7 Immunisations - Vaccines
 8 fake drugs
 9 Feldane/Eldene
 10 FOSAMAX
 11 BEXTRA (arthritis)

\1 Antibiotics

give your body a rest when you're recovering from an infection. It may be especially important if you're using fluoroquinolone antibiotics, often prescribed for urinary tract, pulmonary, and other infections. Fluoroquinolones may affect tendons in the knee, thigh, calf or shoulder, making them more susceptible to injury in some people. Ask if your antibiotics are fluoroquinolones. These include olprofloxacin, pefloxacin, ofloxacin, norfloxacin, temafloxacin, and ciprofloxacin. If you are prescribed one of these, you can help reduce your risk of injury by taking a break from high-impact exercise or activities such as weight training. If you do experience tenderness or discomfort in a tendon, let your doctor know right away. A study conducted at the Univ of Pittsburgh Med Ctr McKeesport Hosp in Penn suggests that eating yogurt may reduce the incidence of diarrhea that often occurs while taking antibiotics. This research was presented recently at the 64th Annual Scientific Meeting of the American College of Gastroenterology. You may have heard about eating yogurt in the past, and this study appears to back up that advice. Diarrhea is the most common side-effect of antibiotic treatment. Antibiotics are usually taken to cure an infection that is being caused by a certain bacterium. In the process of killing these bacteria, helpful bacteria may be killed as well. These helpful bacteria are often responsible for keeping still other types of organisms at bay; and when the helpful bacteria are destroyed these other organisms may multiply, causing diarrhea, vaginal yeast infections, or thrush. Scientists believe that the lactobacillus cultures present in yogurt help to stabilize the intestinal environment, putting these "good" bacteria back in the driver's seat. A total of 202 patients who were taking antibiotics participated in this study. Patients with lactose intolerance or who were allergic to components of yogurt were not included in the study. Half of the participants were given a dietary supplement of 16 ounces of commercial vanilla-flavored yogurt (eight ounces at lunch and at dinner) for eight days. All patients were followed for seven days and observed for diarrhea, bloating, and frequent bowel movements. Those who ate the yogurt had less diarrhea (9% vs 19%) and bloating (5% vs 9%) than those who did not eat the yogurt. These researchers believe this study confirms that yogurt is a safe and economical way to prevent diarrhea associated with antibiotic use.

Antibiotics are medicines that kill the bacteria that cause infections. Once started, finish the entire Rx. STOP only if an allergic reaction occurs and seek medical attention immediately.

Different antibiotics destroy bacteria in different ways. Some short-circuit the processes by which bacteria receive energy. Others disturb the structure of the bacterial cell wall, as shown in the illustration above. Still others interfere with the production of essential proteins.

Purpose - Antibiotics have been used since the 1930s to treat or prevent a wide variety of infections. Before then, there were few effective ways of combating infections caused by bacteria. Illnesses such as pneumonia , tuberculosis , and typhoid fever were considered untreatable. Even minor infections could rage out of control and turn deadly.

Since the introduction of antibiotics in the mid 1930s, physicians and patients have come to depend on these drugs to treat everything from sore throats and urinary tract infections to meningitis and tuberculosis. These drugs are also used to prevent infections before, during, and after surgery. Many new antibiotics have been developed over the years, and by the 1970s, it seemed as if infectious diseases were on the verge of being eliminated.

But in recent years, health experts have noticed that antibiotics are becoming less and less effective as people use them more and more. This happens because of antibiotic resistance, a problem that develops when antibiotics are overused or misused. Each time an antibiotic is used to treat an infection, it kills the bacteria that cause the infection. But sometimes a few bacteria exist that can fight off the antibiotic.

Thus, even in the presence of an antibiotic, these bacteria survive and reproduce, passing on their antibiotic resistance.Because bacteria reproduce so quickly, producing a new generation as often as every 15 minutes, these new defenses can rapidly be passed on through generations of bacteria until almost all are immune to the effects of a particular antibiotic.

The more people use antibiotics, the more rapidly the process happens. And although new antibiotics once seemed to keep a step ahead of resistant bacteria, that's not happening any more -- resistance often occurs faster than new antibiotics can be developed. Today, almost every known disease-causing bccterium is resistant to at least one antibiotic.

Health experts are particularly concerned about antibiotic resistance in bacteria that cause certain serious infections. For example, some strains of Staphylococcus aureus, that may cause boils , pneumonia, or bloodstream infections, are resistant to almost all antibiotics, making those conditions very difficult to treat. Many strains of tuberculosis, also an infectious disease, also are now resistant to one or more of the agents used to control tuberculosis.

Everyone can help keep antibiotic resistance from becoming an even bigger problem than it already is. Here are some important guidelines:  Do not pressure a physician to prescribe an antibiotic for a cold or flu. Usually, such illnesses are due to a viral infection, which cannot be treated with an antibiotic. Taking an antibiotic when it is not needed will only encourage the spread of resistant bacteria in the body and in the community.

* If a physician prescribes an antibiotic, do not be afraid to ask why the medicine is being prescribed. Make sure the physician has good reason to believe that the medicine will effectively treat the particular condition for which it is being prescribed.

* When an antibioticiis appropriately prescribed, be sure to take all the medicine, for as long as directed. When a patient stops taking the medicine too soon, only the most vulnerable bacteria are killed, leaving the rest to thrive. Any illness caused by the remaining, resistant bacteria will then be harder to treat.

Description - Different antibiotics kill bacteria in different ways. Some short-circuit the processes by which bacteria get energy, others disturb the structure of the bacterial cell wall, and still others interfere with the production of essential proteins.

Some 150 antibiotics are available. These include tetracyclines , aminoglycosides , penicillins , cephalosporins , fluoroquinolones , streptogramins, sulfonamides , and erythromycins .

Antibiotics are classified as narrow-spectrum drugs when they work against only a few types of bacteria. Broad-spectrum antibiotics are effective against a wide range of bacteria. However, broad-spectrum antibiotics are more likely to promote antibiotic resistance. For that reason, narrow-spectrum antibiotics, which often cost less, should be used whenever possible. Broad-spectrum antibiotics should be reserved for infections that do not respond to treatment with narrow-spectrum drugs.

Recommended dosage - The dosage depends on the type of antibiotic and the form in which it is being taken. Doses may be different for different patients. For the correct dosage, check with the physician who prescribed the medicine or the pharmacist who filled the prescription.

Precautions - To completely clear up infections and to help prevent antibiotic resistance, take antibiotics exactly as directed. Do not stop taking the medicine just because symptoms begin to improve.

People who have certain medical conditions or who are taking certain other medicines may have problems if they take antibiotics. For details, see entries on specific types of antibiotics.

Side effects - Antibiotics may cause a number of side effects. For details, see entries on specific types of antibiotics. Anyone who has unusual or disturbing symptoms after taking antibiotics should call the physician as soon as possible.

Interactions - Antibiotics may interact with other medicines as well as with foods. When this happens, the effects of the antibiotic or the risk of side effects may be greater. Anyone who takes antibiotics should let the physician know all other medicines he or she is taking. For details of drug interactions, see entries on specific types of antibiotics.

Key Terms * Bacteria Tiny, one-celled forms of life that cause many diseases and infections.

* Inflammation Pain, redness, swelling, and heat that usually develop in response to injury or illness.

* Meningitis Inflammation of tissues that surround the brain and spinal cord.

* Microorganism An organism that is too small to be seen with the naked eye.

* Organism A single, independent unit of life, such as a bacterium, a plant or an animal.

* Pneumonia A disease in which the lungs become inflamed. Pneumonia may be caused by bacteria, viruses, or other organisms, or by physical or chemical irritants.

* Tuberculosis An infectious disease that usually affects the lungs, but may also affect other parts of the body. Symptoms include fever, weight loss, and coughing up blood.

* Typhoid fever A life-threatening disease with symptoms that include prolonged fever, distended abdomen, rosy spots on the chest and abdomen, depression, and diarrhea.

--------------------------------------------------------- ANTIBIOTICS NOT FOR ALL INFECTIONS. A new brochure explains why antibiotics are no longer recommend for most respiratory tract infections, such as colds, sore throats and bronchitis. The American College of Physicians and the American Society of Internal Medicine are concerned that overuse of anti-biotics might breed potentially fatal drug-resistant germs. "Patients should not think they are getting poor treatment if their doctors don't prescribe antibiotics," said researcher Vincenza Snow. "Most colds and other respiratory tract infections are caused by viruses, and antibiotics don't affect viruses. Try nasal sprays, decongestants, cough drops and saltwater gargles to relieve symptoms before youccall the doctor. Finally, don't expect the symptoms to clear up right away. Colds usually last for up to two weeks." The new guidelines cover healthy adults, and are not intended for people over age 65 or those with long-term medical conditions such as diabetes, heart or lung problems. The new brochure is available by calling 8800) 523-1546, extension 2600, or by visiting www.doctorsforadults.com.

The new medical guidelines are available at www.acponline.org/sci-pol...ecent.htm.

 Contraindications/side effects  See ROUTINE note also. ALWAYS advise physican if you have ever had a bad reaction to penicillin. Otherwise it can be a SHOCKing experience.

Antibiotics are only used to treat bacterial infections. They are useless against viruses as upper respiratory infections as bronchitis and colds. Antiobiotics use in these cases only increases drug resistance of bacteria.

Nausea and vomiting without diarrhea should never be treated with antibiotics.

Kanamycin prevents absorption of vitamins K and B12. Neomycin prevents absorption of vitamin D.

 Antibacterial agents are categorized as narrow-, broad-, or extended-spectrum agents. Narrow-spectrum agents (e.g., penicillin G) affect primarily gram-positive bacteria. Broad-spectrum antibiotics, such as tetracyclines and chloramphenicol, affect both gram-positive and some gram-negative bacteria. An extended-spectrum antibiotic is one that, as a result of chemical modification, affects additional types of bacteria, usually gram-negative bacteria. Whether an antimicrobial agent affects a microorganism depends on several factors. The drug must be delivered to a sensitive site in the cell, such as an enzyme that is involved in the synthesis of a cell wall or a protein or enzyme responsible for the synthesis of proteins, nucleic acids, or the cell membrane. Whether the antibiotic enters the cell depends on the ability of the drug to penetrate the outer membrane of the cell, or on the presence or absence of transport systems for the antimicrobial agent, or on the availability of channels in the cell surface. In some cases the microorganism prevents the entry of the antibiotic by producing an enzyme that destroys or modifies the antibiotic by transferring a chemical group. If the antimicrobial agent does not penetrate the organism or is destroyed or modified, or if the organism does not contain a sensitive site, then the microorganism will not be affected; in such a case it is said to be resistant. A major problem associated with the use of antibacterial drugs is that an organism that originally was sensitive to a given drug can become resistant. For example, bacteria undergo spontaneous mutations; and exposure of these bacteria to an antimicrobial can eradicate sensitive organisms, thereby selecting a population resistant to that drug and sometimes to related drugs. Bacteria sensitive to antimicrobial agents can become resistant by acquiring from resistant organisms deoxyribonucleic acid (DNA) containing genes coding for resistance (resistance genes). Bacteria sensitive to an antimicrobial can mate (conjugation) with bacteria containing resistance genes, or they can acquire these resistance genes by transduction. In transduction, a bacterial virus (bacteriophage) incorporates resistance genes into its genome by infecting a resistant bacterium. When the bacterial virus infects another bacterium, the phage DNA (containing resistance genes) can be incorporated into that bacterium and confer resistance. Some bacteria may acquire multiple resistance genes simultaneously and become resistant to several antibiotics. This is possible because circular pieces of DNA (plasmids) can, by recombination, acquire several genes, each of which codes for resistance to a different agent. Plasmids containing these multiple resistance genes can transfer to sensitive bacteria and thereby confer multiple resistance. Transfer of genes into the chromosome or into plasmids is facilitated in many cases because the genes are found on transposons, which are sequences of DNA that can excise themselves from plasmids and chromosomes and insert themselves into other plasmids and chromosomes. Bacteria resistant to as many as 10 different antimicrobial agents are known. One of the major problems associated with the transfer of resistance genes is that they can be transferred not only among similar but also to quite different bacteria. Resistance to antimicrobial agents results from (1) decreased permeability of the organism to the drug; (2) deactivation or modification of the drug by an enzyme; (3) modification of the drug receptor or binding site; (4) increased synthesis of an essential metabolite whose production is blocked by the antimicrobial agent; or (5) production of an enzyme that is altered so that it is not inhibited or affected by the drug. Antibiotics Antibiotics are substances produced by microorganisms that at low concentrations kill or inhibit other microorganisms. They are produced commonly by soil microorganisms and probably represent a means by which organisms in a complex environment, such as soil, control the growth of competing microorganisms. The microorganisms that produce antibiotics useful in preventing or treating disease include bacteria (Bacillus and Streptomyces) and fungi (Penicillium, Cephalosporium, and Micromonospora). Antibiotics can inhibit microbes by inhibiting the synthesis of the cell wall. Other antibiotics, such as the aminoglycosides, chloramphenicol, erythromycins, and clindamycin, inhibit protein synthesis in bacteria. The basic process by which bacteria and animal cells synthesize proteins is similar, but the proteins involved are different. Those antibiotics that are useful as antibacterial agents (selectively toxic) utilize these differences to bind to or inhibit the function of the proteins of the bacterium, thereby preventing the synthesis of new proteins and new bacterial cells. Antibiotics such as polymyxin B and colistin bind to phospholipids in the cell membrane of the bacterium and interfere with its function as a selective barrier; this allows essential macromolecules in the cell to leak out, resulting in the death of the cell. Because other cells, including human cells, have similar or identical phospholipids, these antibiotics are somewhat toxic. One antibiotic, rifampin, interferes with RNA synthesis in bacteria by binding to a subunit on the bacterial enzyme responsible for duplication of RNA. Since the affinity of rifampin is much stronger for the bacterial enzyme than for the mammalian enzyme, the mammalian cells are unaffected at therapeutic dosages. Bacteria, unlike animal cells, have a cell wall surrounding a cytoplasmic membrane. Production of the cell wall involves the partial assembly of wall components inside the cell, transport of these structures through the cell membrane to the growing wall, assembly into th  wall, and finally cross-linking of the strands of wall material. Antibiotics that inhibit the synthesis of a cell wall have a specific effect on one or another phase. The result is an alteration in the cell wall and in the shape of the organism and the eventual death of the bacterium. The penicillins and cephalosporins both have a unique structure, a -lactam ring, that is responsible for their antibacterial activity. The -lactam ring interacts with proteins in the cell responsible for the final step in the assembly of the cell wall. Thus, the mechanism of action is identical for both antibiotics; however, the basic chemical structure of the penicillins and cephalosporins differs in other respects, resulting in some difference in pharmacokinetics and the spectrum of antimicrobial activity. The penicillins can be divided into two groups: the naturally occurring penicillins (penicillin G, penicillin V, and benzathine penicillin) and the semisynthetic penicillins. The semisynthetic penicillins are produced by growing the mold Penicillium under conditions whereby only the basic molecule (6-aminopenicillanic acid) is produced. By adding certain chemical groups to this molecule, several different semisynthetic penicillins are produced that vary in resistance to degradation by -lactamase (penicillinase), an enzyme that specifically breaks the -lactam ring, thereby inactivating the antibiotic. In addition, the antimicrobial spectrum of activity and pharmacological properties of the natural penicillins can be changed and improved by these chemical modifications. The naturally occurring penicillins are important chemotherapeutic agents. Even after 40 years of use they are still the drugs of choice for treating streptococcal sore throat, tonsillitis, pneumococcal pneumonia, endocarditis caused by some streptococci, syphilis, gonorrhea, meningococcal infections, and infections caused by some anaerobic organisms. Several microorganisms, most notably the staphylococci, developed resistance to the naturally occurring penicillins, which led to the production of the penicillinase-resistant penicillins (methicillin, oxacillin, nafcillin, cloxacillin, and dicloxacillin). To extend the usefulness of the penicillins to the treatment of infections caused by gram-negative rods, the broad-spectrum penicillins (ampicillin, amoxicillin, carbenicillin, and ticarcillin) were developed. These penicillins are sensitive to penicillinase, but they are useful in treating urinary tract infections caused by gram-negativerrods as well as in treating typhoid and enteric fevers. The extended-spectrum agents (mezlocillin, azlocillin, and piperacillin) are unique in that they have greater activity against gram-negative bacteria, including Pseudomonas aeruginosa. They have decreased activity, however, against penicillinase-resistant Staphylococcus aureus. The penicillins are the safest of all antibiotics. The major adverse reaction associated with their use is hypersensitivity, with reactions ranging from a rash to bronchospasm and anaphylaxis. The more serious reactions are uncommon. The cephalosporins are produced by Cephalosporium acremonium. Modification of the basic molecule (7-aminocephalosporanic acid) has resulted in three generations of cephalosporins. The first-generation cephalosporins (cefazolin, cephalothin, and cephapirin) have a range of antimicrobial activity similar to the broad-spectrum penicillins. The second-generation cephalosporins (cefamandole, cefonicid, cefotetan, cefoxitin, and cefuroxime) have greater -lactamase stability than the earlier cephalosporins, and their antibacterial spectrum has been extended to include greater activity against additional species of gram-negative rods. They have decreased activity, however, against gram-positive bacteria. Like the penicillins, the cephalosporins are relatively nontoxic. Because the structure of the cephalosporins is similar to that of penicillin, hypersensitivity reactions can occur in penicillin-hypersensitive patients. Cycloserine, an antibiotic produced by Streptomyces orchidaceus, is a structural analogue of the amino acid D-alanine, and it interferes with enzymes necessary for incorporation of D-alanine into the bacterial cell wall. It is rapidly absorbed from the gastrointestinal tract and penetrates most tissues quite well; high levels are found in urine. It is used in the treatment of tuberculosis and in some urinary tract infections. Bacitracin is produced by a special strain of Bacillus subtilis. Because of its toxicity its use is limited to the topical treatment of skin infections caused by streptococci and staphlococci and for eye and ear infections. Vancomycin, an antibiotic produced by Streptomyces orientalis, is poorly absorbed from the gastrointestinal tract and is usually given by intravenous injection. It is an excellent antibiotic for the treatment of serious staphylococcal infections caused by strains resistant to the various penicillins. The aminoglycosides (streptomycin; neomycin; paromomycin; kanamycin and its derivative, amikacin; tobramycin; netilmicin; and spectinomycin) are produced by Streptomyces species. Gentamicin is produced by the molds Micromonospora purpurea and M. echinospora. All of the aminoglycosides inhibit protein synthesis, although spectinomycin, which has a different structure, does so by a mechanism different from the other aminoglycosides.

The aminoglycosides are poorly absorbed from the gastrointestinal tract, so, with some exceptions, they are given by intramuscular injection. Neomycin is toxic and is used topically. Because it is poorly absorbed from the gastrointestinal tract, paromomycin is used in the treatment of protozoal infections of the intestinal tract. Streptomycin was the first of the aminoglycosides to be discovered and the second antibiotic used in chemotherapy. One of its more important uses had been as part of the combined therapy for tuberculosis. It still has some use in combination with penicillin for treating infections of heart valves (endocarditis) and with tetracyclines in the treatment of plague, tularemia, and brucellosis. Kanamycin is used in the treatment of septicemia (blood poisoning), meningitis, and urinary tract infections caused by gram-negative bacteria. Because many organisms are resistant to its effects, however, kanamycin is now being replaced by other drugs. Gentamicin, tobramycin, netilmicin, and amikacin are similar in their range of antimicrobial activity. They are effective against infections caused by staphylococci and gram-negative bacteria, including Pseudomonas aeruginosa. The major problem with the aminoglycosides is that the margin of safety between a toxic and a therapeutic dose is narrow. Nephrotoxicity (harmful to kidney cells) and ototoxicity (harmful to the eighth cranial nerve of the organs of hearing and balance) are frequent, and the risk of these reactions increases with age and with preexisting renal diseases or hearing loss. Spectinomycin does not have the serious toxicity associated with the other aminoglycosides. It is used solely in treating gonorrhea in persons who are hypersensitive to penicillin or in those with gonococcal organisms resistant to penicillin. Tetracyclines have a common structure but differ from each other by the presence or absence of chloride, methyl, and hydroxyl groups. Although these modifications do not change their broad-spectrum antimicrobial activity, they do affect pharmacological properties such as half-life in serum and protein-binding ability in serum. The tetracyclines all have the same antimicrobial spectrum, although there are some differences in sensitivity of the microorganisms to the various types of tetracyclines. They inhibit protein synthesis in both bacterial and animal cells. Bacteria have a system that allows tetracyclines to be transported into the cell, whereas animal cells do not; animal cells therefore are spared the effects of tetracycline on protein synthesis. All tetracyclines are absorbed from the gastrointestinal tract after oral administration, and most can be given intravenously or intramuscularly. Because calcium, magnesium, aluminum, and iron form insoluble products with most tetracyclines, they cannot be given simultaneously with substances containing these minerals (e.g., milk). They are the drugs of choice in the treatment of cholera, rickettsial infections, relapsing fever, trachoma (a chronic infection involving the eye), psittacosis (a disease transmitted by certain birds), brucellosis, tularemia, and respiratory infections. Tetracyclines are also used for acne vulgaris. Because not all of the orally administered tetracycline is absorbed from the gastrointestinal tract, the bacterial population of the intestine can become resistant to tetracyclines, resulting in overgrowth (suprainfection) of resistant organisms. Complexes between tetracyclines and calcium can cause staining of teeth and retardation of bone growth in young children or in the newborn if tetracyclines are taken by the mother after the fourth month of pregnancy. Tetracycline can also cause photosensitivity in patients exposed to sunlight. Chloramphenicol now is synthesized chemically, but originally it was isolated from cultures of the bacterium Streptomyces venezuelae. It is administered either orally or parenterally, but since it is readily absorbed from the gastrointestinal tract, parenteral administration is reserved for serious infections. It is a broad-spectrum antibiotic used in the treatment of typhoid fever and for infections caused by microorganisms resistant to penicillin. Because newborns, particularly the premature newborn, cannot metabolize chloramphenicol, high levels accumulate and can cause inadequate oxygenation, the "gray syndrome." The most serious adverse effect is a toxic decrease in bone-marrow activity and aplastic anemia. Erythromycin is produced by Streptomyces erythreus. It is usually administered orally, but it can be given parenterally. Although erythromycin has relatively few primary uses, it is valuable in treating pharyngitis and pneumonia caused by streptococci in persons sensitive to penicillin. It is also used in treating pneumonias caused either by Mycoplasma species or by the organism causing Legionnaire's disease; and it is used in treating pharyngeal carriers of the bacillus responsible for diphtheria. Clindamycin is a derivative of lincomycin that has better microbial activity and rate of gastrointestinal absorption. As a result, lincomycin has limited use. Clindamycin is active against staphylococci, some streptococci, and anaerobic bacteria. Because it has been associated with pseudomembranous colitis (inflammation of the small intestine and the colon), it must be used with caution. Other antibiotics, however, can cause an identical colitis. The polymyxins are produced by Bacillus polymyxa and are designated as polymyxin A through E. Two of these, polymyxin B and polymyxin E (colistin), are useful in treating infection. Polymyxins B and E are polypeptide antibiotics with an affinity for phospholipids (important elements in cell membranes).

Polymyxins accumulate in the cell membrane of bacteria and affect selective permeability. They also react with and affect the membranes of animal cells, resulting in kidney damage and neurotoxicity. Because they are not well absorbed from the gastrointestinal tract, oral admin is occasionally used for the treatment of diarrhea. Polymyxins can be administered by intramuscular injection. They are used primarily in treating infections caused by Pseudomonas aeruginosa, but they are also used topically for the treatment of eye and ear infections. The availability of other excellent antibiotics limits their use.

Rifampin, a semisynthetic agent derived from a rifamycin produced by Streptomyces mediterranei, inhibits RNA synthesis. It is absorbed from the gastrointestinal tract, penetrates tissue well, including the lung, and is used in the treatment of tuberculosis. Rifampin administration is associated with several side effects, mostly gastrointestinal in nature. The urine, feces, saliva, sweat, and tears can be red-orange in colour.

Antibiotics May Put Tendons at Risk. It's always a good idea to give your body a rest when you're recovering from an infection. It may be especially important if you're using fluoroquinolone antibiotics, often prescribed for urinary tract, pulmonary, and other infections. Fluoroquinolones may affect tendons in the knee, thigh, calf or shoulder, making them more susceptible to injury in some people.

Ask if your antibiotics are fluoroquinolones. These inc olprofloxacin, pefloxacin, ofloxacin, norfloxacin, tema-floxacin, and ciprofloxacin. If you are prescribed one of these, you can help reduce your risk of injury by taking a break from high-impact exercise or activities such as weight training. If you do experience tenderness or discomfort in a tendon, let your doctor know right away.

A study conducted at the Univ of Pittsburgh Med Ctr McKeesport Hosp in Penn suggests that eating yogurt may reduce the incidence of diarrhea that often occurs while taking antibiotics. This research was presented recently at the 64th Annual Scientific Meeting of the American Coll of Gastroenterology. You may have heard about eating yogurt in the past, and this study appears to back up that advice.

Diarrhea is the most common side-effect of antibiotic treatment. Antibiotics are usually taken to cure an infection that is being caused by a certain bacterium. In the process of killing these bacteria, helpful bacteria may be killed as well. These helpful bacteria are often responsible for keeping still other types of organisms at bay; and when the helpful bacteria are destroyed these other organisms may multiply, causing diarrhea, vaginal yeast infections, or thrush.

Scientists believe that the lactobacillus cultures present in yogurt help to stabilize the intestinal environment, putting these "good" bacteria back in the driver's seat. A total of 202 patients who were taking antibiotics participated in this study. Patients with lactose intolerance or who were allergic to components of yogurt were not included in the study. Half of the participants were given a dietary supplement of 16 ounces of commercial vanilla-flavored yogurt (eight ounces at lunch and at dinner) for eight days. All patients were followed for seven days and observed for diarrhea, bloating, and frequent bowel movements.

Those who ate the yogurt had less diarrhea (9% vs 19%) and bloating (5% vs 9%) than those who did not eat the yogurt. These researchers believe this study confirms that yogurt is a safe and economical way to prevent diarrhea associated with antibiotic use. 12/99

Excessive Antibiotic Use for Acute Respiratory Infections in the US [Gonzales R et al]: The authors review the 1998 data from the National Ambulatory Med Care Survey, which surveys U.S. physician practices to determine the freq of patient visits for acute respiratory infections and the freq of antibiotic prescriptions. The results showed 76 million primary care office visits and 41 mil antibiotic prescriptions.

The breakdown showed that antibiotics were given to 76% of those with otitis media, 62% of those with pharyngitis 59% of those with bronchitis, and 70% of those with sinusitis. The authors point out that the prevalence of treatable bacteria in these conditions are as follows: otitis-65%, sinusitis-40%, pharyngitis-25%, bronchitis-10%, and URI-5%. The conclusion is that 55% of the total antibiotics prescribed were for infections that are unlikely to have a bacterial etiology. The total annual antibiotic bill for this group was $726 million dollars.

Comment: This is another of multiple reports by Ralph Gonzales, Merle Sande, and colleagues who have analyzed a national database to point out the abuse of practicing physicians for antibiotic prescribing for infections unlikely to have treatable bacterial pathogens.

One could seriously question the data they provide in this report regarding the prevalence of bacterial infections, which seems to grossly over-estimate the true frequency, at least according to the recent guidelines from the CDC and the ACP guidelines. Nevertheless, the conclusion is the same and it seems to be a message that is now the subject of an epidemic of reports regarding antibiotic abuse, especially for respiratory infections. By John G. Bartlett, M.D., posted 10/4/2001

Modern Med: Antibiotics by Dr Iain Corness PM 8/09/02 Perhaps one of the greatest discoveries in medicine was the antibiotic. For countless centuries mankind (and women too!) died from bacterial diseases. Microbes that could bring armies to their knees went unchecked. Plagues decimated populations, but smarty pants that we are, we developed antibiotics and we reversed the tables. Human beings kill millions of bacteria could even be the headline for a newspaper!

However, it wasnt that easy. We did develop antibiotics. They did kill bacteria. But the bacteria did not take all this lying down either. They developed new strains which became resistant to the antibiotics and started to become rampant again. We, in retaliation, developed new antibiotics and the balance of power returned to our favour. After all, the good guys should be the winners!

But are we? There has been a price to pay for all our smartness with now a plethora of pills and potions. That price is even more noticeable in countries like Thailand, where self medication is the norm. The price includes more antibiotic resistant strains of bacteria, more symptoms caused by the antibiotics themselves and an overgrowth of other organisms such as yeasts.

This was all brought home to me the other day when I chanced upon a discussion in my city office. The manager had a chronic sinus condition and was raking through his desk drawer to see what antibiotic he had to combat this. Coming across some self prescribed amoxycillin he asked me what did I think. I replied that I considered that it was probably next to useless for a chronic sinus condition, so he put them back in his desk. However, the office girl piped up that she needed some, so she would have them! Now both of them are intelligent people and I consider them as friends, but the medical training that either of them has had in pharmaceuticals, let alone clinical medicine, is one big fat zero. Yet both of them feel qualified to prescribe potent medications for themselves. This is potentially dangerous.

Coming to the sinus problem - amoxycillin, one of the earlier penicillin derivatives, is not an antibiotic which gets good tissue levels in the sinus region and by this time, most bacteria which inhabit the ear-nose-and throat have long since become resistant to amoxycillin. For my money, taking amoxycillin for his chronic sinus problem is a waste of his money!

Now the young lady - it turned out that her symptoms were not pathological, but represented a normal situation. If she had taken the amoxycillin she would have ended up with a severe attack of Thrush an irritating complaint that ladies can well do without.

So in these cases, indiscriminate antibiotics would have been a waste of money and not done the trick for one person and given the other another nasty condition as well. Perhaps now you can see why I am not altogether in favour of self medication with prescription drugs. If it were just a case of any old antibiotic will do then it would be different, however, antibiotic prescribing is a sensitive and difficult area of medicine.

Going back to our friend amoxycillin, adverse effects include superinfection, a nasty type of bowel disease and liver and blood disturbances as well as interacting badly with the contraceptive pill and gout medication. Is it worth it? See your doctor instead!

GOLDEN RULES OF ED ANTIBIOTIC USE Sect 2 of 11

NB: A one-pg ref table with key therapy recommendations taken from this article can be downloaded in Acrobat format. www.emedicine.com/emerg/topic803.htm

Because medication sales are greatly profitable, new antibiotics are continuously and aggressively advertised even in the lay press. In 1991, estimated sales of cephalosporins accounted for roughly 80% of all medication sales in the United States. Cardiologist W Proctor Harvey proposed a 5-year rule stating, A new drug, procedure, technique or piece of equipment should ideally stand the test of time (approximately 5 y) before it is fully utilized. Time-honored antibiotics have the advantage of being well understood, particularly with respect to side effects, and are less expensive for patients.

We recommend that emergency physicians familiarize themselves with a short list of inexpensive and established antibiotics. These should be considered the main arsenal against microbial disease and, except in unusual circumstances, should be used before other treatments.

Antibiotics prescribed but not taken are worth little to a sick patient. Furthermore, a few underlying assumptions about human nature, as highlighted by Sanson- Fisher et al, may ensure that a Rx translates to more than a slip of paper.

No patients take pills more than 3 times daily. No patients take a medication for more than 5 days in a row. No patients take medication that makes them feel worse. No patients pay more than $15 of their own money for a prescription.

For these reasons, single-dose courses administered in the ED (eg, benzathine penicillin, cefixime, ciprofloxacin, fluconazole, metronidazole) greatly improved compliance over traditional multiday multidose regimens in studies by Cockburn et al and Eisen et al.

Throughout this article, antibiotics appearing in boldface are favored by the authors because of their availability, cost, dosing schedule, and spectrum of coverage.

BREAKING ISSUES Sect 3 of 11 Several new-generation fluoroquinolones recently have been introduced as powerful broad-spectrum antibiotics. Levofloxacin, trovafloxacin, grepafloxacin, and sparfloxacin are marketed heavily for a wide variety of inpatient and ambulatory indications. These include chronic bronchitis, nosocomial and community-acquired pneumonia, diabetic foot infection, osteomyelitis, and uncomplicated urinary tract infection. These new agents distinguish themselves from older fluoroquinolones by their activity against gram-positive bacteria (eg, penicillin-resistant Streptococcus pneumoniae and Staphylococcus aureus); gram-negative bacteria, and anaerobes. Under most conditions, they achieve equal serum levels whether dosed orally or intravenously (IV) and are given in single daily doses. Trovafloxacin is the most potent of the fluoroquinolones, with more activity against anaerobes than the others and activity against Pseudomonas aeruginosa equal to that of ciprofloxacin.

Prior to reports of adverse hepatic effects, initial marketing of trovafloxacin was broad, concentrating not only on hospital-based practitioners who deal in severe inpatient infections, but also on primary care practitioners who are based largely in outpatient clinics. No discrimination was made between serious infective processes, which could kill patients, and mild infective processes (eg, bronchitis), which often are mediated virally, are self-limited, and cause little morbidity. Because of its broad antibacterial coverage, trovafloxacin was offered as a general first-line antimicrobial agent for use against nearly any potential bacterial infection.

Why not use trovafloxacin empirically and indiscriminately for all infections? The major argument against such use is the development of resistant organisms. Routine use of broad-spectrum antibiotics for minor infections significantly adds to infection and colonization of the general population with increasingly hardy and difficult-to-treat microbes. According to the Centers for Disease Control and Prevention (CDC) sources, indiscriminate use of broad-spectrum antibiotics more than doubles an individual's chance of acquiring future infection with resistant organisms. According to Dowell and Schwartz, the relative risk increases from 3.1 to 5.6. For trovafloxacin, this argument is even more important because resistance to fluoroquinolones is mediated by a single plasmid, which confers resistance to the entire class of agents. Major resistance thus may rapidly be acquired, unless strict controls against widespread use are put into place.

For these reasons, the newer broad-spectrum fluoroquinolones, particularly trovafloxacin, should be reserved as second-line agents for use ween traditional broad-spectrum antibiotics are contraindicated or have failed. This approach is similar to some hospital policies reserving such antimicrobials as vancomycin, ceftriaxone, and imipenem. From a patient-based perspective, such a policy protects individuals from the more-than-doubled risk of future superinfection with highly resistant organisms. From a population-based perspective, this protects communities from multidrug-resistant endemics. Multidrug-resistant S aureus, Enterococcus species, P aeruginosa, malaria, and tuberculosis (TB) are current examples of endemics resulting from a failure to control utilization of antimicrobial therapy.

Two other arguments against indiscriminate use of newer-generation fluoroquinolones are also pertinent. First, all fluoroquinolones are contraindicated in pregnancy and children because of cartilage destruction observed in experimental models of juvenile animals. Second, scant clinical evidence supports use of any fluoroquinolone for treatment of critically ill patients.

Single daily dosing of aminoglycosides is recommended, as it reduces renal toxicity and obviates the need for blood level monitoring. In patients with normal renal function, daily dosing for gentamicin is 5 mg/kg/d ($9.04/320 mg), rounded to the nearest 10 mg. Because of limited data, such dosing is not recommended in children or in patients with liver failure, cystic fibrosis, endocarditis, pregnancy, burns, TB, neutropenia, or severe renal failure with creatinine clearance less than 20 mL/min. Dosing interval in patients with mild renal failure can be calculated easily by multiplying the serum creatinine by the interval used in usually healthy patients.

Some experts use aztreonam ($16.74/g) instead of aminoglycosides; according to Marino, coverage spectrum is identical, and renal toxicity is avoided.

Penicillin allergy cross-reactivity with cephalosporins is a myth. Cross-reactivity between penicillins and cephalosporins is negligible, not 10-15% as commonly cited. However, if a patient has known anaphylaxis to penicillin, caution with cephalosporin use still is warranted.

Finally, updated guidelines for rabies postexposure prophylaxis from the CDC now recommend infiltration of as much immune globulin as possible around the wound, rather than half around the wound and half intramuscularly (IM) as before.

- EMPIRIC ANTIBIOTIC THERAPY Section 4 of 11 Introduction - Emergency medicine is unique because of the frequent need to treat sick or injured patients prior to making a diagnosis. This is especially true for patients who present with suspected infections for which the source and exact microbial species are unknown. In certain cases (eg, suspected meningitis, gram-negative sepsis, penetrating trauma to the gut), early empiric therapy is an essential part of emergency resuscitation and may be lifesaving.

Antibiotic therapy ideally is determined by isolation of the offending organism and determination of its antibiotic susceptibility pattern. The choice of an antimicrobial agent always should be based on the most likely involved organism. Guides, such as Sanford, are useful in suggesting initial therapy and may be supplemented by knowledge of a certain hospital's susceptibility patterns. In the setting of suspected bacteremia, always obtain blood for culture prior to starting treatment, unless this would cause undue delay. In the setting of suspected meningitis, antibiotics should be initiated immediately, preferably before or at the same time cerebrospinal fluid (CSF) is drawnffor analysis.

Broad-spectrum antibiotics - These generally are chosen for empiric treatment of potentially life-threatening infections of unknown bacterial origin. Unfortunately, indiscriminate use has contributed to major antibiotic resistance. Single agents mostly are related to penicillin (eg, second- or third-generation cephalosporins, imipenem, beta-lactam/beta-lactamase inhibitors [BL/BLI]), with the exception of the newer generation fluoroquinolones and chloramphenicol. This last agent is used widely outside the United States because of its low cost ($8.20/g IV) and availability as an inexpensive oral treatment ($0.37/250 mg tablet).

In the US, chloramphenicol may be considered an alternative i  cases of penicillin-resistant bacteria or in penicillin-allergic patients with sepsis or meningitis. Within the United States, large differences in cost exist between commonly used broad-spectrum antibiotics, as demonstrated by these prices: ceftriaxone ($80.36/2 g), cefotaxime ($20.99/2 g), imipenem ($48.26/1 g),ticarcillin/clavulanate ($13.35/3.1 g), piperacillin/tazobactam ($14.80/3.375 g), and ampicillin/sulbactam ($12.88/3 g).

Second-generation cephalosporins - When in doubt, these are a good choice for many bacterial infections. Antimicrobial coverage is largely similar within this class and includes gram-positive, gram-negative, and strict anaerobic species. Coverage differences are minor and are primarily relevant for presence of P aeruginosa (see Pseudomonal infections section). Examples of this class include cefmetazole, cefuroxime, cefoxitin, cefotetan, and cefamandole.

In certain hospitals, one second-generation cephalosporin may be less expensive than others due to special agreements with the supplier. Use the least expensive one. Relative to the cost of IV setup (>$100), however, cost differences between cephalosporins may be small. Published market prices to pharmacies for typical unit doses of these drugs are as follows: cefuroxime ($16.15/1.5 g), cefmetazole ($14.38/2 g, $6/2 g for bulk use from manufacturer), cefoxitin ($18.48/2 g), cefotetan ($22.32/2 g), cefamandole ($18.12/2 g). Despite variations in approved dosing intervals, half-lives for each of these is similar (0.8-2 h). If in doubt, a typical dosing is usually 1-2 g IV every 8 hours.

Anaerobes - Antibiotics with good anaerobic coverage include metronidazole ($16.76/500 mg), clindamycin ($5.80/600 mg), and any BL/BLI. For surgical and gynecologic cases in which a soiled peritoneum is possible, metronidazole must be used because it is the only agent that covers Bacteroides fragilis, the most common colonic microbe. Although practically all antibiotics have been associated with Clostridium difficile colitis, clindamycin bears the dubious distinction of causing the most cases of this potentially fatal adverse effect. For this reason, metronidazole is the preferred agent for anaerobic coverage.

Gram-negative sepsis - is assoc with high rates of morbidity and mortality due to production of bacterial endotoxin. For presumptive treatment of life-threatening sepsis in adults, coverage for possible gram-negative bacteremia is recommended using 2 antibiotics with good gram-negative activity. Good choices include a third-generation cephalosporin or BL/BLI, plus aztreonam or an aminoglycoside. Examples of such coverage include ceftriaxone and gentamicin, ticarcillin/sulbactam and aztreonam, or cefmetazole and ciprofloxacin. Many possible drug combinations are acceptable as long as the antibiotics are not of the same class.

Pseudomonal infections - If serious pseudomonal infection is suspected, double coverage is recommended. Antibiotics with activity against P aeruginosa include ceftazidime, ticarcillin, aminoglycosides, imipenem, meropenem, levofloxacin, ciprofloxacin, and trovafloxacin. As for other antimicrobial regimens, the 2 agents chosen should be from different classes. For example, the combination of ticarcillin and gentamicin is good, whereas a combination of ceftazidime and imipenem is not. Piperacillin/tazobactam (Zosyn) is a poor choice for treating pseudomonal infections unless used in higher-than-normal doses and combined with an aminoglycoside. Deaths have been reported from pseudomonads when using manufacturer-recommended doses of this drug, even when combined with a second agent.

Gram-positive cocci resistance - Multiple species of resistant gram-positive cocci warrant special consideration, particularly life-threatening infections when initially missing a resistant organism with antibiotic coverage may lead to death. For this reason, vancomycin ($15.60/g) should be used initially for presumed line sepsis to cover methicillin-resistant S aureus (MRSA), endocarditis, and meningitis (in most areas due to highly resistant pneumococcus). In these situations, vancomycin should be continued until cultures exclude MRSA and demonstrate sensitivity to other agents.

Bacterial meningitis - If meningitis is suspected, administer antibiotics without delay, prior to lumbar puncture. Antibiotics will not affect CSF cell counts for several hours, and more importantly, the patient will receive early treatment for a possibly rapid and fulminant disease. For immune-competent adults, use a third-generation cephalosporin alone (eg, ceftriaxone). For infants, elderly, or immunocompromised patients (eg, alcoholics, patients with renal failure), add ampicillin to cover Listeria monocytogenes. In regions with documented highly resistant pneumococcus, the CDC recommends adding vancomycin until culture results return.

About 5% of all pneumococci in the United States are now resistant, although rates are as high as 25% have been reported in some areas. Resistance observed in blood and CSF cultures from hospital inpatients is usually lower than resistance from other reservoir cultures (eg, nasopharyngeal swabs, sputum), probably because of antibiotic overuse in the outpatient setting.

Pneumonia - In patients who have community-acquired pneumonia and require hospitalization, a second-generation cephalosporin alone or with a macrolide (cefmetazole +/- azithromycin) is recommended. This covers the 7 most likely pathogens: S pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, S aureus, Mycoplasma pneumoniae, Legionella pneumoniae, and Chlamydia pneumoniae. Patients requiring admission to an intensive care unit should receive both a macrolide and a cephalosporin to cover L pneumoniae, now known to be among the top 4 microbial causes of community-acquired pneumonia. Institutionalized patients and those with known bronchiectasis (including patients with cystic fibrosis) should be treated for pseudomonads.


\2 Acetaminophen

Most people have the notion that over-the-counter (OTC) medications-in particular, non-narcotic analgesic drugs (pain-killers)-must be completely safe, or else they would require a prescription. Some OTC pain meds, such as aspirin and NSAID, do have beneficial effects; aspirin has long been recommended for use by heart patients, and ibuprofen has been found to slow the progression of Alzheimer's disease and some cancers (Mitchell et al. 00, 01). These drugs are recommended by the Foundation for use in treating those diseases.

However, acetaminophen (sold under Tylenol and other brand names) has dangerous side effects that most people are not aware of. Many people either use this class of drug chronically or take higher-than-recommended doses, not realizing that they are causing liver, and kidney damage. The long-term use of acetaminophen medications can cause other problems as well.

Acetaminophen - is one of the more potentially dangerous analgesic drugs. An intentional overdose can be fatal, and chronic use may cause liver and kidney damage (McLaughlin et al. 85; Siegers et al. 89; Price et al. 91; Bonkovsky et al. 94; Blakely et al. 95).

When a person takes acetaminophen, it is metabolized by a number of metabolic systems in the liver, including one called the P450 system. This results in an intermediate by-product, or metabolite, that is very reactive and can kill liver cells. This intermediate metabolite is normally converted to a harmless final metabolite by an antioxidant in the liver called glutathione (Uhlig et al. 1990; Deleve et al. 1991; Richie et al. 1992).

A large dose of acetaminophen reduces the glutathione supply, resulting in progressive necrosis of the liver, sometimes evidenced in as little as 5 days. Alcoholics and those on certain medications that stimulate the P450 system are at particular risk because, with increased P450 activity, more toxic intermediate is created than there is glutathione available to further metabolize it to something harmless. Although not fatal, chronic acetaminophen use decreases the functional capacity of the liver.

Acetaminophen can also cause permanent kidney damage when taken over extended periods of time. This damage can be lethal to those with underlying kidney disease. The Food and Drug Administration does not require the manfs of Tylenol and other brands of acetaminophen to adequately warn people with kidney disease to avoid this pain medication. However, for those in chronic pain who cannot find relief from natural pain relief therapies (see Pain and Arthritis protocols), it is suggested that Tylenol and other brands of acetaminophen be used sparingly.

To illustrate how dangerous acetaminophen can be, one study showed that people who used acetaminophen with other pain relievers on a regular basis had a three- to eightfold increase in their risk of kidney cancer. Kidney cancer is very difficult to treat. The liver-kidney-heart muscle toxicities and the cancer risks of analgesic drugs have not been reported by most media sources, which reap tremendous profits from the ads of pain relief products.

Acetaminophen poisoning is a toxic reaction resulting from the ingestion of excessive doses of the drug. In adults, dosages exceeding 10-15 grams can produce liver failure and dosages exceeding 25 grams can be fatal. Symptoms such as nausea and vomiting, profuse sweating, pallor, and oliguria (scanty amounts of urine) are assoc with the onset of acetaminophen poisoning. Jaundice and pain in the upper abdomen, hypoglycemia, encephalopathy, abnormal functioning of brain tissue, and kidney failure may become apparent as drug toxicity increases.

Headache and Analgesic Rebound - One of the more common reasons for chronic analgesic use is for the treatment of headaches. Many patients suffer from chronic headaches for years, some conditions lasting over 10 years in duration. These patients have seen numerous physicians, including neurologists and pain specialists, and have received countless studies, incl MRIs and CTs of the brain. They have also had several diags over the course of their treatment. A large proportion of these patients suffered from a condition that has been described in the literature as analgesic rebound.

Simply stated, the problem began when the patients first experienced a few headaches in succession and began taking analgesic medications. They quickly increased the dose and found that they could not survive without the meds. However, the meds failed to totally relieve their headaches. The treatment, from the doctor's perspective, is simple: stop taking all pain meds. The cause of the headaches is a rebound effect from the cessation of large dosages of analgesic medications.

If the patients can get through several weeks of total cessation of the use of all analgesic medications, the headaches will cease. Needless to say, it is not surprising how difficult it is to convince them of this!

Headache sufferers may attempt various types of treatment to help break the cycle, including acupuncture, ortho-molecular dosages of intravenous vit-C, intravenous dime-thylsulfoxide (DMSO), and short-time low-dose cortico-steroid administration. Ultimately, it may be the cessa-tion of all analgesic drug use that finally ends the headache. However, to help deal with the pain during the two-week treatment program, the administration of intra-venous DMSO or short-term corticosteroid has been most helpful. Next to "cold turkey," intravenous DMSO is probably the best way to go.

Treatment - Some people alternate other types of OTC pain-relieving drugs, such as aspirin, ddvil, and Naprosyn, to avoid using acetaminophen on a daily basis. Alternating their usage may help to reduce their toxicity

If a person attempts to commit suicide by taking an entire bottle of acetaminophen, the emergency room doctor will admin an antioxidant drug called Mucosil (Mucomyst). If admin in time, Mucosil can save the patient's life by inhibiting free-radical damage to the liver caused by acetaminophen-induced depletion of hepatic glutathione (Deleve et al. 1991). The active ingredient in Mucosil is the nutrient N-acetylcysteine (NAC). NAC suppresses the toxic free radicals generated by ingested acetaminophen.

If you have to take acetaminophen, we suggest you take 600 mg of the amino acid N-acetylcysteine or L-cysteine and at least 1gm of vit-C with each dose of acetaminophen

NB: When using the drug Mucosil (N-acetylcysteine) to treat acute liver failure from acetaminophen overdose, it is crucial that the drug be admin immediately and that it be continued for at least 36 hrs in all cases (Clemmesen et al. 96). Optimal results occur when NAC is admin within 10 hrs of acetaminophen overdose. NAC is also effective when given after 15 hrs of acetaminophen poisoning (Graudins et al. 1995; Jones 1998).

Treatment with N-acetylcysteine (NAC) should not be discontinued until all clinical signs of toxicity have subsided. Permanent liver injury can occur if NAC therapy is discontinued too soon. Patients who develop chronic liver failure should be treated with a prolonged course of NAC under a physician's care (Kind et al. 1996).

Another approach to protecting against acetaminophen-induced free-radical liver damage is to take one capsule of a multinutrient formula that contains glutathione, vitamin C, and cysteine with each dose of acetaminophen. This antioxidant formula will provide significant protection to the liver. Additionally, for those who must take acetaminophen chronically, the herb milk thistle (silibinin) may offer some liver protection by increasing the amount of the protective antioxidant glutathione (Zhao et al. 1999).

For those whose liver function has been compromised by analgesics or other toxins, treatment with SAMe (S-adeno-sylmethionine) may help to repair the liver (Lieber 97).

There are no nutrient supplements known to protect against acetaminophen-induced kidney damage, although the amino acid taurine (1000-3000 mg a day) and high doses of vitamin E succinate (800-1200 IU a day) might be helpful.

Polyenylphosphatidylcholine - Polyenylphosphatidylcholine (PPC), a supernutrient, is a 94-95% pure mixture of polyunsaturated phosphatidylcholines extracted from soybeans that appears to protect against liver injury evoked by fibrosis, oxidative stress, medicinal poisoning such as acetaminophen, or alcohol abuse.

When taking high doses of analgesics such as ibuprofen, aspirin, naprosyn or prescription anti-inflammatory drugs, PPC can assist in protecting the gastric mucosa, making the stomach less vulnerable to irritation, inflammation and ulceration (Anand BS et al 1999; Dunjic BS. et al. 1993).

Research confirms that silibinin (milk thistle), when complexed with phosphatidylcholine at a dosage of 400 mg/kg, was protective against acetaminophen hepatotoxicity. The expected increase in liver enzymes, often observed during liver trauma, was not as extreme when silibinin and phosphatidylcholine was administered (Conti et al. 1992). The protective effect of silibinin is probably related to its antioxidant activities and to stimulating the hepatic synthesis of RNA and proteins.

The source of the phosphatidylcholine also determines its effectiveness. Soybean-derived phosphatidylcholine, administered 2 hours prior to acetaminophen, lessened the increase in serum transaminase activity, whereas egg yolk phosphatidylcholine failed to protect against acetamino-phen hepatotoxicity (Jaeschke et al. 1987). Phosphatidyl-choline has a history of not only being liver-protective, but also being able to enhance the bioavailability of various nutrients and herbs, such as milk thistle. The following research corroborates this finding.

Chemically intoxicated mice were protected from liver damage when treated with PPC liposomes and vit-E acetate. Liver protection was not evidenced when phosphatidyl-choline was removed from the complex, suggesting that vitamin E and liposomes lost effectiveness without PPC. Vitamin E is, however, thought to improve the protective spectrum, illustrating the usefulness of phosphatidyl-choline in enhancing the delivery and utilization of beneficial nutrients (Werner et al. 1990).

Acetaminophen poisoning is not unlike any other massive assault upon the liver caused by substances known to degrade liver performance. Protocols to assist the liver in recovery from diverse poisons may have universal application, such as the treatment of an alcoholic liver. A study conducted at the Mount Sinai School of Medicine and Alcohol Research and Treatment Center, determined that PPC decreased the activity of CYP2E1, part of the cytochrome P450 detoxification family. It was also shown that PPC opposes hepatic oxidative stress and fibrosis (Lieber 2000).

Fibrosis is a state of proliferation of fibrous connec-tive tissue that forms as scar tissue replaces normal tissue lost through injury or infection. The fibrous connective tissue spreads over or replaces normal organ tissue. Because of the benefits described with PPC usage, it is now being tested clinically for the prevention and treatment of liver disease in the alcoholic.

Summary - The following protocol is intended to support organs susceptible to damage by acetaminophen, either through prolonged usage or alcohol-acetaminophen inter-actions. This program is not intended to replace medical attention if acetaminophen poisoning is suspected.

1. Acetaminophen, while generally safe for short-term use, can cause problems with long-term administration. These problems include liver and kidney damage and gastrointestinal bleeding. Those who drink excessive alcohol are at risk and should not take Tylenol at all.

2. Those who must chronically take acetaminophen drugs should take vitamin C, NAC, L-cysteine, taurine, vitamin E succinate, and milk thistle extract. Those who develop liver damage should consider taking SAMe.

WARNING: A known acetaminophen overdose is an emergency situation requiring hospitalization. If the amount of acetaminophen taken is unknown, do not wait until symptoms develop to make a decision to seek hosp care. By that time it is too late and death may be likely. Do not attempt to treat this at home with oral Mucosil (N-acetylcysteine.) Hosp monitoring is essential.

3. N-acetylcysteine (NAC), the active ingredient in Mucosil, suppresses the toxic free radicals generated by ingested acetaminophen. Take N-acetylcysteine or L-cysteine, 300-600 mg, with at least 1 gram of vitamin C with each dose of acetaminophen. Use at least 3 times more vitamin C than NAC or L-cysteine.

4. Acetaminophen-induced free-radical liver damage may be treated by taking one capsule of a multinutrient formula that contains glutathione, vitamin C, and cysteine with each dose of acetaminophen. This antioxidant formula will provide significant protection to the liver. Use as directed, 2-3 times a day.

5. For chronic use of acetaminophen, the herb milk thistle (silibinin), 120 mg, 2-3 times daily, may increase the amount of the protective antioxidant glutathione.

6. S-adenosylmethionine (SAMe), for prevention and reversal of liver damage, 200-800 mg a day. Dosages above 400 mg can cause dry mouth, gastric problems, and restlessness. Build slowly to tolerance.

7. Taurine, 1000-3000 mg a day, supports the kidney under stress.

8. Vit-E succinate, 800-1200 IU a day, supports the kidney under stress.

9. Polyenylphosphatidylcholine (PPC), 1800 mg a day, protects the liver from noxious materials.

10. Chronic use of analgesic drugs to treat headaches may actually be the cause of the headaches. Under a doc's care, try stopping all use of these drugs. If this proves to be very difficult, consult with a physician who utilizes intravenous DMSO or would consider short-term administration of corticosteroids.

Tylenol - for mild pain relief and reduce fever as an alternative for aspirin. acetaminophen (N-(4-hydroxyphenyl) acetamide. Liver damage can result with high dosage or prolonged therapy. Tylenol with codine is used for more severe pain relief. ! should not be combined with alcohol. Acetaminophen can be very useful in reducing pain, but when combined with alcohol, acetaminophen may cause serious liver damage. Do not use any form of acetaminophen with alcohol and never exceed the recommended dose of acetaminophen. Especially avoid using acetaminophen to fight hangovers, since the hangover is caused by excess alcohol in your body.


\3 Aspirin

Generic: ASPIRIN,ACETAMINOPHEN, IBUPROFEN,NAPROXEN,SODIUM etc. Brand Names: A.S.A., Aspergum, Aspirjen Jr., Bayer Timed-Release, Buffinol, Easprin, Ecotrin, Empirin, Measurin, Zorprin, Anacin, Panadol Advil, Nuprin, Aleve. and Tylenol. Precautions: Do not take ASPIRIN with vitamin C or alcohol or attempt to use it to relieve tooth aches, or extractions by applying it directly or in gargles. Do not use ASPIRIN that smells vinegary, it has decomposed. If you have abnormalities, consult doctor before starting. Salicylate in aspirin weakens the hair cells of the inner ear resulting in ringing in the ears and hearing loss if taken excessively over long periods of time.

Interactions with other drugs: Ammonium chloride (and other urine acidifiers): increased blood levels of aspirin products. Monitor for over dose. Antacids in high doses (and other urine alkalinizers): decreased levels of aspirin products. Corticosteroids: Enhanced elimination. Monitor for decreased effects. Oral anti-coagulants and heparin: increase risk of bleeding. A void using together if possible.

NB: Do not use if you have a gastric ulcer, or gastric bleeding. Not recommended for children or teenagers with chicken pox or influenza-like illness. DO NOT take with alcohol.

Possible Side Effects: Prolonged bleeding time; ringing in the ears and hearing loss; nausea, vomiting, gastric distress, hidden bleeding, rash, bruising, hypersensiti-vity manifested by shock and/or asthma.

Invented in the late 1890s by German chemist Felix Hoffmann, who was seeking to ease his father's arthritis pain. In the 100 years since then, aspirin-or as it is known to chemists, acetylsalicylic acid, has become the world's most widely used drug. But until recently, no one knew how aspirin actually works. In the 1970s scientists learned that injuries to human tissue trigger the release of prostaglandins, hormonelike molecules that cause fever and inflammation. They also discovered that aspirin somehow blocks the production of these molecules. To reveal exactly how this happens, a team of researchers, including myself, began several years ago to analyze the enzyme that produces prostaglandins--prostaglandin H2 synthase, or PGHS.

Using x-ray analysis of PGHS crystals, we discovered that the enzyme contains two protein subunits, each with a long interior channel. Molecules of arachidonic acid--an essential fatty acid--enter these channels and undergo a chemical transformation in the enzyme's core, converting to molecules of prostaglandin H2. Aspirin prevents this change by sealing the channels: the aspirin molecule's acetyl group binds to a site inside the channel, blocking the path of the arachidonic acid. Other anti-inflammatory drugs, such as ibuprofen and naproxen, work by physically plugging the enzyme's channels rather than chemically altering them.

Aspirin (oral) BRAND: Acuprin 81, Bayer Aspirin, Bufferin, Easprin, Ecotrin, Empirin, Halfprin, Norwich Aspirin, St. Joseph Aspirin, Zorprin

Take aspirin with milk, food, or an antacid to lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach. Enteric-coated aspirin can be, but does not have to be, taken with milk, food, or an antacid. Do not break, chew, or crush the enteric-coated tablets. These have a special coating to protect your stomach. Swallow them whole.* Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate damage to your stomach. Avoid alcohol or use it with moderation while taking aspirin. If you drink more than three alcoholic beverages a day, aspirin may increase the risk of stomach bleeding. It is often combined with other analgesic as phenacetin and caffeine (APC). In large continued doses, it produces gastritis and ringing in the ears.

Acetylsalicylic Acid, derivative of salicylic acid that is a mild, nonnarcotic analgesic useful in the relief of headache and muscle and joint aches. Aspirin is also effective in reducing fever, inflammation, and swelling and thus has been used for treatment of rheumatoid arthritis, rheumatic fever, and mild infection. In these instances, aspirin generally acts on the symptoms of disease and does not modify or shorten the duration of a disease. It has been used, however, as an anticoagulant in the treatment of such conditions as unstable angina or following a minor stroke or heart attack because of its ability to inhibit the production of blood platelet aggregates (which may cut off the blood supply to regions of the heart or brain). The drug acts by inhibiting the production of prostaglandins, body chemicals that are necessary for blood clotting and are noted for sensitizing nerve endings to pain. The use of aspirin has been known to cause allergic reaction and gastrointestinal problems in some people. It has also been linked to the development in children (primarily those 2 to 16 years old) of Reye's syndrome, an acute disorder of the liver and central nervous system that may follow viral infections such as influenza and chicken pox. Like almost all drugs, aspirin is to be avoided during pregnancy. Compare acetaminophen; ibuprofen

Lancet (11/30/91) reports that low dosage aspirin (75mg) taken daily reduces the risk of colon and rectal cancer, cerebral thrombosis (stroke), and heart attacks, specifically ATRIAL FIBRILLATION by inhibiting clotting. Begin at age 45-50 when cancer risk increases.

NOT to be used for children under 21. See Med. Aspirin may pose risks of bleeding in digestive tract causing gastro-intestinal problems, however the benefits generally outweigh the risks.

Precautions: Do not take ASPIRIN with vit-C or alcohol or attempt to use it to relieve tooth aches, or extractions by applying it directly or in gargles. Do not use ASPIRIN that smells vinegary, it has decomposed. If you have abnormalities, consult doctor before starting. Salicylate in aspirin weakens the hair cells of the inner ear resul-ting in ringing in the ears and hearing loss if taken excessively over long periods of time.

Interactions with other drugs: Ammonium chloride (and other urine acidifiers): increased blood levels of aspirin products. Monitor for over dose. Antacids in high doses (and other urine alkalinizers): decreased levels of aspirin products. Corticosteroids: Enhanced elimination. Monitor for decreased effects. Oral anti-coagulants and heparin: increase risk of bleeding. A void using together if possible.

NB: Do not use if you have a gastric ulcer, or gastric bleeding. Not recommended for children or teenagers with chicken pox or influenza-like illness. DO NOT take with alcohol.

Possible Side Effects: Prolonged bleeding time; ringing in the ears and hearing loss; nausea, vomiting, gastric distress, hidden bleeding, rash, bruising, hypersensiti-vity manifested by shock and/or asthma.

To reduce the possibility of gastric distress, take the aspirin after meals with a glass of water. Controls pain for about four hours.

BABY ASPIRIN, GOOD NEWS - Low doses of aspirin may help infertile women get pregnant, finds a new study. Women undergoing in-vitro fertilization who took 100 mg of aspirin daily along with ovary-stimulating drugs produced nearly twice as many eggs each month as those who didn't take aspirin. Better still, they were 50% more likely to become pregnant. By Janice M. Horowitz

 Aspirin side effects - Aspirin is a drug that has some key benefits, but it can also cause some serious problems. Aspirin has been used by the human race for many years. It was first produced by the Bayer company.

It is has been thought that aspirin gets in the way of prostaglandin production and causes a reduction in inflammation and pain. Prostaglandin affects the flow of blood platelets, which are the key in blood clotting. If plaque tears inside a coronary artery, then clotting begins at that site. This may then cause cardiac arrest or a myocardial infraction. In todays day and age doctors can prescribe medicine such as aspirin to patients that have a history of heart disease. This can then reduce that persons risk of a second event.

Aspirin is called an analgesic drug because it is a pain reliever. Aspirin has many alternatives such as Ibuprofen, also known as Advil. Acetaminophen is also a well know alternative better known as Tylenol. Advil is a non-steroidal anti-inflammatory drug similar to Aspirin. Acetaminophen does not have the same side effects as aspirin so it is considered a safer drug for the majority of the population.

Aspirin has many side effects that other pain relievers do not have. Aspirin can cause gastro-intestinal discomfort if taken in large doses.

Another side effect is that is prevent blood from clotting. Aspirin is not used in hospitals because of this reasoning. When you are about to go into surgery your doctor will remind you not to take aspirin 24 hours before surgery because this may cause complications during surgery.

If you are a youngster and are experiencing fever like symptoms it is important for you to stay away form aspirin. If you are experiencing a fever or chicken pox symptoms and taking aspirin than you have a chance of getting a sickness called Reyes syndrome. This can be deadly to young children if it is serious enough.

Cnsult a doctor before deciding to use aspirin for any type of symptom. Berlin patent #36433 3/06/1899.

 Aspirin can reduce severity of ischemic stroke Dec 07 01 (Reuters Health) - Individuals who took just a single aspirin in the week before they suffered an ischemic stroke lowered their risk of severe, stroke-related damage, study findings suggest.

An ischemic stroke, the most common type of stroke, occurs when a blood clot or other blockage reduces the flow of blood and oxygen in the brain. Patients can experience permanent neurological damage including paralysis and loss of speech.

In the new study, which included more than 1,200 patients, investigators found that about 50% of aspirin users had mild strokes and nearly 10% had severe strokes. In comparison, 43% of non-users had a mild stroke and about 15% experienced a severe stroke, according to a measure developed by the National Institutes of Health.

Another rating scale that measures the severity of muscle weakness in the limbs found that 20% of aspirin users suffered a severe stroke, compared with 24% of those who did not take aspirin.

Nearly 40% of patients overall had taken aspirin at least once in the week preceding their stroke. Rates of death after 1 week and 3 months did not differ between the aspirin-taking and non-aspirin-taking groups, according to the report in the Dec issue of Stroke: Journal of the American Heart Assoc.

The results of the study suggest that aspirin does not only cut stroke risk, as previous research has shown, but may also be associated with milder ischemic strokes, Dr. Janet L. Wilterdink, the study's lead author, told Reuters Health. "Therefore, if a patient has a minor stroke on aspirin, he or she should not consider that the aspirin failed but that the stroke may well have been more severe if he or she had not been on the aspirin," said Wilterdink, of Brown Univ in Providence, RI. She added that patients should take a daily aspirin only on the advice of a doctor.

The researchers did not investigate how aspirin might reduce the severity of an ischemic stroke but they suspect that it can help prevent blood clots, thus improving blood circulation in the brain. Also, they add, aspirin is believed to have antioxidant properties, so it could prevent tissue damage caused by cell-damaging molecules known as oxygen free radicals.

The study notes that patients did not report the frequ-ency of aspirin use or whether they were taking other drugs to reduce blood clotting. Therefore, other studies are needed to further investigate the effect of aspirin on the severity of ischemic stroke, the authors note. "Nonetheless, because there is an excellent rationale for aspirin's benefit in reducing stroke severity, it seems more likely than not that the effect is real," Wilterdink said in a prepared statement. SOURCE: Stroke 2001;32.

 Aspirin: The Bayer Facts - Aspirin is a member of a family of chemicals called salicylates (see below for chemistry and structure). These chemicals have been known to people interested in medicine for centuries.

One of the first and most influential physicians, Hippocrates, wrote about a bitter powder extracted from willow bark that could ease aches and pains and reduce fevers as long ago as the fifth century B.C. In the 1700s, the scientist Reverend Edmund Stone wrote about the success of the bark and the willow in the cure of the "agues," or fevers with aches. With a bit of chemical detective work, scientists found out that the part of willow bark that was (1) bitter and (2) good for fever and pain is a chemical known as salicin.

This chemical can be converted (changed) by the body after it is eaten to another chemical, salicylic acid. It was a pharmacist known as Leroux who showed in 1829 that salicin is this active willow ingredient, and for many years it, salicylic acid (made from salicin for the first time by Italian chemist Piria), and close relatives were used at high doses to treat pain and swelling in diseases like arthritis and to treat fever in illnesses like influenza (flu).

Salicylic acid - The problem with these chemicals was that they upset the user's stomach fairly badly. In fact, some people had bleeding in their digestive tracts from the high doses of these chemicals needed to control pain and swelling. One of these people was a German man named Hoffmann. His arthritis was pretty bad, but he just couldn't "stomach" his salicylic acid. Enter this man's son, German chemist Felix Hoffmann, who worked for a chemical company known as Friedrich Bayer & Co.

Felix wanted to find a chemical that wouldn't be so hard on his dad's stomach lining; reasoning that salicylic acid may be irritating because it is an acid, he put the compound through a couple of chemical reactions that covered up one of the acidic parts with an acetyl group, converting it to acetylsalicylic acid (ASA). He found that ASA not only could reduce fever and relieve pain and swelling, but he believed it was better for the stomach and worked even better than salicylic acid.

Acetylsalicylic acid - Unfortunately, Hoffmann had to wait for fame. He finished his initial studies in 1897, and his employers didn't pay much attention to it because it was new and they were cautious -- they didn't think it had been tested enough. By 1899, though, one of Bayer's top chemists, a scientist named Dreser, had finished demonstrating the usefulness of the potent new medicine and even gave it a new name: aspirin.

It is believed that the name comes from a plant relative of a rose that makes salicylic acid (several plants make this compound, not just the willow). The Bayer company could then support the tested medicine; they spread the word and marketed the new pill widely. Over the next hundred years, this medicine would fall in and out of favor, at least two new families of medicines would be derived from it, and innumerable research articles would be published about aspirin.

Thousands have been published in the past five years alone! One of the most important pieces of research about aspirin came in the early 1970s, when a British scientist named John Vane and his colleagues showed how aspirin works (see the following sections). His work was so important that he and his colleagues were awarded the Nobel Prize in Medicine in 1982. Dr. Vane was even made a British knight for his work!

You're Giving Me a Headache! No one completely understands how pain works. Actually, a lot is known about pain, but the more we find out the more questions arise. So let's take a simplified view. Pain is really something you feel in your brain. For example, let's say you hit your finger with a hammer (please don't try this at home).

The part of your finger that is damaged has nerve endings in it -- these are little detectors in your joints and your skin that feel things like heat, vibration, light touch from things like the mouse you're holding, and, of course, big crushing shocks like being hit with a hammer. There are different receptors for each of these types of sensations.

The damaged tissue in your finger also releases some chemicals that make those nerve endings register the crushing shock even stronger -- like turning up the volume on your stereo so you can hear it better. Some of these chemicals are prostaglandins, and working cells in the damaged tissues make these chemicals using an enzyme called cyclooxygenase 2 (COX-2).

Because of the prostaglandins, the nerve endings that are involved now send a strong signal through nerves in your hand, then through your arm, up your neck and into your brain, where your mind decides this signal means, "HEY! PAIN!" The prostaglandins seem to contribute just a portion of the total signal that means pain, but this portion is an important one.

In addition, prostaglandins not only help you to feel the pain of the damaged finger, but they also cause the finger to swell up (this is called inflammation) to bathe the tissues in fluid from your blood that will protect it and help it to heal. Remember this is a simplified version of the pain story; lots of chemicals seem to be involved in this process, not just prostaglandins.

This pathway works very well as far as telling you your finger is hurt. The pain serves a purpose here: It reminds you that your finger is damaged and that you need to be careful with it and not use it until it's healed. The problem is that, sometimes, things hurt without the hammer or for any other good reason. For example, sometimes you get a headache, probably because your scalp and neck muscles are contracted from stress or because a blood vessel in your brain has a spasm.

Many people have arthritis, which is swelling and pain in the joints such as the knuckles or knees, and this problem can not only make people uncomfortable, it can damage the joints permanently. And many women have pain in their abdomens during their periods, usually known as cramps, for no known useful reason. These processes appear to involve prostaglandins as well.

Aspirin You Shall Receive - Aspirin helps these problems by stopping cells from making prostaglandins. Remember the enzyme, COX-2? It is a protein made by your body's cells whose job is to take chemicals floating around in your tissues and turn them into prostaglandins.

COX-2 can be found in lots of normal tissues, but much more of it is made in tissue that has been damaged in some way. Aspirin, it turns out, sticks to COX-2 and won't let it do its job; it's like a lock you put on your bicycle. The bicycle won't move with the lock on, and COX-2 can't work with aspirin stuck in it. So by taking aspirin, you don't stop the problem that's causing the pain, like the tight muscles in your scalp, or the cramping in your abdomen, or the hammer-damaged finger. But it does "lower the volume" on the pain signals getting through your nerves to your brain.

One common question about aspirin and other medicines is, "How does it know how to get to where the pain is?" The answer is that it doesn't! When you take aspirin, it dissolves in your stomach or the next part of the digestive tract, the small intestine, and your body absorbs it there. Then it goes into the bloodstream and it goes through your entire body. Although it is everywhere, it only works where there are prostaglandins being made, which includes the area where it hurts.

You may ask, "How come I have to keep taking aspirin if it works so well?" As with almost all chemicals, your body has ways of getting rid of aspirin. In this case, your liver, stomach, and other organs change aspirin to... surprise! Salicylic acid! This chemical then slowly gets changed a bit more by the liver, which sticks other chemicals onto the salicylic acid so that your kidneys can filter it out of your blood and send it out in your urine. This whole process takes about four to six hours, so you need to take another pill at that time to keep the effect going.

The problem with the fact that aspirin goes through your entire bloodstream is that your body needs prostaglandins for some reasons. One place they are useful is in the stomach; it turns out another enzyme called COX-1 makes a prostaglandin that seems to keep your stomach lining nice and thick.

Aspirin keeps COX-1 from working (it keeps most prostag-landins from being made equally well, it's "nonselec-tive"), and your stomach lining gets thin, allowing the digestive juice inside to irritate it. This is probably the biggest reason why aspirin and its relatives upset stomachs (not only because it's an acid, as Hoffmann had thought).

COX-2 also works in some normal tissues like the brain and kidney; at normal amounts, one dose of aspirin probably doesn't affect these areas much. And there are other places in the body where prostaglandins have a job in normal tissues, such as the blood...

The Wonder Drug - In the last few decades, it has been found that aspirin's action of stopping prostaglandin production has effects on things besides pain, inflammation, and the stomach. For example, some types of prostaglandins cause tiny particles in your blood (known as platelets) to stick together to form a blood clot. By inhibiting prostaglandin production, aspirin slows down clot production.

Although this can be bad, such as with a bloody nose -- in which case you want a clot to form -- blood clots can be damaging as well, such as in causing heart attacks by clogging the blood vessels that bring oxygen and energy to the beating heart. For this reason, many adults now take aspirin to prevent heart attacks, and it also helps people who have already had a heart attack stay alive.

Surely Hoffmann (and the Bayer company) could never have predicted this effect. And as noticed at least as far back as Hippocrates in ancient Greece, aspirin and its relatives also lower fevers; this seems to be an effect on a part of the brain known as the hypothalamus, which controls temperature (as well as other body functions).

A lot of research is being done now to find out if aspirin can be used for other problems; it has already shown some promise in helping with problems as diverse as cataracts in the eyes, some cancers, gum disease, and high blood pressure during pregnancy!

Wonder What's Wrong? Just like all medicines, aspirin isn't all good. It has effects on the body that you and your doctor don't want (side effects). Some of them have already been mentioned; for example, if you hit your finger with a hammer and it's bleeding, an aspirin may help the pain and swelling, but the wound may take longer to clot and stop bleeding. Also, it can be very upsetting to the stomach, especially at the high doses often used in arthritis.

Aspirin also isn't used as much for fevers in children since research has suggested that aspirin given to kids with flu, chickenpox, or other viral sicknesses may cause a potentially deadly problem called Reye syndrome. Aspirin also changes the way your kidneys make urine, can cause some people to have trouble breathing (rarely), and can be dangerous at very high doses.

For these reasons, chemists have found other chemicals closely related to aspirin that have some of its good effects and lack some of its bad effects. For example, ibuprofen and naproxen (or Motrin and Naprosyn, respecti-vely) also treat pain, swelling and fever, but they seem to have less of an effect on platelets than aspirin does. These medicines are called the non- steroidal antiinflam-matory drugs (NSAIDs) because they decrease swelling but they aren't steroids, which are the most potent antiinflammatory chemicals we have.

Another family of medicines related to aspirin includes acetaminophen (or Tylenol), which decreases fevers and pain, but it doesn't affect either swelling or your stomach as much as the true NSAIDs do.

Felix Hoffmann was sure that aspirin would make a good drug for arthritis. But as he struggled to prove it to his cautious employer, how could he have known it would save lives, and in so many ways? So the next time you get out the hammer, think of Felix and set aside an aspirin or two. He deserves the tribute, and it's best to be prepared for hitting the wrong nail.

Aspirin was invented in the late 1890s by German chemist Felix Hoffmann, who was seeking to ease his father's arthritis pain. In the 100 years since then, aspirin-or as it is known to chemists, acetylsalicylic acid-has become the world's most widely used drug. But until recently, no one knew how aspirin actually works.

In the 1970s scientists learned that injuries to human tissue trigger the release of prostaglandins, hormonelike molecules that cause fever and inflammation. They also discovered that aspirin somehow blocks the production of these molecules. To reveal exactly how this happens, a team of researchers, including myself, began several years ago to analyze the enzyme that produces prostaglandins--prostaglandin H2 synthase, or PGHS.

Using x-ray analysis of PGHS crystals, we discovered that the enzyme contains two protein subunits, each with a long interior channel. Molecules of arachidonic acid--an essential fatty acid--enter these channels and undergo a chemical transformation in the enzyme's core, converting to molecules of prostaglandin H2. Aspirin prevents this change by sealing the channels: the aspirin molecule's acetyl group binds to a site inside the channel, blocking the path of the arachidonic acid. Other anti-inflammatory drugs, such as ibuprofen and naproxen, work by physically plugging the enzyme's channels rather than chemically altering them.

ASPIRIN by R. Michael Garavito Assoc Prof of Biochemistry, Michigan State Univ.

 Aspirin (oral) BRAND: Acuprin 81, Bayer Aspirin, Bufferin, Easprin, Ecotrin, Empirin, Halfprin, Norwich Aspirin, St. Joseph Aspirin, Zorprin

What is the most important info I should know about aspirin? Take aspirin with milk, food, or an antacid to lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach. Enteric-coated aspirin can be, but does not have to be, taken with milk, food, or an antacid. Do not break, chew, or crush the enteric-coated tablets. These have a special coating to protect your stomach. Swallow them whole.* Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate damage to your stomach. Avoid alcohol or use it with moderation while taking aspirin. If you drink more than three alcoholic beverages a day, aspirin may increase the risk of stomach bleeding.

often combined with other analgesic as phenacetin and caffeine (APC). In large continued doses, it produces gastritis and ringing in the ears.

 aspirin also called Acetylsalicylic Acid, derivative of salicylic acid that is a mild, nonnarcotic analgesic useful in the relief of headache and muscle and joint aches. Aspirin is also effective in reducing fever, inflammation, and swelling and thus has been used for treatment of rheumatoid arthritis, rheumatic fever, and mild infection. In these instances, aspirin generally acts on the symptoms of disease and does not modify or shorten the duration of a disease. It has been used, however, as an anticoagulant in the treatment of such conditions as unstable angina or following a minor stroke or heart attack because of its ability to inhibit the production of blood platelet aggregates (which may cut off the blood supply to regions of the heart or brain). The drug acts by inhibiting the production of prostaglandins, body chemicals that are necessary for blood clotting and are noted for sensitizing nerve endings to pain. The use of aspirin has been known to cause allergic reaction and gastrointestinal problems in some people. It has also been linked to the development in children (primarily those 2 to 16 years old) of Reye's syndrome, an acute disorder of the liver and central nervous system that may follow viral infections such as influenza and chicken pox. Like almost all drugs, aspirin is to be avoided during pregnancy. Compare acetaminophen; ibuprofen.

 Good News, GOODBYE REYE'S Today, 20 years after doctors realized that Reye's syndrome was linked to taking aspirin, the dreaded childhood illness has virtually disappeared. Only two cases were reported in the U.S. in 1997, in contrast to 550 in 1980. The appearance of even two cases suggests that despite warnings on bottle labels, parents are still giving kids aspirin for viral diseases. That's a no-no, especially with chickenpox or the flu.

Good News: New England Journal of Medicine (5/6/99).

-- Aspirin and NSAIDs -- See also NSAIDs. Aspirin is commonly used to treat many forms of arthritis. Although aspirin is often very important, medication is only part of a total treatment pgm for arthritis. You need to learn from your doc what else to do for your disease. A typical pgm includes med therapy as well as exercise, rest, and joint protection.

Aspirin and related drugs (salicylates) - The salicylates are a family of related drugs that reduce the effects of inflammation, a reaction of the body that causes pain, swelling, redness, and heat. The word salicylate refers to the active ingredient in the drugs. Aspirin (acetylsalicylic acid or ASA) is one of these drugs.

Many of the others are chemically related to aspirin. Although salicylates differ from each other slightly in chemical structure, they have similar effects in the body. These drugs break down into salicylate, a chemical that is found in the bark of willow trees and in certain plants. Small amounts of salicylate can relieve head-aches, mild pain, and fever. Larger amounts taken regul-arly over a period of time relieve some of the pain, heat, redness, and swelling associated with the inflamma-tion of many forms of arthritis. Still larger amounts can cause toxicity (poisoning), which may be mild or severe.

Characteristics of NSAIDS - Aspirin and the other sali-cylates belong to a group of drugs called nonsteroidal anti-inflammatory drugs (or NSAIDs for short).

Reducing inflammation - All NSAIDs have the ability to reduce the effects of inflammation present in most types of arthritis. They are not related to the steroid drugs, which are a diff group of well-known anti-inflammatory drugs similar to hormones such as cortisone. The NSAIDs appear to work by blocking the action of various body chemicals, which cause some of the pain and inflammation of arthritis.

An advantage of aspirin over the other NSAIDs is that aspirin costs less. Because a person with arthritis must take medication for a long time, aspirin's fairly low cost is often a major factor in the choice of drug treatment.

Dosage and warnings - Arthritis affects people in diff ways. For this reason, only your physician can determine how much aspirin you need to effectively treat the symptoms of your disease, and how much you can tolerate.

How is dosage determined? You could make a serious err if you tried to figure out your own dosage schedule. Each person's body handles salicylates differently. A certain daily dose may be too small for one person, just right for another, or cause serious toxicity for another.

To determine the best dose of aspirin for you, the doc may check your blood level from time to time. He or she may also ask you to be aware of certain side effects. When the proper dose has been determined, it must be taken regularly. "Regularly" means at certain times of the day, every day--not just when you're in pain. A certain level of aspirin must be maintained in your blood to control swelling, pain, and stiffness. Therefore, the benefits of aspirin may be lost if it is not taken as prescribed by your physician.

Different brands of aspirin contain different amounts of the drug in each tablet. Be sure to check the dosage your doctor has prescribed with the amount per tablet you are taking. A standard tablet contains 5 grains of aspirin, which is equal to 325 milligrams of the drug. Aspirin advertised as "arthritis strength" or "extra strength" contains more aspirin per tablet (usually 500 mg). This is the same amount of aspirin as if you simply took more tablets of another brand with less aspirin in each pill.

Many common pain and cold remedies also contain some aspirin. You should not take one of them in addition to your regular aspirin without first checking with your doctor. You could be overdosing yourself w/o realizing it. Always read the labels of drugs you buy without a prescription before taking them. Check to see if they contain aspirin or other salicylates.

Can aspirin conflict with other medications? Aspirin can be taken safely with many other meds. There are some drugs, however, such as certain ones taken for gout and diabetes, that should not be taken with aspirin. It is very important to tell your doctor all the drugs you are taking for any condition. This includes any medications bought w/o a Rx and those prescribed by another doc.

Selecting over-the-counter salicylates - Always read the ingredients listed on the label of other products, especially those for pain, headaches, and other types of discomfort. "Acetylsalicylic acid" or "salicylate" are the key ingredients to look for.

Brand selection - Not all aspirin or salicylate tablets are the same. They come in several forms that have been developed to be more convenient to take and, sometimes, to help avoid stomach distress. These include liquid forms, buffered tablets, tablets with a special coating (called enteric coating) that keeps them from dissolving in the stomach, and capsules or tablets that release aspirin very slowly into the bloodstream. There are also the other salicylates--the chemically modified types of aspirin--which are longer acting than aspirin and can be taken less often.

Non brand-name or generic aspirin usually costs less and works just as well as popular brands. The least expensive way to buy plain aspirin is in bottles of 1,000 tabs. If you tolerate a certain brand, stay with it. Differences in the way various tablets dissolve may cause some brands to irritate the stomach more than other brands.

Packaging - Safety regulations require that aspirin prods like all drugs sold without Rx, must be pkged in contai-ners that are both tamper-resistant and child resistant. Unfortunately, these pkges may be very difficult to open for people whose hands are affected by arthritis. There are, however, ways to overcome this prob.

Most aspirin producers offer one size that is not child-resistant (usually small sizes that aren't as economical as larger ones). If you have trouble opening the pkgng or the container itself, ask the pharmacist or clerk to transfer the medicine to an easy-to-open container for you. Friends and family members can do the same. Always keep aspirin and other meds safely out of reach of kids to avoid accidental poisonings, which may be fatal.

 Aspirin - history analgesic Johann A.Buchner extracted acide salicylice in 1838. In 1897 Felix Hoffmann (Bayer) synthesised it into acety-salicylic acid, modern day aspirin.

John Vane (England) discovered the anti-inflammatory properties of salicylates that got him the Nobel Prize in 1982. bayer.com/aspirin-live

\4  DRUG DOSAGE FORMS and Dosage measurments

MEDICATIONS OFTEN CONSIST OF VERY SMALL QUANTITIES OF CHEMICALS KNOWN AS "ACTIVE INGREDIENT" THAT ARE COMBINED WITH INACTIVE INGREDIENTS TO MAKE CONVENIENT DOSAGE FORMS. DOSAGE FORMS ARE DESIGNED TO HELP PATIENTS TAKE MEDICATIONS BY IMPROVING TASTE, APPEARANCE, STABILITY, AVAILABILITY, AND ABSORPTION. SOME MEDICATIONS ARE PREPARED IN MORE THAN ONE DOSAGE FORM.

Capsules - Small, oblong gelatin "containers" filled with medication. Many patients prefer capsules to tablets - capsules are easier to swallow because of their shape and because their gelatin exteriors become slippery when patients take them with water.

Tablets - Solid dosage forms that vary greatly in shape, size, weight, and many other properties. Many tablets are swallowed whole with water and later break apart and dissolve in the digestive tract. Some tablets are scored with a groove that allows the tablet to be broken easily so patients can take a fraction of the dose. Tablets can also be coated with a gelatin covering.

Controlled Release - These products release medication over extended time periods to avoid high concentrations in the digestive tract or to provide longer duration of action than are available through conventional dosage forms.

abbreviations - LA (Long Acting), SA (Sustained Action) SR (Sustained Rlse), TR (Time Rlse), ER (Extended Rlse)

ORAL LIQUID DOSAGE FORMS - Solutions - Preparations in which the solid ingredients of medicationsare dissolved in a liquid (usually water). Solutions may have color but are usually clear - you can see through them

Suspensions - Preparations in which medication particles are suspended in liquid - usually water; the medication is not dissolved. In order to help the med stay equally suspended (distributed throughout the liquid), an agent is added to make the preparation thick. "Shake Well"

Elixirs - Clear, hydroalcoholic (combinations of water and alcohol) liquids intended for oral use. They often contain flavoring substances.

Syrups - These are concentrated solutions of sugar in water with active ingredients. They may contain alcohol

TOPICAL DOSAGE FORMS - Ointments - Greasy preparations, usually with a petroleum jelly base. They are good for delivering medication to areas of the skin that need protection. Ointments leave oily coatings on the skin.

Creams - Combinatins of water, oil, and other substances. They usually do not offer as much protection as oint-ments, but they are more appealing to patients because creams are less greasy and are absorbed by the skin.

Lotion - These are like creams, but they contain more liquid and are applied more easily over larger areas of the body.

NATIONAL DRUG CODE (NDC) - The National Drug Code (NDC) number is assigned by the manufacturer and placed on all prescriptin stock packages. Each package size has its own NDC number, which gives three piece of information about the medication:

Sequence - The first five digits identify the maker. The next four digits identify the name, strength and dosage form of the medication The last two digits identify the package size - Example: 01234-0123-01

 There are so many ways to measure medications you would think conversion tables would be rather common. And yet, this obvious need identified by parents is not so obvious to the physicians that prescribe the medications. Liquid medications are commonly written in cc's, ml's, and table spoons. Directions for formula may be described in cc's. ml's, cups, or ounces. How confusing it can all get!

Therefore, it is always important to ask the pharmacist about how to best measure your medications. Much of the time, they will supply you with a handy measuring device with cc's, ml's, and tsp's already marked free of charge.

Nonetheless, I will certainly take your advice and supply a conversion chart. But before I do let me help you with your conversion: 6cc's = 6ml's = 1 1/5 tsp's As you can see, it will be a bit difficult to measure out 1/5 of a teaspoon. Therefore, I suggest you obtain an accurate metric measuring device and use the cc's.

cc's stands for cubic centimeters. ml's stands for milliliters One cc = one ml They are equivalent. One teaspoon = 5 cc = 5 ml One Tablespoon (Tbl) = 15 cc = 15 ml One Tablespoon = 3 teaspoons One ounce = 30 cc = 30 ml = 2 Tablespoons = 6 teaspoons 8 ounces (The common size for a formula bottle) = 240 cc = 240 ml

\5  Drug Interactions - Self Medicating

Dangerous Liaisons! Well, that got your interest up, didnt it? There are (have been) plenty of dangerous liaisons in the world, and weve probably all had one (or two)? However, the liaisons I want to discuss today are the interactions between various drugs and how to avoid a fairly explosive situation in the way some drugs can interact with you.

What is the commonest drug taken by human beings in the western world? Hands up all of you who said alcohol. Yes, our old friend ethanol, AKA booze, is really a drug. It is a depressant, it dilates arteries and does all kinds of neat things to the body (and the brain). One of the big problems though, is that alcohol can heighten the effects of other drugs. In other words, it is not a simple 1+1 additive effect - the combination multiplies the effects of both the alcohol and the other drug too. For example, the anti-anxiety drug Valium (which I used to call the Health Food of the Nation in my younger and more cynical days) plus alcohol make a very nasty cocktail. This combination produces space travel without having to go to Cape Canaveral. A most dangerous way to be bombed out of your brain.

Simple cough medicines are another group of drugs that do not combine well with alcohol. A couple of beers and a shot of something for your cough can combine to produce a lethal combination. Lethal in the fact that the interaction can make you fall asleep at the wheel.

Lets imagine that you have now found out that you have high blood pressure and have gone on a type of medication called Beta Blockers. They do work well at reducing blood pressure. They also stop trembling hands, and many people take them for this - even concert pianists. There are some drawbacks, though. One it can exacerbate asthma, and two, it can make Willy the Wonder Wand not work like it used to. A dangerous way to draw a halt to dangerous liaisons!

Some of you will be on medication to reduce your blood sugar, a condition we sometimes called NIDDM (Non Insulin Dependent Diabetes Mellitus). You may also get indigestion. There is a particularly nasty interaction between certain sugar reducers and some antacids, which can make you go into a hypoglycaemic coma. Again, not the best way to spend a Saturday afternoon!

Now heres one for all the people who have had a stroke, or a heart attack or a deep vein thrombosis and have been put on a blood thinner, such as warfarin (also known as rat poison). Got a headache today? Taken a common old aspirin for it? You have just set the scene for a haemorrhage, as the effects of these two are again multiplied.

So just what is the message I am putting across this week? Well, it is simple. Whilst it is great that you can just wander into a pharmacy and buy all the cheap drugs you want and self-medicate with whatever you think you need, there can be a downside to all this. And it can be a big downside. Letting your doctor prescribe is much safer than doing it yourself. After all, the doctor has been trained to look for the dangerous liaisons! by Dr Iain Corness

 - Meds are meant to help one feel better, but many people are not aware that one med may interact with another one and cause new problems. At the worst, drug interactions can be fatal; but they can also cause psychiatric symptoms such as confusion, memory impairment, anxiety, and depression. Therefore, if you are are taking more than one med, you should make sure that at least one physician (if you have more than one) knows everything you are taking.

Some pharmacies also maintain computer records that can check for adverse drug interactionsbut they wont catch over-the-counter meds or herbal remedies mixed with Rx meds or the new age shit. Be an informed and responsible consumer. After all, it's your life, and you only get one chance at it. There are no reruns.

 TELL your doctor about all drugs you take (allergy pills, laxatives, vitamins, diet pills, even aspirin and herbs, etc.) before you take any new drug.

Don't take drugs prescribed for someone else--even if your symptoms are the same.

Keep your prescription drugs to yourself. Your drugs may be harmful to someone else.

Tell your doctor about any symptoms you believe are caused by a drug prescription or non-prescription that you take. Does it change your mood or behavior.

Take only medicines that are necessary. Avoid taking non-prescription drugs while taking prescription drugs for a medical problem.

Before your doctor prescribes for you, tell him about your previous drug experiences as to reaction or allergies.

Be sure of the medicine you take as to time and dosage. It can be fatal to take the wrong drug at the wrong time.

Don't keep any drugs that change mood, alertness or judgment as sedatives, narcotics or tranquilizers by your bedside. These have caused many accidental deaths by overdose. You may unknowingly repeat a dose when you are half asleep or confused.

Check all prescriptions to make sure it's correct. Know your medicine color form dosage. Study the labels of all drugs you need and be familar with them. If you have questions, ask the doctor or pharmacist for more details.

If you must deviate from your prescribed dose schedule, tell your doctor. Know what to do if you miss a dose.

 "People tend to be very lackadaisical about all the diff chemicals they put into their body at the same time," says American Pharmaceutical Assoc spokesman Daniel Albrant, who heads the health care consulting firm Pharmacy Dynamics, based in Arlington, Virginia. "And they often think, mistakenly, that any drug they can pick up at the convenience store is harmless."

Today it is widely understood that problems can occur when drugs are combined or when certain drugs are taken with certain foods. Yet many people are unaware that a wide variety of commonly used drugs, inc prescription, OTC and herbal products-can affect the body's response to exercise, potentially increasing the risk of injury.

Dangerous Duos - Most people know that the caffeine found in coffee, colas and some aspirin products is a stimu-lant. However, many don't realize that cold medications, diet pills, allergy remedies and herbal teas may also contain compounds that can elevate the heart rate. For the general pop, taking a normal dose of any one of these stimulants is unlikely to cause a problem.

But problems can arise when several of these products are combined and then exercise, which is also a stimulant, is added to the mix. "It's not surprising," Albrant says, "that worrisome things can happen, especially if you're dehydrated."

When people are dehydrated, Albrant notes, "their bloodstream is more concentrated, which can increase the effect of a drug." Because "most Americans don't drink enough water," he says, they are in a chronic state of dehydration. Drinking alcoholic beverages raises the risk of dehydration, as does exercise if lost fluids are not replaced regularly.

Other drugs can affect performance by impairing coordi-nation and judgment, causing drowsiness or accelerating dehydration. Even meds designed to enhance performance put users at some health risk. That's one reason why the International Olympic Committee (IOC) has banned the use of certain stimulants, pain relievers, steroids, diure-tics and hormones. IOC-prohibited products include many popular over-the-counter preparations, such as Actifed, Afrin Tablets, Alka-Seltzer Plus, Dexatrim, Midol, Sudafed, Vicks Inhaler, and herbal teas containing ma huang (herbal ephedrine).

A Prescription for Disaster - Among Rx drugs, a class of antibiotics called fluoroquinolones has attracted the attn of sports med experts in recent years. Routinely prescribed for upper-respiratory, intestinal and urinary-tract infections, these antibiotics have been linked to serious tendon injuries, often in the shoulder, hand and Achilles tendon (Huston 1994; McGarvey, Singh & Trevino 1996). The most commonly prescribed drug in this class is Ciprofloxacin, known as Cipro.

"Cipro is a great drug, but I generally will not use it in an athlete," says Riley Williams, MD, an orthopedic surgeon in sports medicine at the Weill College of Medicine at Cornell University Hospital in New York City.

In a recent study, Williams incubated human musculo-skeletel cells with differing strengths of Cipro and found that the cells manufactured destructive enzymes in response to the drug. Higher doses resulted in more severe effects, according to the study, which was pub in the May-Jun 2000 iss of the Amer Jrnl of Sports Medicine.

"In most cases, there's a prodrome [preliminary symptom], which usually consists of pain or soreness that occurs in the affected area during or after physical activity," Williams says. "It's common for athletes to try to work through this sort of thing, but if they do that while they're on this drug, they'll get into trouble."

In the wake of reports of adverse reactions to fluoroqui-nolones, the FDA has requested that manfs of these prods update their labeling to inc a warning about potential tendon rupture; the labels should also recommend that users stop taking the drug and refrain from exercise at the first sign of tendon pain or inflammation (FDA 1996). Unfortunately, Williams says, many doctors are not aware of this advice.

Therefore, it behooves fitness professionals to know that the exercisers taking fluoroquinolones who are at greatest risk are those who do high-impact activities, heavy weight lifting or sports involving jumping and rapid acceleration and deceleration.

An Ounce of Caution - Athletes can also run into trouble by ignoring usage directions for meds. eg, it was rept last year that hockey star Eric Lindros worsened the migraine headaches he was experiencing after suffering a concussion by taking up to 18 over-the-counter ibuprofen pills a day--three times the maximum recommended dosage stated on the label (Maaddi 2000). Long-term use of high doses of ibuprofen has also been linked to kidney and liver damage, notes Pharmacy Dynamics's Albrant.

Touted in ads featuring older athletes like baseball's Nolan Ryan and tennis great Jimmy Connors, ibuprofen and other nonsteroidal anti-inflammatory drugs are often overused by aging exercise enthusiasts, says Carol Newman editor of the American Running Association's newsletter Running & FitNews. "As baby boomers rage against age," she says, "many think, 'I can't do my five-mile run unless I take an Advil with my coffee and toast."'

Exercisers who rely on these drugs to mask pain "will buy themselves a bigger problem," says Mark Chamberlain, a drug information specialist at the University of Maryland at Baltimore. Pain is the body's signal that something is wrong, Chamberlain cautions, so trying to block it out may lead to serious injury.

Injury can also occur when exercisers take drowsiness-inducing medications, such as alcohol and many antihis-tamines, prior to engaging in physical activity. "These medications can decrease reaction time, balance and coordination," says Chamberlain. "People taking them should avoid things like cycling or using mechanical equipment like a treadmill."

Fitness professionals, in particular, need to pay attn to what they--and their clients--are putting into their bodies. "Always read labels and foll dirs," Chamberlain advises. "And remember that just because you can buy a product over the counter, it doesn't mean it's harmless."

Carol Krucoff is an award-winning journalist and founding editor of the Health Section of the Washington Post. She is author, with her husband Mitchell Krucoff, MD, of Healing Moves: How to Cure, Relieve and Prevent Common Ailments With Exercise (healingmoves.com). Her inty column, Bodyworks, ran in newspapers around the world for 12 years. She is an ACE-certified personal trainer and a yoga instructor. She also holds a second-deg black belt in karate.

CONTRAINDICATED means a medication may have a risk for reasons listed leading to an adverse reaction.

With all medication: know what, why, and how to take it.

\6 Pharmacies in Thailand

.. give out many medications that one would need a prescription for elsewhere. To name but a few, anti-biotics, birth control, asthma inhalers, heart meds, and antidepressants are all available over the counter.

Meds are notoriously cheaper in Thailand than in many other countries and visitors can be found stocking up on their prescription drugs when they pass through. For example, the same asthma inhaler that would cost US$37 in the United States can be had for a mere US$5 here. Many other meds are avail as Thai-produced generics meaning that a well-known brand name drug is sold under a different name.

Every major block seems to have a pharmacy or five. They range from the small to the immense and from the chaotic to the super-messy. Most pharmacies have a scale that customers can use free of charge.

Not all meds are avail over the counter, however. There are controlled substance drugs in Thailand and Rx are needed before certain pills will be dispensed. Pharmacists also give doctor-like diags to those coming in asking for assistance. If you show up with a small cough, a bottle of codeine cough syrup and a box of antibiotics is more than likely to be placed in front of you.

Thailand's pharmacies, hospital and doctors all tend to over-prescribe. Something worth noting is that pharmacies have cross-reference books available in English. It is well worth doing some reading in them before deciding to purchase an unfamiliar medication. I once went to a pharmacy complaining of nausea and was offered medication used to treat epilepsy.

Suphawon Virotesiri is a 33-year-old woman who runs her own pharmacy in my neighbourhood. She studied at university for five years in southern Thailand to become a pharmacist and upon graduating got a full-time job at a government hospital in her field and made 7,000 baht (US$159) a month. She studies English at school and can speak it quite well.

She has been married for nine years and is has a four-year-old daughter who is very often at the store with her mother when she is not attending school. Suphawon moved from southern Thailand to Bangkok after getting married. "I got a job at a private hospital as a pharmacist and was paid 17,000 baht (US$377) a month. I worked there for six months. Then I became a sales representative for an international pharmaceutical company. I could earn 35,000-40,000 (US$777-889) baht per month. I got to go to Europe with the company two times," she said. She also opened a small dry cleaning business next to her pharmacy six months ago. "Business is not going good or bad," she stated.

She opened her medium-sized pharmacy two years ago after moving the business from a location about fifteen minutes down the street. Her present store is in a good location and is well stocked and well kept.

"This store makes about the same amount of money as my old store did. I pay 7,500 baht (US$167) a month in rent and 5,000 baht (US$11) a month for electricity. I let the restaurant next store use my electricity meter and bill them, so actually my electricity bill is 3-4,000 baht a month because I use the air cond," she explained.

She did not want to state specifically how much her present business earns per month, but informed me that it was over 20,000 baht (US$444). Suphawon employs a shop assistant and she is paid 4,800 baht (US$107) per month.

Suphawon works from 10 am-8 pm Monday through Friday. Her husband works full time as an engineer for Thai Airways. "On the weekends I take care of my family and do the shopping. I have a maid to help me during the week." She lives in a three-bedroom house with her mother-in-law and daughter that she and her husband own.

When asked what she likes to do for fun, she replied, "I watch TV. I like to rent video CDs. I like Hollywood movies. I also like shopping for clothes, shopping for everything actually. I like to travel. In Thailand I enjoy going to Phuket and Chiang Mai."

If hypothetically given 5,000 baht, Suphawon said she would spend it. "I would go shopping and buy things for my daughter, things for myself and a little bit of stuff for my husband," she declared with a smile.

She is content with her job and said, "I like to sell things. Anything!" She is a clever, energetic and highly motivated businesswoman who is doing well for herself and her family. When asked what the most popular products in her store were, she giggled and said, "Birth control and Tylenol but I make the most profit by selling diet supplements and vitamins."

--------------------------------------------------------- Caution: That Dose May Be Too High By ABIGAIL ZUGER

Twenty percent of prescription drugs are marketed with instructions for use that must later be corrected by the manufacturer, researchers say  almost always to lower the recommended dose or to warn that the drug may be hazardous to certain patients.

Drugs released in the last five years are even more likely to have their instructions changed than older ones. These findings by Georgetown Univ researchers, along with similar data from Europe, support longstanding concerns among some experts that drugs are being studied at excessively high doses to emphasize their effects, and then marketed at the same high doses to maximize profits.

Some experts say these patterns may contribute to the high frequency of serious and life-threatening drug side effects. The Georgetown study examined the recommended doses of 354 prescription drugs released from 1980 to 1999. Of those drugs, the instructions on the label were corrected for 73, or 21 percent, after the drug came to market.

Eighty percent of the corrections consisted of a reduction in the original dose or a new restriction for certain groups of patients, like those with liver or kidney disease or those taking certain other medications. Drugs approved by the FDA through its so-called fast-track system adopted a decade ago for lifesaving compounds seemed no more likely to have corrections than other drugs.

Drugs with label corrections came from all drug classes and include the potency drug Viagra, which was restricted from certain cardiac patients after the drug was first approved; the H.I.V. drug AZT, whose dose was cut in half after its release in 1987; and the antidepressant Prozac, which should be started in the elderly in smaller doses than usual.

The Georgetown study did not include drugs often used at doses that are different from the ones recommended by manufacturers (like pain relievers), or drugs that have been reintroduced in low-dose variants (like birth control pills), and for this reason its figures represent a low-end estimate of the number of drugs with dosage corrections after they are on the market.

The study will be pub in the med jrnl Pharmacoepidemiology and Drug Safety, and was released on the its Web site Aug 02. "We've seen a lot of situations where drugs are approved by the FDA and subsequent important info about their optimal dose is not determined until afterward," said James Cross, the study's lead author, who did the research at Georgetown's Center for Drug Development Science and now works for the food and drug agency.

"I don't think that the results are alarming," Mr. Cross said, "but they shouldn't be taken with indifference either. Patients and prescribers need to be aware that a drug label is a dynamic piece of information; it doesn't just get approved and then sit there on a shelf never to be heard from again."

Dr Wayne Ray, a prof of preventive medicine at Vanderbilt and its director of pharmacoepidemiology, said: "These results don't surprise me at all. It's sort of an unintended consequence of the way we approve drugs. They've put their finger on an important policy issue."

When a drug is being studied for possible marketing, the recommended dose is set very early in the process, based on small studies, so that manufacturers can efficiently carry out large studies of the drug's safety and efficacy.

Because manufacturers have a strong incentive for the drug to show an effect in these studies, they often choose to study a relatively high dose, which may prove to be too high, Dr. Ray said.

The process has other inherent limitations that help explain why so many drug doses change, Mr. Cross said. "Manufacturers can't test drugs in millions of people, so inevitably things are detected after approval," he said.

For instance, if a new drug interacts badly with a drug for a different purpose already on the market, the recommended dose of the older drug may have to change for people taking both, a situation that could not have been foreseen when the old drug was first marketed.

"Still," Mr Cross said, "tools are avail to the drug companies about better analyzing the data from premarketing trials." Such tools incl lab analyses of drug molecules and sophisticated analysis of clinical data from the first people to take the drug, so that some dosing corrections might be made earlier.

Drug makers and regulatory agencies anticipate learning new details of a drug's effects and interactions after it goes to market. Even the largest clinical trials cannot always identify patterns that emerge when drugs are used by millions of people.

Drug companies maintain that the high rate of label corrections indicates the progress of science. "The central issue is that we're constantly learning about a drug throughout its life cycle," said Dr. Alan Goldhammer, an assoc VP at Pharmaceutical Research and Manfs of America, a trade group. "We can't know everything about a drug before it goes to market. That would mean long regulatory delays and the American public would not want that."

Manufacturers always continue to assess a drug's safety after marketing, Dr. Goldhammer said.

The Georgetown team found that when its data were adjusted for the length of time a drug was on the market, those released from 1995 to 1999 had a chance of label correction that was roughly threefold greater than the rate for those released from 1980 to 1984. The corrections occurred after an average of 16 years on the market for the older drugs, but after only 3 for newer ones.

Under the F.D.A.'s fast-track policy, some watchdog groups have said drugs are being rushed to market without adequate testing. But Mr. Cross said that most accelerated drug approvals were in cancer and H.I.V. drugs and that these were no more likely to have labeling corrections than others.

Rather, he said, the recent spate of label corrections may reflect more vigilance from manufacturers and the F.D.A. to find dosage problems early and correct them. Further evidence that the recent acceleration in dose corrections is not directly related to federal regulatory policy comes from a new European study with very similar findings for drugs marketed there.

Published with the American study, the European research used marketplace data compiled by the World Health Organization to show that from 1982 to 2000, 115 drugs used in Europe had their standard doses corrected. Most were reductions, and they became more frequent in the middle to late 1990's. Drugs that were first marketed in the United States were no more likely to have dose corrections than were drugs first sold in Europe.

"We can't say if it's the mistakes that are happening at a rising rate or if it's the mechanisms for finding them that are getting better," said Dr. John Urquhart, a professor of pharmacoepidemiology at Maastricht University in the Netherlands and an author of the European study.

Economic factors also come into the equation. Although some drugs have similar prices set for a range of doses, most "are priced on a per-milligram basis," Dr. Urquhart said. This explains manufacturers' desire to sell as many milligrams as possible, he said, while giving groups that pay for prescription drugs an incentive to finance studies supporting lower doses.

For some experts, these results only confirm long-held views that drug-dosing and marketing policies are fundamentally flawed.

"It's long been known that for individual subjects the dosage listed on a drug label is not necessarily the right one," said Dr. Carl C. Peck, the director of Georgetown's drug development center and an author of the its study. "We're aware of the pressures drug developers feel to select a dose and invest in that dose. But one in five is a high error rate. Both doctors and patients should be concerned."

Dr. Peck said that, except in medical emergencies, for many patients a policy of "start low and go slow" is the best way to begin a prescription medicine, with frequent visits to a doctor who is committed to readjusting doses based on the patient's response. In the future, he said, genetic-based analysis of a patient's metabolic idiosyncrasies may help streamline this process.

Dr. Jay S. Cohen, an associate professor of family and preventive medicine at the University of California at San Diego, said the Georgetown data illuminated only part of the problem. "The findings don't include a lot of drugs whose doses should be reduced but aren't," he said. In his book "Overdose" published last year, he argued that for many people the recommended drug doses were much too high.

Dosage recommendations are based on small studies done on young, healthy people, usually men, Dr. Cohen said. But people have such variability in size, shape, age and patterns of metabolizing drugs, not to mention concurrent illnesses and necessary medicines, that the notion of a single optimal treatment makes no sense, he said. About 75 percent of the serious side effects occur at recommended doses, he added.

"If a dose is reduced 7 or 10 years after the drug was first marketed," Dr. Cohen said, "you wonder how many side effects, what great costs to patients and to the medical system could have been avoided."

 NB: There is limited if any EMS in foreign countries.


\7 Immunisations - Vaccines

What Is Immunization? General Guidelines. Experts recommend that all children be routinely vaccinated against measles, mumps, rubella (German measles), diphtheria, tetanus, pertussis (whooping cough), poliomyelitis, chicken pox, hep-B, and Haemophilus influenza type B (a cause of meningitis). Other vaccines such as one for rotavirus, which causes childhood diarrhea, may soon be added to the list.

Many vaccinations are started in infancy. Even premature infants can, in most cases, be given vaccinations on a normal schedule. Vaccinations against influenza, pneumococcal pneumonia, and tetanus are also recommended routinely for certain adults, and others are useful for travelers of all ages.

Vaccines are currently administered either orally or by injection. They usually contain either a live but weakened virus or an inactivated bacteria, virus, or toxoid that will cause the body to produce antibodies, special agents of the immune system designed to attack the harmful invader. The weakened agent in the vaccine acts as a sparring partner for the immune system. While fighting this imitator, the antibodies learn to recognize the real agent and attack it when the person becomes exposed to the infection. The antibodies remain in the body, preventing future illnesses of the disease - this is called immunity.

Live-virus vaccines provide longer immunity than inactivated ones, but they can cause serious infection in people with weakened immune systems and have also been associated with severe med disorders in rare instances. Inactivated vaccines are safe even in people with impaired immune systems. Passive immunity uses immune globulin -- blood products containing antibodies.

Immune globulin is generally used for people who cannot be vaccinated, when immediate protection is required, or to prevent severe complications of the disease. In some circumstances passive immunity can interfere with active vaccinations, particularly live- virus vaccines, so, if possible, they should not be administered within weeks or even months of each other.

In general, American vaccination rates are now high, averaging 90% of all children. Studies suggest, however, that in some states and cities up to one third of children less than two years old are missing at least one dose of either the DTP (diptheria, tetanus, and pertussis) or the MMR (measles, mumps, and rubella) vaccines, and many are not receiving varicella and hepatitis B vaccines. The rate of vaccinations in adults is far worse. One study estimated that 65,000 adult deaths could be prevented each year by increasing vaccinations against pneumonia, influenza, and hep-B.

Vaccinations during Pregnancy: Inactivated-virus and toxoid vaccines are usually safe in pregnant women, although any vaccination should be delayed, if possible, until the second or third trimester. Because of a poss risk to the fetus, live-virus vaccines should not be given to pregnant women or to those likely to become pregnant within three months unless such women need immediate protection against life-threatening diseases, such as yellow fever, that are only prevented using live-virus vaccines.

The live-virus MMR combination, which vaccinates against measles, mumps, and rubella, should never be given to pregnant women because of the theoretical risk of the live-rubella vaccine on the fetus (see individual discussion of vaccines below).

Vaccinations in People with Compromised Immune Systems In general, live-virus vaccines can cause serious and widespread disease in people whose immune systems have been impaired or compromised. Live-virus vaccines, then, are not usually given to persons who have immune defici-ency diseases (such as HIV or AIDS), active leukemia, lymphoma, or who are taking treatments that suppress the immune system, such as corticosteroids, alkylating drugs, antimetabolites, or radiation.

(Some exceptions are noted in discussion of individual vaccinations below.) Short- term corticosteroids -- less than two weeks -- do not suppress the immune system and so should not affect any live-virus vaccination. It should be noted that some topical corticosteroids are suppressive, and patients who need vaccinations and who take long-term or high-dose topical steroids should check with their physicians.

In general, vaccines are not as effective for patients with compromised immune systems as they are for other people. Often, such patients are given immune globulin if they are exposed to infection. Experts estimate that it takes three months to a year before a person who has stopped taking immunosuppressant drugs regains the full ability to be successfully immunized against disease.

What Are the Vaccines for Diptheria, Tetanus, and Pertussis? Descriptions of Diptheria, Tetanus, and Pertussis

Diphtheria is caused by a bacterium, Corynebacterium diphtheriae, which can occur as either a toxic or nontoxic strain. In the first quarter of the twentieth century diptheria infected 200,000 people every year and killed between 5% and 10% of them, mostly the very young and very old. When only the skin is involved, it is known as cutaneous diphtheria, and is likely to be a nontoxic strain.

When the toxic strain affects the mucus linings in the body, such as the throat, diphtheria becomes life threatening. At this time, although 97% of children are vaccinated against this serious disease, many adults lack protection. The very poor and certain Native Americans are most vulnerable. People who develop the disease may not necessarily become immune to it, and they require vaccinations after recovery. When a person is vaccinated protection lasts at least 10 years, although if they become infected after that time, the disease is almost always mild.

Pertussis (whooping cough) was a very common childhood illness throughout the first half of the century. The disease is very easily spread from one person to another. Although immunizations caused a decline in pertussis to only 1,700 cases in 1980, the incidence has risen again to over 4,600 annual cases, mostly in adolescents and adults, and such cases may be greatly underreported.

A recent study suggested that as many as 25% of adults who see a doctor for persistent cough may actually have pertussis, but it may go undiagnosed because symptoms are usually mild and adults are unlikely to have the classic "whooping" cough. This is of some concern, because such adults may unknowingly infect unvaccinated children who are exposed to them. The younger the patient the higher the risk for severe complications, including pneumonia, seizures, and even death.

Vaccinations for Diphtheria, Tetanus, and Pertussis Diptheria, tetanus, and pertussis are very different disorders, but an injection that combines all three vaccines (DTP) has been routinely given to children since the 40s. Recently, a new vaccine combination called DTaP that uses a different form of the pertussis component, known as acellular pertussis, has been approved.

Acellular pertussis consists of only of a single weakened toxoid; previous pertussis vaccines contained multiple toxoids. Experts hope that DTaP will prove to have fewer side effects than DTP, particularly in older people who are more prone to them, and so allow adults to have a pertussis booster. It is more expensive than the older version, however, and may not be as effective. Also of interest are studies using diptheria and tetanus vaccines that can be applied to the skin and do not require needles.

Diphtheria, Tetanus, and Pertussis Vaccines in Childhood The combined DTP or DTaP vaccine should be given to all children less than seven years old. The infant receives a series of three vaccinations at two, four, and six months of age. A fourth dose is given some time between ages 15 and 18 months. (Infants at higher risk, such as those exposed to an outbreak of pertussis, may be given these vaccinations earlier.) The child receives a booster shot between ages four and six, unless the last shot in the initial four-dose series was given on or after the child reached four years old. (In such cases, the child may not need this booster.)

If a child has a moderate or severe current or recent fever-related illness, vaccinations should be postponed until after recovery. Colds or other mild respiratory are no cause for delay. Parents should not be unduly concerned if the interval between shots is longer than that recommended. The immunity from any previous vaccinations persists, and the physician does not have to start a new series from scratch.

Tetanus and Diptheria (Td) Vaccines for Older Children and Adults. Children between the ages of eleven and fifteen years old should receive a tetanus and diptheria (Td) booster shot. The Td vaccine contains the standard dose against tetanus and a less potent one against diptheria and does not contain the pertussis component. (The pertussis component of the vaccination is usually not given to people over seven years old because whooping cough is less severe as people get older while the side effects of the vaccine may be more severe.)

All vaccinated adults should have a Td booster at least every ten years throughout their lifetimes. All adults who did not receive the primary childhood vaccinations should have a series of three Td vaccinations. The first two doses should be given at least a month apart and the third dose given six to 12 months after the second. Unvaccinated pregnant women should receive two doses of Td, properly spaced, and previously vaccinated women should have a booster.

Some experts are considering recommending continuing immunization against whooping cough in older people, who might become reinfected and threaten unvaccinated children. The new acellular pertussis vaccine may make such adult boosters feasible.

Preventing Tetanus in Individuals with Wounds. A patient who requires medical care for any wound must be a candidate for tetanus immunity. Wounds that put patients at highest risks are puncture wounds and those contami- nated with dirt, feces, and saliva. The physician should first determine when the last tetanus of DTP shot had been administered.

A booster is needed if the last shot was five or more years before the injury. Children under seven are usually given DTP if they are not fully vaccinated and the Td vaccination if they have been vaccinated. Older patients who had experienced a hyper- sensitive response (a high fever and malaise) to the previous tetanus booster, may have a severe adverse response to a tetanus shot given within ten years. Such people may be given the tetanus immune globulin (TIG).

Side Effects of Diptheria-Tetanus-Pertussis Vaccines Allergic Reactions. In rare cases, people may be allergic to the DTP vaccine. Parents should tell their doctor if their children have any allergies. No deaths have been reported from an allergic reaction -- even a severe (anaphylactic) one -- to the DTP vaccine (see Symptoms of Severe Reactions to Vaccinations). The DTaP vaccine may pose a slightly increased risk for an allergic reaction than the DTP.

Children who have severe responses should not be given further vaccinations. A rash that occurs after a dose of DTP is of little consequence. In fact, it does not usually indicate an allergic response but only a temporary immune reaction and does not usually recur with subsequent shots.

Pain at the Injection Site. Some children may feel pain at the injection site or they may develop a mild fever after a vaccination. In some cases, a small lump may persist at the site for several weeks. Placing a clean, cool washcloth over any swollen, hot, or red area can help. A sponge bath in lukewarm -- not cold -- water may also relieve fever or pain. Children should not be covered or wrapped tightly in clothes or blankets.

Fever and Other Symptoms. A child may develop a mild fever, irritability, drowsiness, and loss of appetite after a DTP shot. Acetaminophen (Children's Tylenol and other brands) helps to reduce fever and alleviate pain. The physician may suggest that children who have had previous high fevers or other reactions to the DTP shot be given acetaminophen at the time of the vaccination and every four hours afterward for 24 hours. (The doctor will determine the dosage according to the weight of the child.)

Children should never be given aspirin. A new fever that develops 24 hours after the vaccination or a fever that persists for longer than 24 hours is most likely due to other causes. A very high fever in children (over 105 degrees) may cause convulsions and should be reported immediately to the physician. Although frightening, such fever-related seizures rarely have any long-term effect, and a recurrence after a subsequent vaccination is very unlikely.

A high fever (more than 103 degrees Fahrenheit) after a Td booster shot in an older person often indicates that the individual already has high levels of tetanus immunity; such people should not receive additional tetanus shots -- even for wounds -- until ten years have passed.

Neurologic Effects. In young children, high fever from a vaccination can, in rare instances, trigger seizures, which are almost always temporary and have no serious consequences (see Symptoms of Severe Reactions). Of concern have been a few reports of permanent neurologic abnormalities -- including brain damage (encephalopathy) and even death -- that occurred following DTP vaccinations.

The primary suspect is the pertussis component; it is well proven that the diptheria and tetanus components have no adverse neurologic effects. Three major studies have failed to confirm a causal relationship between neurologic problems and the pertussis vaccination. One study that did find an association between the vaccination and neurologic abnormalities in a few children suggested that, in most of the cases, the effects may have been related to high fevers.

Some experts suggest that some children who have neurologic events following their DTP shot may already have a preexisting impairment, such as epilepsy or abnormal brain development, which is revealed -- but not caused -- by the vaccine.

In any case, there is no evidence to date that proves the pertussis vaccine itself causes these neurologic events, which some experts describe as so infrequent that they are nearly unmeasurable. Children with known neurologic abnormalities may be at risk for an outbreak of symptoms two or three days after the vaccination.

Such a temporary worsening of their disease does not appear to pose a danger to the child, however. In general, for infants with suspected neurologic problems, a decision to vaccinate may be delayed until their neurologic situation is clarified (but no later than their first birthday). Children with neurologic problems that have been corrected can be vaccinated.

Other claims that DTP may be responsible for spinal column abnormalities or long-term neurologic disorders, such as attention deficit disorder, learning disorders, or autism, have no scientific basis. In fact, one study indicated that children who received pertussis vaccine had fewer problems in school than those who were not vaccinated, regardless of family income levels.

Other Serious Conditions Attributed to DTP Several large studies have found no association between DTP and either SIDS or any other unexpected deaths in infants. There is also no proof that DTP causes anemia or other blood disorders. It is very important to stress that rare severe reactions to vaccinations pose a far lower risk to children than the illnesses themselves.

What Are the Vaccines for Measles, Mumps, and Rubella? Description of Measles, Mumps, and Rubella

Measles can cause pneumonia and -- in about 1 out of 1000 cases -- encephalitis (brain damage) or death. The risk for these severe complications is highest in the very young and very old. In pregnant women, measles increases the rates for miscarriage and low birth weight and birth defects in their infants. Aggressive vaccination programs have reduced the incidence of measles to the lowest point in US history, although experts remain concerned about cases imported from other countries. Measles remains a serious international problem, with 42 million cases and over one million deaths in small children each year.

Mumps In about 15% of cases, mumps affects the lining of the brain and spinal cord, although this is usually not ultimately harmful. Swelling of the testicles occurs in between 20% and 30% of males who have reached puberty, although sterility is rare. Deafness in one ear occurs in one patient out of 20,000 with mumps.

Rubella (German Measles) When rubella, commonly known as German measles, infects children or adults, it causes a mild illness that includes a rash, enlarged lymph nodes, and sometimes a fever. If a pregnant woman is infected during her first trimester, however, her baby has a 80% chance for developing birth defects, including heart abnormalities, cataracts, mental retardation, and deafness. Before the vaccine became available, about 56,000 cases of rubella occurred annually. Vaccination programs have dramatically reduced the incidence, but between 6% and 11% of adults are still susceptible.

Vaccines for Measles, Mumps, and Rubella Safe and effective live-virus vaccines for measles, mumps, and rubella have been developed over recent decades. They are usually combined in children as the MMR vaccine. Individual live-virus vaccines or the combined MMR may be given to adults, depending on their risk factors.

Measles-Mumps-Rubella (MMR) Vaccine in Early Childhood The combined MMR vaccine should be given between ages 12 and 15 months for the first dose and ages four to six years for the second dose.

Measles-Mumps-Rubella (MMR) in Older Children and Adults Most people born before 1957 have experienced these once-common childhood diseases and don't require vaccination. Experts recommend that all unvaccinated people born after 1956 who did not already have measles and mumps be given two doses of the live MMR vaccine administered at least one month apart.

Many people received an inactivated-measles-virus vaccine in the early 1960s or an inactivated-mumps-virus vaccine between 1950 and 1978; such people need revaccination with two doses of the live MMR vaccine. (This will cause no harm even if someone had a previous live-virus-mumps vaccination.)

In general, the live-virus MMR vaccine is not given to persons who are immunocompromised. It appears to be safe (and is very important), however, for people with asymptomatic HIV infection. It may even be considered for some patients who have symptoms of AIDS.

It is particularly important for any unvaccinated nonpregnant woman who wants her children to be vaccinated against rubella. Except under very special circumstances, no live-virus vaccine, especially MMR, should be given to an already pregnant women, since there is a theoretical risk for birth defects from the rubella vaccine.

Fortunately, the risk is low; in one study of 500 women who had been vaccinated with the live rubella virus vaccine within three months of conception, there were no malformations in the newborns that could be associated with rubella. Still, to be safe, women should avoid live-virus vaccinations during pregnancy.

Side Effects of Live Measles Mumps-Rubella (MMR) Vaccines Allergic Reaction People who have known anaphylactic allergies (very severe reactions) to eggs or neomycin are at high risk for a severe allergic response to the MMR vaccine. People with allergies that do not cause anaphylactic shock to these substances are not at increased risk for a serious allergic reaction to the vaccine. Mild allergic reactions may occur in some people, including rash and itching. A rash occurs in about 5% of people who are vaccinated with a live-measles vaccine. A live-mumps vaccination has caused rash and itching, but these symptoms are usually mild.

Common Side Effects Common side effects from the MMR vaccination include fever, rash, and joint pain. Children are more likely to experience such side effects from the second dose (at 10 to 12 years) than from the first (at four to six years). About 5% to 15% of people who are vaccinated with any live measles virus vaccine develop a fever of 103 degrees Fahrenheit or greater, usually between five and 15 days after the vaccination. It usually just lasts one or two days but can persist up to five days.

In very young children, seizures can occur from high fever but they are rare and almost never have any long-term effects. The live-mumps vaccine can cause mild swelling in the glands that are situated near the ears. Up to 25% of women have joint pain one to three weeks after a vaccination with a live-rubella virus; it lasts for one day to three weeks. Such pain does not usually interrupt daily activities. Rarely, it recurs or becomes persistent.

Interaction with Tuberculosis Test The live-measles vaccine may interfere with a tuberculosis test, so the two should be administered at least four to six weeks apart. No evidence exists that the vaccine has an adverse effect on tuberculosis itself.

Severe Side Effects In very rare cases, encephalopathy (brain damage) associated with the live-measles vaccine has occurred. A syndrome that includes intestinal disorders and developmental problems has been reported after vaccinations, but it is very rare and a causal relationship has not been proven.

What Are the Vaccines for Varicella-Zoster Virus (Chicken Pox)? Description of Varicella-Zoster Virus (Chicken Pox) Chicken pox (caused by the varicella-zoster virus) is a very common disease and most adults are immune to it.

The infection rarely causes complications in healthy children. Chicken pox can be severe in adults and very serious in anyone with a compromised immune system. In addition, in about 20% of adults who had had chicken pox, the varicella virus (which persists after the childhood disease) erupts as a painful and distressing condition called herpes zoster (shingles).

Vaccines for Varicellavirus (Chicken Pox) A live-virus vaccine (Varivax) produces persistent immunity against chicken pox. Major medical organizations now recommend that all children between the ages of 18 months and adolescence who have not yet had chicken pox be vaccinated with the varicella live-virus vaccine. Experts also urge its use in certain adults without a history of chicken pox, particularly those who are in close contact with patients with serious medical conditions. Some experts suggest that every healthy adult without a known history of chicken pox be vaccinated.

One recent study indicated, however, that less than half of pediatricians are complying with the recommendations for universal vaccinations in children. Many of these physicians are concerned that because the initial vaccination series wears off, then children who do not have a booster shot later on will be at risk for catching chicken pox in adulthood, when it is more severe.

Experience with other childhood live-virus vaccines indicates, however, that there will be an overall reduction in incidence in chicken pox both in children and adults. The vaccine is protective in about 85% of cases, and even if a vaccinated person becomes infected, the disease is almost always mild. Studies are also finding that protection is long lasting.

As with other live-virus vaccines, the chicken pox vaccine is not recommended for pregnant women or people whose immune systems are compromised by disease or drugs. The vaccine is being studied, however, for its safety in patients with impaired immune systems or children with cancer or other high-risk conditions. Experts report that it is safe in children with acute lymphoblastic leukemia (ALL), who should receive two doses. Trials are underway to determine if it is safe for children with HIV or AIDS.

Reports to date are encouraging. At present, however, patients with compromised immune systems are given immune globulin -- antibodies -- against varicella virus if they are exposed to chicken pox; this helps prevent complications of the disease if they become infected.

Side Effects of the Varicella (Chicken Pox) Vaccine About 20% of vaccine recipients have pain, swelling, or redness at the injection site. The vaccine may also produce a mild rash within about a month of the vaccination, which has been known to transmit chicken pox to others. Individuals who have recently been vaccinated should avoid close contact with anyone who might be susceptible to severe complications from chicken pox until the risk for a rash has passed.

In addition, months or even years after the vaccination, some people develop a mild infection termed modified varicella-like syndrome (MVLS). The condition appears to be less contagious and have fewer complications than naturally acquired chicken pox. Reports of serious events, including seizures, pneumonia, anaphylactic reaction, or death have been reported in two out of 100,000 doses. It is not known if there is any causal relationship between these events and the vaccination.

What Are the Vaccines for Hep-B? Description. About 350 million people carry hepatitis B worldwide. The average lifetime risk for acquiring the infection in the US is about 5% although some groups have a much higher risk. In the US, there are about 1-1.35 million people with chronic hepatitis B, which poses a risk for cirrhosis and liver cancer. Pregnant women with hepatitis B can transmit the virus to their babies. Even if they are not infected at birth, unvaccinated children of infected mothers run a 60% risk of developing hepatitis B before age five. Each year in the United States, approximately 4,000 persons die of HBV-related cirrhosis and 800 of HBV- related liver cancer.

Vaccine for Hep-B. Several inactivated virus vaccines, including Recombivax HB, GenHevac B, Hepagene, and Engerix-B, can prevent hepatitis B and are safe, even for infants and children. Vaccination programs are also proving to reduce the risk for liver cancer.

Hepatitis B Vaccine for Early Childhood. Because the incidence of hep-B is rising in the US, experts recommend immunizations against hepatitis B in all infants and in all children not previously vaccinated by the time they reach seventh grade. Infants of mothers infected with HBV should be treated with immune globulin and a series of vaccinations at birth, one month, and six months.

Hepatitis B Vaccine for Older Children and Adults Healthcare and public safety workers who may be exposed to blood products have a risk for hepatitis B virus that ranges from 15% to 30% and should certainly be vaccinated. People in the same household as HBV infected individuals should also be vaccinated, as should travelers to developing countries.

Anyone who is not infected with HBV and requires transfusions should be vaccinated; those with blood clotting disorders should have the vaccination administered under the skin not injected in the muscle. Other people at risk are sexually active people with multiple partners, patients and workers in mental institutions, morticians, patients on hemodialysis, and people who use injected drugs.

People on hemodialysis may need larger doses or boosters; they also may need to be re-vaccinated if blood tests indicate they are losing immunity. Pregnant women who at risk for the virus should be vaccinated; there is no evidence that the vaccine is dangerous to the fetus. People receiving treatments or have conditions that suppress the immune system may need the vaccination, although its benefits for this group are unclear except for those at high risk, such as people with HIV or spleen abnormalities.

Hepatitis B vaccine protection lasts at least seven years. Booster shots after that may be recommended depending on continuing risk. Three doses given over six months are usually required for adults; a recent study reported that older adults would benefit from a fourth dose without incurring serious side effects. People with alcoholism may need high doses. A small percentage of people do not develop immunity even after a vaccine has been given repeatedly.

A more potent vaccine is proving to be effective in many people who do not respond to a standard vaccine. This vaccine loses its effect after five years in about a third of those who have it. Unvaccinated people who have had intimate exposure to people with HBV may be protected with immune globulin, sometimes administered with the vaccine.

Side Effects of the Hepatitis B Vaccine Soreness at the injection site is the most common side effect. More serious side effects, such as nerve inflammation, are rare.

What Are the Vaccines for Poliomyelitis? Description of Poliomyelitis Poliomyelitis is a disorder marked by potentially paralyzing nerve-related damage, which can be fatal.

Vaccines for Poliovirus Two poliovirus vaccines are available in the U.S.: oral poliovirus vaccine (OPV), which is a live-virus vaccine, and inactivated poliovirus vaccine (IPV), which is a killed vaccine that is administered by injection. Both produce immunity in over 95% of people. The vaccines are given to children in a series of four doses: at two and four months of age and then at any time between six to 18 months after the second dose.

A fourth dose is given between four and six years. Either OPV or IPV can be used for the full series, but the FDA now recommends that most children receive the first two doses as inactivated poliovirus vaccine and the second two doses as oral polio virus.

Poliovirus Vaccine in Older Children and Adults The poliovirus vaccine is not usually recommended for people over 18. Exceptions are unvaccinated healthcare workers, laboratory technicians, or others exposed to polioviruses. Travelers to developing countries where outbreaks of poliovirus have been reported should be vaccinated. Adults should be given the inactivated poliovirus vaccine (IPV), since they may be at slightly higher risk for paralysis associated with the oral polio vaccine (see Side Effects below).

Side Effects of the Poliomyelitis Vaccines. Allergic Reactions. The inactivated poliovirus vaccine (IPV) contains small amounts of streptomycin and neomycin, so people allergic to these antibiotics can also have an allergic response to this vaccine. Patients should report any allergies to their physician.

Paralysis Rare cases of paralysis have occurred in people taking the oral live poliovirus vaccine or in those exposed to recipients of this vaccine. It should be stressed the risk is very small, with 8 to 10 cases reported each year out of millions of doses. The newly recommended series that uses inactivated poliovirus (IPV) vaccine (which does not pose any danger) for the first two doses and OPV for the second two doses should reduce even this small risk. People with compromised immune systems may be at particular risk for this side effect if they are exposed to a person vaccinated with OPV. Anyone receiving a vaccination who is likely to have contact with vulnerable individuals should be given the IPV vaccine.

What Is the Vaccine for Pneumococcal Pneumonia? Description of Pneumococcal Pneumonia The pneumococcal bacterium (also called Streptococcus pneumoniae) is responsible for diseases, particularly pneumonia, that kill 40,000 people every year in the United States, particularly those over 65 years. This bacterium is also dangerous for people with serious underlying chronic medical conditions and illnesses and is the leading cause of ear infections in children

Vaccine for Pneumococcal Pneumonia in Children & Adults. The pneumococcal vaccine contains material derived from the 23 most common strains of pneumococci; there are no living bacteria in the vaccine. Experts are now recom-mending that more people, including healthy older people, be given the pneumococcal vaccine, particularly in light of the increase in antibiotic-resistant bacteria.

People who should especially be vaccinated are adults and children who are receiving treatments to suppress the immune system or who have immune deficiencies (eg, HIV), kidney disease or kidney transplants, problems in the spleen, alcoholism (especially with cirrhosis), or any condition that places them at high risk for pneumonia. Protection lasts for over six years in most people, although the protective value may be lost at a faster rate in elderly people than in younger adults.

Unfortunately, the current vaccine is not very effective for young children or anyone with immune deficiencies -- who need protection the most. New vaccines are being developed that may prove to be effective for boosting immunity in many of these people.

One study reported that an effective vaccine for children under two could be available by 2000. Those at high risk for serious pneumonia should be re-vaccinated six years after the first dose. Older people who have had transplant operations or those with kidney disease may also require a revaccination.

Side Effects of the Pneumococcal Pneumonia Vaccine Side effects include pain and redness at the injection site, fever, and joint aches. Rarely, such local reactions can be severe. Even if a person is mistakenly re-vaccinated before the effects of the first vaccination have worn off, the risk for severe side effects is very low. Allergic reactions are very rare. Because the vaccine is inactive, it is safe for pregnant women and people with immune deficiencies.

What Are the Vaccines for Viral Influenza? Description of Viral Influenza Every year, influenza (the "flu") strikes millions of people worldwide. Although it is usually not serious in most healthy children and adults, the flu can cause severe complications, particularly pneumonia, in the elderly and those with underlying medical problems. Nursing homes are especially hard-hit by flu epidemics, with fatality rates as high as 30%. Influenza epidemics are most serious when they involve a new strain against which most people are not immune. Such pandemics are worldwide; they can infect more than one fourth of the population within a three month period.

Vaccines for Viral Influenza The two major influenza viruses are called A and B. Unfortunately, influenza A viruses undergo changes (antigenic drift) over time, so a vaccine that works one year may not work the next. Vaccines are then redesigned annually to match the current strain. Influenza B viruses tend to be more stable than influenza A viruses, but they too vary. The vaccines use inactivated, not live, viruses. Flu shots are given in the fall, usually between October and December. Amantadine (Symmetrel) and rimantadine (Flumadine) are drugs that offer some protection against influenza A, and may also shorten the duration and lessen the severity of the flu if given within 48 hours of onset of symptoms. They are not effective, however, against influenza B. An experimental vaccine (FluMist) is made from weakened influenza viruses that are engineered to grow only in cooler temperatures found in the nasal passages -- not in the warmer temperatures of the lungs and lower airways. The vaccine boosts the specific immune factors in the mucous membranes of the nose that fight off the actual viral infections. It is employed using a nasal spray and in one study provided protection against the flu in 93% of children.

Influenza Vaccine in Children Any child with a condition that requires regular medical care or who has been hospitalized for a serious illness should be vaccinated against influenza. Children who are receiving long-term aspirin therapy should also be immunized against the flu, because they are at higher risk for Reyes syndrome, a life-threatening disease, if they get the flu.

Influenza Vaccines in Older Children and Adults The vaccines may be slightly less effective in the elderly, the very young, and patients with certain chronic diseases than in healthy young adults. Even in people with a weaker response, however, the vaccine is usually protective against serious flu complications, particularly pneumonia, although patients may still experience symptoms in the upper respiratory tract (the nose and throat). All adults 65 years and older -- particularly those in nursing homes -- and anyone at risk for serious complications from the flu should have an annual vaccination. Those at high risk include people with heart disease, lung problems, immune deficiencies, diabetes, kidney disease, or chronic blood disease, such as sickle cell disease. Certain other younger adults who should be vaccinated include health care workers and others who may expose high-risk people to the flu. People with HIV should be vaccinated, although the vaccine does not appear to be very effective in those with advanced cases and a booster shot adds little value. People at risk for complications for influenza and who are traveling to the tropics at any time or to the southern hemisphere between April and September should consider vaccination. Pregnant women who are at risk for complications of influenza should be vaccinated, usually after the first trimester unless they are in their first trimester during flu season and their risk from complications of the flu is higher than any theoretical risk to the baby from the vaccine.

Side Effects of the Influenza Vaccines Newer vaccines contain very little egg protein, but an allergic reaction still may occur in people with strong allergies to eggs. Almost a third of people who receive the influenza vaccine develop redness or soreness at the injection site for one or two days afterward. Other side effects include mild fatigue and muscle aches and pains; they tend to occur between six and 12 hours after the vaccination and last up to two days. It should be noted that these symptoms are not influenza itself but an immune response to the virus proteins in the vaccine. Anyone with a fever, however, should not be vaccinated until the ailment has subsided.

What Are the Vaccines for Haemophilus Type B? Description of Haemophilus influenzae Type B Haemophilus influenza is a bacterium, which, despite its name, is entirely different from the viruses that cause influenza (see above). Before vaccination, Haemophilus influenzae type B was the most common cause of childhood bacterial meningitis, killing 600 American children every year and leaving others deaf, mentally retarded, or epileptic. It is rarely troublesome for adults, although it can be dangerous for anyone with chronic lung disease and those susceptible to infections.

Vaccine for Haemophilus influenzae Type B



Three equally effective inactivated bacterial vaccines are available for Haemophilus influenzae type B (called Hib vaccines). All children under five should be vaccinated against Haemophilus influenzae. The vaccine is administered as an injection at two, four, and six months and then as a booster some time between 12 and 15 months of age. In children older than 15 and 18 months, the Hib and DTaP vaccines are being combined in a single injection. Experts warn, however, that some physicians are administering this combined vaccine to infants six months and younger, which may reduce the effectiveness of the Hib component in such small children. The Hib vaccine may also benefit older people who have had splenectomies or illnesses that put them at risk for pneumonia, including sickle cell disease, leukemia, and HIV infection and adults.

Side Effects of Haemophilus influenzae Type B Vaccine Side effects of the Hib vaccine include redness and pain at the injection site, moderate fever, and, in rare cases, weakness, nausea, and dizziness.

What is the Vaccine for Rotavirus? Description of Rotavirus Rotavirus is the most common cause of diarrhea, cramps, and vomiting in infants, and affects about 3.5 million children in the US each year. As many as 80% of small children become infected with the virus. Although most cases in this country are mild, more than 50,000 American children are hospitalized and as many as 125 die from severe diarrhea every year. Worldwide the virus can be devastating, causing up to one million infant deaths annually.

Vaccines for Rotavirus An oral vaccine completely prevents rotavirus illness in 68% of vaccinated children and prevents severe complications in anyone who becomes infected. The vaccine is now recommended for all infants ages two, four, and six months of age. The vaccine series should not be started in children over six months old.

Symptoms of Severe Reactions to Vaccinations Call the doctor immediately, if a child has any of the following symptoms: Extremely High Fever A rectal temperature of 105 degrees Fahrenheit or higher. (Temperatures taken under the arm or by mouth often register lower than actual temperatures.)

Inconsolable Crying The child has been crying for over 3 hours without stopping or has a cry that isn't normal, such as being high-pitched.

Convulsions The child's body starts shaking, twitching, or jerking. This is usually in response to a high fever. Place the child face down with the head to one side, protecting the head from hitting anything hard. Be sure the child can breath freely. Seizures caused by fevers usually last less than 15 minutes.

Shock The child collapses. Severe Allergic (Anaphylactic) Reaction Swelling in the mouth and throat, wheezing and breathing difficulties, dizziness. The child collapses or is pale and limp.

Call the doctor if the following symptoms persist for more than 24 hours: the injection site is still red and tender *fever does not go down *the child is still fussy

Less Common Vaccinations Disease Who Should be Vaccinated Side Effects and Comments

Rabies Anyone exposed to secretions of an animal suspected of having rabies should be given the rabies vaccine. They should also receive immune globulin unless they were previously vaccinated. Veterinarians and animal handlers should be vaccinated. This does not eliminate the need for treatment if they are exposed to rabies, but it reduces the intensity of the treatment.

Pain, redness, and swelling at the injection site. Headache, nausea, stomach pain, muscle aches, and dizziness. Allergic response, which can occur after the first shot and as long as 21 days after a booster shot. Rare cases of neurologic disorders that cause pain and paralysis in the legs and arms, which clear up in about 12 weeks.

Plague Veterinarians and assistants in Western US or anyone who works with potentially plague-infected animals; travelers to developing countries where outbreaks have occurred.

Not wholly protective; may only lessen severity of the disease. Preventive antibiotics needed for anyone exposed. Side effects include headache, malaise, fever, swollen lymph nodes. Occasionally, non-infected abscesses. Allergic reaction, particularly in those sensitive to beef, soy, milk, and phenol.

Anthrax People who work with imported animal hides, furs, bonemeal, wool, animal hair (especially goat hair), and bristles.

Yellow Fever Travelers to developing countries where outbreaks have occurred, currently parts of Africa and Central and South America.

Anaphylactic reactions in those allergic to eggs. Lower immunity when given with cholera vaccine -- the vaccines should be given three weeks apart.

Cholera Travelers to developing countries where outbreaks have occurred.

Anaphylactic reactions in those allergic to eggs. Pain and swelling at injection site. Fever, malaise, and headache. Lower immunity when given with yellow fever vaccine. In general, vaccine only 50% protective. Vaccination of dubious benefit.

Typhoid Travelers to developing countries where outbreaks have occurred. Oral vaccine using weakened bacteria is preferred to older injected inactivated vaccine. Side effects of oral vaccine (uncommon): nausea, cramps, rash or hives. Side effects of inactivated vaccine: irritation at the injection site. Oral vaccine not recommended for young children or those with impaired immune systems.

Tuberculosis Individuals exposed to infected people. Bacille Calmette-Guerin vaccine has been standard vaccine, but its effectiveness has been questioned. No longer recommended in US except for certain high-risk children. Adults and others at risk usually take the drug isoniazid for prevention.

Hepatitis A Travelers to developing countries, people living in communities where outbreaks occur, sexually active homosexual men, people with chronic liver disease, health care workers exposed to the virus. Individuals should also receive immune globulin if they are exposed within four weeks of the vaccination. Although not yet routinely given to children under two, the vaccine is proving to be safe for infants.

The vaccine is very safe and effective. It can be given along with immune globulin and other vaccines. Allergic responses can occur.

Meningitis caused by meningococcal bacteria People exposed to single cases or outbreaks; travelers to developing countries where outbreaks have occurred; patients with problems in the spleen.

Available vaccine effective against four subtypes of meningococcal bacteria but not for serogroup B, which causes up to 40% of meningococcal disease in the US.

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Adult Immunizations - Including Chemoprophylaxis Against Influenza A By U.S. Department of Health and Human Services Guide to Clinical Preventive Services

Recommendation: Annual influenza vaccine is recommended for all persons aged 65 and older and persons in selected high-risk groups (see Clinical Intervention). Pneumococcal vaccine is recommended for all immunocompetent individuals who are age 65 years and older or otherwise at increased risk for pneumococcal disease (see Clinical Intervention). There is insufficient evidence to recommend for or against pneumococcal vaccine for high-risk immunocompromised individuals, but recommendations for vaccinating these persons may be made on other grounds. The series of combined tetanus-diphtheria toxoids (Td) should be completed for adults who have not received the primary series, and all adults should receive periodic Td boosters. Vaccination against measles and mumps should be provided to all adults born after 1956 who lack evidence of immunity. A second measles vaccination is recommended for adolescents and young adults in settings where such individuals congregate (e.g., high schools and colleges). Hepatitis B vaccine is recommended for all young adults not previously immunized and for all persons at high risk for infection (see Clinical Intervention). Hepatitis A vaccine is recommended for persons at high risk for hepatitis A virus (HAV) infection (see Clinical Intervention). Varicella vaccine is recommended for susceptible adults.

Influenza - Burden of Suffering, which frequently causes incapacitating malaise for several days, is responsible for significant morbidity and decreased productivity during epidemics. Twenty thousand or more excess deaths have been reported during each of 10 different epidemics from 1972-1973 to 1990-1991; more than 40,000 excess deaths occurred in each of three of these epidemics.1 During severe pandemics (e.g., 1957 and 1968), there are often high attack rates across all age groups, and mortality usually is markedly increased. Elderly persons and persons of all ages with certain chronic medical disorders (see Clinical Intervention) are at increased risk for complications from influenza infections. More than 90% of the deaths attributed to pneumonia and influenza in these epidemics occurred among persons aged 65 and older.1 Influenza has been estimated to cause a yearly average of 4.1-4.4 million excess respiratory illnesses and 16.6-17.9 million excess bed and restricted activity days in persons over 20 years of age.2 Excess rates of hospitalization have also been documented for children with influenza who have chronic conditions such as severe asthma, cystic fibrosis, and diabetes.3

Efficacy of Vaccine Inactivated (killed-virus) influenza vaccine containing antigens identical or similar to currently circulating influenza A and B viruses has been shown in controlled trials to be 70-80% effective in preventing influenza illness or reducing severity of influenza illness in healthy children, adolescents, and adults under age 65.4-8 The vaccine has also been reported to reduce clinical symptoms in health care workers,9 which may translate into a reduction in transmission to high-risk patients.

Only one randomized placebo-controlled trial has studied vaccine efficacy in high-risk persons for whom the vaccine is generally recommended. This trial enrolled 1,838 persons aged 60 years and older, three fourths of whom had no risk factors other than age.10 During the influenza season, the vaccine significantly reduced the proportion with influenza-like illness (from 3% to 2%) and with serologically diagnosed infections (from 9% to 4%). In stratified analyses, protective efficacy was similar in healthy older adults and those with chronic disease but was reduced in subjects 70 years of age or older. In a poorly reported randomized controlled trial comparing different types and dosages of influenza vaccine in elderly persons living in the community,11 one of the vaccines reduced clinical illness rates by 50-70% compared with other vaccine types and dosages. Illness rates were also substantially reduced compared to an unvaccinated cohort not enrolled in the trial. In a large serial cohort study of community-dwelling elderly persons, influenza vaccination reduced hospitalization rates by 48-57% for pneumonia and influenza and by 27-39% for all acute and chronic respiratory conditions, after adjustment for covariates.12 Case-control studies in persons who are 65 years or older have reported that during epidemic periods when there was a good antigenic match between vaccine and virus, influenza vaccination prevented 31-45% of hospitalizations for pneumonia and influenza 13-15 and 43-49% of deaths due to all respiratory conditions.13 In a separate analysis using vital statistics data, influenza vaccination reduced total mortality by 27-30% among individuals aged 45 years or older.13

Adequately designed and performed observational studies conducted during influenza outbreaks also generally support the efficacy of influenza vaccine in preventing illness, hospitalization, and mortality in the institutionalized elderly population and in community-dwelling elderly persons with high-risk chronic conditions, although efficacy estimates vary widely (e.g., 24-58% efficacy against pneumonia).16-22 Vaccination of nursing home residents also may prevent institutional outbreaks.23 Randomized controlled trials in nursing homes have suggested that greater protection may be offered by other, as yet unlicensed, vaccine formulations or combinations (e.g., diphtheria toxoid conjugate vaccine or addition of live intranasal vaccine).24,25 Data are more limited for younger high-risk persons. One cohort study in children with moderate to severe asthma demonstrated 49% vaccine efficacy against clinical illness despite a poor antigenic match with the epidemic influenza A virus, but no effect was seen on hospitalizations or asthma attack rates or severity.26

Because of frequent seasonal variation in the hemagglutinin and neur-aminidase antigens of circulating viruses ("antigenic drift"), it is necessary to administer the vaccine annually each fall, prior to the epidemic season. This schedule allows the annually reformulated influenza vaccine to include antigens detected from recent global viral surveillance, which are likely to be circulating during the subsequent season. Although allergic reactions have been described, principally in patients with hypersensitivity to eggs, serious adverse effects from influenza vaccine are quite uncommon.1 Randomized placebo-controlled trials of influenza vaccine have reported no difference in systemic reactions, but mild local side effects were more common after vaccine and occurred in up to 20% of patients.27,28

Amantadine and rimantadine are 70-90% effective in preventing illness caused by outbreaks of naturally occurring strains of influenza A viruses when used prophylactically in healthy community-living or institutionalized persons.29-34 Several trials have shown much lower protection rates,35,36 however, possibly due to late initiation of chemoprophylaxis or inadequate compliance. No controlled trials of these medications have been conducted in nursing home populations, but observational studies support the efficacy of chemoprophylaxis as an adjunct to vaccination during influenza A outbreaks in these institutions.21,37,38 Neither drug is effective as prophylaxis against influenza A for household members of simultaneously treated index cases,39,40 although amantadine has been proven efficacious in preventing influenza A disease when the index case is not treated.41 Transmission of resistant viruses from treated patients may reduce the efficacy of chemoprophylaxis in household or institutional contacts.22,39 Neither drug prevents influenza B infection, so they are appropriate only in presumed influenza A epidemics.

Amantadine and rimantadine produce transient insomnia, anxiety, nausea, dizziness, and impaired concentration in 5-25% of patients.42-47 The risk of adverse central nervous system effects has been shown to be significantly lower with rimantadine.33 Adverse effects occur more frequently and with greater severity in older persons and have been associated with increased risk of falls.48,49 Toxic levels resulting from reduced drug clearance have been identified in elderly persons.42,49

Pneumococcal Disease Burden of Suffering Pneumococcal disease is a significant cause of morbidity and mortality in the U.S. Although pneumococcal infection is not a reportable disease, population-based surveillance studies have reported annual invasive pneumococcal disease rates of at least 15-19/100,000 population and pneumococcal meningitis rates of 0.3-1.2/100,000.50-54 Significantly higher incidence rates are reported for persons less than 5 years of age or over age 65; blacks, Native Americans, and Alaska Natives; nursing home residents; alcoholics; and those with underlying chronic medical or immunodeficient conditions.50-57 Pneumococcal disease accounts for about 15% of severe community-acquired pneumonia, which has a case-fatality rate (proportion of cases resulting in death) of 9-26%.58-63 Pneumococcal bacteremia and meningitis are also associated with high case-fatality rates.50-54,63,64 The highest case-fatality rates from invasive pneumococcal infection occur in elderly persons (30-43%) and patients with co-morbid conditions (25-27%), and the lowest occur in healthy children (0-3%).50-53,63 In recent years, drug-resistant strains of Streptococcus pneumoniae have emerged; recent estimates suggest that in some locales 15% or more of pneumococcal isolates are drug resistant.50,65,65a The emergence of drug-resistant strains underscores the importance of preventing pneumococcal disease by vaccination.

Efficacy of Vaccine The 14-valent polysaccharide pneumococcal vaccine, which was licensed in 1977, was replaced in 1983 by a 23-valent polysaccharide vaccine.66 The latter contains purified capsular materials from 88% of the strains of S. pneumoniae causing bacteremic pneumococcal disease reported in the U.S.67 In randomized controlled trials, 4- to 13-valent pneumococcal vaccines were 76-92% efficacious in preventing pneumococcal pneumonia in healthy young adult populations living in epidemic conditions.68-70 A 14-valent vaccine was also efficacious in reducing respiratory mortality in a population from a developing country.71 The efficacy of pneumococcal vaccine in the general U.S. population has not been determined with certainty. Controlled trials in the U.S. involving low-risk middle-aged and older adults failed to demonstrate protective efficacy,72 although the relatively low incidence of pneumococcal infection in healthy U.S. adults makes efficacy difficult to establish in a prospective clinical trial. A meta-analysis combining the most recent trials (follow-up periods of 16-36 months) in low-risk populations in the U.S. and elsewhere reported significant reductions in definitive and presumptive pneumococcal pneumonia with vaccination.73 Vaccinated individuals had 11 fewer episodes of definitive pneumococcal pneumonia and 25 fewer episodes of presumptive pneumococcal pneumonia per 1,000 subjects. Results were similar for definitive and presumptive pneumonia due to vaccine types only. Small reductions in mortality were not statistically significant.

Trials in relatively healthy institutionalized elderly (greater than or equal to 50-55 years of age) have demonstrated significant reductions in the incidence of pneumonia, and in mortality in one study, with 3- and 14-valent vaccines, although these trials were limited by flaws in design and conduct.74,75 Other trials of 14- to 17-valent vaccines in high-risk populations, all adequately designed and conducted, have been unable to detect significant reductions in pneumococcal or all-cause pneumonia or mortality.76-79 A meta-analysis combining five trials in high-risk populations also reported no effects of vaccine on pneumococcal pneumonia, all-cause pneumonia, or mortality.73 The sample sizes were much smaller than for the analyses in low-risk populations, but effect estimates for most outcomes did not suggest important benefits.

One possible explanation for the lack of vaccine efficacy in trials in high-risk populations is that the trials may have included subsets of individuals for whom the vaccine has little benefit. Case-control studies and indirect cohort studies (comparing the distribution of pneumococcal serotypes in the blood of vaccinated and unvaccinated persons) have been much more feasible to perform than controlled trials, although such observational studies may be more prone to bias. These studies support the protective value of pneumococcal vaccine in immunocompetent recipients, with vaccine efficacy estimates of 60-75% reported but not in severely or relatively immunocompromised individuals, including those with alcoholism, chronic renal failure, immunoglobulin deficiency, nephrotic syndrome, sickle cell disease, multiple myeloma, metastatic or hematologic malignancies, or systemic lupus erythematosus.80-86 For some of these disorders, efficacy point estimates suggest a benefit, but confidence intervals are wide and include the possibility of no benefit. Additional research is needed to obtain more definitive data on the efficacy of pneumococcal vaccine and to develop vaccines that have better efficacy in both immunocompetent and immunocompromised individuals, as well as in high-risk children under 2 years of age.

The total duration of antibody protection from pneumococcal vaccination is unknown; elevated titers appear to persist in adults for at least 5 years after immunization, but in some persons, they may fall to prevaccination levels within 10 years.66 A case-control study reported a statistically significant decline in protective efficacy with increasing time since vaccination (e.g., from 88% within 3 years to 75% if greater than or equal to 5 years since vaccination in persons aged 55-64).81 On the other hand, an indirect cohort study reported that clinical efficacy persisted at least 7-10 years.84

There is little evidence of serious adverse effects from this vaccine, although erythema, induration, or pain at the injection site occur in about one third to one half of patients. Fever, myalgia, and severe reactions occur in no more than 1% of patients.66,72 Most evidence indicates little difference in adverse reactions to revaccination compared to initial vaccination.66

Tetanus and Diphtheria Burden of Suffering Largely as a result of routine immunization, tetanus and diphtheria have become uncommon diseases in the U.S.: 51 cases of tetanus (0.02/100,000) and 2 cases of diphtheria were reported in 1994.86a In 1948, before tetanus and diphtheria toxoids were widely introduced, there were over 600 cases of tetanus and about 9,500 cases of diphtheria in the U.S.87 The prevalence of immunity to tetanus in the U.S. population, as measured by serum antibodies, declines with age beginning at age 40 and is only 28% among persons ages 70 or older.88 Adults ages 50 and older account for the majority of cases of tetanus.87,88 Tetanus remains a serious infection, with death occurring in 19-24% of cases.88,89 Reports may underrepresent tetanus mortality by as much as 60%.90 The tetanus case-fatality rate increases with age and is 26% for persons ages 70 and older.88 The case-fatality rate is also high in neonates, indicating the need to adequately immunize women of childbearing age against tetanus. Diphtheria is a potentially severe illness, with a case-fatality rate of 5-10% in unvaccinated individuals. The disease is rare in the U.S., but large outbreaks have occurred in other developed countries despite relatively high rates of childhood immunization.91-94

Efficacy of Vaccine The efficacy of the tetanus and diphtheria toxoids is established on the basis of clinical studies and decades of experience with universal childhood immunization.95,96 A primary series of three doses of Td, followed by a booster dose, is highly effective in producing protective antibody titers lasting as long as 15-25 years and results in anamnestic responses with booster immunization as much as 20-30 years later.97-104 In Sweden, a five-dose regimen (primary series plus boosters at age 8-10 and 18 years) resulted in greater than 90% of subjects having protective tetanus antitoxin levels at age 50 years, slightly fewer than at age 30.105 Tetanus is unlikely in Americans who have received a primary vaccination series,89,90,106 although clinical immunity may wane somewhat after 10-20 years.89 Td often produces mild local inflammation, occasionally Arthus-type reactions and peripheral neuropathy (following frequent boosters), and rarely, anaphylaxis.107-110

Measles, Mumps, and Rubella Burden of Suffering Measles, a childhood illness, was reported in 232 (0.1/100,000) American adults (aged 20 or older) in 1994, a substantial decline from the recent peak of 6,210 cases (3.9/100,000) reported in 1990.87,111 Adults accounted for nearly one fourth of all cases with known age reported in 1994.111 About one third of adult infections occur among persons ages 20-24,87 often in places where young adults congregate, such as schools or college campuses.111 Hospitalization for measles and complications such as pneumonia and encephalitis are more common in adults than in school-aged children. Mumps infection was reported in 319 persons greater than or equal to 20 years of age in 1993 (0.2/100,000), accounting for 20% of reported cases with known age.87 Mumps outbreaks continue to occur periodically in schools and similar settings; in several recent outbreaks, most of those infected had previously been vaccinated against mumps.111ac

Efficacy of Vaccine

The 14-valent polysaccharide pneumococcal vaccine, which was licensed in 1977, was replaced in 1983 by a 23-valent polysaccharide vaccine.66 The latter contains purified capsular materials from 88% of the strains of S. pneumoniae causing bacteremic pneumococcal disease reported in the U.S.67 In randomized controlled trials, 4- to 13-valent pneumococcal vaccines were 76-92% efficacious in preventing pneumococcal pneumonia in healthy young adult populations living in epidemic conditions.68-70 A 14-valent vaccine was also efficacious in reducing respiratory mortality in a population from a developing country.71 The efficacy of pneumococcal vaccine in the general U.S. population has not been determined with certainty. Controlled trials in the U.S. involving low-risk middle-aged and older adults failed to demonstrate protective efficacy,72 although the relatively low incidence of pneumococcal infection in healthy U.S. adults makes efficacy difficult to establish in a prospective clinical trial. A meta-analysis combining the most recent trials (follow-up periods of 16-36 months) in low-risk populations in the U.S. and elsewhere reported significant reductions in definitive and presumptive pneumococcal pneumonia with vaccination.73 Vaccinated individuals had 11 fewer episodes of definitive pneumococcal pneumonia and 25 fewer episodes of presumptive pneumococcal pneumonia per 1,000 subjects. Results were similar for definitive and presumptive pneumonia due to vaccine types only. Small reductions in mortality were not statistically significant.

Trials in relatively healthy institutionalized elderly (greater than or equal to 50-55 years of age) have demonstrated significant reductions in the incidence of pneumonia, and in mortality in one study, with 3- and 14-valent vaccines, although these trials were limited by flaws in design and conduct.74,75 Other trials of 14- to 17-valent vaccines in high-risk populations, all adequately designed and conducted, have been unable to detect significant reductions in pneumococcal or all-cause pneumonia or mortality.76-79 A meta-analysis combining five trials in high-risk populations also reported no effects of vaccine on pneumococcal pneumonia, all-cause pneumonia, or mortality.73 The sample sizes were much smaller than for the analyses in low-risk populations, but effect estimates for most outcomes did not suggest important benefits.

One possible explanation for the lack of vaccine efficacy in trials in high-risk populations is that the trials may have included subsets of individuals for whom the vaccine has little benefit. Case-control studies and indirect cohort studies (comparing the distribution of pneumococcal serotypes in the blood of vaccinated and unvaccinated persons) have been much more feasible to perform than controlled trials, although such observational studies may be more prone to bias. These studies support the protective value of pneumococcal vaccine in immunocompetent recipients, with vaccine efficacy estimates of 60-75% reported but not in severely or relatively immunocompromised individuals, including those with alcoholism, chronic renal failure, immunoglobulin deficiency, nephrotic syndrome, sickle cell disease, multiple myeloma, metastatic or hematologic malignancies, or systemic lupus erythematosus.80-86 For some of these disorders, efficacy point estimates suggest a benefit, but confidence intervals are wide and include the possibility of no benefit. Additional research is needed to obtain more definitive data on the efficacy of pneumococcal vaccine and to develop vaccines that have better efficacy in both immunocompetent and immunocompromised individuals, as well as in high-risk children under 2 years of age.

The total duration of antibody protection from pneumococcal vaccination is unknown; elevated titers appear to persist in adults for at least 5 years after immunization, but in some persons, they may fall to prevaccination levels within 10 years.66 A case-control study reported a statistically significant decline in protective efficacy with increasing time since vaccination (e.g., from 88% within 3 years to 75% if greater than or equal to 5 years since vaccination in persons aged 55-64).81 On the other hand, an indirect cohort study reported that clinical efficacy persisted at least 7-10 years.84

There is little evidence of serious adverse effects from this vaccine, although erythema, induration, or pain at the injection site occur in about one third to one half of patients. Fever, myalgia, and severe reactions occur in no more than 1% of patients.66,72 Most evidence indicates little difference in adverse reactions to revaccination compared to initial vaccination.66

Tetanus and Diphtheria Burden of Suffering Largely as a result of routine immunization, tetanus and diphtheria have become uncommon diseases in the U.S.: 51 cases of tetanus (0.02/100,000) and 2 cases of diphtheria were reported in 1994.86a In 1948, before tetanus and diphtheria toxoids were widely introduced, there were over 600 cases of tetanus and about 9,500 cases of diphtheria in the U.S.87 The prevalence of immunity to tetanus in the U.S. population, as measured by serum antibodies, declines with age beginning at age 40 and is only 28% among persons ages 70 or older.88 Adults ages 50 and older account for the majority of cases of tetanus.87,88 Tetanus remains a serious infection, with death occurring in 19-24% of cases.88,89 Reports may underrepresent tetanus mortality by as much as 60%.90 The tetanus case-fatality rate increases with age and is 26% for persons ages 70 and older.88 The case-fatality rate is also high in neonates, indicating the need to adequately immunize women of childbearing age against tetanus. Diphtheria is a potentially severe illness, with a case-fatality rate of 5-10% in unvaccinated individuals. The disease is rare in the U.S., but large outbreaks have occurred in other developed countries despite relatively high rates of childhood immunization.91-94

Efficacy of Vaccine The efficacy of the tetanus and diphtheria toxoids is established on the basis of clinical studies and decades of experience with universal childhood immunization.95,96 A primary series of three doses of Td, followed by a booster dose, is highly effective in producing protective antibody titers lasting as long as 15-25 years and results in anamnestic responses with booster immunization as much as 20-30 years later.97-104 In Sweden, a five-dose regimen (primary series plus boosters at age 8-10 and 18 years) resulted in greater than 90% of subjects having protective tetanus antitoxin levels at age 50 years, slightly fewer than at age 30.105 Tetanus is unlikely in Americans who have received a primary vaccination series,89,90,106 although clinical immunity may wane somewhat after 10-20 years.89 Td often produces mild local inflammation, occasionally Arthus-type reactions and peripheral neuropathy (following frequent boosters), and rarely, anaphylaxis.107-110

Measles, Mumps, and Rubella Burden of Suffering Measles, a childhood illness, was reported in 232 (0.1/100,000) American adults (aged 20 or older) in 1994, a substantial decline from the recent peak of 6,210 cases (3.9/100,000) reported in 1990.87,111 Adults accounted for nearly one fourth of all cases with known age reported in 1994.111 About one third of adult infections occur among persons ages 20-24,87 often in places where young adults congregate, such as schools or college campuses.111 Hospitalization for measles and complications such as pneumonia and encephalitis are more common in adults than in school-aged children. Mumps infection was reported in 319 persons greater than or equal to 20 years of age in 1993 (0.2/100,000), accounting for 20% of reported cases with known age.87 Mumps outbreaks continue to occur periodically in schools and similar settings; in several recent outbreaks, most of those infected had previously been vaccinated against mumps.111a

Efficacy of Vaccine A single dose of measles vaccine is 95% effective in producing long-term immunity.112,113 Seropositivity rates remain high at least 10-15 years following vaccination,114,115 and cohorts of known seroconverters have shown little evidence of increasing disease incidence with time since immunization.115 Adult infections occur primarily in persons who have not been naturally infected or appropriately vaccinated in the past,111 as well as those who were vaccinated before age 15 months.116,117 Persons born before 1957 are likely to have been naturally infected and need not be considered susceptible.118 Based on the age distribution and location of recent measles outbreaks,111,117 revaccination of young adults in settings such as colleges and the workplace is likely to be most effective in reducing incidence in adults. Measles outbreaks are less common at colleges where two doses of vaccine are required prior to matriculation.119 When outbreaks do occur in these settings, attack rates are lower among persons who have had two doses of vaccine.117,120,122-124 Measles has been virtually eliminated among military recruits by revaccinating those whose screening sera suggest they are susceptible despite a history of vaccination.125

Since the introduction of mumps vaccine in the United States in 1967, there has been a 99% decline in the incidence of mumps, supporting the efficacy of this vaccine.111a The incidence of mumps in adults declined 50% between 1988-1990 and 1991-1993.111a Recommendations issued in 1989 for a two-dose measles vaccination schedule, with MMR recommended as the preferred vaccine, may have contributed to this recent decline. The age distribution and location of recent mumps outbreaks also suggests that revaccinating young adults in settings such as schools and colleges may be effective in reducing the incidence in adults. As with measles, persons born before 1957 can generally be considered immune to mumps and need not be vaccinated.

Adverse effects of measles or combined measles-mumps-rubella (MMR) vaccine in adults are usually mild and self-limited.118,126 Administration of MMR vaccine is not associated with adverse effects in persons already immune to these diseases, and thus the combined MMR vaccine is preferable to individual vaccines such as measles vaccine, since many recipients may be susceptible to more than one of the three diseases MMR prevents.

Hepatitis B Burden of Suffering An estimated 200,000-300,000 persons become infected with hepatitis B virus (HBV) in the U.S. each year and more than 10,000 require hospitalization.127,128,188 The risk of developing a chronic HBV infection (i.e., carrier state) after acute infection is about 6-10% in adults.127,130,131 Some 1-1.25 million persons in the U.S. are chronic HBV carriers.188 About one quarter of carriers develop chronic active hepatitis, which can progress to cirrhosis; carriers are also at risk for developing hepatocellular carcinoma.128,132,133 Some 5,000 hepatitis B-related deaths occur each year as a result of cirrhosis and liver cancer.128 Persons with acute or chronic HBV infection are also at risk for infection with hepatitis delta virus (HDV), which can itself cause acute, possibly fulminant, hepatitis or chronic hepatitis that may progress to cirrhosis.128 Since HDV cannot be transmitted in the absence of HBV infection, measures to prevent HBV infection will also prevent the complications of HDV infection.

Efficacy of Vaccine Plasma-derived hepatitis B vaccine, which became available in 1982, has 85-95% protective efficacy when administered in three intramuscular doses to immunocompetent patients.134-138 Controlled trials and time series in adult responders to plasma-derived vaccine indicate persistent protection against clinical HBV infection and chronic carriage lasting at least 7-9 years despite declines in protective antibody levels.139-141,147 The recombinant vaccines licensed in 1986 and currently in use in the U.S. induce antibody responses and short-term efficacy (up to 5 years) similar to those of the plasma-derived vaccine.142-145 Information on longer-term efficacy is not yet available for recombinant vaccines. The possible need for booster doses after longer intervals will be assessed as additional data become available.

Compared to healthy young persons, older adults, overweight persons, smokers, chronic hemodialysis patients, injection drug users, and human immunodeficiency virus (HIV)-infected patients are significantly less likely to have an adequate antibody response to the vaccine; those who do respond have a more rapid decline in antibody levels.142,146-155 A repeat vaccination series in persons who fail to respond to the first series results in moderate antibody response in up to 50%.156 Injection into the buttocks has been associated with a suboptimal immune response, and therefore the deltoid muscle is the preferred injection site.128,146 Local soreness at the injection site is a common side effect.145 There have been several case reports of nonfatal anaphylaxis from recombinant hepatitis B vaccine.157

Hepatitis A Burden of Suffering Almost 27,000 cases of hepatitis A were reported in the U.S. in 1994 (10.3/100,000),86a although the actual number of cases is estimated to be several times higher.128 Adults aged 20-39 years account for 43% of reported cases.87 About half of reported hepatitis cases in the U.S. are attributable to hepatitis A.128 The case-fatality rate and clinical severity of hepatitis A increase with increasing age.128,158 Groups at high risk for hepatitis A include certain Alaska Native, Pacific Islander, and Native American populations, institutionalized persons and workers in these institutions, men who have sex with men, users of injection or street drugs (depending on local epidemiology), certain laboratory workers, some religious communities, and travelers to countries where hepatitis A has intermediate or high endemicity.128,159,160 For susceptible travelers visiting developing countries, the incidence rate of hepatitis A has been estimated at 300 cases per 100,000 persons per month and the mortality rate at 3 deaths per 100,000 per month.160

Efficacy of Vaccine Inactivated hepatitis A vaccine, now licensed in the U.S., has been proven efficacious against hepatitis A in randomized controlled trials in children.161,162 Although trials evaluating clinical outcomes have not been performed in adults, hepatitis A vaccine produces seroconversion rates of 90-100% after one dose and 99-100% after two doses in healthy adult volunteers, including Alaska Natives.163-169 The duration of immunity has not been established, but in adults, protective levels of antibody have been shown to persist at least 4 years after administration of three doses of vaccine.164,168,170,170a Estimates from models of antibody decline after vaccination predict that protective levels could last at least 20 years.164 Vaccine efficacy is low in the first week after vaccination, rising to 77-90% at 2 weeks and 90-100% at 3-4 weeks.162,165,171,172,176

To provide immediate protection for those at high risk of exposure (e.g., travelers to endemic areas), giving immune globulin (IG) with the first vaccine dose may be necessary. Although several studies have reported lower mean antibody titers when the vaccine is administered concomitantly with IG, vaccine seroconversion rates appear to be comparable.173,176,181 Seroconversion rates do not appear to be adversely affected when hepatitis A vaccine is given with hepatitis B vaccine.174

In direct comparisons with IG, traditionally used as preexposure prophylaxis against hepatitis A for high-risk persons, the vaccine led to higher and longer-lasting antibody titers.175-181 The reported protective efficacy of hepatitis A vaccine is higher than that reported for, but the clinical efficacies of the two interventions have not been directly compared.

Adverse effects of the vaccine, including mild local reactions (pain, tenderness, redness, and swelling) and minor systemic symptoms such as fever, headache, and malaise, occur in 10-30% of recipients and are more common after the second and third doses.161,162,169,170,182,183 Serious allergic reactions without long-term consequences have been reported rarely in temporal association with hepatitis A vaccine.160

Recommendations of Other Groups Guidelines on adolescent and adult immunizations have been published by the American College of Physicians (ACP) and the Infectious Diseases Society of America (IDSA),184 the American Academy of Family Physicians,185 the American Academy of Pediatrics,3 the Canadian Task Force on the Periodic Health Examination,186 the American College of Obstetricians and Gynecologists (ACOG),186a and the Advisory Committee on Immunization Practices (ACIP).187 ACIP has also issued specific recommendations on the use of Td;96 pneumococcal,66 influenza,1 hepatitis B,128,170a,188 rubella,189 measles,118 varicella,189a and hepatitis A189b vaccines; and the use of vaccines in persons with altered immunocompetence.190 ACOG has issued detailed guidelines on the use of vaccines during pregnancy.191

A few of these recommendations differ from those made in this chapter. The Canadian Task Force recommends against pneumococcal vaccine in immunocompromised individuals and found insufficient evidence to recommend for or against routine pneumococcal vaccination for healthy community-living elderly persons.186 ACP184 recommends that a single Td booster at age 50 for those who have completed the full five-dose pediatric series is an equally acceptable alternative strategy to decennial Td boosters.96 ACIP and AAP recommend catch-up immunization with hepatitis B vaccine for adolescents aged 11-12 who have not been vaccinated previously, but they do not recommend routine hepatitis B vaccination for low-risk persons over 12 years, primarily because of cost and implementation considerations.3,188 ACIP recommends two doses of live measles vaccine or evidence of measles immunity for two groups in addition to those entering schools or colleges: persons who travel abroad and medical personnel at the time they begin employment.118 ACOG recommends routine influenza vaccine beginning at age 55 rather than 65 and hepatitis B vaccine only for high-risk groups.186a

Antiviral chemoprophylaxis against influenza A, using either rimantadine hydrochloride or amantadine hydrochloride, has been recommended by the ACP, IDSA, and ACIP for high-risk persons and their caretakers who cannot be or have very recently been vaccinated (i.e., within 2 weeks for adults; within 2 weeks of the second dose for children), immunodeficient individuals as a supplement to vaccine, and residents and unvaccinated staff during outbreaks in institutions.184,192

Discussion Most adults have not been immunized in accordance with existing immunization guidelines.193 Perceptions that adult vaccine-preventable infections are not important health problems and that available vaccines are not safe and efficacious193 can be readily refuted by the evidence already described. The cost of vaccines is another possible barrier to widespread immunization, but studies have shown that the prevention of morbidity and mortality from infectious diseases makes immunization cost-effective. For example, analyses of routine influenza and pneumococcal vaccination of persons aged 65 and older suggest that their cost-effectiveness is comparable to that of other widely recommended preventive services such as mammography or screening for hypertension.12,15,194,195 Hepatitis B vaccination of high-risk groups (those with HBV incidence 5%), with or without prior screening for susceptibility, has been shown to be cost-effective, even cost-saving in some analyses.196-198

Cost-effectiveness analysis may also provide guidance on appropriate vaccination strategies. Vaccination of high-risk newborns and adults against hepatitis B has been ineffective in eliminating the disease. One cost-effectiveness analysis reported that vaccinating all adolescents against hepatitis B, in addition to the current strategy of screening pregnant women and vaccinating high-risk newborns, would cost only $3,695 per year of life saved.198 While Td booster vaccination every 10 years is efficacious in preventing disease, antibody studies suggest that an interval of 15-30 years between boosters is likely to be adequate, especially given the small absolute risk of either disease in the U.S. A recent cost-effectiveness analysis reported that a decennial-booster strategy added a 2-minute survival advantage compared with a single booster at age 65 years, at a cost of $281,748 per year of additional life saved,199 although potential costs related to diphtheria were not incorporated into the analysis.200

Compared to IG, hepatitis A vaccine appears to have greater and longer-lasting efficacy against infection with fewer adverse effects, but it is unclear whether the benefits outweigh the costs of the vaccine. One cost-effectiveness analysis reported that for all age groups, use of IG for post-exposure prophylaxis or for preexposure short-term (less than or equal to 6 months) prophylaxis is less expensive than vaccination.201 Testing for hepatitis A antibodies in groups with a high prevalence of immunity (e.g., frequent travelers, military personnel, older persons) reduces vaccination costs, however. An analysis for British soldiers calculated a more favorable cost-benefit ratio for the vaccine than for IG if there were at least two exposures to areas endemic for hepatitis A in 4 years.202

Clinical Intervention Influenza vaccine should be administered annually to all persons ages 65 and older and to persons 6 months of age or older who are residents of chronic care facilities or suffer from chronic cardiopulmonary disorders, metabolic diseases (including diabetes mellitus), hemoglobinopathies, immunosuppression, or renal dysfunction ("B" recommendation). Influenza vaccine is also recommended for health care providers for high-risk patients ("B" recommendation). In persons at high risk for influenza A (e.g., during institutional outbreaks), amantadine or rimantadine prophylaxis (200 mg/day orally) may be started at the time of vaccination and continued for 2 weeks ("B" recommendation). A lower dose (less than or equal to 100 mg/day) of amantadine is recommended for persons with reduced creatinine clearance and those 65 years of age and older. A reduced dosage (100 mg/day) of rimantadine is indicated for those with reduced renal or hepatic function and for elderly nursing home residents and may also be necessary in healthy persons 65 years and older who experience side effects. Amantadine and rimantadine are most useful as short-term prophylaxis for high-risk persons who have not yet received the vaccine or are vaccinated after influenza A activity in the community has already begun; when the vaccine may be ineffective due to major antigenic changes in the virus; for unimmunized persons who provide care for high-risk persons; to supplement protection provided by vaccine in persons who are expected to have a poor antibody response; and for high-risk persons in whom the vaccine is contraindicated (i.e., those with anaphylactic hypersensitivity to egg protein). If vaccine is contraindicated, amantadine or rimantadine should be started at the beginning of the influenza season and continued daily for the duration of influenza activity in the community.

Pneumococcal vaccine is recommended for all immunocompetent individuals who are aged 65 years and older or otherwise at increased risk for pneumococcal disease ("B" recommendation). High-risk groups include institutionalized persons greater than or equal to 50 years of age, persons greater than or equal to 2 years of age with certain medical conditions, including chronic cardiac or pulmonary disease, diabetes mellitus, and anatomic asplenia (excluding sickle cell disease), and persons greater than or equal to 2 years of age who live in special environments or social settings with an identified increased risk of pneumococcal disease (e.g., certain Native American and Alaska Native populations). Routine revaccination is not recommended, but it may be appropriate to consider revaccination in immunocompetent individuals at highest risk for morbidity and mortality from pneumococcal disease (e.g., persons greater than or equal to 75 years of age or with severe chronic disease) who were vaccinated more than 5 years previously. Revaccination with the 23-valent vaccine may be appropriate for high-risk persons who previously received the 14-valent vaccine. There is insufficient evidence to recommend for or against pneumococcal vaccine as an efficacious vaccine for immunocompromised individuals, but recommendations for vaccinating these persons may be made on other grounds, including high incidence and case-fatality rates of pneumococcal disease and minimal adverse effects from the vaccine ("C" recommendation). Immunocompromised conditions associated with high risk for pneumococcal disease include alcoholism, cirrhosis, chronic renal failure, ne-phrotic syndrome, sickle cell disease, multiple myeloma, metastatic or hematologic malignancy, acquired or congenital immunodeficiency (including HIV infection), and other conditions associated with immunosuppression, such as organ transplant. It may be appropriate to consider periodic revaccination in these high-risk immunocompromised patients, who are likely to have poor initial antibody response and rapid decline of antibodies after vaccination.

The Td vaccine series should be completed for patients who have not received the primary series, and all adults should receive periodic Td boosters ("A" recommendation). For persons not previously immunized, the recommended schedule for the primary Td series is 0, 2, and 8-14 months. The optimal interval for booster doses is not established. The standard regimen is to provide a Td booster at least once every 10 years, but in the U.S., intervals of 15-30 years between boosters are likely to be adequate in persons who received a complete five-dose series in. For international travelers, an interval of 10 years between boosters is recommended.

Hepatitis B vaccine is recommended for all young adults not previously immunized ("A" recommendation). Hepatitis B vaccine is also recommended for susceptible adults in high-risk groups, including men who have sex with men, injection drug users and their sex partners, persons who have a history of sexual activity with multiple partners in the previous 6 months or have recently acquired another sexually transmitted disease, international travelers to countries where HBV is of high or intermediate endemicity, recipients of certain blood products (including hemodialysis patients), and persons in health-related jobs with frequent exposure to blood or blood products ("A" recommendation). The recommended regimen for the recombinant hepatitis B vaccine is to administer 10 or 20 mcg (depending on vaccine product) intramuscularly in the deltoid muscle at the current visit and at 1 and 6 months later. Clinicians should consider testing antibody response to the vaccine in individuals at very high risk from hepatitis B who are likely to have an inadequate antibody response (i.e., chronic renal dialysis patients, injection drug users, HIV-infected patients).

Hepatitis A vaccine is recommended for all high-risk adults ("B" recommendation). High-risk groups include persons living in, traveling to, or working in areas where the disease is endemic and periodic hepatitis A outbreaks occur (e.g., Alaska Native, Pacific Islander, and Native American communities, certain religious communities, countries with high or intermediate endemicity), men who have sex with men, users of injection or street drugs (depending on local epidemiology), military personnel, and certain hospital and laboratory workers. Hepatitis A vaccine may also be considered for institutionalized persons (e.g., in prisons and institutions for the developmentally disabled) and workers in these institutions and in day care centers. Where tracking or identification of high-risk patients is not practical or cost-effective, universal vaccination may be a reasonable policy given the minimal adverse consequences of the vaccine. At this writing, the only licensed hepatitis A vaccine is Havrix (SmithKline Beecham Pharmaceuticals). (*) Two doses (1,440 ELISA units/dose) at 0 and 6-12 months are recommended for persons over age 18 years. The need for periodic booster doses of the vaccine has not been established. For persons requiring immediate protection against hepatitis A (e.g., travelers to high-risk areas who have not previously been vaccinated), clinicians may wish to consider giving IG simultaneously with the first dose of hepatitis A vaccine, although the clinical efficacy of this approach has not been established. IG can also be recommended as an efficacious intervention for short-term (less than or equal to 5-6 months) preexposure prophylaxis against hepatitis A. While some evidence suggests that the vaccine may be more efficacious than IG, the clinical efficacies of these two interventions have not been directly compared. Other factors to consider in choosing between these two interventions include patient preference, the likely duration of exposure, the need for immediate vs. long-term protection, and cost.

(*) Use of trademarks is for identification only and does not imply endorsement by the Public Health Service or the U.S. Department of Health and Human Services.

Two doses of varicella vaccine delivered 4-8 weeks apart are recommended for healthy adults with no history of varicella infection or previous vaccination ("B" recommendation). Vaccination efforts should be targeted to susceptible health care workers and family contacts of immunocompromised individuals, and may also be targeted to susceptible adults who live or work in environments with a high likelihood of varicella transmission (e.g., day care centers, residential institutions, colleges, military bases). Given the high prevalence of immunity in adults with no history of chickenpox and the results of cost-effectiveness analysis, clinicians may wish to offer serologic testing for varicella susceptibility to history-negative adults who are likely to comply with return visits.

The draft update of this chapter was prepared for the U.S. Preventive Services Task Force by Carolyn DiGuiseppi, MD, MPH, based in part on background papers prepared for the U.S. Preventive Services Task Force by Modena Wilson, MD, MPH, and Donald Robinson, MD, MPH (measles vaccine), and for the Canadian Task Force on the Periodic Health Examination by Elaine Wang, MD, CM, FRCPC (pneumococcal vaccine).


\8 fake drugs

The Murderous Trade in Fake Drugs - Daily Policy Digest Health Issues / International Drug Issues Apr 9 02.

The WHO estimates that 10% of global pharmaceutical commerce is in fake drugs. Most of this trade takes place in the developing world, particularly SE Asia, where traffickers have networks of distributors as well as laboratories for making pills.

A recent survey of pharmacies in the Philippines found 8% of drugs bought were fakes. A countrywide survey in Cambodia in 1999 showed that 60 percent of 133 drug vendors sampled sold, as the antimalarial mefloquine, tablets that contained the ineffective but much cheaper sulphadoxine-pyrimethamine, obtained from stocks that should have been destroyed, or fakes that contained no drug at all.

Another recent survey found that 38% of tablets sold in five countries in SE Asia as the new antimalarial artesunate were phony. The use of fake drugs is not only killing people, it is also sending the incorrect message that parasites are becoming resistant to vital medicines. For example, reports of resistance to a key antimalarial in Cambodia turned out in fact to be due to the use of fake inactive drugs.

 Standards: Fake Drugs a Growing Problem By JOHN O'NEIL NYT Apr 16 02. The sale of fake or diluted drugs has reached disturbing proportions in the developing world, according to an article in The British Medical Journal.

A sampling of drugs sold by vendors in Cambodia found that 60 percent of the antimalaria pills sampled were either fake or cheaper, less effective compounds than were claimed.

Another survey found that 38% of the antimalaria medicine sold in five countries in SE Asia were fakes, and testing of the overall stocks of pharmacies in the Philippines indicated that 8 percent were fakes, the article said. The article's author, Dr Paul N. Newton of Oxford Univ, said some fakes were worse than ineffective.

Some adulterated versions of antimalaria drugs in Africa have been found to contain aspirin, which can be harmful to children, he said. Another side effect of such adulteration has been a loss in confidence in medicines, reflected in reports of drug-resistant strains of tropical illnesses that have turned out to reflect widespread sales of fake drugs.

American pharmacists have led successful crackdowns on fake cancer drugs, Dr. Newton said, but fighting adulteration in poor countries is harder. Even so, a campaign in Cambodia that relied on posters and radio announcements to educate people on how to spot fake antimalaria tablets has helped make the bogus drugs sold there less common, he said.

 Many drugs can be bought over the counter abroad. Do not do so without competent medical advice. When you do buy the stuff, check expiration date. Consider that the stuff may not have been stored under ideal conditions, unrefrigerated, in the sun, etc.

Some Third world countries in africa, SE asia, and oceania reportedly pack expensive capsules with flour, sugar, chalk, talc, and other shit. If you need it bring it with you or check with the embassy.

\9 Feldane/Eldene

Feldene Gel 100 gm. 1tube. Low back pain Apply to the surface area involved 1-3 g. daily.

- Feldane is both analgesic and nonsteroidal antiinflam-mation med. Methcarbol is a muscle relaxant. It is most appropriate that you take the above as well as the vicodin or tramadol. Try using prune juice warmed if necessary and high fiber. I like that you are getting a wider array of meds to telp take care of the medical part of the treatment.

"contains piroxicam which is a member of the oxicam group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each maroon and blue capsule contains 10 mg piroxicam, each maroon capsule contains 20 mg piroxicam for oral administration. The chemical name for piroxicam is 4-hydroxyl-2-methyl-N-2-pyridinyl-2H-1,2,-benzothiazine-3- carboxamide 1,1- dioxide. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions. It exhibits a weakly acidic 4-hydroxy proton (pKa 5.1) and a weakly basic pyridyl nitrogen (pKa 1.8). The molecular weight of piroxicam is 331.35. Its molecular formula is C15H13N3O4S" http://www.pfizer.com/hml/pi's/feldenepi.html Feldene (Piroxicam) Contraindications and precautions : University of Iowa Nursing: "Contraindications: patients with previous hypersensitivity to Feldene, cross-sensitivity may exist with other NSAIDS including aspirin. Do not use. with hemophilia, gastrointestinal bleeding or ulcer disease. Safety not established. in children, lactating or pregnant women. Monitor closely using this medication. while on coumadin therapy. Precautions: use cautiously in patients with bleeding, GI, or cardiac. disorders. Drug Interactions: Anticoagulants, Heparin, thrombolytic agents- may prolong bleeding time. Lithium- may increase lithium toxicity Alcohol- increase risk of GI bleeding Aspirin- decreased blood level of piroxicam decreasing effectiveness." http://pedspain.nursing.uiowa.edu/NSAIDS/Feldentt.htm

Pharmacological action for Feldene (Piroxicam): Malahyde Information Systems: "Feldene (piroxicam) is a non-steroidal anti-inflammatory agent which also possesses analgesic and antipyretic properties. Oedema, erythema, tissue proliferation, fever, and pain can all be inhibited in laboratory animals by the administration of Feldene (piroxicam). hile its mode of action is not known for certain, a common mechanism for the above effects may exist in the ability of Feldene (piroxicam) to inhibit the biosynthesis of prostaglandins, known mediators of inflammation. It is established that Feldene (piroxicam) does not act by pituitary-adrenal axis stimulation. Feldene (Piroxicam) is absorbed following oral administration. The extent and rate of absorption are not influenced by administration in the fasting state. The plasma half-life is approximately 36 - 45 hours in man and stable plasma concentrations are maintained throughout the day on once-daily dosage. After repeated administration, plasma concentrations increase for five to seven days, by which time a steady state is reached which is not exceeded following further constant daily drug administration. Feldene (piroxicam) is extensively metabolised and less than 5% of the daily dose is excreted unchanged in urine and faeces. One important metabolic pathway is hydroxylation of the pyridyl ring of the Feldene (piroxicam) side chain, followed by conjugation with glucuronic acid and urinary elimination. Feldene (piroxicam) is highly protein bound, and therefore might be expected to displace other protein bound drugs."

http://home.intekom.com/pharm/pfizer/felden-c.htm

Side effects of Feldene (Piroxicam): Health Square: "More common side effects may include:Abdominal pain or discomfort,anemia,constipation,diarrhea, dizziness, fluidretention,gas, general feeling of ill health, headache, heartburn, indigestion, inflammation inside the mouth, itching, loss of appetite, nausea, rash, ringing in ears,sleepiness, stomach upset, vertigo Less common or rare side effects may include: Abdominal bleeding, severe allergic reactions, angioedema (swelling of lips, face, tongue and throat), black stools, blood in the urine, blurred vision, bruising, colicky pain, congestive heart failure (worsening of), depression, dry mouth, eye irritations, fatigue, fever, flu-like symptoms, hepatitis, high blood pressure, hives, inability to sleep, joint pain, labored breathing, low or high blood sugar, nervousness, nosebleed, serum sickness (fever, painful joints, enlarged lymph nodes, skin rash), skin allergy to sunlight, skin eruptions, Stevens-Johnson syndrome (blisters in the mouth and eyes), sweating, swollen eyes, vomiting, vomiting blood, weight loss or gain, wheezing, worsening of angina, yellow eyes and skin." http://www.healthsquare.com/pdrfg/pd/monos/feldene.htm# WHAT.SIDES

Clinical Pharmacology of Feldene (Piroxicam): RxList: "In the event treatment for overdosage is required the long plasma half-life (see CLINICAL PHARMACOLOGY), of piroxicam should be considered. The absence of experience with acute overdosage precludes characterization of sequelae and recommendation of specific antidotal efficacy at this time. It is reasonable to assume, however, that the standard measures of gastric evacuation and general supportive therapy would apply. In addition to supportive measures, the use of activated charcoal may effectively reduce the absorption and reabsorption of piroxicam. Experiments in dogs have demonstrated that the use of multiple-dose treatments with activated charcoal could reduce the half-life of piroxicam elimination from 27 hours (without charcoal) to 11 hours and reduce the systemic bioavailability of piroxicam by as much as 37% when activated charcoal is given as late as 6 hours after administration of piroxicam. FELDENE should not be used in patients who have previously exhibited hypersensitivity to it, or in individuals with the syndrome comprised of bronchospasm, nasal polyps, and angioedema precipitated by aspirin or other nonsteroidal anti-inflammatory drugs." http://www.rxlist.com/cgi/generic/piroxicam_od.htm

Symptoms of an overdose of Feldene (piroxicam): Web Med: "body as a whole unsteadiness eyes, ears, nose, and throat, ringing in the ears, blurred, vision,skin, rash, gastrointestinal, nausea and/or vomiting, diarrhea, stomach pain, possible loss of blood in the stomach and intestinal areas, nervous system, severe headache, agitation,incoherence (not understandable) confusion, coma, drowsiness, seizures. Expectations (Prognosis)Recovery is very likely if the acidification of the blood can be neutralized and maintained near normal levels." http://webmd.lycos.com/content/asset/adam_poison_feldene_ overdose

Pitition to ban Piroxicam (Feldene): Citizen.org: "In spite of overwhelming evidence in the literature and elsewhere attesting to the excess risk for piroxicam to cause GI ulceration, bleeding and perforation, it is indeed surprising to note that the company and the FDA continue to maintain in the 1995 Physicians' Desk Reference that, "Studies to date are inconclusive concerning the relative risk of various NSAIDs in causing such [gastrointestinal] reactions". The only advantage of piroxicam which appears appealing is its once-a-day dosing. Significantly increased toxicity, however, (a predictable concomitant of many long-lasting drugs) is a dangerous price to pay for convenience. Piroxicam should not be used just because of its once-a-day convenience for patients, all of whom could use low doses of other NSAIDs or other safer alternatives to piroxicam. In conclusion, there is a growing body of data from studies conducted in eight different countries all of which collectively demonstrate piroxicam's greater propensity to cause serious GI bleeding, perforation and ulceration compared to other drugs in its class that are on the U.S. market. In addition, we have reviewed the pharmacokinetic and dose-response (ulcer incidence) data which explain why piroxicam is so dangerous. The evidence presented warrants a ban on piroxicam for people of all ages. Ibuprofen or enteric-coated aspirin are a preferable first choice for most arthritis patients because of their relatively low incidence of serious GI toxicity. If they do not work, there are still a variety of other drugs, safer than piroxicam, which can be tried." http://www.citizen.org/publications/release.cfm?ID=5568

Action and kinetics Feldene (Piroxicam):Nurses PDR: "Action/Kinetics: May inhibit prostaglandin synthesis. Effect is comparable to that of aspirin, but with fewer GI side effects and less tinnitus. May be used with gold, corticosteroids, and antacids. Peak plasma levels: 1.5-2 mcg/mL after 3-5 hr (single dose). Steady-state plasma levels (after 7-12 days): 3-8 mcg/mL. t1/2: 50 hr. Analgesia, onset: 1 hr; duration: 2-3 days. Anti-inflammatory activity, onset: 7-12 days; duration: 2-3 weeks. Metabolites and unchanged drug excreted in urine and feces. Uses: Acute and chronic treatment of rheumatoid arthritis and osteoarthritis. Investigational: Juvenile rheumatoid arthritis, primary dysmenorrhea, sunburn." http://www.nursespdr.com/members/database/ndrhtml/ piroxicam.html

Feldene (Piroxicam) pharmacokinetics: Health and Age: "Absorption: FELDENE is well absorbed following oral administration. Drug plasma concentrations are proportional for 10 and 20 mg doses and generally peak within three to five hours after medication. The prolonged half-life (50 hours) results in the maintenance of relatively stable plasma concentrations throughout the day on once daily doses and to significant accumulation upon multiple dosing. A single 20-mg dose generally produces peak piroxicam plasma levels of 1.5 to 2 mcg/mL, while maximum drug plasma concentrations, after repeated daily ingestion of 20 mg FELDENE, usually stabilize at 3-8 mcg/mL. Most patients approximate steady state plasma levels within 7-12 days. Higher levels, which approximate steady state at two to three weeks, have been observed in patients in whom longer plasma half-lives of piroxicam occurred.With food there is a slight delay in the rate but not the extent of absorption following oral administration. The concomitant administration of antacids (aluminum hydroxide or aluminum hydroxide with magnesium hydroxide) have been shown to have no effect on the plasma levels of orally administered piroxicam.Distribution: The apparent volume of distribution of piroxicam is approximately 0.14 L/kg. Ninety-nine percent of plasma piroxicam is bound to plasma proteins. Piroxicam is excreted into human milk. The presence in breast milk has been determined during initial and long-term conditions (52 days). Piroxicam appeared in breast milk at about 1% to 3% of the maternal concentration. No accumulation of piroxicam occurred in milk relative to that in plasma during treatment. Metabolism: Metabolism of piroxicam occurs by hydroxylation at the 5 position of the pyridyl side chain and conjugation of this product; by cyclodehydration; and by a sequence of reactions involving hydrolysis of the amide linkage, decarboxylation, ring contraction and N-demethylation. The biotransformation products of piroxicam metabolism are reported to not have any anti-inflammatory activity.Excretion: FELDENE and its biotransformation products are excreted in urine and feces, with about twice as much appearing in the urine as in the feces. Approximately 5% of a FELDENE dose is excreted unchanged. The plasma half-life (T ?) for piroxicam is approximately 50 hours." http://www.healthandage.com/html/res/pdr/html/62950670. htm

How can this Feldene (Piroxicam) affect other medicines?: Net doctor: "Piroxicam may enhance the effect of the following medicines, resulting in an increased risk of side-effects or toxicity: cyclosporin, lithium, methotrexate, morphine, phenytoin, quinolone antibiotics, zidovudine and blood-thinning or anti-clotting medicines. Piroxicam can also enhance the effect of antidiabetic tablets (belonging to the sulphonylurea group), which could lead to low blood sugar levels. The effect of piroxicam is enhanced by the anti-viral medicine ritonavir. The resultant increased risk of toxicity is such that the two should not be used together. The effect of water tablets (diuretics) and blood pressure lowering agents may be reduced by piroxicam, resulting in their being less effective. Use of piroxicam with diuretics or ACE inhibitors may increase the risk of kidney problems and/or an altered potassium balance as a side effect. NSAIDS should not be used within 8-12 days of taking mifepristone. Piroxicam should not be taken with any other NSAID."

Why is this drug prescribed?

Feldene, a nonsteroidal anti-inflammatory drug, is used to relieve the inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis and osteoarthritis (the most common form of arthritis). It is prescribed both for sudden flare-ups and for long-term treatment.

 --

Most important fact about this drug

In a few patients on long-term therapy, Feldene can cause stomach ulcers and bleeding. Warning signs include severe abdominal or stomach cramps, pain or burning in the stomach, and black, tarry stools. Inform your doctor immediately if you develop any of these symptoms.

 --

How should you take this medication?

To avoid digestive side effects, take Feldene with food or an antacid, and with a full glass of water. Never take it on an empty stomach.

Take this medication exactly as prescribed by your doctor. Avoid alcohol and aspirin while taking this drug.

If you miss a dose...

If you forget to take a dose, take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take two doses at the same time.

Storage instructions...

Store at room temperature. Protect from light and heat.

 --

What side effects may occur?

Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Feldene.

More common side effects may include: Abdominal pain or discomfort, anemia, constipation, diarrhea, dizziness, fluid retention, gas, general feeling of ill health, headache, heartburn, itching, loss of appetite, nausea, rash, ringing in ears, sleepiness, stomach ulcers or bleeding, stomach upset, vertigo, vomiting

Less common or rare side effects may include: Severe allergic reactions, angioedema (swelling of lips, face, tongue and throat), anxiety, asthma, belching, black stools, blood in the urine, blurred vision, bruising, colicky pain, coma, confusion, congestive heart failure, convulsions, depression, dream abnormalities, drowsiness, dry mouth, eye irritations, fainting, fatigue, fever, flu-like symptoms, hair loss, hallucinations, hearing loss, heart attack, hepatitis, high or low blood pressure, hives, inability to sleep, infection, inflammation in the mouth or digestive tract, joint pain, labored breathing, low or high blood sugar, nervousness, nosebleed, rapid or irregular heartbeat, rectal bleeding, serum sickness (fever, painful joints, enlarged lymph nodes, skin rash), skin allergy to sunlight, skin eruptions, Stevens-Johnson syndrome (blisters in the mouth and eyes), sweating, swollen or inflammed eyes, tingling or burning feeling, tremors, urinary problems, vertigo, vomiting blood, weakness, weight loss or gain, worsening of angina, yellow eyes and skin

 --

Why should this drug not be prescribed?

If you are sensitive to or have ever had an allergic reaction to Feldene, aspirin, or similar drugs, or if you have had asthma attacks caused by aspirin or other drugs of this type, you should not take this medication. If you develop breathing difficulties or allergic symptoms after taking Feldene, seek emergency treatment immediately.

 --

Special warnings about this medication

The chances that Feldene will cause a stomach ulcer or bleeding are dramatically higher if you've had such problems previously. Severe stomach reactions are also more likely among older adults, those in poor health, smokers, heavy drinkers, and people taking steroids or blood thinners.

If you have heart disease, or high blood pressure, or other conditions that cause fluid retention, use this drug with caution. Feldene can increase water retention.

Feldene has been known to damage the kidneys, and is not recommended for people with advanced kidney disease. Feldene can also cause liver damage. If you develop warning signs of liver dysfunction such as fatigue, itchiness, yellow skin or eyes, a flu-like feeling, and pain in the upper right abdomen, stop taking Feldene and see your doctor immediately.

Drugs such as Feldene may cause eye disturbances in some people. If you develop visual problems, notify your eye doctor.

 --

Possible food and drug interactions when taking this medication

If Feldene is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Feldene with the following:

Anticoagulants (blood thinners such as Coumadin) Aspirin Blood pressure medications known as ACE inhibitors, including Accupril, Altace, Mavik, Prinivil, and Zestril Furosemide (Lasix) Lithium (Lithobid, Lithonate) Methotrexate (Rheumatrex) Thiazide-type water pills such as HydroDIURIL

Feldene (Piroxicam). Each maroon and blue capsule contains 10mg piroxicam, each maroon capsule contains 20 mg piroxicam for oral admin. Piroxicam occurs as a white crystalline solid, sparingly soluble in water, dilute acid and most organic solvents. It is slightly soluble in alcohol and in aqueous solutions.

Pharmacological action for Feldene (Piroxicam): Malahyde Info Systems: Feldene, a NSAID has analgesic and antipy-retic properties. Oedema, erythema, tissue proliferation, fever, and pain can all be inhibited in lab animals by the admin of Feldene. While its mode of action is not known for certain, a common mechanism for the above effects may exist in the ability of Feldene to inhibit the biosynthesis of prostaglandins, known mediators of inflammation.

It is established that Feldene does not act by pituitary-adrenal axis stimulation. Feldene (Piroxicam) is absorbed following oral administration. The extent and rate of absorption are not influenced by admin in the fasting state. The plasma half-life is approx 36-45 hrs in man and stable plasma concentrations are maintained through-out the day on once-daily dosage. After repeated admin, plasma concentrations increase for five to seven days, by which time a steady state is reached which is not exceeded following further constant daily drug admin.

Feldene is extensively metabolised and less than 5% of the daily dose is excreted unchanged in urine and faeces. One important metabolic pathway is hydroxylation of the pyridyl ring of the Feldene side chain, followed by conjugation with glucuronic acid and urinary elimination. Feldene is highly protein bound, and therefore might be expected to displace other protein bound drugs."

Side effects of Feldene: Health Square: "More common side effects may include:Abdominal pain or discomfort, anemia, constipation, diarrhea, dizziness, fluidretention, gas, general feeling of ill health, headache, heartburn, indigestion, inflammation inside the mouth, itching, loss of appetite, nausea, rash, ringing in ears,sleepiness, stomach upset, vertigo Less common or rare side effects may include: Abdominal bleeding, severe allergic reac-tions, angioedema (swelling of lips, face, tongue and throat), black stools, blood in the urine, blurred vision, bruising, colicky pain, congestive heart failure (worsening of), depression, dry mouth, eye irritations, fatigue, fever, flu-like symptoms, hepatitis, high blood pressure, hives, inability to sleep, joint pain, labored breathing, low or high blood sugar, nervousness, nose bleed, serum sickness (fever, painful joints, enlarged lymph nodes, skin rash), skin allergy to sunlight, skin eruptions, Stevens-Johnson syndrome (blisters in the mouth and eyes), sweating, swollen eyes, vomiting, vomiting blood, weight loss or gain, wheezing, worsening of angina, yellow eyes and skin."

Symptoms of an overdose of Feldene: Web Med: "body as a whole unsteadiness eyes, ears, nose, and throat, ringing in the ears, blurred, vision,skin, rash, gastrointes-tinal, nausea and/or vomiting, diarrhea, stomach pain, possible loss of blood in the stomach and intestinal areas, nervous system, severe headache, agitation, inco-herence (not understandable) confusion, coma, drowsiness, seizures. Expectations (Prognosis)Recovery is very likely if the acidification of the blood can be neutralized and maintained near normal levels."

http://webmd.lycos.com/content/asset/adam_poison_feldene_ overdose

\10 FOSAMAX is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Pkts of 10mg or 40mg tablets

For the treatment of osteoporosis, FOSAMAX increases bone mass and prevents fractures, including those of the hip, wrist, and spine (vertebral compression fractures). Osteoporosis may be confirmed by the findingof low bone mass (for example, at least 2 standard deviations below the premenopausal mean) or by the presence or history of osteoporotic fracture.

For the prevention of osteoporosis, FOSAMAX may be considered in postmenopausal women who are at risk of developing osteoporosis and for whom the desired clinical outcome is to maintain bone mass and to reduce the risk of future fracture.

Bone loss is particularly rapid in postmenopausal women younger thanage 60. Risk factors often associated with the development of postmenopausal osteoporosis include early menopause; moderately low bone mass (for example, at least 1 standard deviation below the mean for healthy young adultwomen); thin body build; Caucasian or Asian race; and family history of osteoporosis. The presence of such risk factors may be important when considering the use of FOSAMAX for prevention of osteoporosis.

FOSAMAX is indicated for the treatment of Paget's disease of bone.

Treatment is indicated in patients with Paget's disease of bone having alkaline phosphatase at least two times the upper limit of normal, orthose who are symptomatic, or those at risk for future complications from their disease.

Contraindications - Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia

Inability to stand or sit upright for at least 30 minutes

Hypersensitivity to any component of this product

Precautions - General - There have been rare (post-marketing) reportsof gastric and duodenal ulcers, some severe and with complications, althoughno increased risk was observed in pre-marketing clinical trials.

FOSAMAX is not recommended for patients with renal insufficiency (creatinine clearance <35 mL/min). (See DOSAGE AND ADMINISTRATION.)

Causes of osteoporosis other than estrogen deficiency and aging shouldbe considered.

Hypocalcemia must be corrected before initiating therapy with FOSAMAX(see CONTRAINDICATIONS). Other disturbances of mineral metabolism (such as vitamin D deficiency) should also be effectively treated. Presumablydue to the effects of FOSAMAX on increasing bone mineral, small, asymptomatic decreases in serum calcium and phosphate may occur, especially in patients with Pagets disease, in whom the pretreatment rate of bone turnovermay be greatly elevated. Adequate calcium and vitamin D intake should be ensuredto provide for these enhanced needs.

Info for Patients - Patients should be instructed that the expected benefits of FOSAMAX may only be obtained when each tablet is swallowed with plain water the first thing upon arising for the day at least 30 minutes before the first food, beverage, or medication of the day. Even dosing withorange juice or coffee has been shown to markedly reduce the absorption of FOSAMAX.

Calcium Supplements/Antacids - It is likely that calcium supplements, antacids, and some oral medications will interfere with absorption of FOSAMAX. Therefore, patients must wait at least one-half hour after taking FOSAMAX before taking any other drug.

Aspirin - In clinical studies, the incidence of upper gastrointestinal adverse events was increased in patients receiving concomitant therapywith doses of FOSAMAX greater than 10 mg/day and aspirin-containing compounds.

Nonsteroidal Anti-inflammatory Drugs (NSAIDs) FOSAMAX may be administered to patients taking NSAIDs. In a 3-year, controlled, clinical study (n= 2027) during which a majority of patients received concomitant NSAIDs,the incidence of upper gastrointestinal adverse events was similar in patients taking FOSAMAX 5 or 10 mg compared to those taking placebo. However,since NSAID use is associated with gastrointestinal irritation, caution shouldbe used during concomitant use with FOSAMAX.

Use in Men - Safety and effectiveness in male osteoporosis have not been established.

To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation patients should be instructed to swallow FOSAMAXwith a full glass of water (6-8 oz) and not to lie down for at least 30 minutes and until after their first food of the day. Patients should not chewor suck on the tablet because of a potential for oropharyngeal ulceration. Patients should be specifically instructed not to take FOSAMAX at bedtimeor before arising for the day. Patients should be informed that failureto follow these instructions may increase their risk of esophageal problems. Patients should be instructed that if they develop symptoms of esophageal disease (such as difficulty or pain upon swallowing, retrosternal painor new or worsening heartburn) they should stop taking FOSAMAX and consult their physician.

Patients should be instructed to take supplemental calcium and vitaminD, if daily dietary intake is inadequate. Weight-bearing exercise should be considered along with the modification of certain behavioral factors,such as excessive cigarette smoking, and/or alcohol consumption, if thesefactors exist.

Physicians should instruct their patients to read the patient packageinsert before starting therapy with FOSAMAX and to reread it each time the prescription is renewed.

Dosage and Admin - FOSAMAX must be taken at least one-half hour beforethe first food, beverage, or medication of the day with plain water only(see PRECAUTIONS, Information for Patients). Other beverages (including mineral water), food, and some medications are likely to reduce the absorptionof FOSAMAX. Waiting less than 30 min, or taking FOSAMAX with food, beverages (other than plain water) or other meds will lessen the effect of FOSAMAXby decreasing its absorption into the body.

To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, FOSAMAX should only be swallowed upon arisingfor the day with a full glass of water (6-8 oz) and patients should not lie downfor at least 30 minutes and until after their first food of the day. FOSAMAX should not be taken at bedtime or before arising for the day. Failureto follow these instructions may increase the risk of esophageal adverse experiences (see WARNINGS).

Patients should receive supplemental calcium and vitamin D, if dietary intake is inadequate (see PRECAUTIONS, General).

No dosage adjustment is necessary for the elderly or for patients with mild-to-moderate renal insufficiency (creatinine clearance 35 to 60 mL/min). FOSAMAX is not recommended for patients with more severe renal insufficiency (creatinine clearance <35 mL/min) due to lack of experience.

Treatment of osteoporosis in postmenopausal women The recommended dosage is 10 mg once a day.

Prevention of osteoporosis in postmenopausal women. The recommended dosage is 5 mg once a day.

Safety of treatment or prevention of osteoporosis with FOSAMAX for longer than four years has not been studied; extension studies are ongoing.

--------------------------------------------------------- ----------- Warnings - FOSAMAX, like other bisphosphonates, may cause local irritation of the upper gastrointestinal mucosa.

Esophageal adverse experiences, such as esophagitis, esophageal ulcersand esophageal erosions, occasionally with bleeding, have been reported in patients receiving treatment with FOSAMAX. In some cases these have been severe and required hospitalization. Physicians should therefore be alertto any signs or symptoms signaling a possible esophageal reaction and patients should be instructed to discontinue FOSAMAX and seek medical attentionif they develop dysphagia, odynophagia or retrosternal pain.

The risk of severe esophageal adverse experiences appears to be greaterin patients who lie down after taking FOSAMAX and/or who fail to swallowit with a full glass (6-8 oz) of water, and/or who continue to take FOSAMAX after developing symptoms suggestive of esophageal irritation. Therefore,it is very important that the full dosing instructions are provided to,and understood by, the patient (see DOSAGE AND ADMINISTRATION). In patientswho cannot comply with dosing instructions due to mental disability, therapy with FOSAMAX should be used under appropriate supervision.

Because of possible irritant effects of FOSAMAX on the upper gastrointestinal mucosa and a potential for worsening of the underlying disease, caution should be used when FOSAMAX is given to patients with active upper gastrointestinal problems, (such as dysphagia, esophageal diseases, gastritis, duodenitis, or ulcers).

ADVERSE REACTIONS - Clinical Studies In clinical studies adverse experiences associated with FOSAMAX usuallywere mild, and generally did not require discontinuation of therapy

FOSAMAX has been evaluated for safety in approximately 3800 postmenopausal women in clinical studies.

Treatment of osteoporosis - In two large, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational), discontinuation of therapy due to any clinical adverse experience occurred in 4.1% of 196 patients treated with FOSAMAX 10 mg/day and 6.0% of 397 patients treated with placebo. Adverse experiences reported by the investigators as possibly, probably, or definitely drug related in ?1%of patients treated with either FOSAMAX 10 mg/day or placebo are presentedin the following table.

Ask your healthcare provider about FOSAMAX, its uses and whether it isright for you.

FOSAMAX is for the treatment or prevention of osteoporosis (thinningof bone) in postmenopausal women. It reduces the chance of fractures, including those of the spine and hip.

FOSAMAX is a treatment to increase bone mass in men with osteoporosis.

FOSAMAX is for the treatment of osteoporosis in certain men and women receiving corticosteroid medications in a 7.5 mg or higher prednisone equivalent dose who have low bone mass.

FOSAMAX is for the treatment of Pagets disease of bone in certain menand women. Click here to find out about The Paget's Patient Support Program.

Important Information About FOSAMAX FOSAMAX should not be used if you have certain disorders of the esophagus (the tube that connects your mouth with your stomach, or are unable tostand or sit upright for at least 30 minutes, have severe kidney disease, low blood calcium, are allergic to FOSAMAX, or are pregnant or nursing. Usewith caution if you have certain stomach or digestive problems.

Side effects in clinical studies usually have been mild and generallyhave not caused patients to stop taking FOSAMAX.

The most commonly reported side effect in clinical studies was abdominal (stomach) pain. Some patients may develop severe digestive reactions including irritation, inflammation, or ulceration (occasionally severe and/or with bleeding) of the esophagus (see Patient Product Informationfor more details). So, if you experience new or worsening heartburn, difficulty or pain when swallowing, or chest pain, stop taking FOSAMAX and talkto your doctor.


\11 BEXTRA

Bextra is a member of the relatively new class of painkillers called COX-2 inhibitors. It is prescribed for the relief of osteoarthritis, rheumatoid arthritis, and painful menstruation (dysmenorrhea). 50 for $165. COX-2 inhibitors are part of a larger group of meds called nonsteroidal anti-inflammatory drugs (NSAIDs). All the drugs in this category (incl such familiar remedies  aspirin, Motrin, and Naprosyn) relieve pain and inflam- mation by limiting the effect of a natural enzyme called COX-2. Unlike the older NSAIDs, however, the new COX-2 inhibitors do not interfere with COX-1, a related enzyme that exerts a protective effect on the lining of the stomach. As a result, Bextra and other COX-2 inhibitors are less likely to cause the bleeding and ulcers that sometimes accompany sustained use of the older NSAIDs. 

Most important fact about this drug - Altho the chances of stomach or intestinal bleeding are low, a slight danger remains. Be sure to tell your doctor if you've ever had this type of problem, and be alert for signs of bleeding such as stomach discomfort or black, tarry stools. The problem becomes more likely the longer you take this med, but can strike at any time w/o warning. 

How to use this med:  Bextra can be taken with or without food, and can be taken along with antacids if necessary. Take it exactly as directed. If you miss a dose  Take it as soon as you remember. If it is almost time for your next dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at once. Store at room temp. 

What side effects may occur?  Side effects cannot be anticipated. If any develop or change in intensity, inform your doc ASAP. Only your doc can determine if it is safe for you to continue taking Bextra. More common side effects may incl: Abdominal pain, diarrhea, headache indigestion, nausea, swelling in the hands and feet, upper respiratory infection 

Less common and rare side effects may incl: Abdominal fullness, abnormal or bloody stools, abnormal taste, acne, allergic reactions, anxiety, appendicitis, appetite changes, back pain, bad breath, bad dreams, belching, blood disorders, breast pain, brittle bones, burning or tingling sensation, cervical dysplasia, chest pain, chills, clotting problems, colitis, confusion, constipation, convulsions, coughing, cysts and tumors, dehydration, depression, digestive tract inflammation, dizziness, drowsiness, dry mouth, ear and vision problems, eye pain and problems, facial swelling, fatigue, fever, gallstones, general feeling of illness, generalized swelling, glandular problems, goiter, gout, hair loss, heart and circulation problems, heartburn, hemorrhoids, hepatitis, high cholesterol, high or low blood pressure, hot flushes, incontinence, impotence, infections, inflamed tendons or bones, intestinal problems and bleeding, joint problems, kidney failure, loss of sensation, mania, menstrual problems, migraine, mouth inflammation, muscle pain, muscle tension, nerve pain and problems, nervousness, nosebleeds, pain, prostate problems, psychosis, rash and other skin problems, respiratory problems, runny nose, skin inflammation, sleep problems, sore throat, stiff neck, stroke, swallowing problems, sweating, swelling around the eyes, tarry stools, thirst, tooth disorders, tremors, tumors, twitching, ulcer, urinary problems, vertigo, vomiting, weakness, weight changes 

Why should this drug not be prescribed? Do not take Bextra if aspirin or others NSAIDs have ever given you asthma, hives, or an allergic reaction. The possibility of a severe reaction exists. 

Special warnings about this med - Warning signs of a dangerous allergic reaction to Bextra incl swelling of the face, tongue, or throat and difficulty breathing. Seek med help immediately if these symptoms develop after a dose of Bextra. 

Bextra is more likely to cause serious stomach problems if you've had ulcers or bleeding in the past. Gizzers and those in poor health are also more vulnerable, as are people being treated with steroids such as prednisone or blood thinners such as aspirin and Coumadin. Other factors that increase your risk incl smoking, alcoholism, and long-term use of NSAIDs. If you meet any of these criteria, use Bextra with extreme caution. 

Bextra and other NSAIDs occasionally cause liver problem Warning signs include nausea, fatigue, rash, itching, right upper stomach pain, flu-like symptoms, and yellowing of the skin and eyes. If you develop these symptoms, stop taking Bextra and call your MD imediately.

Long-term use of NSAIDs such as Bextra can injure the kidneys, especially in people with heart failure, poor kidney function, or liver problems. Also at higher risk of a problem are older adults, individuals suffering dehydration, and people taking water pills or ACE inhibitors for high blood pressure. If any of these factors apply to you, make sure the doctor is aware of it. If you have advanced kidney disease, Bextra is not recommended. 

Bextra sometimes causes fluid retention, which can aggravate swelling, high blood pressure, and heart failure. Use this drug with caution if you have any of these conditions. Caution is also warranted if you have asthma. Bextra could trigger a serious attack, especially if you are also sensitive to aspirin. 

If you've been taking a steroid medication for arthritis, do not discontinue it abruptly when you begin taking Bextra. Bextra is not a substitute for such drugs. Because Bextra relieves inflammation, fever, and pain, it may hide signs of an infection. Let any doctor you're seeing know that you're taking this drug. 

Bextra has not been tested for use in children under 18. 

 Possible food and drug interactions when taking this medication. If Bextra is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Bextra with the following:

Aspirin - Blood pressure medications known as ACE inhibitors, incl Capoten, Lotensin, and Vasotec. Cough medications containing dextromethorphan, such as Benylin and Robitussin Honey Cough meds. Fluconazole (Diflucan). Ketoconazole (Nizoral) Lithium (Eskalith, Lithobid). Warfarin (Coumadin) Water pills (diuretics) such as Lasix and HydroDIURIL.

 Special info if you are pregnant or breastfeeding. Bextra should never be used during the third trimester of  preg- nancy because it may cause problems in the developing baby. If you are pregnant or plan to become pregnant, consult your doctor. It is not known whether Bextra appears in breast milk, but if it does, it could cause serious side effects in the nursing infant. If you decide to take Bextra, you should give up breastfeeding. 

 Osteoarthritis and Rheumatoid Arthritis  The recommended dose is 10 milligrams once a day. 

Painful Menstruation - The recommended dose is 20 milligrams twice a day. 

 Overdosage - Any medication taken in excess can have serious consequences. If you suspect an overdose, seek med attn immediately. 

Warning signs of Bextra overdose may incl: Drowsiness, lack of energy, nausea, stomach pain, vomiting Stomach or intestinal bleeding may develop. Kidney failure, diminished breathing, and coma are possible, but rare. 

-- Bextra Now Widely Available in U.S. for Arthritis Pain/Inflammation  ArthritisSupport.com 04-12-2002 - The newest COX-2 specific inhibitor, Bextra (valdecoxib), is now available nationwide for the treatment of osteoarthritis (OA), adult rheumatoid arthritis (RA).

Pharmacia Corp and Pfizer Inc. today announced the avail of the new med, which was approved by the U.S. Food and Drug Admin in late 2001. A once-daily 10 mg dose of Bextra offers 24-hour pain relief for both OA and RA. 

"Bextra provides a new option to help patients who need powerful arthritis pain relief," said Gary Williams, MD, PhD, Chairman, Department of Medicine, Scripps Clinic Med Grp, La Jolla, CA. "The national avail of Bextra offers physicians a once-daily treatment option which in clinical studies has demonstrated a reduced incidence of endoscopically-detected ulcers compared to ibuprofen, naproxen and diclofenac." 

Since Feb 02, thousands of patients suffering from arthritis or painful menstrual cramping in the US have been treated with Bextra through an Early Experience Pgm. Participating physicians had the opportunity to gain experience with Bextra in their own clinical setting. This week, Bextra will be intro to primary care docs, rheumatologists, gastroenterologists, and OB/GYNs. 

"We are encouraged by the positive response we have received from physicians and patients through our Early Experience Program," said Carrie S. Cox, Executive Vice President and President, Global Prescription Business, Pharmacia Corporation. "Our COX-2 specific inhibitor portfolio with Celebrex [celecoxib] and Bextra provides options physicians need to effectively treat arthritis and other painful conditions." 

Bextra was well-tolerated with a superior upper GI safety profile. In two large, randomized, three-month studies, the incidence of endoscopically-observed gastroduodenal ulcers was significantly lower for Bextra than the comparator non-steroidal anti-inflammatory drugs (NSAIDs) ibuprofen, diclofenac and naproxen. The correlation between findings of endoscopic studies and the incidence of clinically relevant serious upper GI events has not been established. The most common adverse events were headache, abdominal pain, dyspepsia, upper respiratory infection, nausea and diarrhea. 

More than 23 mil Americans have some form of arthritis. Among the various forms of arthritis, osteoarthritis is the most prevalent, affecting 21 million Americans. Characterized by the degeneration of joint cartilage and adjacent bone, OA is a chronic disorder that can cause pain and stiffness. Rheumatoid arthritis, which affects more than 2.1 million Americans, is a painful, systemic, autoimmune disease that affects primarily joint lining, cartilage and bones. 

FDA Approves Bextra for Treating Arthritis Pain and Inflammation ArthritisSupport.com  11-21-2001. The U.S. FDA has approved Bextra(R) (valdecoxib tablets), a COX-2 specific inhibitor, for treating the signs and symptoms of osteoarthritis and adult rheumatoid arthritis. 

Bextra offers 24-hour arthritis pain relief in a once-a- day 10 mg dose. In global clinical trials involving more than 5,000 patients, Bextra demonstrated comparable effectiveness while offering improved gastrointestinal safety and tolerability versus conventional NSAIDs such as, naproxen, ibuprofen and diclofenac. 

"With the approval of Bextra, people with arthritis pain now have an important new once-a-day treatment option," said Gary Williams, MD, PhD, Chairman, Dept of Med, Scripps Clinic Med Grp, VP, Med Services. "Bextra offers these patients powerful arthritis pain relief comparable to the prescription strength drug naproxen but with a significantly improved gastrointestinal safety profile." 

In clinical studies lasting 3 to 6 months, Bextra (10 mg once daily) was as effective as commonly prescribed doses of the conventional NSAIDs, ibuprofen (800 mg three times daily), diclofenac (75 mg twice daily) and naproxen (500 mg twice daily), for treating the signs and symptoms of osteoarthritis. In addition Bextra was also as effective as naproxen (500 mg twice daily) for treating the signs and symptoms of rheumatoid arthritis. 

In one placebo-controlled study of osteoarthritis patients, the incidence of stomach and duodenum ulcers with 10mg of Bextra was similar to placebo (3% vs. 4%, respectively) and was approx one third of that seen with naproxen 500 mg twice daily (10%). 

In a six-month study of both osteoarthritis and rheumatoid arthritis patients, Bextra at therapeutic doses of 20 mg or 40 mg twice daily demonstrated rates of stomach and duodenum ulcers (4 percent and 8 percent, respectively), approximately one-third to one-half of that seen with naproxen 500 mg twice daily (18 percent). 

Relief from Menstrual Pain In two placebo-controlled studies, Bextra (20 mg twice daily as needed) was assoc with comparable pain relief versus the conventional NSAID naproxen sodium (550 mg twice daily). In addition, more than 80 percent of women treated with Bextra required only one dose of med within the first 24 hours. 

The most common adverse events were dyspepsia, headache, abdominal pain, nausea and diarrhea.

It provides powerful arthritis pain relief. Once-daily Rx BEXTRA provides the kind of 24-hour relief many arthritis sufferers are looking for. Its tough on pain and inflammation. And theres one convenient dose thats powerful enough to tackle both the pain of osteoarthritis and adult rheumatoid arthritis.

In fact, clinical studies show that one 10-mg. tablet of BEXTRA is as effective in relieving arthritis pain as two 500-mg. tablets of naproxen (the active ingredient in Naprosyn*, a commonly prescribed arthritis medicine).

BEXTRA provides powerful primary dysmenorrhea relief. BEXTRA also delivers relief to the pain associated with moderate to severe menstrual cramping (primary dysmenorrhea).

BEXTRA is a medicine for: relief of osteoarthritis (OA) (the arthritis caused by wear and tear on bones and joints).

Relief of adult rheumatoid arthritis (RA) (the arthritis that affects joint membranes, cartilage and bones). Treatment of primary dysmenorrhea (painful menstrual cramping).

BEXTRA is not for everyone. Prescription BEXTRA should not be taken if youve had allergic reactions to certain drugs called sulfonamides, aspirin or other arthritis medicines or if youve had aspirin-sensitive asthma. It is not recommended if you have advanced kidney disease.

BEXTRA should not be taken in late pregnancy. Tell your doc if you have kidney, liver or fluid retention problems. In rare cases, serious stomach problems such as bleeding can occur without warning. Serious skin reactions can occur. If you experience any of these problems or other severe or unusual symptoms while taking BEXTRA, tell your doctor immediately.

The most common side effects are headache, abdominal pain, indigestion, upper respiratory infection, nausea and diarrhea.

How does BEXTRA work? BEXTRA is a powerful med that targets an important source of arthritis pain. BEXTRA is what doctors call a COX-2 specific inhibitor. The body produces both COX-2 and a related enzyme called COX-1. The COX-2 enzyme plays a role in causing arthritis pain and inflammation. The COX-1 enzyme is important because one of the things it does is help the body produce chemicals that protect the lining of the stomach.

BEXTRA works by targeting the action of the COX-2 enzyme to relieve the pain, stiffness and inflammation associated with arthritis. But, at recommended doses, BEXTRA does not target the COX-1 enzyme.

Find out more about arthritis treatments by visiting our Resources and Links section. Or, go to the Treating Arthritis section of Arthritis.com to read more about treatments including COX-2 specific inhibitors.