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| |  Augmentin Cleared for a More Convenient Pediatric Dosing Regimen in U.S. PHILADELPHIA, June 3, 1996 -- SmithKline Beecham (SB) (NYSE: SBH) announced today that it has received U.S. marketing clearance for a more convenient pediatric dosing regimen of Augmentin amoxicillin/clavulanate potassium), one of the most frequently used antibiotics for infections involving drug-resistant bacteria. Also cleared were new pediatric formulations in new dosage strengths. The new, twice-daily (BID) pediatric dosing schedule provides the same convenience made available through the BID regimen for adults that was introduced earlier this year. And Augmentin is the only oral broad-spectrum antibiotic with specific dosing for patients younger than 12 weeks of age. Previously, the only dosing schedule for both children and adults was three times daily (TID). In addition to offering more convenience, the BID regimen has been shown to reduce the incidence of diarrhea by 58 percent when compared to the original TID regimen in clinical trials involving children treated for acute otitis media (middle-ear infection). The new formulations for the BID regimen will be available in fruit flavors: orange-raspberry for the oral suspension, and cherry-banana for the chewable tablets. "As a broad-spectrum antibiotic designed to overcome an increasingly common mechanism of drug resistance, Augmentin has established a record of impressive efficacy," said Dr. Daniel Burch, SB's Director of Anti-Infective Medical Affairs. "Now Augmentin also offers the convenience of twice-a-day dosing, which makes it easier to take the medicine as directed. Parents will no longer need to worry about that 'middle dose' of the TID regimen that could be missed while their children are in day care or school. "Add to this enhanced convenience improved gastrointestinal tolerability, plus more new flavors that children like, and this new product offers significant advantages in the treatment of otitis media and other infections." In clinical trials, the efficacy of the BID and TID regimens were equivalent. But among children treated for acute otitis media, the BID regimen significantly lowered the incidence of diarrhea, to 14.3 percent from 34.3 percent -- a 58-percent reduction. In addition to otitis media, the indications for Augmentin include pneumonia, acute exacerbations of chronic bronchitis, sinusitis, skin infections, and urinary-tract infections. Augmentin combines amoxicillin, an antibiotic, with clavulanate, which inhibits an important and increasingly common mechanism of bacterial resistance. That mechanism is the production of beta- lactamases -- enzymes that destroy many antibiotics in both the penicillin and cephalosporin classes. By binding irreversibly to beta- lactamases, clavulanate protects amoxicillin from destruction. Among the common bacterial pathogens that can produce beta-lactamases are Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus. Augmentin can now be taken every 12 hours. For otitis media and other more severe infections, dosing with the oral suspension or the chewable tablet consists of 45 milligrams (mg) of amoxicillin and 6.4 mg of clavulanate for each kilogram of body weight per day. For less severe infections, such as those of the skin, dosing consists of 25 mg of amoxicillin and 3.6 mg of clavulanate for each kilogram of body weight per day. The oral suspension will be available in strengths of 200 mg amoxicillin/28.6 mg clavulanate/5 milliliters (ml) and 400 mg amoxicillin/57.1 mg clavulanate/5 ml. The chewable tablets will be available in strengths of 200 mg amoxicillin/28.6 mg clavulanate and 400 mg amoxicillin/57.1 mg clavulanate. The new-strength Augmentin suspensions will come in bottle sizes of 50 ml, 75 ml, and 100 ml, and the new-strength chewable tablets in quantities of 20 tablets per bottle. The new dosage strengths and formulations will be made available in several weeks. The side effects of Augmentin, usually mild and self-limiting, include diarrhea and nausea. Augmentin should not be used in patients with a history of allergic reactions to any penicillin, nor in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with Augmentin. SmithKline Beecham -- one of the world's leading healthcare companies -- discovers, develops, manufactures, and markets pharmaceuticals, vaccines, over-the-counter medicines, and health-related consumer products, and provides healthcare services including clinical-laboratory testing, disease management, and pharmaceutical-benefit management.
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