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| |  Augmentin ES-600 (Amoxicillin/Clavulanate) Available in US For Pediatric Middle Ear Infections PHILADELPHIA, PA -- October 1, 2001 -- GlaxoSmithKline today announced that Augmentin ES-600™ (amoxicillin/clavulanate potassium) Powder for Oral Suspension is now available in drug stores throughout the United States. The availability of Augmentin ES-600 coincides with the beginning of the cough, cold and flu season. It is the first antibiotic approved by the U.S. Food and Drug Administration (FDA) for children at risk for repeat episodes of middle ear infection (acute otitis media, or AOM). Augmentin ES-600 is approved by the FDA for the treatment of children with recurrent or persistent middle ear infections due to Streptococcus pneumoniae (penicillin minimum inhibitory concentrations [MICs] less than or equal to 2 micrograms/mL), Haemophilus influenzae (including Beta-lactamase producing strains) or Moraxella catarrhalis (including Beta-lactamase producing strains). Children with AOM are candidates for treatment with Augmentin ES-600 if they are characterized by the following risk factors: they have been given an antibiotic for middle ear infections within the preceding three months and are either two years of age or younger or attend daycare. An estimated three out of five young children (infants and toddlers) are in child-care. Further, three out of four children will contract an ear infection before the age of three. S. pneumoniae, H. influenzae and M. catarrhalis are the three most common bacterial causes of middle ear infections. Acute otitis media due to S. pneumoniae alone can be treated with amoxicillin. Augmentin ES-600 is not indicated for the treatment of acute otitis media due to S. pneumoniae with penicillin MICs greater than or equal to 4 micrograms/mL. "Physicians have relied on Augmentin for years. Now with Augmentin ES-600, GlaxoSmithKline offers the first antibiotic specifically indicated for tough-to-treat pediatric ear infection," said Brian Lortie, Vice President, Anti-Infectives, GlaxoSmithKline. New Augmentin ES-600 provides double the daily dose of amoxicillin (90 mg/kg/day versus 45 mg/kg/day) and the same dose of clavulanate potassium as compared to regular strength Augmentin® (amoxicillin/clavulanate potassium). H. influenzae and M. catarrhalis often produce an enzyme called Beta-lactamase that renders many antibiotics, including amoxicillin, penicillin and several cephalosporin antibiotics, inactive. The clavulanate potassium component in Augmentin ES-600 inactivates Beta-lactamase. Augmentin ES-600 is contraindicated in patients with a history of allergic reactions to any penicillin or cholestatic jaundice/hepatic dysfunction associated with Augmentin. Common adverse events related or probably related to Augmentin ES-600 were contact dermatitis (i.e., diaper rash) (3.5 percent), diarrhea (2.9 percent), vomiting (2.2 percent), moniliasis (1.4 percent) and rash (1.1 percent). The Centers for Disease Control and Prevention (CDC) have attributed the increase in treatment failures and/or repeat episodes of illness to the failure of some antibiotics to eradicate the bacteria causing an infection. The surviving bacteria may re-grow and cause additional illness. Recognizing the growing public health concern of acute otitis media, the CDC issued pediatric middle ear infection treatment recommendations. High dose amoxicillin/clavulanate (80-90 mg/kg/day of the amoxicillin component) is part of the CDC recommendation for the treatment of middle ear infections. Augmentin ES-600 (90mg/kg/day of the amoxicillin component) meets the CDC recommendation. "While I see more cases of repeat ear infections among children who attend group child care than those who do not, there are things that parents and pediatricians can do to reduce this problem," said Candice E. Johnson, M.D., Professor of Pediatrics at the University of Colorado School of Medicine and based at The Children's Hospital in Denver, Colorado. "We can work to ensure that when an antibiotic is needed to treat an ear infection, the drug is prescribed based on its ability to fight bacteria, not on convenience or taste. Augmentin ES-600 will be vital for the treatment of middle ear infections, particularly in children at risk for repeated cases, because of its ability to eradicate bacteria," Dr. Johnson added. Augmentin ES-600 is a powder that when reconstituted gives an orange-raspberry suspension that contains 600 mg amoxicillin and 42.9 mg clavulanate potassium. The dosage is based on the child's body weight and is given twice a day for 10 days. The ratio of amoxicillin to clavulanate potassium in Augmentin ES-600 is different than that in the regular strength Augmentin and, therefore, these products are not interchangeable. Next to the common cold, ear infections are the most common childhood illness and are responsible for more than 30 million doctor visits each year. Three out of four children experience at least one middle ear infection before they are three years old and of these, almost half experience three or more episodes. Using an effective antibiotic for the eradication of bacteria from the infection site is important because when surviving bacteria re-grow they may become resistant to that particular antibiotic, making the next infection difficult to treat. On rare occasions, improperly treated ear infections may develop into a serious complication such as mastoiditis (infection of the skull adjacent to the ear), meningitis or hearing impairment. SOURCE: GlaxoSmithKline
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