FDA approves Augmentin ES-600™ for children at risk for repeat middle ear infections

Pediatric Nursing, Nov-Dec, 2002

GlaxoSmithKline has announced that Augmentin ES-600[TM] (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 Food and Drug Administration (FDA) for children at risk for repeat episodes of middle ear infection (acute otitis media [AOM]).

Augmentin ES-600 is approved by the FDA for the treatment of children with recurrent or persistent middle ear infections due to Streptococcus pneumonia (penicillin MICs 2 g/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 (a) they have been given an antibiotic for middle ear infections within the preceding 3 months and (b) are either 2 years of age or younger or attend daycare.

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[R] (amoxicillin/clavulanate potassium). H. influenzae and M. catarrhalis often produce an enzyme called B-lactamase that render 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 a new 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, therefore; these products are not interchangeable.

For additional information on Augmentin and Augmentin ES-600 including contraindications, warning, precautions, adverse reactions, and dosage, and administration. Please go to www.gsk.com or call (888) 825-5249.