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Amoxicillin; clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below.

Lower Respiratory Tract Infections: Caused by b-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Otitis Media: Caused by b-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Sinusitis: Caused by b-lactamase-producing strains of Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.

Skin and Skin Structure Infections: Caused by b-lactamase-producing strains of Staphylococcus aureus, Escherichia coli and Klebsiella spp.

Urinary Tract Infections: Caused by b-lactamase-producing strains of Escherichia coli, Klebsiella spp. and Enterobacter spp.

While amoxicillin; clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to amoxicillin; clavulanate potassium treatment due to its amoxicillin content. Therefore, mixed infections caused by ampicillin-susceptible organisms and b-lactamase-producing organisms susceptible to amoxicillin; clavulanate potassium should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity against Streptococcus pneumoniae than does ampicillin or penicillin, the majority of S. pneumoniae strains with intermediate susceptibility to ampicillin or penicillin are fully susceptible to amoxicillin and amoxicillin; clavulanate potassium. (See CLINICAL PHARMACOLOGY, Microbiology.)

Bacteriological studies, to determine the causative organisms and their susceptibility to amoxicillin; clavulanate potassium, should be performed together with any indicated surgical procedures.

Therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies to determine the causative organisms and their susceptibility to amoxicillin; clavulanate potassium when there is reason to believe the infection may involve any of the b-lactamase-producing organisms listed above. Once the results are known, therapy should be adjusted, if appropriate.

DOSAGE AND ADMINISTRATION

Oral Solution and Chewable Tablets

Pediatric Patients

Based on the amoxicillin component, amoxicillin; clavulanate potassium should be dosed as follows.

Neonates and Infants Aged <12 weeks (3 months): Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended dose of amoxicillin; clavulanate potassium is 30 mg/kg/day divided q12h, based on the amoxicillin component. Clavulanate elimination is unaltered in this age group. Experience with the 200 mg/5 ml formulation in this age group is limited and, thus, use of the 125 mg/5 ml oral suspension is recommended.