(Approval lapsed) Amoxicillin and clavulanate potassium for oral suspension, USP 400mg/57mg per 5mL (Aurobindo)

Amoxicillin and clavulanic acid is indicated for the short-term treatment of the following bacterial infections when caused by sensitive organisms:

• skin and skin structure infections;
• urinary tract infections (complicated and uncomplicated);
• upper respiratory tract infections including sinusitis and otitis media;
• lower respiratory tract infections including acute exacerbations of chronic bronchitis and community acquired pneumonia.

Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid. However, when there is reason to believe an infection may involve any of the beta-lactamase producing organisms listed in Microbiology, therapy may be instituted prior to obtaining the results from bacteriological and susceptibility studies. Once these results are known, therapy should be adjusted if appropriate.

The treatment of mixed infections caused by amoxicillin susceptible organisms and beta-lactamase producing organisms susceptible to amoxicillin and clavulanic acid should not require the addition of another antibiotic due to the amoxicillin content of Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 400mg/57mg per 5mL (Aurobindo).