(Approval lapsed) Amoxicillin and clavulanate potassium tablets, USP 875mg/125mg (Aurobindo)

Amoxicillin and clavulanate potassium tablets, USP 875mg/125mg (Aurobindo) are indicated for short term treatment of bacterial infections at the following sites when caused by sensitive organisms:

• Urinary Tract Infections (complicated and uncomplicated)
• Lower Respiratory Tract Infections, including community acquired pneumonia and acute exacerbations of chronic bronchitis.
• Upper Respiratory Tract Infections, such as sinusitis, otitis media and recurrent tonsillitis.
• Skin and Skin Structure infections.

Appropriate culture and susceptibility studies should be performed to identify the causative organism(s) and determine its (their) susceptibility to amoxicillin and clavulanic acid tablets. However, when there is reason to believe an infection may involve any of the β-lactamase producing organisms listed above, 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 β-lactamase producing organisms susceptible to amoxicillin and clavulanic acid tablets preparations should not require the addition of another antibiotic due to the amoxicillin content of these products.