Amoxicillin/Clav Pot
Drug Details
- Generic Name
- Amoxicillin/Clav Pot
- Brand Names
- Amoxicillin/Clav Pot
- Application Number
- ANDA205707
- Sponsor
- Direct_Rx
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- AMOXICILLIN, CLAVULANATE POTASSIUM
Indications and Usage
Amoxicillin and clavulanate potassium tablets are indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: • Lower Respiratory Tract Infections- caused by beta‑lactamase‑producing isolates of Haemophilus influenzaeand Moraxella catarrhalis. • Acute Bacterial Otitis Media- caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis. • Sinusitis- caused by beta‑lactamase‑producing isolates of H. influenzaeand M. catarrhalis. • Skin and Skin Structure Infections- caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli,and Klebsiellaspecies. • Urinary Tract Infections- caused by beta‑lactamase‑producing isolates of E. coli, Klebsiellaspecies, and Enterobacterspecies. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets and other antibacterial drugs, amoxicillin and clavulanate potassium tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.