AMOXICILLIN AND CLAVULANATE POTASSIUM Amoxicillin 875 MG Clavulanate 125 MG Oral Tablet
INDICATIONS & USAGE SECTION To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP should be used only to treat 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. Amoxicillin and clavulanate potassium tablets, USP are a combination penicillin-class antibacterial and beta-lactamase inhibitor indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: 1.1 Lower Respiratory Tract Infections caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis. 1.2 Acute Bacterial Otitis Media caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.3 Sinusitis caused by beta-lactamase–producing isolates of H. influenzae and M. catarrhalis. 1.4 Skin and Skin Structure Infections caused by beta-lactamase–producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species. 1.5 Urinary Tract Infections caused by beta-lactamase–producing isolates of E. coli, Klebsiella species, and Enterobacter species. 1.6 Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium tablets, USP should not be used.
DIRECT RX
OVAL WHITE 3 2 X
3 2 X OVAL WHITE
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HOW SUPPLIED SECTION
AMOXICILLIN AND CLAVULANATE POTASSIUM Tablets USP, 250 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side. Bottles of 30 NDC 65862-501-30 Bottles of 500 NDC 65862-501-05 10 x 10 Unit-dose Tablets NDC 65862-501-10
AMOXICILLIN AND CLAVULANATE POTASSIUM Tablets USP, 500 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side. Bottles of 20 NDC 65862-502-20 Bottles of 500 NDC 65862-502-05 10 x 10 Unit-dose Tablets NDC 65862-502-10
AMOXICILLIN AND CLAVULANATE POTASSIUM Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side. Bottles of 20 NDC 65862-503-20 Bottles of 100 NDC 65862-503-01 10 x 10 Unit-dose Tablets NDC 65862-503-10 Dispense in a tight container [see USP]. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.
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