Amoxicillin and Clavulanate Potassium Amoxicillin 500 MG Clavulanate 125 MG Oral Tablet
1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium is 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 influenzae and Moraxella catarrhalis . • Acute Bacterial Otitis Media - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . • Sinusitis - caused by beta‑lactamase‑producing isolates of H. influenzae and M. catarrhalis . • Skin and Skin Structure Infections - caused by beta‑lactamase‑producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species . • Urinary Tract Infections - caused by beta‑lactamase‑producing isolates of E. coli, Klebsiella species , and Enterobacter species. Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. Usage To reduce the development of drug‑resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, and amoxicillin and clavulanate potassium for oral suspension 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. Amoxicillin and clavulanate potassium is a combination of amoxicllin, a penicillin-class antibacterial and clavulanate potassium, a beta‑lactamase inhibitor indicated for treatment of the following infections in adults and pediatric patients: ( 1 ) • Lower respiratory tract infections • Acute bacterial otitis media • Sinusitis • Skin and skin structure infections • Urinary tract infections Limitations of Use When susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium should not be used. ( 1 ) Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, and amoxicillin and clavulanate potassium for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
Sandoz Inc
OVAL WHITE Amc
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16 HOW SUPPLIED/STORAGE AND HANDLING Tablets
AMOXICILLIN AND CLAVULANATE POTASSIUM tablets, USP 500 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, debossed with 500/125 on one side and AMC on the other side. They are supplied in plastic bottles of 20 and 100 (with desiccant) as under: NDC 66685-1002-0 bottles of 20 tablets NDC 66685-1002-2 bottles of 100 tablets
AMOXICILLIN AND CLAVULANATE POTASSIUM tablets, USP 875 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, scored and debossed with 875/125 on one side and AMC on the other side. They are supplied in plastic bottles of 20 and 100 (with desiccant) as under: NDC 66685-1001-0 bottles of 20 tablets NDC 66685-1001-1 bottles of 100 tablets Oral Suspension
AMOXICILLIN AND CLAVULANATE POTASSIUM for oral suspension, USP 200 mg/28.5 mg per 5 mL (each 5 mL of reconstituted caramel-orange-raspberry-flavored suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt) are supplied as under: NDC 66685-1011-0 50 mL bottle NDC 66685-1011-1 75 mL bottle NDC 66685-1011-2 100 mL bottle
AMOXICILLIN AND CLAVULANATE POTASSIUM for oral suspension, USP 400 mg/57 mg per 5 mL (each 5 mL of reconstituted caramel-orange-raspberry-flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt) are supplied as under: NDC 66685-1012-0 50 mL bottle NDC 66685-1012-1 75 mL bottle NDC 66685-1012-2 100 mL bottle Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.
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