amoxicillin and clavulanate potassium tablet film coated amoxicillin and clavulanate potassium powder for suspension
1 INDICATIONS AND USAGE To reduce the development of drugâ€‘resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium and other antibacterial drugs, amoxicillin and clavulanate potassium 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 is 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*: Amoxicillin and clavulanate potassium is a combination penicillin-class antibacterial and betaâ€‘lactamase inhibitor indicated for treatment of the following: Lower respiratory tract infections (1.1) Acute bacterial otitis media (1.2) Sinusitis (1.3) Skin and skin structure infections (1.4) Urinary tract infections (1.5) 1.1 Lower Respiratory Tract Infections caused by betaâ€‘lactamaseâ€“producing isolates of Haemophilus influenzae and Moraxella catarrhalis . 1.2 Acute Bacterial Otitis Media caused by betaâ€‘lactamaseâ€“producing isolates of H. influenzae and M. catarrhalis . 1.3 Sinusitis caused by betaâ€‘lactamaseâ€“producing isolates of H. influenzae and M. catarrhalis . 1.4 Skin and Skin Structure Infections caused by betaâ€‘lactamaseâ€“producing isolates of Staphylococcus aureus, Escherichia coli, and Klebsiella species . 1.5 Urinary Tract Infections caused by betaâ€‘lactamaseâ€“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 should not be used.
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 20Â° to 25Â°C (68Â° to 77Â°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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