Amoxicillin 875 MG Clavulanate 125 MG Oral Tablet
1 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 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 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. Amoxicillin and clavulanate potassium tablets are a combination of amoxicillin, 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 tablets should not be used. ( 1 ) 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 bacteria. ( 1 )
Apotex Corp.
OVAL WHITE APO A C
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16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and clavulanate potassium tablets, USP 250 mg/125 mg Tablets: Each white, oval, biconvex, film-coated tablets, engraved “APO” on one side, “250-125” on the other. Each tablet contains 250 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 20 (NDC 60505-2539-2) Bottles of 30 (NDC 60505-2539-3) Bottles of 500 (NDC 60505-2539-5) 500 mg/125 mg Tablets : Each white, oval, biconvex, film-coated tablets, engraved “APO” on one side, “500-125” on the other. Each tablet contains 500 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 20 (NDC 60505-2540-2) Bottles of 30 (NDC 60505-2540-3) Bottles of 500 (NDC 60505-2540-5) 875 mg/125 mg Tablets: Each white, capsule-shaped, biconvex, film-coated tablets, engraved “APO” on one side, engraved “A” bisect “C” on the other. Each tablet contains 875 mg of amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt (equivalent to 149 mg of clavulanate potassium). Bottles of 20 (NDC 60505-2541-2) Bottles of 30 (NDC 60505-2541-3) Bottles of 500 (NDC 60505-2541-5) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight container. Keep out of the reach of children.
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