amoxicillin 875 MG clavulanate 125 MG Oral Tablet
1 INDICATIONS AND USAGE Amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) are 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, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should not be used. ( 1 ) Usage To reduce the development of drug–resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, amoxicillin and clavulanate potassium for oral suspension, and amoxicillin and clavulanate potassium tablets (chewable) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1 )
Teva Pharmaceuticals USA, Inc.
OVAL WHITE 93 22 75
93 22 75 OVAL WHITE
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Amoxicillin 875 MG Clavulanate 125 MG Oral Tablet
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16 HOW SUPPLIED/STORAGE AND HANDLING
AMOXICILLIN AND CLAVULANATE POTASSIUM tablets, USP are supplied as follows: 500 mg/125 mg: white, oblong–shaped, biconvex, film–coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20 tablets (NDC 0093–2274–34). 875 mg/125 mg: white, capsule–shaped, biconvex, film–coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side. Each tablet contains 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20 tablets (NDC 0093–2275–34). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
AMOXICILLIN AND CLAVULANATE POTASSIUM for oral suspension, USP is supplied as follows: 200 mg/28.5 mg per 5 mL: white to off–white powder – Each 5 mL of reconstituted orange–raspberry–flavored suspension contains 200 mg amoxicillin, USP and 28.5 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 0093–2277–73). 400 mg/57 mg per 5 mL: white to off–white powder – Each 5 mL of reconstituted orange–raspberry–flavored suspension contains 400 mg amoxicillin, USP and 57 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 0093–2279–73). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days.
AMOXICILLIN AND CLAVULANATE POTASSIUM tablets, USP (chewable) are supplied as follows: 200 mg/28.5 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other. They are available in bottles of 20 tablets (NDC 0093–2270–34). 400 mg/57 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other. They are available in bottles of 20 tablets (NDC 0093–2272–34). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light–resistant container as defined in the USP, with a child–resistant closure (as required). Keep this and all medications out of the reach of children.
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