amoxicillin and clavulanate potassium tablet film coated
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) 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, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors indicated in the treatment of infections due to susceptible isolates of the designated bacteria in the conditions listed below*: Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are combination penicillin-class antibacterials and beta-lactamase inhibitors 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 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, USP, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) should not be used.
NuCare Pharmaceuticals, Inc.
OVAL WHITE 93 22 75
93 22 75 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and Clavulanate Potassium Tablets USP Amoxicillin and Clavulanate Potassium Tablets USP are supplied as follows: 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: NDC 66267-859-03 Bottles of 3 NDC 66267-859-04 Bottles of 4 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Advise patients to keep in a closed container. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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