Amoxicillin 875 MG Clavulanate 125 MG Oral Tablet
1 INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium tablets USP, 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 tablets USP 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 tablets USP are combination penicillin-class antibacterial and beta-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 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 should not be used.
denton pharma, inc. dba northwind pharmaceuti
OVAL WHITE I07
I07 OVAL WHITE
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Amoxicillin 875 MG Clavulanate 125 MG Oral Tablet
Denton Pharma, Inc. DBA Northwind Pharmaceuti
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16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and Clavulanate Potassium Tablets USP are supplied as follows: Amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg are white to off-white colored, capsule shaped, biconvex, film-coated tablets debossed with “I 07” on one side score line on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available as follows. Dosepack of 20 NDC 70934-110-91 Dosepack of 30 NDC 70934-110-94 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
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