amoxicillin as amoxicillin trihydrate 500 MG clavulanic acid as clavulanate potassium 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 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 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, indicating no beta-lactamase production, Amoxicillin and Clavulanate Potassium should not be used.
Preferred Pharmaceuticals, Inc
OVAL WHITE 500 125
500 125 OVAL WHITE
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16 HOW SUPPLIED/STORAGE AND HANDLING Tablets: 500 ‑ mg/125-mg Tablets: Each white oval film-coated tablet, debossed with AUGMENTIN on one side and 500/125 on the other side, contains 500mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. Bottles of 8 - 68788-9960-8 Bottles of 20 - 68788-9960-2 875 ‑ mg/125-mg Tablets: Each scored white capsule‑shaped tablet, debossed with AUGMENTIN 875 on one side and scored on the other side, contains 875mg amoxicillin as the trihydrate and 125mg clavulanic acid as the potassium salt. Bottles of 8 - 68788-9961-8 Bottles of 20 - 68788-9961-2 Dispense in original container. Store tablets and dry powder at or below 25°C (77°F). Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.
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