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 tablets, USP and other antibacterial drugs, amoxicillin and clavulanate potassium tablets, USP 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 are 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 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 tablets, USP should not be used.
Preferred Pharmaceuticals, Inc.
OVAL WHITE 33 X
33 X OVAL WHITE
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amoxicillin as amoxicillin trihydrate 500 MG clavulanic acid as clavulanate potassium 125 MG Oral Tablet
Preferred Pharmaceuticals, Inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Amoxicillin and Clavulanate Potassium Tablets USP, 500 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘X’ on one side and ‘33’ on the other side. Bottles of 8 - 68788-9725-8 Bottles of 10 - 68788-9725-1 Bottles of 14 - 68788-9725-4 Bottles of 20 - 68788-9725-2 Amoxicillin and Clavulanate Potassium Tablets USP, 875 mg/125 mg are white to off-white, capsule shaped, film-coated tablets, debossed with ‘X’ on one side and score line in between 3 and 2 on the other side. Bottles of 8 - 68788-9726-8 Bottles of 10 - 68788-9726-1 Bottles of 14 - 68788-9726-4 Bottles of 20 - 68788-9726-2 Dispense in a tight container [see USP]. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep out of the reach of children.
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