Country: United States
Language: English
Source: NLM (National Library of Medicine)
AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
Blenheim Pharmacal, Inc.
AMOXICILLIN
AMOXICILLIN ANHYDROUS 875 mg
ORAL
PRESCRIPTION DRUG
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*: caused by beta-lactamase–producing isolates of Haemophilus influenzae and Moraxella catarrhalis . caused by beta-lactam
A moxicillin and Clavulanate Potassium Tablets USP, 250 mg/125 mg are white to off-white, oval shaped, film-coated tablets, debossed with ‘A’ on one side and ‘63’ on the other side. Bottles of 30 NDC 65862-501-30 Bottles of 500 NDC 65862-501-05 10 x 10 Unit-dose Tablets NDC 65862-501-10 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 20 NDC 65862-502-20 Bottles of 500 NDC 65862-502-05 10 x 10 Unit-dose Tablets NDC 65862-502-10 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 20 NDC 65862-503-20 Bottles of 100 NDC 65862-503-01 10 x 10 Unit-dose Tablets NDC 65862-503-10 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.
Abbreviated New Drug Application
AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM COATED BLENHEIM PHARMACAL, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP. AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP INITIAL U.S. APPROVAL: 1984 TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE EFFECTIVENESS OF AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS AND OTHER ANTIBACTERIAL DRUGS, AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA. INDICATIONS AND USAGE 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) DOSAGE AND ADMINISTRATION Adults and Pediatric Patients > 40 kg: 500 mg/125 mg or 875 mg/125 mg every 12 hours or 250 mg/125 mg or 500 mg/125 mg every 8 hours. (2.1, 2.2) Pediatric patients aged 12 weeks (3 months) and older: 25 to 45 mg/kg/day every 12 hours or 20 to 40 mg/kg/day every 8 hours, up to the adult dose. (2.2) Neonates and infants < 12 weeks of age: 30 mg/kg/day divided every 12 hours, based on the amoxicillin component. Use of the 125 mg/31.25 mg per 5 mL oral suspension is recommended. (2.2) DOSAGE FORMS AND STRENGTHS Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg tablets are scored (3) CONTRAINDICATIONS History of a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin and clavulanate potassium tablets or to other beta-lactams (e.g., penicillins or cephalosporins). (4) History of cholestatic jaundice/hepat Read the complete document