AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Available from:

REMEDYREPACK INC.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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-lactamase–producing isolates of H. influenzae

Product summary:

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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
REMEDYREPACK INC.
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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 FOR ORAL USE
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/hepa