AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Pharmasource Meds, LLC

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 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 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

Resumo do produto:

Tablets Amoxicillin and clavulanate potassium tablets, USP 875 mg/125 mg are white to off-white oblong film coated tablets with beveled edges, scored and debossed with 875/125 on one side and AMC on the other side. NDC 82982-018-14 bottles of 14 tablets Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers. Keep out of the reach of children.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
PHARMASOURCE MEDS, LLC
REFERENCE LABEL SET ID: B6583123-8297-4EB9-AD0F-B074F8707683
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS.
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 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 or 875 mg every 12 hours or
250 or 500 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/5 mL oral suspension is recommended.
(2.2)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to
amoxicillin and clavulanate potassium or to other beta‑lactams
(e.g., penicillins or cephalosporins). (4)
History of cholestatic jaundice/hepatic dysfunction associated with
amoxicillin and clavulanate
potassium. (4)
WARNINGS AND PRECAUTIONS
Serious (including fatal)