AMOXICILLIN AND CLAVULANATE POTASSIUM tablet

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:

Lake Erie Medical DBA Quality Care Products 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, 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 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*: caused by beta-lactamase-producing isolates of Haemophilus influenzae and Moraxella catarrhalis . caused by beta-lactamase-producing isolates of H. influenza  and M. c

Resumo do produto:

875-mg/125-mg T ablets : Each scored white capsule-shaped tablet, debossed with WW949 on the upper side and scored on the other side, contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. NDC 55700-653-20 ........... 20 tablets bottle Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). Advise patients to keep in a closed container. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
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, USPFOR 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: 875 mg
every 12 hours (2.1)
DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/clavulanate content are:
Tablets: 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/hepatic dysfunction associated with
Amoxicillin and Clavulanate
Potassium Tablets (4)
WARNINGS AND PRECAUTIONS
Serious (including fatal) hypersensitivity reactions: Discontinue
Amoxicillin and
Clavulanate Potassium Tablets if a reaction occurs. (5.1)
Hepatic dysfunction and cholestatic jaundice:
Discontinue if signs/symptoms of hepatitis occur. Monitor liver
function tests in patients with