AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet

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:

Hikma Pharmaceutical

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 875 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 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  

Product summary:

NDC 59115-025-22 ........... 20 tablets bottle 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. 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET
HIKMA PHARMACEUTICAL
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLETS.
AMOXICILLIN AND CLAVULANATE POTASSIUM
TABLETS USP, 875 MG/125 MG
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 hepatic impairment. (5.2)
_Clostri