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:

Proficient Rx LP

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, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) 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, Amoxicillin and Clavulanate Potassium for Oral Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP (

Product summary:

Amoxicillin and Clavulanate Potassium Tablets USP Amoxicillin and Clavulanate Potassium Tablets USP are supplied as follows: 500 mg/125 mg: White, oblong-shaped, biconvex, film-coated, unscored tablets, debossed 93 on one side and 2274 on the other side. Each tablet contains 500 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 6, 20, and 21 tablets. 875 mg/125 mg: White, capsule-shaped, biconvex, film-coated, scored tablets, debossed 93 on one side and 22 score line 75 on the other side. Each tablet contains 875 mg amoxicillin, USP as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20 tablets. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
PROFICIENT RX LP
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM TABLETS USP, AMOXICILLIN AND CLAVULANATE
POTASSIUM FOR ORAL
SUSPENSION USP, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP
(CHEWABLE) SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMOXICILLIN AND
CLAVULANATE POTASSIUM
TABLETS USP, AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION
USP, AND
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP (CHEWABLE).
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, AMOXICILLIN AND
CLAVULANATE
POTASSIUM FOR ORAL SUSPENSION USP, AND AMOXICILLIN AND CLAVULANATE
POTASSIUM
TABLETS USP (CHEWABLE) 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, AMOXICILLIN AND
CLAVULANATE POTASSIUM FOR
ORAL SUSPENSION, AND AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS
(CHEWABLE) AND OTHER
ANTIBACTERIAL DRUGS, AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS,
AMOXICILLIN AND
CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, AND AMOXICILLIN AND
CLAVULANATE POTASSIUM
TABLETS (CHEWABLE) SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE
PROVEN OR STRONGLY
SUSPECTED TO BE CAUSED BY BACTERIA.
[INSERT BOXED WARNING HIGHLIGHT TITLE]
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
[Insert boxed warning highlight text]
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium Tablets USP, Amoxicillin and
Clavulanate Potassium for Oral
Suspension USP, and Amoxicillin and Clavulanate Potassium Tablets USP
(Chewable) are combination
penicillin-class antibacterials and beta-lactamase inhibitors
indicated for treatment of the following:
Urinary tract infections (1.5)
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/