AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

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:

Preferred Pharmaceuticals Inc.

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 for Oral Suspension USP Amoxicillin and Clavulanate Potassium for Oral Suspension USP is supplied as follows: 400 mg/57 mg per 5 mL: White to off-white powder – Each 5 mL of reconstituted orange-raspberry-flavored suspension contains 400 mg amoxicillin, USP and 57 mg clavulanic acid as the potassium salt. It is available in bottles of 100 mL (NDC 68788-7128-1). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original containers. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) Amoxicillin and Clavulanate Potassium Tablets USP (Chewable) are supplied as follows: 200 mg/28.5 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2270 on the other. They are available in bottles of 20 tablets (NDC 0093-2270-34). 400 mg/57 mg: Mottled pink, oval, biconvex, unscored tablets, debossed 93 on one side and 2272 on the other. They are available in bottles of 20 tablets (NDC 0093-2272-34). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). 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 POWDER, FOR SUSPENSION
PREFERRED PHARMACEUTICALS INC.
----------
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.
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:
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
•
•
•
DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/clavulanate content are:
Ta