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:

Lake Erie Medical DBA Quality Care Products LLC

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 and other antibacterial drugs, amoxicillin and clavulanate potassium 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, for oral suspension, USP, and chewable tablets, USP 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 isolate

Product summary:

Tablets Amoxicillin and Clavulanate Potassium Tablets, USP, 250 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule shaped, debossed GGN5 on one side and plain on the reverse side, and contains 250 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg: Each film coated tablet, for oral administration, is white, oval-shaped, debossed GGN6 on one side and plain on the reverse side, and contains 500 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. 55700-375-15 55700-375-20 Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg: Each film coated tablet, for oral administration, is white, capsule-shaped, scored and debossed GGN7 on one side and scored on the reverse side, and contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. 55700-306-14 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container; advise patient to keep in closed container. For Oral Suspension Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 200 mg/28.5 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 400 mg/57 mg per 5 mL: as a dry, white powder. Each 5 mL of reconstituted orange-flavored suspension contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. Store dry powder at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container; Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Chewable Tablets Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg tablets, USP (chewable): Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN2 on one side and plain on the reverse side, and contains 200 mg amoxicillin as the trihydrate and 28.5 mg clavulanic acid as the potassium salt. Amoxicillin and Clavulanate Potassium 400 mg/57 mg tablets, USP (chewable): Each chewable tablet is round, pink, cherry-banana flavored, embossed GGN4 on one side and plain on the reverse side, and contains 400 mg amoxicillin as the trihydrate and 57 mg clavulanic acid as the potassium salt. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in original container. Keep out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
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, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
AMOXICILLIN AND CLAVULANATE POTASSIUM, USP.
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, FOR ORAL SUSPENSION
USP, AND
CHEWABLE TABLETS USP, 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 AND OTHER ANTIBACTERIAL DRUGS,
AMOXICILLIN AND
CLAVULANATE POTASSIUM 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, for oral
suspension, USP, and chewable tablets, USP
are a combination penicillin-class antibacterial and beta-lactamase
inhibitor indicated for treatment of the
following:
•
•
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/clavulanate content are:
•
•
•
CONTRAINDICATIONS
•
•
WARNINGS AND PRECAUTIONS
•
•
•
•
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)
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)
Tablets: 250 mg/125 mg, 500 mg/125 mg, 875 mg/125 mg; 875 mg/125 mg
tablets are scored (3)
For Oral Suspension: 200 mg/28.5 mg per 5