AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium powder, for suspension

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Tilgjengelig fra:

Preferred Pharmaceuticals Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Tablets 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. NDC 68788-6012-1 mL bottle 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 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.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
PREFERRED PHARMACEUTICALS INC.
REFERENCE LABEL SET ID: 8F8259CA-F356-4E55-8770-15FB7B345F90
REFERENCE LABEL SET ID: 7CD5A359-4EBC-4B2A-81D7-3B253069E346
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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:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Formulations and amoxicillin/clavulanate content are:
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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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,