AMOXICILLIN AND CLAVULANATE POTASSIUM- 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:

Hikma Pharmaceutical

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 200 mg in 5 mL

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 Powder for Oral Suspension, USP (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, 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 Powder for Oral Suspension, 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  

Product summary:

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5 mL : The dry powder is white to off white with fruity flavor. Each 5 mL of reconstituted creamy suspension contains 200 mg amoxicillin and 28.5 mg clavulanic acid as the potassium salt. NDC 59115-024-50 .................. 50 mL bottle NDC 59115-024-75 .................. 75 mL bottle NDC 59115-024-01 .................. 100 mL bottle Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 400 mg/57 mg per 5 mL: The dry powder is white to off white with fruity flavor. Each 5 ml of reconstituted creamy suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt. NDC 59115-023-50 .................. 50 mL bottle NDC 59115-023-75 .................. 75 mL bottle NDC 59115-023-01 .................. 100 mL bottle Dispense in original container. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep 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
HIKMA PHARMACEUTICAL
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND CLAVULANATE POTASSIUM
POWDER FOR ORAL SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN AND
CLAVULANATE POTASSIUM POWDER FOR ORAL SUSPENSION, USP.
AMOXICILLIN AND CLAVULANATE POTASSIUM POWDER FOR ORAL SUSPENSION, USP
INITIAL U.S. APPROVAL: 1984
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Amoxicillin and Clavulanate
Potassium 200 and 400 and other antibacterial drugs, Amoxicillin and
Clavulanate Potassium 200 and 400 should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria. (11.3)
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium Powder for Oral Suspension, USP
is 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: 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)
DOSAGE FORMS AND STRENGTHS
Formulation and amoxicillin/clavulanate content is:
Powder for Oral Suspension: 200 mg/28.5 mg per 5 mL, 400 mg/57 mg per
5 mL (3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to amoxicillin and clavu
lanate potassium