AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Morton Grove Pharmaceuticals, Inc.

INN (International Name):

AMOXICILLIN

Sammensætning:

AMOXICILLIN ANHYDROUS 250 mg in 5 mL

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and Clavulanate Potassium for Oral Suspension (amoxicillin/clavulanate potassium) and other antibacterial drugs, Amoxicillin and Clavulanate Potassium for Oral Suspension 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 for Oral Suspension 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 and Moraxella catarrhalis . caused by

Produkt oversigt:

Amoxicillin and Clavulanate Potassium for Oral Suspension, USP 250 mg/62.5 mg per 5 mL: Each 5 mL of reconstituted orange-flavored suspension contains 250 mg amoxicillin and 62.5 mg clavulanic acid as the potassium salt, and is available as follows: NDC 60432-065-75            75 mL bottle NDC 60432-065-00          100 mL bottle NDC 60432-065-47          150 mL bottle Dispense in original container. Store dry powder for oral suspension at 20° – 25°C (68° – 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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
MORTON GROVE PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
RX ONLY
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND
CLAVULANATE POTASSIUM FOR ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE
FULL
PRESCRIBING INFORMATION FOR AMOXICILLIN AND CLAVULANATE POTASSIUM FOR
ORAL
SUSPENSION.
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION INITIAL U.S.
APPROVAL: 1984
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION AND OTHER
ANTIBACTERIAL DRUGS,
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION 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 for Oral Suspension 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: 250 mg/62.5 mg per 5 mL
(3)
CONTRAINDICATIONS
History of a serious hypersensitivity reaction (e.g., anaphylaxis or
Stevens-Johnson syndrome) to
Amoxicillin and Clavulanate Potassium for Oral Suspension or to other
beta-lactams (e.g., penicillins or
c