AMOXICILLIN AND CLAVULANATE POTASSIUM powder, for suspension

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Aidarex Pharmaceuticals LLC

INN (Algemene Internationale Benaming):

AMOXICILLIN

Samenstelling:

AMOXICILLIN ANHYDROUS 400 mg in 5 mL

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension, USP and other antibacterial drugs, amoxicillin and clavulanate potassium 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 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 and Moraxella catarrhalis . caused by beta-lactamase–produ

Product samenvatting:

Amoxicillin and Clavulanate Potassium for Oral Suspension USP,  400 mg/57 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, orange flavored suspension contains 400 mg amoxicillin and 57 mg clavulanic acid as the potassium salt.                 Bottles of 50 mL                     NDC 33261-0988-01                 Dispense in original container. Store dry powder at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Keep out of the reach of children.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
AIDAREX PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR
ORAL SUSPENSION, USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR AMOXICILLIN AND CLAVULANATE
POTASSIUM FOR ORAL SUSPENSION, USP.
AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION, USP
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, 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 mg/125 mg or 875 mg/125 mg
every 12 hours or 250 mg/125 mg or 500
mg/125 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/31.25 mg per 5 mL oral suspension is recommended.
(2.2)
DOSAGE FORMS AND STRENGTHS
Powder for Oral Suspension: 200 mg/28.5 mg per 5 mL and 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
clavulanate potassium for oral suspension or to other beta-lactams