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:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

AMOXICILLIN

Sammensetning:

AMOXICILLIN ANHYDROUS 600 mg in 5 mL

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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, 600 mg/42.9 mg per 5 mL is indicated for the treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae (penicillin MICs ≤ 2 mcg/mL), H. influenzae (including beta-lactamase–producing strains), or M. catarrhalis (including beta-lactamase–producing strains) characterized by the following risk fa

Produkt oppsummering:

How Supplied The color of the dry powder for amoxicillin and clavulanate potassium for oral suspension USP, 600 mg/42.9 mg per 5 mL is white to off-white powder. Each 5 mL of reconstituted orange-flavored suspension contains 600 mg amoxicillin trihydrate and 42.9 mg clavulanic acid as the potassium salt. 55700-471-25 Storage Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in original container. Keep tightly closed. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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 POWDER
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 (1).
INDICATIONS AND USAGE
Amoxicillin and clavulanate potassium for oral suspension USP, 600
mg/42.9 mg per 5 mL is indicated for the treatment of
pediatric patients with recurrent or persistent acute otitis media due
to _S. pneumoniae _(penicillin MICs ≤ 2 mcg/mL), _H._
_influenzae _(including beta-lactamase–producing strains), or _M.
catarrhalis _(including beta-lactamase-producing strains)
characterized by the following risk factors (1):
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
600 mg/42.9 mg per 5 mL. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
•
•
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ADVERSE REACTIONS
The most frequently reported adverse reactions were diaper rash (4%),
diarrhea (3%), vomiting (2%), candidiasis (1%),
and rash (1%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACTTEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; OR FDA AT 1-800-FDA-1088
ORhttp://www.fda.gov/medwatch.
To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA,
PHARMACOVIGILANCE at 1-866-832-8537 or
[e-mail]; or FDA at 1-800-FDA-1088 or
http://www.fda.gov/medwatch.or FDA at 1-800-FDA-1088 or
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