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

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharamaceuticals,Inc.

DCI (Dénomination commune internationale):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 600 mg in 5 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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 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: - antiba

Descriptif du produit:

Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 600 mg/42.9 mg per 5 mL is a white to off-white granular powder – Each 5 mL of reconstituted white to pale yellow, strawberry flavored suspension contains 600 mg amoxicillin and 42.9 mg clavulanic acid as the potassium salt. NDC 68071-1661-5 Bottles of 125 mL Storage Store reconstituted suspension under refrigeration. Discard unused suspension after 10 days. Store dry powder for oral suspension at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in original container.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM POWDER, FOR SUSPENSION
NUCARE PHARAMACEUTICALS,INC.
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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 FOR
ORAL USE
INITIAL U.S. APPROVAL: 1984
To reduce the development of drug-resistant bacteria and maintain th e
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 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):
antibacterial drug exposure for acute otitis media within the
preceding 3 months, and either of the following: 1) age 2
years or younger 2) daycare attendance
DOSAGE AND ADMINISTRATION
Pediatric Patients less than 40 kg: 90 mg/kg/day divided every 12
hours, administered for 10 days. ( 2)
DOSAGE FORMS AND STRENGTHS
600 mg/42.9 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 cephalosporins). ( 4.1)
• History of cholestatic jaundice/hepatic dysfunction associated
with amoxicillin and clavulanate potassium for oral
suspension. ( 4.2)
WARNINGS AND PRE