CEFUROXIME AXETIL- cefuroxime axetil tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)

Disponibil de la:

Preferred Pharmaceuticals, Inc.

INN (nume internaţional):

CEFUROXIME AXETIL

Compoziție:

CEFUROXIME 250 mg

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

Cefuroxime axetil tablets, USP are indicated for the treatment of adult patients and pediatric patients (13 years and older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenes . Limitations of Use Cefuroxime axetil tablets, USP are indicated for the treatment of pediatric patients (who can swallow tablets whole) with acute bacterial otitis media caused by susceptible strains of Streptococcus  pneumoniae , Haemophilus influenzae (including β- lactamase-producing strains), Moraxella catarrhalis (including β- lactamase-producing strains), or Streptococcus pyogenes. Cefuroxime axetil tablets, USP are indicated for the treatment of adult and pediatric patients (13 years and older) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniae or Haemophilus influenzae (non- β-lactamase-producing strains only). Limitations of Use The effectiveness of cefuroxime axetil tablets, USP for sinus infections caused

Rezumat produs:

Cefuroxime axetil tablets USP, 250 mg of cefuroxime as cefuroxime axetil, are white film-coated, round-shaped biconvex unscored tablets embossed with W921 on one side and plain on other side as follows: Bottle of 20 - 68788-9333-2 Bottle of 30 - 68788-9333-3 Bottle of 60 - 68788-9333-6 Store at 20° - 25°C (68° - 77°F). Replace cap securely after each opening.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED
PREFERRED PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CEFUROXIME AXETIL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFUROXIME AXETIL
TABLETS.
CEFUROXIME AXETIL TABLETS, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Cefuroxime axetil is a cephalosporin antibacterial drug indicated for
the treatment of the following infections due to
susceptible bacteria: (1)
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefuroxime axetil tablets and other
antibacterial drugs, cefuroxime axetil tablets should be used only to
treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DOSAGE AND ADMINISTRATION
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ADULT PATIENTS AND PEDIATRIC PATIENTS DOSAGE
GUIDELINES FOR CEFUROXIME AXETIL TABLETS
INFECTION
DOSAGE
DURATION (DAYS)
ADULTS AND ADOLESCENTS (13 YEARS AND OLDER)
Pharyngitis/tonsillitis
(mild to moderate)
250 mg
every 12 hours
10
Acute bacterial maxillary sinusitis
(mild to moderate)
250 mg
every 12 hours
10
Acute bacterial exacerbations of
chronic bronchitis (mild to moderate)
250 or 500 mg
every 12 hours
10
Secondary bacterial infections of
acute bronchitis
250 or 500 mg
every 12 hours
5 to 10
Uncomplicated skin and
skin-structure infections
250 or 500 mg
every 12 hours
10
Uncomplicated urinary tract infections
250 mg
every 12 hours
7 to 10
Uncomplicated gonorrhea
1,000 mg
single dose
Early Lyme disease
500 mg
every 12 hours
20
PEDIATRIC PATIENTS YOUNGER THAN 13 YEARS (WHO CAN SWALLOW TABLETS
WHOLE)
Acute bacterial otitis media
250 mg
every 12 hours
10
Acute bacterial maxillary sinusitis
250 mg
every 12 hours
10
DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
Known hypersensitivity (e.g., anaphylaxis) to cefuroxime axetil
tablets or to other β-lactams (e.g., penicillins and
cephalosporins). (4)
WARNINGS AND P