CEFUROXIME AXETIL tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

OrchidPharma Inc

INN (International Name):

CEFUROXIME AXETIL

Composition:

CEFUROXIME 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED
ORCHIDPHARMA 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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1987
INDICATIONS AND USAGE
Cefuroxime axetil tablet is a cephalosporin antibacterial drug
indicated for the treatment of the following infections due to
susceptible bacteria: (1)
Pharyngitis/tonsillitis (adults and pediatric patients) (1.1)
Acute bacterial otitis media (pediatric patients) (1.2)
Acute bacterial maxillary sinusitis (adults and pediatric patients)
(1.3)
Acute bacterial exacerbations of chronic bronchitis (adults and
pediatric patients 13 years and older) (1.4)
Uncomplicated skin and skin-structure infections (adults and pediatric
patients 13 years and older) (1.5)
Uncomplicated urinary tract infections (adults and pediatric patients
13 years and older) (1.6)
Uncomplicated gonorrhea (adults and pediatric patients 13 years and
older) (1.7)
Early Lyme disease (adults and pediatric patients 13 years and older)
(1.8)
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of cefuroxime axetil and other
antibacterial drugs, cefuroxime axetil should be used only to treat or
prevent infections that are proven or strongly
suspected to be caused by bacteria. (1)
DOSAGE AND ADMINISTRATION
Tablets and oral suspension are not bioequivalent and are therefore
not substitutable on a milligram-per-milligram
basis. (2.1)
Administer tablets with or without food. (2.2)
Administer cefuroxime axetil tablets as described in the dosage
guidelines. (2.2)
Dosage adjustment is required for patients with impaired renal
function. (2.5)
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)
25