Country: United States
Language: English
Source: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
Cefuroxime axetil tablets 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 - The efficacy of cefuroxime axetil tablets in the prevention of rheumatic fever was not established in clinical trials. - The efficacy of cefuroxime axetil tablets in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials. Cefuroxime axetil tablets 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 are indicated for the tr
Cefuroxime Axetil Tablets USP, 250 mg of cefuroxime (as cefuroxime axetil), are white to off-white, film-coated, capsule shaped tablets with ‘A33’ debossed on one side and plain on the other side. 2 Tablets/Bottle NDC 68071-2879-2 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Replace cap securely after each opening.
Abbreviated New Drug Application
CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED NUCARE PHARMACEUTICALS,INC. ---------- 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 tablets are 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 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 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) Pharyn Read the complete document