Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
Preferred Pharmaceuticali Inc.
CEFUROXIME AXETIL
CEFUROXIME 500 mg
ORAL
PRESCRIPTION DRUG
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 by β-la
Cefuroxime Axetil Tablets USP, 500 mg of cefuroxime (as cefuroxime axetil), are white to off-white, film-coated, capsule shaped tablets with ‘A34’ debossed on one side and plain on the other side. Bottle of 20 - 68788-9914-2 Bottle of 30 - 68788-9914-3 Bottle of 60 - 68788-9914-6 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 PREFERRED PHARMACEUTICALI 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 USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Cefuroxime axetil tablets USP is a cephalosporin antibacterial drug indicated for the treatment of the following infections due to susceptible bacteria: (1) • • • • • • • • To reduce the development of drug-resistant bacteria and maintain the effectiveness of cefuroxime axetil tablets USP and other antibacterial drugs, cefuroxime axetil tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. DOSAGE AND ADMINISTRATION • • • • 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 mg or 500 mg every 12 hours 10 Secondary bacterial infections of acute bronchitis 250 mg or 500 mg every 12 hours 5 to 10 Uncomplicated skin and skin-structure infe ctions 250 mg 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 • Pharyngitis/tonsillitis (adults and pediatric patients) (1.1) Acute bacterial otitis media (pediatric patients) (1.2) Acute bacterial maxillary Baca dokumen lengkap