Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
Preferred Pharmaceuticals, Inc.
CEFUROXIME AXETIL
CEFUROXIME 250 mg
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 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 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 for sinus infections caused by β-lactamase–producing Haemoph
Cefuroxime axetil tablets USP, 250 mg of cefuroxime (as cefuroxime axetil), are white to off-white, capsule-shaped, film-coated tablets with "LUPIN" debossed on one side and "302" on the other side, supplied in bottles of 20 and 60. Bottle of 20 - 68788-9700-2 Bottle of 30 - 68788-9700-3 Bottle of 60 - 68788-9700-6 Cefuroxime axetil tablets USP, 500 mg of cefuroxime (as cefuroxime axetil), are white to off-white, capsule-shaped, film-coated tablets with "LUPIN" debossed on one side and "303" on the other side, supplied in bottles of 20 and 60. Bottle of 20 - 68788-9701-2 Bottle of 30 - 68788-9701-3 Bottle of 60 - 68788-9701-6 Store the tablets at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Replace cap securely after each opening.
Abbreviated New Drug Application
CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET PREFERRED 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 RECENT MAJOR CHANGES Indications and Usage, Acute Bacterial Exacerbations 11/2016 of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis: Secondary Bacterial Infections of Acute Bronchitis (1.4)-Removed Dosage and Administration, Dosage for CEFTIN Tablets: 11/2016 Secondary Bacterial Infections of Acute Bronchitis (2.2)-Re move d INDICATIONS AND USAGE Cefuroxime axetil tablets are 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 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 • • • • 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 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 Acute bac Διαβάστε το πλήρες έγγραφο