Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
LUPIN LIMITED
CEFUROXIME AXETIL
CEFUROXIME 250 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 - The efficacy of cefuroxime axetil in the prevention of rheumatic fever was not established in clinical trials. - The efficacy of cefuroxime axetil in the treatment of penicillin-resistant strains of Streptococcus pyogenes has not been demonstrated in clinical trials. 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 m
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. 20s Bottle NDC 68180-302-20 60s Bottle NDC 68180-302-60 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. 20s Bottle NDC 68180-303-20 60s Bottle NDC 68180-303-60 Store the tablets at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature].
Abbreviated New Drug Application
CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET LUPIN LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CEFUROXIME AXETIL TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CEFUROXIME AXETIL TABLETS USP. CEFUROXIME AXETIL TABLETS USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1987 INDICATIONS AND USAGE Cefuroxime axetil tablets USP 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 and secondary bacterial infections of acute 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 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 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 USP 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 USP INFECTION DOSAGE DURATION (DAYS) ADUL Прочитайте повний документ