Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
Wockhardt USA LLC.
CEFUROXIME AXETIL
CEFUROXIME 125 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 tablets, USP in the prevention of rheumatic fever was not established in clinical trials. - The efficacy of cefuroxime axetil tablets, USP 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 adu
Cefuroxime axetil tablets USP, 125 mg of cefuroxime as cefuroxime axetil, are white film-coated, round-shaped biconvex unscored tablets embossed with W920 on one side and plain on other side as follows: 20 Tablets/ Bottle NDC 64679-920-01 60 Tablets/ Bottle NDC 64679-920-02 Cefuroxime axetil tablets USP, 250 mg of cefuroxime as cefuroxime axetil, are white film-coated, round-shaped biconvex unscored tablets embossed with W921 on one side and plain on other side as follows: 20 Tablets/ Bottle NDC 64679-921-01 60 Tablets/ Bottle NDC 64679-921-02 Cefuroxime axetil tablets USP, 500 mg of cefuroxime as cefuroxime axetil, are white film-coated, round-shaped biconvex unscored tablets embossed with W922 on one side and plain on other side as follows: 20 Tablets/ Bottle NDC 64679-922-01 60 Tablets/ Bottle NDC 64679-922-02 Store at 20° - 25°C (68° - 77°F). Replace cap securely after each opening.
Abbreviated New Drug Application
CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED WOCKHARDT USA LLC. ---------- 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 of Chronic Bronchitis and Secondary Bacterial Infections of Acute Bronchitis: Secondary Bacterial Infections of Acute Bronchitis (1.4)-Removed 11/2016 Dosage and Administration, Dosage for Cefuroxime Axetil Tablets: Secondary Bacterial Infections of Acute Bronchitis (2.2) -Removed 11/2016 INDICATIONS AND USAGE Cefuroxime axetil 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 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. Citiți documentul complet