Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
CEFUROXIME AXETIL (UNII: Z49QDT0J8Z) (CEFUROXIME - UNII:O1R9FJ93ED)
Direct_Rx
ORAL
PRESCRIPTION DRUG
1.1 Pharyngitis/Tonsillitis 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 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. 1.2 Acute Bacterial Otitis Media 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. 1.3 Acute Bacterial Maxillary Sinusitis Cefuroxime axetil tablets are indicated f
Cefuroxime axetil tablets,USP 250 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with ''204 debossed on one side and plain on the other side as follows: 20 Tablets/Bottle 60 Tablets/Bottle 100 Tablets/Bottle 30 Tablets (3x10 Unit-dose Tablets) Cefuroxime Axetil Tablets,USP 500 mg of cefuroxime (as cefuroxime axetil), are blue, capsule-shaped, biconvex, film-coated tablets with 203'' debossed on one side and plain on the other side as follows: 20 Tablets/Bottle 60 Tablets/Bottle 100 Tablets/Bottle 30 Tablets (3x10 Unit-dose Tablets) NDC 67877-216-84 Store at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]. Replace cap securely after each use.
Abbreviated New Drug Application
CEFUROXIME AXETIL- CEFUROXIME AXETIL TABLET, FILM COATED DIRECT_RX ---------- CEFUROXIME AXETIL 1.1 Pharyngitis/Tonsillitis 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 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. 1.2 Acute Bacterial Otitis Media 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. 1.3 Acute Bacterial Maxillary Sinusitis 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 Haemophilus influenzae or Moraxella catarrhalis in patients with acute bacterial maxillary sinusitis was not established due to insufficient numbers of these isolates in the clinical trials [see Clinical Studies (14.1)]. 1.4 Acute Bacterial Exacerbations of Chronic Bronchitis Cefuroxime axetil tablets are indicated for the treatment of adult patients and pediatric patients (aged 13 and older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae (β-lacta Lugege kogu dokumenti