CEFTIN

LOE Approaching

cefuroxime axetil

GSK
NDAORALFOR SUSPENSION
Approved
Jun 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
3

Mechanism of Action

12.1 Mechanism of Action Cefuroxime axetil is an antibacterial drug [see ]. 12.3 Pharmacokinetics Absorption After oral administration, cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolyzed by nonspecific esterases in the intestinal mucosa and blood to cefuroxime.…

Indications (29)

older) with mild-to-moderate pharyngitis/tonsillitis caused by susceptible strains of Streptococcus pyogenesHaemophilus influenzae (including β-lactamase–producing strains)Moraxella catarrhalis (including β-lactamase–producing strains)Streptococcus pyogenesolder) with mild-to-moderate acute bacterial maxillary sinusitis caused by susceptible strains of Streptococcus pneumoniaeHaemophilus influenzae (non - β-lactamase–producing strains only)older) with mild-to-moderate acute bacterial exacerbations of chronic bronchitis caused by susceptible strains of Streptococcus pneumoniaeHaemophilus influenzae (β-lactamase–negative strains)Haemophilus parainfluenzae (β-lactamase–negative strains)older) with uncomplicated skinskin-structure infections caused by susceptible strains of Staphylococcus aureus (including β - lactamase–producing strains)older) with uncomplicated urinary tract infections caused by susceptible strains of Escherichia coliKlebsiella pneumoniaeolder) with uncomplicated gonorrheaurethralendocervicalcaused by penicillinase-producingnon-penicillinase–producing susceptible strains of Neisseria gonorrhoeaeuncomplicated gonorrhearectalfemalescaused by non-penicillinase–producing susceptible strains of Neisseria gonorrhoeaeolder) with early Lyme disease (erythema migrans) caused by susceptible strains of Borrelia burgdorferidevelopment of drug-resistant bacteriamaintain the effectiveness of cefuroxime axetil tabletsother antibacterial drugscefuroxime axetil tablets should be used only to treatprevent infectionsstrongly suspected to be caused by susceptible bacteria

Clinical Trials (3)

NCT00174811Phase 3Terminated

Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections

Started Jun 2005
639 enrolled
Otitis Media
NCT00269932Phase 3Completed

A Study of the Safety and Effectiveness of Oral Levofloxacin Compared With Cefuroxime Axetil in the Treatment of Adults With Persistent Bronchitis Experiencing Rapid Onset of Severe Worsening of Symptoms Caused by Bacteria

Started Aug 1993
485 enrolled
Bronchitis, Chronic
NCT00257049Phase 2/3Completed

A Study of the Safety and Effectiveness of Levofloxacin Compared With Ceftriaxone Sodium or Cefuroxime Axetil in the Treatment of Adults With Pneumonia

Started Jan 1984
604 enrolled
Pneumonia
Company
GSK
GSK
LONDON, United Kingdom
695 open jobs
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers