CEDAX SUMMARY
CEDAX (ceftibuten capsules) and (ceftibuten for oral suspension) contain the active ingredient ceftibuten as ceftibuten dihydrate. Ceftibuten dihydrate is a semisynthetic cephalosporin antibiotic for oral administration.
CEDAX (ceftibuten) is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below (see
DOSAGE AND ADMINISTRATION
and
CLINICAL STUDIES
sections).
Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
NOTE: In acute bacterial exacerbations of chronic bronchitis clinical trials where Moraxella catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control.
Acute Bacterial Otitis Media due to Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes.
NOTE: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against Streptococcus pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against Streptococcus pneumoniae has been previously administered.
Pharyngitis and Tonsillitis due to Streptococcus pyogenes.
NOTE: Only penicillin by the intramuscular route of administration has been shown to be effective in the prophylaxis of rheumatic fever. Ceftibuten is generally effective in the eradication of Streptococcus pyogenes from the oropharynx; however, data establishing the efficacy of the CEDAX product for the prophylaxis of subsequent rheumatic fever are not available.
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NEWS HIGHLIGHTS
Published Studies Related to Cedax (Ceftibuten)
Comparative study of ceftibuten and cefixime in the treatment of complicated urinary tract infections. [2001.09] Between August 1996 and May 1998, a total of 62 patients who had complicated urinary tract infections treated at the Taipei Veterans General Hospital were enrolled into this study. This prospective, randomized, open-labeled trial aimed at comparing the efficacy and safety of ceftibuten and cefixime, prescribed each at a dose of 200 mg twice daily, in treating complicated urinary tract infection...
[Five days ceftibuten versus 10 days penicillin in the treatment of 2099 patients with A-streptococcal tonsillopharyngitis] [2001.07.19] Group A Streptococci have remained sensitive to penicillins and other betalactam antibiotics, e.rheumatic fever or glomerulonephritis, attributable to either ceftibuten or penicillin were observed in the course of the study.
Oral ceftibuten switch therapy for acute pyelonephritis in children. [2001.06] The available oral third generation of cephalosporin, "ceftibuten" was used to substitute the intravenous drug after defervescence in acute pyelonephritis in children. This randomized controlled study compared the efficacy of an oral ceftibuten switch therapy with a ceftriaxone in both short-term and long-term outcomes...
[Patient adherence in respiratory tract infections: ceftibuten versus other antibiotics (PARTICULAR study)] [2001.06] The study was conducted to evaluate patient compliance to antibiotic therapy in respiratory tract infections. The main aim of the study was to establish whether dosing frequency (1 vs 2 or 3 times daily) and other factors influence compliance...
[Patient adherence in respiratory tract infections: ceftibuten versus other antibiotics (PARTICULAR study)] [2001.06] The study was conducted to evaluate patient compliance to antibiotic therapy in respiratory tract infections. The main aim of the study was to establish whether dosing frequency (1 vs 2 or 3 times daily) and other factors influence compliance...
Clinical Trials Related to Cedax (Ceftibuten)
Short-term Antibiotic Therapy for Pyelonephritis in Childhood [Terminated]
The purpose of this study is to evaluate the efficacy of oral ceftibuten for 7 days versus
10 days in acute pyelonephritis in children.
The main hypothesis is that the ceftibuten for 7 days will be not inferior to ceftibuten 10
days in the rate of renal scarring at 6-12 months.
Patients Response to Early Switch To Oral:Osteomyelitis Study [Not yet recruiting]
Based on the current literature, investigators hypothesize that patients with osteomyelitis
who are treated with the standard approach of intravenous antibiotics for the full duration
of therapy will have the same clinical outcomes as patients treated with the experimental
approach of intravenous antibiotics with early switch to oral antibiotics.
The primary objective of this study is to compare patients with osteomyelitis treated with
the standard approach of intravenous antibiotics for the full duration of therapy versus
patients treated with intravenous antibiotics with an early switch to oral antibiotics in
relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy.
Secondary objectives of the study include the evaluation of adverse events related to the
use of antibiotics as well as the cost of care evaluated from the hospital perspective.
Evaluation Of Safety And Efficacy Of 0.3 Mg/Eye Macugen In Patients With Small Age-Related Macular Degeneration Lesions [Completed]
To evaluate the efficacy, based on the best-corrected visual acuity (using the ETDRS chart),
of a 0. 3 mg/eye pegaptanib sodium intravitreous injection given every 6 weeks for 54 weeks
in patients with exudative age-related macular degeneration and evidence of recent onset,
subfoveal and/or juxtafoveal choroidal neovascularization.
Safety and Efficacy of Talactoferrin in Previously Treated Patients With Non-small Cell Lung Cancer [Completed]
The purpose of this study is to determine whether talactoferrin can improve overall survival
in patients with non-small cell lung cancer (NSCLC) who have been previously treated with
two or more regimens.
Pregabalin In Partial Seizures Extension Study [Completed]
To evaluate long-term efficacy and safety of pregabalin (150 to 600mg/day) as adjunctive
treatment in patients with partial seizures.
Reports of Suspected Cedax (Ceftibuten) Side Effects
Incorrect Storage of Drug (5),
Wrong Technique in Drug Usage Process (3),
Haematochezia (2),
Diarrhoea (2),
Rhonchi (2),
Abdominal Pain (1),
Pancreatitis Acute (1),
Pyrexia (1),
Erythema (1),
Idiopathic Thrombocytopenic Purpura (1), more >>
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Page last updated: 2006-11-05
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