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Cedax (Ceftibuten Dihydrate) - Summary

 
 



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 (beta)-lactamase-producing strains), Moraxella catarrhalis (including (beta)-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 (beta)-lactamase-producing strains), Moraxella catarrhalis (including (beta)-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.


See all Cedax indications & dosage >>

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...

more studies >>

Clinical Trials Related to Cedax (Ceftibuten)

Short-Term Antibiotic Therapy for Pyelonephritis in Childhood [Recruiting]
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.

Study of Posaconazole in the Treatment of Invasive Fungal Infections (Study P02095) (COMPLETED) [Completed]
This study is designed to evaluate the safety, tolerance and efficacy of Posaconazole (SCH 56592) under an open label, treatment protocol for subjects with invasive fungal infections:

A. which are refractory or resistant to standard antifungal therapies; B. for which there are currently no effective therapies; C. with a prior history of serious, severe or life-threatening toxicities while receiving antifungal therapy; D. with pre-existing organ dysfunction which precludes the administration of standard antifungal therapies.

Comparison of Treatment Effect of Chemotherapy With Panitumumab to Chemotherapy Alone

Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy [Completed]
Open label, multicenter, international, randomized, parallel group, phase IIIb study comparing the efficacy and safety of levetiracetam to two standard antiepileptic drugs (CBZ and VPA) in patients with newly diagnosed epilepsy in a clinical practice setting.

SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura [No longer recruiting]
This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose, study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of SB-497115-GR as a treatment for patients with Immune Thrombocytopenic Purpura (ITP) who have failed prior therapy. The study is designed to determine the proportion of patients with a platelet count =50,000/ÁL after 42 days.

In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in a 2: 1 ratio of active: placebo. During the 6 week study period, subjects will start on placebo or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count at day 22.

more trials >>

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 >>


Page last updated: 2006-11-05

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