Telithromycin

Overview

Telithromycin, a semi-synthetic erythromycin derivative, belongs to a new chemical class of antibiotics called ketolides. Ketolides have been recently added to the macrolide-lincosamide-streptogramin class of antibiotics. Similar to the macrolide antibiotics, telithromycin prevents bacterial growth by interfering with bacterial protein synthesis. Telithromycin binds to the 50S subunit of the 70S bacterial ribosome and blocks further peptide elongation. Binding occurs simultaneously at to two domains of 23S RNA of the 50S ribosomal subunit, domain II and V, where older macrolides bind only to one. It is used to treat mild to moderate respiratory infections.

Indication

临床主要用于敏感菌所致的呼吸道感染，包括社区获得性肺炎、慢性支气管炎、急性上颌窦咽炎及扁桃体炎。

Associated Conditions

Mild community-acquired pneumonia
Moderate Community acquired pneumonia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Risk of Acute Liver Injury in Users of Antimicrobials	2011/09/14	NCT01434173	N/A	Completed	Bayer
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media	2008/03/19	NCT00638534	Phase 3	Completed	Sanofi
Japanese Study Evaluating the Effects of Telithromycin in Children With Community-Acquired Pneumonia	2008/03/19	NCT00638859	Phase 3	Completed	Sanofi
Ketek in CAP / AECB in Ambulatory Adult Patients	2007/10/19	NCT00546676	Phase 4	Completed	Sanofi
Telithromycin: in the Treatment of Acute Exacerbation of Chronic Bronchitis in Adult Outpatients With COPD	2007/10/02	NCT00538148	Phase 4	Completed	Sanofi
Telithromycin, Treating Adult Outpatients With Mild to Moderate Community-acquired Pneumonia (CAP) in High Bacterial Resistance Areas	2007/10/02	NCT00538018	Phase 4	Completed	Sanofi
AMS VS MOXI Ketek vs Avelox in AMS	2007/10/01	NCT00537563	Phase 3	Completed	Sanofi
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections	2006/12/06	NCT00408135	Phase 3	Completed	Sanofi
Controlled Trial: 5-day Course of Telithromycin Versus Doxycycline for the Treatment of Mild to Moderate Scrub Typhus	2006/07/12	NCT00351182	Phase 3	Completed	Dong-Min Kim
Intrapulmonary Pharmacokinetics of Antibiotics	2006/04/18	NCT00315601	Phase 4	Terminated	University of Illinois at Chicago

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
KETEK	sanofi-aventis canada inc	02247520	Tablet - Oral	400 MG	5/29/2003

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

AI-Powered Research

Premium Access