Linked Life Data

11120961

Source:http://linkedlifedata.com/resource/pubmed/id/11120961

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
1
pubmed:dateCreated
2001-2-5
pubmed:abstractText
Telithromycin (HMR 3647) is a novel ketolide antimicrobial with good activity against both common and atypical respiratory pathogens, including many resistant strains. This randomized, three-period crossover study determined the dose proportionality of telithromycin pharmacokinetics after single and multiple dosing in healthy subjects. In each treatment period, subjects received a single oral dose of 400, 800 or 1,600 mg of telithromycin followed 4 days later by the same dose once daily for 7 days. Blood and urine samples were taken throughout the study for determination of pharmacokinetic parameters for telithromycin and RU 76363, its main metabolite. Telithromycin and RU 76363 achieved steady state within 2 to 3 days of once-daily dosing. A slight accumulation of telithromycin was observed after 7 days of therapy, with values of the area under the concentration-time curve from 0 to 24 h approximately 1.5 times higher than those achieved with the single dose. The pharmacokinetics of telithromycin and RU 76363 deviated moderately from dose proportionality. At a dose of 800 mg/day, telithromycin attained mean maximal and trough plasma concentrations of 2.27 and 0. 070 mg/liter respectively. Elimination was biphasic; initial and terminal half-lives were 2.87 and 9.81 h for the 800-mg dose. Study medication was well tolerated, although adverse events tended to be more frequent at the 1,600-mg dose. This study showed that telithromycin was generally well tolerated and suggests that a once-daily 800-mg oral dose of telithromycin maintains an effective concentration in plasma for the treatment of respiratory tract infections involving the key respiratory pathogens.
pubmed:commentsCorrections
http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-10027978, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-10052892, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-10418764, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9184373, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9248979, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9559816, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9624482, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9624505, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9635909, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9806981, http://linkedlifedata.com/resource/pubmed/commentcorrection/11120961-9869571
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jan
pubmed:issn
0066-4804
pubmed:author
pubmed:issnType
Print
pubmed:volume
45
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
170-5
pubmed:dateRevised
2009-11-18
pubmed:meshHeading
pubmed:year
2001
pubmed:articleTitle
Pharmacokinetics of the new ketolide telithromycin (HMR 3647) administered in ascending single and multiple doses.
pubmed:affiliation
Aventis Pharma, Hoechst Marion Roussel/Romaineville, 93235 Romainville Cedex, France. florence.namour@aventis.com
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't