Document Detail

Pharmacokinetics and safety of single intravenous and oral doses of dolasetron mesylate in healthy women.
MedLine Citation:
PMID:  9158883     Owner:  NLM     Status:  MEDLINE    
Twenty-four healthy women received 2.4 mg kg-1 dolasetron mesylate (1.8 mg kg-1 dolasetron base) by a 10 min intravenous administration and by oral administration. Pharmacokinetics of dolasetron and of its active reduced metabolite MDL 74156 were monitored for 48 h in plasma. Urine was collected from 0 to 48 h, blood pressure and heart rate were measured at 0, 0.08, 1, 2, 12, 24, and 36 h, and ECGs were measured at 0, 0.08 (intravenous only), 1, 2, and 36 h after dosing. Dolasetron was widely distributed and rapidly reduced (mean t1/2 = 0.23 h) to MDL 74156 (mean t1/2 = 8.05 and 9.12 h after intravenous and oral administration respectively). MDL 74156 was extensively distributed; between 27 (oral route) and 33% (intravenous route) was eliminated unchanged in urine. Safety assessment showed mild to moderate headache, dizziness, and hot flushes after the intravenous administration and headache, abdominal cramps or pain, and constipation after oral administration. Small and clinically non-significant changes in PR, QRS, and QTc intervals were observed. We conclude that there is no obvious difference in dolasetron pharmacokinetics between healthy women and men and that dolasetron can be used as safely in women as in men.
A C Keung; H Landriault; M Lefebvre; D Gossard; E E Dempsey; M Juneau; D Dimmitt; M Castles; L Roberts; J Spenard
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Biopharmaceutics & drug disposition     Volume:  18     ISSN:  0142-2782     ISO Abbreviation:  Biopharm Drug Dispos     Publication Date:  1997 May 
Date Detail:
Created Date:  1997-07-18     Completed Date:  1997-07-18     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  7911226     Medline TA:  Biopharm Drug Dispos     Country:  ENGLAND    
Other Details:
Languages:  eng     Pagination:  361-9     Citation Subset:  IM    
Hoechst Marion Roussel, Kansas City, MO 64134-0627, USA.
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MeSH Terms
Administration, Oral
Antiemetics / administration & dosage,  adverse effects*,  pharmacokinetics*
Cross-Over Studies
Indoles / administration & dosage,  adverse effects*,  pharmacokinetics*
Injections, Intravenous
Middle Aged
Quinolizines / administration & dosage,  adverse effects*,  pharmacokinetics*
Serotonin Antagonists / administration & dosage,  adverse effects*,  pharmacokinetics*
Sex Factors
Reg. No./Substance:
0/Antiemetics; 0/Indoles; 0/Quinolizines; 0/Serotonin Antagonists; 115956-13-3/dolasetron mesylate

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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