Document Detail


Safety and tolerance of trospium chloride in the high dose range.
MedLine Citation:
PMID:  8494577     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The safety and tolerance of increasing single oral doses of 20, 40, 80, 120, 180, 240 and 360 mg trospium chloride (Spasmo-lyt, CAS 10405-0204) were investigated in 29 healthy male volunteers in a double-blind placebo-controlled study. Blood pressure, heart rate, ECG, pupillary diameter, salivary secretion, and subjective reports of tolerance revealed no essential differences between placebo and trospium chloride in doses up to 120 mg. Starting with single doses of 180 mg, anticholinergic effects were observed with increasing intensity, i.e., dilatation of the pupils, reduction of salivary flow, and increase of heart rate. While the highest administered dose of 360 mg trospium chloride did not cause any relevant changes of vital parameters (blood pressure, pulse, ECG), it was subjectively rated as quite unpleasant. The data show that trospium chloride is well tolerated in single oral doses well above the current therapeutic daily dose of up to 40 mg.
Authors:
H P Breuel; G Mürtz; S Bondy; J Horkulak; B M Gianetti
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Publication Detail:
Type:  Clinical Trial; Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Arzneimittel-Forschung     Volume:  43     ISSN:  0004-4172     ISO Abbreviation:  Arzneimittelforschung     Publication Date:  1993 Apr 
Date Detail:
Created Date:  1993-06-15     Completed Date:  1993-06-15     Revised Date:  2013-05-22    
Medline Journal Info:
Nlm Unique ID:  0372660     Medline TA:  Arzneimittelforschung     Country:  GERMANY    
Other Details:
Languages:  eng     Pagination:  461-4     Citation Subset:  IM    
Affiliation:
AFB Clinical Pharmacology Division, Berlin, Fed, Rep. of Germany.
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MeSH Terms
Descriptor/Qualifier:
Adult
Blood Pressure / drug effects
Double-Blind Method
Electrocardiography / drug effects
Humans
Male
Middle Aged
Nortropanes / administration & dosage,  toxicity*
Parasympatholytics / administration & dosage,  toxicity*
Pulse / drug effects
Pupil / drug effects
Salivation / drug effects
Chemical
Reg. No./Substance:
0/Nortropanes; 0/Parasympatholytics; 1E6682427E/trospium chloride

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


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