| Safety and tolerance of trospium chloride in the high dose range. | |
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MedLine Citation:
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PMID: 8494577 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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H P Breuel; G Mürtz; S Bondy; J Horkulak; B M Gianetti |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Arzneimittel-Forschung Volume: 43 ISSN: 0004-4172 ISO Abbreviation: Arzneimittelforschung Publication Date: 1993 Apr |
Date Detail:
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Created Date: 1993-06-15 Completed Date: 1993-06-15 Revised Date: 2004-11-17 |
Medline Journal Info:
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Nlm Unique ID: 0372660 Medline TA: Arzneimittelforschung Country: GERMANY |
Other Details:
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Languages: eng Pagination: 461-4 Citation Subset: IM |
Affiliation:
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AFB Clinical Pharmacology Division, Berlin, Fed, Rep. of Germany. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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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:
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0/Nortropanes; 0/Parasympatholytics; 10405-02-4/trospium chloride |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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