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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A Clinically Oriented Review of New Antipsychotics for Schizophrenia.
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Eur Neuropsychopharmacol
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SCIENCES Lab, Department of Psychiatry, University of Ottawa, Ottawa, Canada; Department of Child and Adolescent Psychiatry, Charité Universitätsmedizin, Berlin, Germany; Department of Mental Health, The Ottawa Hospital, Ottawa, Canada; Ottawa Hospital Research Institute: Clinical Epidemiology Program, University of Ottawa, Ottawa, Canada; School of Epidemiology and Public Health, Faculty of Medicine, University of Ottawa, Ottawa, Canada. Electronic address:
The United States Food and Drug Administration approved xanomeline-trospium combination for schizophrenia on September-26-2024. We conducted a PRISMA 2020-compliant systematic review with random-effects meta-analysis on the efficacy and safety of xanomeline-trospium in randomized controlled trials in patients with schizophrenia (MEDLINE, EMBASE, Cochrane, PsycINFO, October-01-2024). Co-primary outcomes were Positive And Negative Syndrome Scale (PANSS) total score (standardized mean difference=SMD), and all-cause discontinuation (risk ratio=RR).
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Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.
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