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The tolerability of intramuscular ziprasidone and haloperidol treatment and the transition to oral therapy

Daniel, David G.a; Zimbroff, Dan L.b; Swift, Rachel H.c; Harrigan, Edmund P.c

International Clinical Psychopharmacology: January 2004 - Volume 19 - Issue 1 - p 9-15
ORIGINAL ARTICLES
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The intramuscular (i.m.) formulation of ziprasidone offers promise as an alternative to conventional i.m. agents for the short-term management of agitated patients with psychosis. This 7-day, randomized, open-label study evaluated the tolerability of ziprasidone i.m. and haloperidol i.m. in hospitalized patients with a psychotic disorder and moderate psychopathology. Patients received three fixed doses of ziprasidone i.m. 5 mg qid (n=69), 10 mg qid (currently maximum recommended daily dose in USA; n=71), 20 mg qid (n=66), or flexible-dose/flexible-schedule haloperidol i.m. up to 10 mg bid-qid (n=100) for 3 days. This was followed by oral treatment with the same medication for 4 days. Ziprasidone i.m. was associated with a notably lower burden of movement disorders than haloperidol i.m. (mean 11 mg/day). No bradycardia, sinus pauses, disinhibition, confusion, excessive sedation or respiratory depression was observed with ziprasidone. No safety issues were identified with the coadministration of lorazepam with the i.m. formulations of either agent. All three ziprasidone i.m. doses and haloperidol i.m. maintained control of symptoms and, following the transition to oral treatment, symptoms remained controlled. Ziprasidone i.m. 5,10, and 20 mg qid, given for 3 days were well tolerated. The transition from i.m. to oral ziprasidone was well tolerated with continuing maintenance of symptom control.

aBioniche Development Inc., McLean, Virginia

bPacific Clinical Research, Upland, California

cPfizer Global Research and Development, Pfizer Inc., New London, Connecticut, USA

Correspondence and requests for reprints to David G. Daniel, PO Box 6207, McLean, Virginia 22106, USA

Tel: +1 703 5563345; fax: +1 703 5563347;

e-mail: drdaniel@bionichegroup.com

Received 22 May 2003 Accepted 8 September 2003

© 2004 Lippincott Williams & Wilkins, Inc.