Antipsychotic AgentsAbilify (aripiprazole) Tablets
Drug Approval Classification: Supplemental New Drug Application (Approval Date: 04/08/04)
New Warnings: This supplemental NDA is for revised labeling regarding hyperglycemia occurrence in patients taking Abilify (aripiprazole):
Drug Approval Classification: Original New Drug Application (Approval Date: 03/29/04)
Indication: This NDA provides for the use of Zyprexa IntraMuscular (olanzapine) for Injection for the treatment of agitation associated with schizophrenia and bipolar I mania.
Dosing: The recommended dose in patients with agitation associated with schizophrenia or bipolar I mania is 10 mg. A lower dose of 5 or 7.5 mg may be considered. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. The efficacy of repeated doses of intramuscular olanzapine for injection in agitated patients has not been evaluated in controlled clinical trials.
Pharmacokinetics: Olanzapine intramuscular injection is absorbed rapidly, and peak plasma concentrations occur within 15 to 45 minutes. In healthy volunteers, a 5-mg dose of intramuscular olanzapine for injection produces a maximum plasma concentration approximately 5 times higher than the maximum plasma concentration produced by a 5-mg dose of oral olanzapine.
Medscape Pharmacists. 2004;5(1) © 2004 Medscape
Cite this: May 2004 - Medscape - Jun 04, 2004.