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(IM ziprasidone, Pfizer)
An intramuscular formulation of the atypical antipsychotic for treating acute agitation in schizophrenic patients who need an IM antipsychotic for rapid control of agitation. The first atypical antipsychotic to be approved in an IM formulation.
* Recommended Dosage: 10 mg (every 2 hours) to 20 mg (every 4 hours) as needed up to a maximum of 40 mg/day.
* Special Considerations: Contraindicated in patients with QTc prolongation, due to dose-related effect on prolongation of the QTc interval of the electrocardiogram.
In studies of oral Geodon, some patients had QTc increases, which can lead to torsades de pointes, but there were no cases of arrhythmias or sudden unexplained deaths. Modest increases in the mean QTc interval also were seen within 2 hours of the intramuscular dose, Pfizer reported at an FDA advisory panel meeting in 2001. Coadministration with oral Geodon not recommended.
* Comment: This approval "is a significant advancement in treatment options for patients who are suffering with acute agitation," said Dr. Daniel Casey, chief of psychiatric research and psychopharmacology ...