(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 at Veterans Affairs Medical Center, Portland, Ore. It "will be used in a wide range of clinical situations where significant agitation is the immediate clinical concern," he predicted.
IM Geodon has the advantage of having "equal or better efficacy" than the shortacting antipsychotics used for decades in treating acute agitation in patients with a wide range of diagnoses, but it has far fewer side effects, particularly extrapyramidal symptoms, Dr. Casey noted. Geodon is nor associated with dysphoria, a common side effect of typical antipsychotics, and does not pose a risk of dependence, an issue with intramuscular benzodiazepines, he added.
QTc prolongation with Geodon is "very well characterized, and there are no data to suggest that it correlates with any clinical consequences," Dr. Casey said. Among more than 200,000 patients who have been treated with oral Geodon, there have been no reports of torsades, other arrhytmias, or increased rates of sudden unexpected deaths. There is no evidence that the IM formulation will be different, he said.
Dr. Casey was a consultant to Pfizer in the analysis of the clinical trial data.
COPYRIGHT 2002 International Medical News Group
COPYRIGHT 2002 Gale Group