Ziprasidone chemical structure
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Geodon

Ziprasidone (sold as Geodon®) was the fifth atypical antipsychotic to gain FDA approval. Ziprasidone is FDA approved for the treatment of schizophrenia, and the intramuscular injection form of ziprasidone is approved for acute agitation in schizophrenic patients. Clinical trials were conducted in acute cases of mania. Long-term trials have not been conducted for acute bipolar symptoms. Any "hypersensitivity to the product" – including any of the adverse events noted during clinical trials – should be grounds for discontinuance. more...

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It has been approved for acute episodes indicative of bipolar type I. It has not been studied in adolescents or children (under age 10). Such a trial has been ordered by the FDA as one condition during the approval process. The brand name Geodon® has been suggested to bring to mind the phrase 'down (don) to earth (geo)' referring to the goals of medication.

Pharmacology

Ziprasidone has a high affinity for dopamine, serotonin, and alpha-adrenergic receptors and a medium affinity for histaminic receptors. Ziprasidone is somewhat unique among the "atypicals" in that it also displays some inhibition of synaptic reuptake of serotonin and norepinephrine, although the clinical significance of this is unknown. The mechanism of action of ziprasidone is unknown. However it is theorized that its antipsychotic activity is mediated primarily by antagonism at dopamine receptors, specifically D2. Serotonin antagonism may also play a role in the effectiveness of ziprasidone, but the significance of 5-HT2A antagonism is debated among researchers. Antagonism at histaminic and alpha adrenergic receptors likely explains some of the side effects of ziprasidone, such as sedation and orthostasis.

Pharmacokinetics

The systemic bioavailability of ziprasidone administered intramuscularly is 100%, or 60%, administered orally with food. After a single dose intramuscular administration, the peak serum concentration typically occurs at about 60 minutes after the dose is administered, or earlier. Steady state plasma concentrations are achieved within one to three days. The mean half-life (T 1/2) ranges from two to five hours. Exposure increases in a dose-related manner and following three days of intramuscular dosing, little accumulation is observed.

Metabolism

Ziprasidone is hepatically metabolized by aldehyde reductase. Minor metabolism occurs via cytochrome P450 3A4. Medication that induce (e.g carbamazepine) or inhibit (e.g. ketoconazole) CYP3A4 have been shown to decrease and increase, respectively, blood levels of ziprasidone. There are no known induces or inhibitors of aldehyde reductase.

Adverse events

Ziprasidone may increase the QTc interval in some patients and may increase the risk of a type of heart arrythmia known as torsades de pointes. Ziprasidone should be used cautiously in patients taking other medications likely to interact with ziprasidone or increase the QTc interval.

Adverse events reported for ziprasidone include sedation, insomnia, orthostasis, akathisia and other permanent extrapyramidal side-effects such as tardive dyskinesia. Rarely, temporary speech disorders may result.

The medication can cause any conceivable side effect. See the FDA label for more information.

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New Schizophrenia Drug - Geodon from Pfizer - Brief Article
From FDA Consumer, 5/1/01

People with schizophrenia now have available another drug treatment, although approval of the medication comes with a strong warning about a serious health risk and requires that the manufacturer change the drug's brand name.

The Food and Drug Administration approved Geodon (ziprasidone) to treat schizophrenia, a lifelong mental illness that affects a person's behavior, thinking, and emotions. The product will carry a warning on its labeling about possible heart problems associated with its use. The antipsychotic medication may cause a heart rhythm irregularity, and even death. People with significant heart disease should not use the drug.

Schizophrenia affects about 1 percent of the world's population. Typically, the illness strikes men and women in adolescence or young adulthood. Schizophrenia is chronic, often with multiple relapses and impaired daily functioning. People with schizophrenia may experience hallucinations and delusions.

The drug's manufacturer, Pfizer Inc., of New York, planned to market the medication under the name Zeldox, but the FDA believed it sounded too similar to other medications and had the potential to cause confusion. Pfizer settled on the alternative name Geodon.

The most common side effects reported with the drug, which was approved in February, included sleepiness and abnormal movements. Pfizer has agreed to continue studying the drug's effects on the heart.

Serious Product Problem? Report It

Health professionals can report serious adverse reactions or other product problems to FDA's MedWatch program by:

* Mail: Use the postage-paid MedWatch form, available from the FDA Web site or by calling the toll-free number below.

* Phone: 1-800-FDA-1088 (1-800-332-1088)

* Fax: 1-800-FDA-0178 (1-800-332-0178)

* Internet: www.fda.gov/medwatch/

Call the 800 number or visit the Web site for further assistance.

COPYRIGHT 2001 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group

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