Ziprasidone Hydrochloride (2 brand names, 2 dosage forms, 1 route)
Available dosage forms: CAPSULE, SUSPENSION.
Routes of administration: ORAL.
Brand Names
- GEODON
- ZIPRASIDONE HYDROCHLORIDE
Boxed Warning
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone hydrochloride is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions ( 5.1 )].
Indications and Usage
Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [ see Warnings and Precautions ( 5.3) ]. Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [ see Warnings and Precautions ( 5.3) ] Schizophrenia • Ziprasidone capsules are indicated for the treatment of schizophrenia in adults [ see Clinical Studies ( 14.1) ]. Bipolar I Disorder (Acute Mixed or Manic Episodes and Maintenance Treatment as an Adjunct to Lithium or Valproate) • Ziprasidone capsules are indicated as monotherapy for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder [ see Clinical Studies ( 14.2) ]. • Ziprasidone capsules are indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [ see Clinical Studies ( 14.2) ].
Drug Interactions
Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using ziprasidone in combination with other drugs have been evaluated as described below. All interactions studies have been conducted with oral ziprasidone. Based upon the pharmacodynamic and pharmacokinetic profile of ziprasidone, possible interactions could be anticipated:
Mechanism of Action
The mechanism of action of ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D 2) and serotonin type 2 (5HT 2) antagonism.