GEODON® (ziprasidone HCl) Capsules Indication Statement
GEODON is indicated for schizophrenia and acute bipolar manic or mixed episodes, with or without psychotic features.
For full symptoms and diagnostic criteria, see the DSM-IV-TR® (2000).
GEODON® (ziprasidone mesylate) Injection Indication Statement
GEODON IM is indicated for acute agitation in schizophrenia. For full symptoms and diagnostic criteria, see the DSM-IV-TR® (2000).
GEODON Important Safety Information
GEODON is contraindicated in patients with a known history of QT prolongation, recent acute myocardial infarction, or uncompensated heart failure, and should not be used with certain other QT-prolonging drugs. GEODON has a greater capacity to prolong the QTc interval than several antipsychotics. In some drugs, QT prolongation has been associated with torsade de pointes, a potentially fatal arrhythmia. In many cases this would lead to the conclusion that other drugs should be tried first. Hypokalemia may increase the risk of QT prolongation and arrhythmia.
As with all antipsychotic medications, a rare and potentially fatal condition known as neuroleptic malignant syndrome (NMS) has been reported with GEODON. NMS can cause hyperpyrexia, muscle rigidity, diaphoresis, tachycardia, irregular pulse or blood pressure, cardiac dysrhythmia, and altered mental status. If signs and symptoms appear, immediate discontinuation, treatment, and monitoring are recommended.
Prescribing should be consistent with the need to minimize tardive dyskinesia (TD), a potentially irreversible dose- and duration-dependent syndrome. If signs and symptoms appear, discontinuation should be considered since TD may remit partially or completely.
Hyperglycemia-related adverse events, sometimes serious, have been reported in patients treated with atypical antipsychotics. There have been few reports of hyperglycemia or diabetes in patients treated with GEODON, and it is not known if GEODON is associated with these events. Patients treated with an atypical antipsychotic should be monitored for symptoms of hyperglycemia.
Precautions include the risk of rash, orthostatic hypotension, and seizures.
In short-term schizophrenia trials, the most commonly observed adverse events associated with GEODON at an incidence of ≥5% and at least twice the rate of placebo were somnolence and respiratory tract infection.
The most common adverse events associated with GEODON in bipolar mania were somnolence, extrapyramidal symptoms, dizziness, akathisia, and abnormal vision.
In short-term schizophrenia clinical trials, 10% of GEODON-treated patients experienced a weight gain of ≥7% of body weight vs. 4% for placebo.
In fixed-dose, pivotal studies, the most commonly observed adverse events associated with the use of GEODON for Injection (incidence ≥5%) and observed at a rate in the higher GEODON dose groups (10 mg, 20 mg) of at least twice that of the lowest GEODON dose group (2 mg control) were somnolence (20%), headache (13%), and nausea (12%).
IM administration of GEODON for more than 3 consecutive days has not been studied.
Since there is no experience regarding the safety of administering GEODON for Injection to schizophrenic patients already taking oral GEODON, the practice of coadministration is not recommended.
GEODON for Injection has not been systematically evaluated in elderly patients or in patients with hepatic or renal impairment. As the cyclodextrin excipient is cleared by renal filtration, GEODON should be administered with caution to patients with impaired renal function.