Description

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Indications

GEODON is indicated for the treatment of schizophrenia as monotherapy for acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for maintenance therapy of bipolar disorder. GEODON is intramuscularly indicated for acute arousal in patients with schizophrenia. When choosing among alternative treatments, the Prescriber should consider which condition needs to be treated for the greater ability of ziprasidone to prolong the QT/QTc interval compared to several other antipsychotic drugs. Prolongation of the QTc interval is associated with some other drugs with the ability to cause arrhythmias such as torsade de pointes, potentially fatal polymorphic ventricular tachycardia and sudden death. In many cases, this will lead to the conclusion that other medications should be tried first. Whether ziprasidone will cause pointe de torsade or increase the rate of sudden death is not yet known.

Schizophrenia

Geodon is indicated for the treatment of schizophrenia. The efficacy of oral ziprazidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic patients and in one supportive trial of stable adult schizophrenic inpatient patients.

Bipolar disorder I (acute mixed or manic episodes and maintenance Treatment as a supplement to lithium or valproate)

Geodone is indicated as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar disorder I. Efficacy has been established in two three-week monotherapy studies in adult patients.

Geodone is indicated as an adjunct to lithium or valproate for the supportive treatment of bipolar disorder I. Efficacy has been established in a supportive study in adult patients. The efficacy of Geodon as a monotherapy for the supportive treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials.

Acute treatment of agitation in schizophrenia

GEODON is intramuscularly indicated for the treatment of acute arousal in patients with schizophrenia for whom ziprasidone treatment is suitable and who need intramuscular antipsychotic drugs for rapid control of agitation. The efficacy of intramuscular ziprasidone for acute arousal in schizophrenia has been established in one-day controlled studies of agitated schizophrenic inpatient

“Psychomotor agitation” is defined in the DSM-IV as “Excessive motor activity associated with a feeling of internal tension.” Schizophrenic patients experiencing arousal often exhibit behaviors that interfere with their diagnosis and care, e.g., threatening behavior, aggravation or urgent distress or self-deprecating behavior, prompting physicians to use intramuscular antipsychotic medications to achieve immediate arousal control.

Since there is no experience regarding the safety of intramuscular administration of ziprasidone to patients with schizophrenia taking oral ziprasidone, the practice of joint use is not recommended.

Intramuscularly ziprasidone is intended for intramuscular use only and should not be administered intravenously.