ziprasidone 80 MG Oral Capsule

1. INDICATIONS AND USAGE Ziprasidone hydrochloride 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 is 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 is 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 is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder in adults [see Clinical Studies ( 14.2 )] . Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone to prolong the QT interval and may consider the use of other drugs first ( 5.3 ) Ziprasidone hydrochloride capsules are indicated as an oral formulation for the: Treatment of schizophrenia. Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate.

Zydus Pharmaceuticals (USA) Inc.

FDA Reported Adverse Reactions
[1] drug ineffective    [2] pain    [3] fatigue    [4] nausea    [5] headache    [6] arthralgia    [7] dyspnoea    [8] off label use    [9] diarrhoea    [10] vomiting