ziprasidone 40 MG Oral Capsule
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)] . Ziprasidone hydrochloride is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone capsules to prolong the QT interval and may consider the use of other drugs first ( 1 ) Ziprasidone capsules are indicated for the: treatment of schizophrenia in adults. ( 1 ) acute treatment of adults as monotherapy of manic or mixed episodes associated with bipolar I disorder. ( 1 ) maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults. ( 1 )
Aurobindo Pharma Limited
CAPSULE BLUE F 38
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16 HOW SUPPLIED/STORAGE AND HANDLING Ziprasidone capsules USP, 20 mg are blue opaque cap/off-white opaque body, size “5” hard gelatin capsule shells, filled with creamy to pale pinkish granular powder, imprinted with “F” on cap and “26” on body with black ink. Bottles of 60 NDC 65862-702-60 Bottles of 1,000 NDC 65862-702-99 8 x 10 Unit-dose capsules NDC 65862-702-80 Ziprasidone capsules USP, 40 mg are blue opaque cap/blue opaque body, size “3” hard gelatin capsule shells, filled with creamy to pale pinkish granular powder, imprinted with “F” on cap and “38” on body with black ink. Bottles of 60 NDC 65862-703-60 Bottles of 1,000 NDC 65862-703-99 8 x 10 Unit-dose capsules NDC 65862-703-80 Ziprasidone capsules USP, 60 mg are off-white opaque cap/off-white opaque body, size “2” hard gelatin capsule shells, filled with creamy to pale pinkish granular powder, imprinted with “F” on cap and “39” on body with black ink. Bottles of 60 NDC 65862-704-60 Bottles of 1,000 NDC 65862-704-99 8 x 10 Unit-dose capsules NDC 65862-704-80 Ziprasidone capsules USP, 80 mg are blue opaque cap/off-white opaque body, size “1” hard gelatin capsule shells, filled with creamy to pale pinkish granular powder, imprinted with “X” on cap and “66” on body with black ink. Bottles of 60 NDC 65862-705-60 Bottles of 1,000 NDC 65862-705-99 8 x 10 Unit-dose capsules NDC 65862-705-80 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].
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