ziprasidone hydrochloride ziprasidone 20 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 capsules are 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 )
Golden State Medical Supply, Inc.
CAPSULE PURPLE APO ZIP 20
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16 HOW SUPPLIED/STORAGE AND HANDLING Ziprasidone capsules, USP are differentiated by capsule color/size and are imprinted in black ink with “APO ZIP” and a unique number. Ziprasidone capsules, USP are supplied for oral administration in 20 mg (purple/white), 40 mg (purple/purple), 60 mg (white/white), and 80 mg (purple/white) capsules. They are supplied in the following strengths and package configurations: Ziprasidone capsules Package Configuration capsule Strength (mg) NDC (National Drug Code) Imprint Bottles of 60 20 NDC-60429-765-60 APO ZIP 20 Bottles of 60 40 NDC-60429-766-60 APO ZIP 40 Bottles of 60 60 NDC-60429-767-60 APO ZIP 60 Bottles of 60 80 NDC-60429-768-60 APO ZIP 80 Store at 20°C to 25°C (68°F to 77°F); excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].
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