ZIPRASIDONE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)

Available from:

NuCare Pharmaceuticals,Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 (

Product summary:

Ziprasidone capsules, USP 20 mg (ziprasidone), are light pink to brown granular powder filled in size “4” hard gelatin capsules having Lavender opaque cap and Flesh opaque body, imprinted “RDY” on cap and “256” on body with black ink, and are supplied in bottles of 30’s, 60’s, 90’s, 100’s, 500’s and unit dose package of 30 (3 x 10), unit dose package of 100 (10 x 10). NDC 68071-3418-9 BOTTLES OF 90 Ziprasidone capsules, USP should be stored at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIPRASIDONE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZIPRASIDONE CAPSULES.
ZIPRASIDONE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE
AT AN INCREASED RISK OF DEATH. ZIPRASIDONE IS NOT APPROVED FOR THE
TREATMENT OF
PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS ( 5.1)
INDICATIONS AND USAGE
Ziprasidone capsule is an atypical antipsychotic. In choosing among
treatments, prescribers should be
aware of the capacity of ziprasidone capsule 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)
DOSAGE AND ADMINISTRATION
Administer capsules orally with food. Do not open, crush, or chew. (
2.1)
Schizophrenia: Initiate at 20 mg twice daily. Daily dosage may be
adjusted up to 80 mg twice daily.
Dose adjustments should occur at intervals of not less than 2 days.
Safety and efficacy has been
demonstrated in doses up to 100 mg twice daily. The lowest effective
dose should be used. (2.2)
Acute treatment of manic/mixed episodes of bipolar I disorder:
Initiate at 40 mg twice daily. Increase to
60 mg or 80 mg twice daily on day 2 of treatment. Subsequent dose
adjustments should be based on
tolerability and efficacy within the range of 40 to 80 mg twice daily.
(2.3)
Maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate: Continue tr