ZIPRASIDONE HYDROCHLORIDE capsule

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

REMEDYREPACK INC.

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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. NDC: 70518-3048-00 NDC: 70518-3048-01 PACKAGING: 30 in 1 BOX PACKAGING: 1 in 1 POUCH Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

授权状态:

Abbreviated New Drug Application

产品特点

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
REMEDYREPACK 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 ( 5.1)
ZIPRASIDONE HYDROCHLORIDE IS NOT APPROVED FOR THE TREATMENT OF
PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS (5.1)
INDICATIONS AND USAGE
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 (5.3)
Ziprasidone capsules are indicated as an oral formulation for the:
Treatment of schizophrenia. ( 1)
Acute treatment 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. ( 1)
DOSAGE AND ADMINISTRATION
Give oral doses with food.
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. ( 2.1)
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.
( 2.2)
Maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate: Continue treatment
at the same dose on which the patient