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:

Bryant Ranch Prepack

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 (5.3) ] Schizophrenia • Ziprasidone capsules are indicated for

產品總結:

Ziprasidone capsules, USP 40 mg are blue/ blue, size 2, hard gelatin capsules imprinted in black ink with “CL63” on cap and “40 mg” on the body containing pale pink coloured powder. NDC: 63629-3331-3: 30 CAPSULEs in a BOTTLE NDC: 63629-3331-1: 60 CAPSULEs in a BOTTLE NDC: 63629-3331-2: 28 CAPSULEs in a BOTTLE NDC: 63629-3331-4: 90 CAPSULEs in a BOTTLE Store ziprasidone capsules, USP at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Preserve in well-closed containers, and store at controlled room temperature. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

授权状态:

Abbreviated New Drug Application

产品特点

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
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 CAPSULES ARE NOT APPROVED
FOR THE
TREATMENT OF PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (5.1)
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 5/2021
INDICATIONS AND USAGE
Ziprasidone hydrochloride is an atypical antipsychotic. In choosing
among treatments, prescribers should
be aware of the capacity of ziprasidone hydrochloride 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 40-80 mg twice daily.
(2.3)
Maintenance treatment of bi