ZIPRASIDONE HYDROCHLORIDE- ziprasidone hcl capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

American Health Packaging

ИНН (Международная Имя):

ZIPRASIDONE HYDROCHLORIDE

состав:

ZIPRASIDONE 20 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

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 the following strengths and packaging configurations: 20 mg: purple/white capsules imprinted “APO ZIP 20” supplied as unit dose packages of 80 (8 x 10) NDC 68084-103-09 40 mg: purple/purple capsules imprinted “APO ZIP 40” supplied as unit dose packages of 80 (8 x 10) NDC 68084-104-09 60 mg: white/white capsules imprinted “APO ZIP 60” supplied as unit dose packages of 80 (8 x 10) NDC 68084-105-09 80 mg: purple/white capsules imprinted “APO ZIP 80” supplied as unit dose packages of 80 (8 x 10) NDC 68084-106-09 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]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HCL CAPSULE
AMERICAN HEALTH PACKAGING
----------
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 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 (5.3)
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)
Mainte