GEODON ziprasidone hydrochloride capsule

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

REMEDYREPACK INC.

ИНН (Международная Имя):

ZIPRASIDONE HYDROCHLORIDE

состав:

ZIPRASIDONE HYDROCHLORIDE 20 mg

Тип рецепта:

PRESCRIPTION DRUG

Статус Авторизация:

New Drug Application

Характеристики продукта

GEODON - ZIPRASIDONE HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE
ALL THE INFORMATION NEEDED
TO USE GEODON SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR GEODON. GEODON (ZIPRASIDONE
HCL) CAPSULES GEODON (ZIPRASIDONE MESYLATE) INJECTION FOR
INTRAMUSCULAR 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 COMPARED TO PLACEBO TREATMENT (5.1)
GEODON IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (5.1)
INDICATIONS AND USAGE
GEODON is an atypical antipsychotic. In choosing among treatments,
prescribers should be aware of the capacity of
GEODON to prolong the QT interval and may consider the use of other
drugs first (5.2)
GEODON is indicated as an oral formulation for the:
Treatment of schizophrenia. (1.1)
Adults: Efficacy was established in four 4–6 week trials and one
maintenance trial in adult patients with schizophrenia
(14.1)
Acute treatment as monotherapy of manic or mixed episodes associated
with bipolar I disorder (1.2)
Adults: Efficacy was established in two 3-week trials in adult
patients with manic or mixed episodes. (14.2)
Maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate. (1.2)
Adults: Efficacy was established in one maintenance trial in adult
patients. (14.2)
GEODON as an intramuscular injection is indicated for the:
Acute treatment of agitation in schizophrenic patients. (1.3)
Adults: Efficacy was established in two short-term trials in agitated
patients with schizophrenia. (1.3)
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