GEODON ziprasidone hydrochloride capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

ziprasidone hydrochloride (UNII: 216X081ORU) (ziprasidone - UNII:6UKA5VEJ6X)

זמין מ:

Cardinal Health

INN (שם בינלאומי):

ziprasidone hydrochloride

הרכב:

ziprasidone 20 mg

סוג מרשם:

PRESCRIPTION DRUG

מצב אישור:

New Drug Application

מאפייני מוצר

GEODON- ZIPRASIDONE HYDROCHLORIDE CAPSULE
GEODON- ZIPRASIDONE MESYLATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
CARDINAL HEALTH
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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)
RECENT MAJOR CHANGES
Indications and Usage: Bipolar Disorder Maintenance treatment (as an
adjunct to lithium or
valproate) [1.2]
11/2009
Dosage and Administration: Bipolar Disorder Maintenance treatment (as
an adjunct to lithium or
valproate) [2.2]
11/2009
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 establi