ZIPRASIDONE HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Cardinal Health

INN (Internationale Bezeichnung):

ZIPRASIDONE HYDROCHLORIDE

Zusammensetzung:

ZIPRASIDONE 20 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
CARDINAL HEALTH
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIPRASIDONE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZIPRASIDONE.
ZIPRASIDONE HCL CAPSULES
INITIAL U.S. APPROVAL: 2001
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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INDICATIONS AND USAGE
Ziprasidone is an atypical antipsychotic. In choosing among
treatments, prescribers should be aware of the capacity of
ziprasidone to prolong the QT interval and may consider the use of
other drugs first (5.2)
Ziprasidone is indicated as an oral formulation for the:
Treatment of schizophrenia. (1.1)
•
Acute treatment as monotherapy of manic or mixed episodes associated
with bipolar I disorder (1.2)
•
Maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate. (1.2)
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DOSAGE AND ADMINISTRATION
Give oral doses with food.
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS TREATED WITH
ANTIPSYCHOTIC DRUGS ARE AT AN
INCREASED RISK OF DEATH COMPARED TO PLACEBO TREATMENT (5.1)
ZIPRASIDONE IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (5.1)
Adults: Efficacy was established in four 4–6 week trials and one
maintenance trial in adult patients with schizophrenia
(14.1)
Adults: Efficacy was established in two 3-week trials in adult
patients with manic or mixed episodes. (14.2)
Adults: Efficacy was established in one maintenance trial in adult
patients. (14.2)
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 di