ZIPRASIDONE HYDROCHLORIDE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

REMEDYREPACK INC.

INN (Internationale Bezeichnung):

ZIPRASIDONE HYDROCHLORIDE

Zusammensetzung:

ZIPRASIDONE 40 mg

Verschreibungstyp:

PRESCRIPTION DRUG

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIPRASIDONE HYDROCHLORIDE
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZIPRASIDONE HYDROCHLORIDE
CAPSULES.
ZIPRASIDONE HYDROCHLORIDE 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 COMPARED TO PLACEBO TREATMENT ( 5.1)
ZIPRASIDONE HYDROCHLORIDE CAPSULES ARE NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA- RELATED
PSYCHOSIS ( 5.1)
RECENT MAJOR CHANGES
Warnings and Precautions ( 5.4) 08/2015
INDICATIONS AND USAGE
Ziprasidone hydrochloride capsules are an atypical antipsychotic. In
choosing among treatments, prescribers should be
aware of the capacity of ziprasidone hydrochloride capsules to prolong
the QT interval and may consider the use of other
drugs first ( 5.2)
Ziprasidone hydrochloride capsules are indicated as an oral
formulation for the: Treatment of schizophrenia. ( 1.1)
Adults: Efficacy was established in four 4 to 6 week trials and one
maintenance trial in adult patients with schizophrenia (
14.1)
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 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)
DOSAGE FORMS AND STRENGTHS
Capsules: 20 mg, 40 mg, 60 mg, and 80 mg ( 3)
CONTRAINDICATIONS
Do not use in patients with a known history of QT prolongation ( 4.1)
Do not use in patients with recent acute myocardial infarction ( 4.1)
Do not use in patients with uncompensated heart failure ( 4.1)
Do not