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 is not approved for elderly patients with dementia-related
psychosis (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.9) 02/2017
INDICATIONS AND USAGE
Ziprasidone hydrochloride capsule is an atypical antipsychotic. In
choosing among treatments, prescribers should be aware
of the capacity of ziprasidone hydrochloride capsule to prolong the QT
interval and may consider the use of other drugs
first (5.2)
Ziprasidone hydrochloride capsule is 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 use in combination with other drugs tha