ZIPRASIDONE HYDROCHLORIDE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Bryant Ranch Prepack

INN (International Name):

ZIPRASIDONE HYDROCHLORIDE

Sammensætning:

ZIPRASIDONE 80 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Ziprasidone capsules are indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone’s greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)]. Schizophrenia Bipolar I Disorder (Acute Mixed or Manic Episodes

Produkt oversigt:

NDC: 71335-0263-1: 60 Capsules in a BOTTLE NDC: 71335-0263-2: 30 Capsules in a BOTTLE NDC: 71335-0263-3: 28 Capsules in a BOTTLE NDC: 71335-0263-4: 90 Capsules in a BOTTLE

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIPRASIDONE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZIPRASIDONE CAPSULES.
ZIPRASIDONE 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._
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RECENT MAJOR CHANGES
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 (1)
Ziprasidone capsules are indicated for the:
•
•
•
DOSAGE AND ADMINISTRATION
•
•
•
•
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 (5.1)
ZIPRASIDONE CAPSULES ARE NOT APPROVED FOR THE TREATMENT OF PATIENTS
WITH
DEMENTIA-RELATED PSYCHOSIS (5.1)
Dosage and Administration (2.1) 5/2021
treatment of schizophrenia in adults. (1)
acute treatment of adults as monotherapy of manic or mixed episodes
associated with bipolar I
disorder. (1)
maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate in adults. (1)
Administer capsules orally with food. Do not open, crush, or chew.
(2.1)
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. (2.2)
Acute treatment of manic/mixed episodes of bipolar I disorder:
Initiate at 40 mg twice daily. Increase
to 60 mg or 80 mg twice daily on day 2 of treatment. Subsequent dose
adjustments should be based
on tolerability and efficacy withi