ZIPRASIDONE- ziprasidone hydrochloride capsule

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Tersedia dari:

Avera McKennan Hospital

INN (Nama Internasional):

ZIPRASIDONE HYDROCHLORIDE

Komposisi:

ZIPRASIDONE 40 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Ziprasidone is 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 (5.2) ]. 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 (5.2)] . Ziprasidone is indicated for the treatment of schizophrenia. The efficacy

Ringkasan produk:

Ziprasidone 40mg capsules NDC 59762-2002-1 bottle of 60 NDC 69189-2003-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Ziprasidone capsules should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].

Status otorisasi:

New Drug Application Authorized Generic

Karakteristik produk

ZIPRASIDONE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
AVERA MCKENNAN HOSPITAL
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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_
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 (5.4)
9/2015
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)
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)
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)
Acute treatment of manic/mixed episodes of bipolar I disorder:
Initiate at 40 mg twice daily. Increa