ZIPRASIDONE HYDROCHLORIDE- 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:

Unit Dose Services

INN (Nama Internasional):

ZIPRASIDONE HYDROCHLORIDE

Komposisi:

ZIPRASIDONE 20 mg

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. 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 hydrochloride capsules are indicated for the treatment of schizophrenia. The efficacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic inpatien

Ringkasan produk:

Product: 50436-0331 NDC: 50436-0331-1 60 CAPSULE in a BOTTLE

Status otorisasi:

Abbreviated New Drug Application

Karakteristik produk

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
UNIT DOSE SERVICES
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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 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 use in combination