ZIPRASIDONE HYDROCHLORIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Wockhardt USA LLC.

INN (mednarodno ime):

ZIPRASIDONE HYDROCHLORIDE

Sestava:

ZIPRASIDONE 20 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Ziprasidone hydrochloride capsule is 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 capsule is 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 inpatients

Povzetek izdelek:

Ziprasidone hydrochloride capsules are differentiated by capsule color/size and are imprinted in black ink. Ziprasidone hydrochloride capsules are supplied for oral administration in : 20 mg- White cap and white body, size "4" hard gelatin capsule imprinted with "W991" in black ink on body, filled with white to pink color powder. 40 mg- Blue cap and white body, size "3" hard gelatin capsule imprinted with "W992" in black ink on body, filled with white to pink color powder. 60 mg- Pink cap and white body, size "2" hard gelatin capsule imprinted with "W993" in black ink on body, filled with white to pink color powder. 80 mg- Blue cap and blue body, size "1" hard gelatin capsule imprinted with "W994" in black ink on body, filled with white to pink color powder. They are supplied in the following strengths and package configurations: Ziprasidone hydrochloride capsules should be stored at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
WOCKHARDT USA LLC.
----------
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 IS NOT APPROVED FOR ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions (5.4) 8/2015
INDICATIONS AND USAGE
Ziprasidone hydrochloride capsule is 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 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