ZIPRASIDONE HYDROCHLORIDE capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

BluePoint Laboratories

INN (Rahvusvaheline Nimetus):

ZIPRASIDONE HYDROCHLORIDE

Koostis:

ZIPRASIDONE 20 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Ziprasidone hydrochloride 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 •  

Toote kokkuvõte:

Ziprasidone hydrochloride capsules are available as: Ziprasidone hydrochloride capsules, 20 mg are size '4' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V51" on body in black ink, containing off-white to pinkish granular powder. NDC 68001-136-06    Bottles of 60's Ziprasidone hydrochloride capsules, 40 mg are size '4' capsules with dark blue opaque cap and dark blue opaque body, imprinted axially with "LU" on cap and "V52" on body in black ink, containing off-white to pinkish granular powder. NDC 68001-137-06   Bottles of 60's Ziprasidone hydrochloride capsules, 60 mg are size '3' capsules with white opaque cap and white opaque body, imprinted axially with "LU" on cap and "V53" on body in black ink, containing off-white to pinkish granular powder. NDC 68001-138-06    Bottles of 60's Ziprasidone hydrochloride capsules, 80 mg are size '2' capsules with dark blue opaque cap and white opaque body, imprinted axially with "LU" on cap and "V54" on body in black ink, containing off-white to pinkish granular powder. NDC 68001-139-06    Bottles of 60's Ziprasidone hydrochloride capsules should be stored at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Maalox ® is a registered trademark of Novartis.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
BLUEPOINT LABORATORIES
----------
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 ( 5.1)
ZIPRASIDONE HYDROCHLORIDE CAPSULES ARE NOT APPROVED FOR ELDERLY
PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS ( 5.1)
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 ( 5.3)
Ziprasidone hydrochloride capsules are indicated as an oral
formulation for the:
Treatment of schizophrenia.(1)
Acute treatment 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. (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)
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 within the range of 40 to 80 mg twice daily.
( 2.2)
Maintenance treatment of bipolar I disorder as an adjunct to lithium