ZIPRASIDONE HYDROCHLORIDE capsule

Երկիր: Ամերիկայի Միացյալ Նահանգներ

Լեզու: անգլերեն

Աղբյուրը: NLM (National Library of Medicine)

Ակտիվ բաղադրիչ:

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

Հասանելի է:

REMEDYREPACK INC.

Կառավարման երթուղին:

ORAL

Ռեկվիզորի տեսակը:

PRESCRIPTION DRUG

Թերապեւտիկ ցուցումներ:

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 WAR

Ապրանքի ամփոփագիր:

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 68180-331-07    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 68180-332-07    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 68180-333-07    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 68180-334-07    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.

Լիազորման կարգավիճակը:

Abbreviated New Drug Application

Ապրանքի հատկությունները

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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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 ( 5.1)
ZIPRASIDONE HYDROCHLORIDE CAPSULES ARE NOT APPROVED FOR ELDERLY
PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS ( 5.1)
RECENT MAJOR CHANGES
Boxed Warning 11/2018
Dosage and Administration (2.4) Removed 11/2018
Warnings and Precautions ( 5.1, 5.2) 11/2018
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.
Acute treatment as monotherapy of manic or mixed episodes associated
with bipolar I disorder.
Maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate.
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