ZIPRASIDONE HYDROCHLORIDE- ziprasidone hcl capsule

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

A-S Medication Solutions

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Ziprasidone 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 Ziprasidone capsules are indicated for the trea

পণ্য সারাংশ:

Product: 50090-3349 NDC: 50090-3349-0 60 CAPSULE in a BOTTLE

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HCL CAPSULE
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIPRASIDONE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ZIPRASIDONE CAPSULES.
ZIPRASIDONE 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 CAPSULES ARE NOT APPROVED FOR THE TREATMENT OF PATIENTS
WITH DEMENTIA-
RELATED PSYCHOSIS (5.1)
INDICATIONS AND USAGE
Ziprasidone capsules are an atypical antipsychotic. In choosing among
treatments, prescribers should be
aware of the capacity of ziprasidone capsules to prolong the QT
interval and may consider the use of other
drugs first (5.3)
Ziprasidone 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 40-80 mg twice daily.
(2.2)
Maintenance treatment of bipolar I disorder as an adjunct to lithium
or valproate: Continue treatment
at the same dose on which the patient was initially stabi