ZIPRASIDONE HYDROCHLORIDE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

TYA Pharmaceuticals

INN (International Name):

ZIPRASIDONE HYDROCHLORIDE

Sammensætning:

ZIPRASIDONE 20 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 ]. 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 WARNINGS AND PRECAUTIONS ( ) 5.2 Ziprasidone hydrochloride capsules are indicated for the treatment of schizophrenia. The efficacy of oral ziprasidone was

Produkt oversigt:

NDC:64725-2164-1 in a CONTAINER of 30 CAPSULES

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
TYA PHARMACEUTICALS
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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 INITIAL U.S. APPROVAL: 2001
WARNING
INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
•
•
RECENT MAJOR CHANGES
Warnings and Precautions: Hyperprolactinemia ( ) 5.11
INDICATIONS AND USAGE
Ziprasidone hydrochloride capsules are an atypical antipsychotic. In
choosing among treatments, prescribers should be
aware of the capacity of ziprasidone hydrochloride capsules to prolong
the QT interval and may consider the use of other
drugs first ( ) Ziprasidone hydrochloride capsules are indicated as an
oral formulation for the: Treatment of schizophrenia. (
) 5.2
1.1
•
DOSAGE AND ADMINISTRATION
Give oral doses with food.
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
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
Metabolic Changes ( ) 07/2013 5.5
Adults: Efficacy was established in four 4 to 6 week trials and one
maintenance trial in adult patients with
schizophrenia ( ) 14.1
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
Capsules: 20 mg, 40 mg, 60 mg, and 80 mg ( ) 3
Do not use in patients with a known history of QT prolongation ( ) 4.1
Do not use in patients with