Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)
Avera McKennan Hospital
ZIPRASIDONE HYDROCHLORIDE
ZIPRASIDONE 40 mg
ORAL
PRESCRIPTION DRUG
Ziprasidone is 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 (5.2) ]. 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 is indicated for the treatment of schizophrenia. The efficacy
Ziprasidone 40mg capsules NDC 59762-2002-1 bottle of 60 NDC 69189-2003-1 single dose pack with 1 capsule as repackaged by Avera McKennan Hospital Ziprasidone capsules should be stored at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
New Drug Application Authorized Generic
ZIPRASIDONE- ZIPRASIDONE HYDROCHLORIDE CAPSULE AVERA MCKENNAN HOSPITAL ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZIPRASIDONE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZIPRASIDONE. ZIPRASIDONE HCL CAPSULES 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 IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (5.1) RECENT MAJOR CHANGES Warnings and Precautions (5.4) 9/2015 INDICATIONS AND USAGE Ziprasidone is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone to prolong the QT interval and may consider the use of other drugs first. (5.2) Ziprasidone is indicated as an oral formulation for the: Treatment of schizophrenia. (1.1) Adults: Efficacy was established in four 4–6 week trials and one maintenance trial in adult patients with schizophrenia. (14.1) Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder. (1.2) Adults: Efficacy was established in two 3-week trials in adult patients with manic or mixed episodes. (14.2) Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate. (1.2) Adults: Efficacy was established in one maintenance trial in adult patients. (14.2) 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. Increa Lugege kogu dokumenti