Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)
LUPIN LIMITED
ZIPRASIDONE HYDROCHLORIDE
ZIPRASIDONE 20 mg
ORAL
PRESCRIPTION DRUG
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 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 hydrochloride capsules are indicated for the treatment of schizophrenia. The efficacy of oral ziprasidone was established in four short-term (4- and 6-week) controlled trials of adult schizophrenic inpatien
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.
Abbreviated New Drug Application
ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE LUPIN LIMITED ---------- 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 COMPARED TO PLACEBO TREATMENT (5.1) ZIPRASIDONE HYDROCHLORIDE CAPSULES ARE NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS (5.1) RECENT MAJOR CHANGES Warnings and Precautions (5.4) 08/2015 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 (5.2) Ziprasidone hydrochloride capsules are indicated as an oral formulation for the: Treatment of schizophrenia. (1.1) Adults: Efficacy was established in four 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia (14.1) 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) DOSAGE FORMS AND STRENGTHS Capsules: 20 mg, 40 mg, 60 mg, and 80 mg (3) CONTRAINDICATIONS Do not use in patients with a known history of QT prolongation (4.1) Do not use in patients with recent acute myocardial infarction (4.1) Do not use in patients with uncompensated heart failure (4.1) Do not use in combination with Lugege kogu dokumenti