Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
ZIPRASIDONE HYDROCHLORIDE (UNII: 216X081ORU) (ZIPRASIDONE - UNII:6UKA5VEJ6X)
Cardinal Health
ZIPRASIDONE HYDROCHLORIDE
ZIPRASIDONE 20 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE CARDINAL HEALTH ---------- 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_ • • 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) • Acute treatment as monotherapy of manic or mixed episodes associated with bipolar I disorder (1.2) • Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate. (1.2) • DOSAGE AND ADMINISTRATION Give oral doses with food. • • • DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS • • • • • 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) Adults: Efficacy was established in four 4–6 week trials and one maintenance trial in adult patients with schizophrenia (14.1) Adults: Efficacy was established in two 3-week trials in adult patients with manic or mixed episodes. (14.2) Adults: Efficacy was established in one maintenance trial in adult patients. (14.2) 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 di Izlasiet visu dokumentu