ZIPRASIDONE HYDROCHLORIDE- ziprasidone hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

REMEDYREPACK INC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ziprasidone hydrochloride capsule is an atypical antipsychotic. In choosing among treatments, prescribers should be aware of the capacity of ziprasidone hydrochloride capsule to prolong the QT interval and may consider the use of other drugs first (5.2) Ziprasidone hydrochloride capsule is indicated as an oral formulation for the treatment of schizophrenia. (1.1) Adults: Efficacy was established in 4 to 6 week trials and one maintenance trial in adult patients with schizophrenia  (14.1) Because of ziprasidone's dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs, ziprasidone is contraindicated: - in patients with a known history of QT prolongation (including congenital long QT syndrome) - in patients with recent acute myocardial infarction - in patients with uncompensated heart failure Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive eff

Product summary:

Ziprasidone hydrochloride capsules, 20 mg (ziprasidone), are light pink to brown granular powder filled in size "4" hard gelatin capsules having Lavender opaque cap and Flesh opaque body, imprinted "RDY" on cap and "256" on body with black ink, and are supplied in unit dose package of 40 (4x10). Unit dose package of 40 (4 x 10)    NDC 0904-6269-08 Ziprasidone hydrochloride capsules, 40 mg (ziprasidone), are light pink to brown granular filled in size "4" hard gelatin capsules having Lavender opaque cap and LT Turquoise blue opaque body, imprinted "RDY" on cap and "257" on body with black ink, and are supplied in unit dose package of 40 (4x10). Unit dose package of 40 (4 x 10)    NDC 0904-6270-08 Ziprasidone hydrochloride capsules, 60 mg (ziprasidone), are light pink to brown granular powder filled in size "3" hard gelatin capsules having Flesh opaque cap and Flesh opaque body, imprinted "RDY" on cap and "258" on body with black ink, and are supplied in unit dose package of 40 (4x10). Unit dose package of 40 (4 x 10)    NDC 0904-6271-08 Ziprasidone hydrochloride capsules, 80 mg (ziprasidone), are light pink to brown filled in size "2" hard gelatin capsules having LT Turquoise blue opaque cap and Flesh opaque body, imprinted "RDY" on cap and "259" on body with black ink, are supplied in unit dose package of 40 (4x10). Unit dose package of 40 (4 x 10)    NDC 0904-6272-08 Ziprasidone hydrochloride capsules should be stored at 20 - 25°C (68 - 77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HYDROCHLORIDE CAPSULE
REMEDYREPACK INC.
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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)
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. Increase to 60 mg or 80
mg twice daily on day 2 of