ZIPRASIDONE HYDROCHLORIDE- ziprasidone hcl capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

ZIPRASIDONE HYDROCHLORIDE

Composition:

ZIPRASIDONE 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 inpat

Product summary:

Ziprasidone hydrochloride capsules are differentiated by capsule color/size and are imprinted in black ink with “APO ZIP” and a unique number. Ziprasidone hydrochloride capsules are supplied for oral administration in 20 mg (purple/white), 40 mg (purple/purple). They are supplied in the following strengths and package configurations: 20MG: NDC 63187-448-30 Bottle of 30 NDC 63187-448-60 Bottle of 60 NDC 63187-448-90 Bottle of 90 40MG NDC 63187-431-30 Bottle of 30 NDC 63187-431-60 Bottle of 60 NDC 63187-431-90 Bottle of 90 Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container [see USP].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZIPRASIDONE HYDROCHLORIDE- ZIPRASIDONE HCL CAPSULE
PROFICIENT RX LP
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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, 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_
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RECENT MAJOR CHANGES
Warnings and Precautions: (5.4) 12/2014
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 (5.2)
Ziprasidone hydrochloride capsules are indicated as an oral
formulation for the:
Treatment of schizophrenia. (1.1)
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DOSAGE AND ADMINISTRATION
Give oral doses with food.
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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•
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WARNINGS AND PRECAUTIONS
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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)
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 recent acute myocardial infarction (4.1)
Do not use in pat