ZIPRASIDONE MESYLATE injection, powder, lyophilized, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZIPRASIDONE MESYLATE (UNII: 3X6SAX83JZ) (ZIPRASIDONE - UNII:6UKA5VEJ6X)

Available from:

Dr.Reddy's Laboratories, Inc.

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. 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 (5.3)]. 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 (5.3)] Acute Treatment of Agitation in Schizophrenia - Ziprasidone mesylate for injection intramuscular is indicated for the treatment of acute agitation in schizophrenic adult patients for whom

Product summary:

Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [see Dosage and Administration (2.3)] . Each mL of ziprasidone mesylate for injection (when reconstituted) affords a colorless to pale pink solution that contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD). Ziprasidone mesylate for injection should be stored at 20° to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, Ziprasidone mesylate for injection can be stored, when protected from light, for up to 24 hours at 15°C to 30°C (59°F to 86°F) or up to 7 days refrigerated, 2°C to 8°C (36°F to 46°F).

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ZIPRASIDONE MESYLATE- ZIPRASIDONE MESYLATE INJECTION, POWDER,
LYOPHILIZED,
FOR SOLUTION
DR.REDDY'S LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZIPRASIDONE MESYLATE
FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION
FOR ZIPRASIDONE
MESYLATE FOR INJECTION.
ZIPRASIDONE MESYLATE FOR INJECTION, FOR INTRAMUSCULAR 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 (5.1)
• ZIPRASIDONE MESYLATE FOR INJECTION IS NOT APPROVED FOR THE
TREATMENT OF PATIENTS WITH
DEMENTIA-RELATED PSYCHOSIS (5.1)
INDICATIONS AND USAGE
Ziprasidone mesylate for injection is an atypical antipsychotic. In
choosing among treatments, prescribers
should be aware of the capacity of ziprasidone mesylate for injection
to prolong the QT interval and may
consider the use of other drugs first (5.3)
Ziprasidone mesylate for injection as an intramuscular injection is
indicated for the:
• Acute treatment of agitation in schizophrenic patients. (1)
DOSAGE AND ADMINISTRATION
Acute treatment of agitation associated with schizophrenia
(intramuscular administration): 10 mg to 20
mg up to a maximum dose of 40 mg per day. Doses of 10 mg may be
administered every 2 hours.
Doses of 20 mg may be administered every 4 hours. (2.4)
DOSAGE FORMS AND STRENGTHS
• For injection: 20 mg/mL single-use vials (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 other drugs that have demonstrated
QT prolongation (4.1)
• Do not use in patients with known hypersensitivity to ziprasidone
(4.2)
WARNINGS AND PRECAUTIONS