GEODON- 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:

State of Florida DOH Central Pharmacy

INN (International Name):

ZIPRASIDONE HYDROCHLORIDE

Composition:

ziprasidone 20 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

GEODON is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. GEODON 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 (5.2) ]. 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)]

Product summary:

GEODON Capsules are differentiated by capsule color/size and are imprinted in black ink with "Pfizer" and a unique number. GEODON Capsules are supplied for oral administration in 20 mg (blue/white), 40 mg (blue/blue), 60 mg (white/white), and 80 mg (blue/white) capsules. They are supplied by State of Florida DOH Central Pharmacy as follows: GEODON Capsules should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature]. GEODON 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). GEODON for Injection should be stored at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [See USP Controlled Room Temperature] in dry form. Protect from light. Following reconstitution, GEODON for Injection can be stored, when protected from light, for up to 24 hours at 15°–30°C (59°–86°F) or up to 7 days refrigerated, 2°–8°C (36°–46°F).

Authorization status:

New Drug Application

Summary of Product characteristics

GEODON - ZIPRASIDONE HYDROCHLORIDE CAPSULE
STATE OF FLORIDA DOH CENTRAL PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GEODON SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR GEODON.
GEODON (ZIPRASIDONE HCL) CAPSULES
GEODON (ZIPRASIDONE MESYLATE) 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 COMPARED TO PLACEBO TREATMENT (5.1)
GEODON IS NOT APPROVED FOR ELDERLY PATIENTS WITH DEMENTIA-RELATED
PSYCHOSIS (5.1)
RECENT MAJOR CHANGES
Warnings and Precautions:
Leukopenia, Neutropenia, and Agranulocytosis
8/2009
Indications and Usage: Bipolar Disorder Maintenance treatment (as an
adjunct to
lithium or valproate) [1.2]
Dosage and Administration: Bipolar Disorder Maintenance treatment (as
an adjunct to
lithium or valproate) [2.2]
INDICATIONS AND USAGE
GEODON is an atypical antipsychotic. In choosing among treatments,
prescribers should be aware of the capacity of
GEODON to prolong the QT interval and may consider the use of other
drugs first (5.2)
GEODON 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)
GEODON as an intramuscular injection is indicated for the:
Acute treatment of agitation in schizophrenic patients. (1.3)
Adults: Efficacy