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Geodon

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Geodon

Indications
Dosage
How Supplied

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]. 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]

Schizophrenia

Geodon is 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 inpatients and in one maintenance trial of stable adult schizophrenic inpatients [see Clinical Studies].

Bipolar I Disorder (Acute Mixed or Manic Episodes And Maintenance Treatment As An Adjunct To Lithium Or Valproate)

Geodon is indicated as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Efficacy was established in two 3-week monotherapy studies in adult patients [see Clinical Studies]. Geodon is indicated as an adjunct to lithium or valproate for the maintenance treatment of bipolar I disorder. Efficacy was established in a maintenance trial in adult patients. The efficacy of Geodon as monotherapy for the maintenance treatment of bipolar I disorder has not been systematically evaluated in controlled clinical trials [see Clinical Studies].

Acute Treatment Of Agitation In Schizophrenia

GEODON intramuscular is indicated for the treatment of acute agitation in schizophrenic patients for whom treatment with ziprasidone is appropriate and who need intramuscular antipsychotic medication for rapid control of agitation. The efficacy of intramuscular ziprasidone for acute agitation in schizophrenia was established in single day controlled trials of agitated schizophrenic inpatients [see Clinical Trials]

“Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension”. Schizophrenic patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care, e.g., threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior, leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation.

Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.

Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously.

DOSAGE AND ADMINISTRATION

Schizophrenia

Dose Selection

GEODON Capsules should be administered at an initial daily dose of 20 mg twice daily with food. In some patients, daily dosage may subsequently be adjusted on the basis of individual clinical status up to 80 mg twice daily. Dosage adjustments, if indicated, should generally occur at intervals of not less than 2 days, as steady-state is achieved within 1 to 3 days. In order to ensure use of the lowest effective dose, patients should ordinarily be observed for improvement for several weeks before upward dosage adjustment.

Efficacy in schizophrenia was demonstrated in a dose range of 20 mg to 100 mg twice daily in short-term, placebo-controlled clinical trials. There were trends toward dose response within the range of 20 mg to 80 mg twice daily, but results were not consistent. An increase to a dose greater than 80 mg twice daily is not generally recommended. The safety of doses above 100 mg twice daily has not been systematically evaluated in clinical trials [see Clinical Studies].

Maintenance Treatment

While there is no body of evidence available to answer the question of how long a patient treated with ziprasidone should remain on it, a maintenance study in patients who had been symptomatically stable and then randomized to continue ziprasidone or switch to placebo demonstrated a delay in time to relapse for patients receiving Geodon [see Clinical Studies]. No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should be periodically reassessed to determine the need for maintenance treatment.

Bipolar I Disorder (Acute Mixed Or Manic Episodes And Maintenance Treatment As An Adjunct To Lithium Or Valproate)

Acute Treatment of Manic or Mixed Episodes

Dose Selection--Oral ziprasidone should be administered at an initial daily dose of 40 mg twice daily with food. The dose may then be increased to 60 mg or 80 mg twice daily on the second day of treatment and subsequently adjusted on the basis of tolerance and efficacy within the range 40 mg-80 mg twice daily. In the flexible-dose clinical trials, the mean daily dose administered was approximately 120 mg [see Clinical Studies].

Maintenance Treatment (as an adjunct to lithium or valproate)

Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40 mg-80 mg twice daily with food. Patients should be periodically reassessed to determine the need for maintenance treatment [see Clinical Studies].

Acute Treatment Of Agitation In Schizophrenia

Intramuscular Dosing

The recommended dose is 10 mg to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day. Intramuscular administration of ziprasidone for more than three consecutive days has not been studied.

If long-term therapy is indicated, oral ziprasidone hydrochloride capsules should replace the intramuscular administration as soon as possible.

Since there is no experience regarding the safety of administering ziprasidone intramuscular to schizophrenic patients already taking oral ziprasidone, the practice of co-administration is not recommended.

Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously.

Intramuscular Preparation for Administration

GEODON for Injection (ziprasidone mesylate) should only be administered by intramuscular injection and should not be administered intravenously. Singledose vials require reconstitution prior to administration.

Add 1.2 mL of Sterile Water for Injection to the vial and shake vigorously until all the drug is dissolved. Each mL of reconstituted solution contains 20 mg ziprasidone. To administer a 10 mg dose, draw up 0.5 mL of the reconstituted solution. To administer a 20 mg dose, draw up 1.0 mL of the reconstituted solution. Any unused portion should be discarded. Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final solution. This medicinal product must not be mixed with other medicinal products or solvents other than Sterile Water for Injection. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Dosing In Special Populations

Oral: Dosage adjustments are generally not required on the basis of age, gender, race, or renal or hepatic impairment. Geodon is not approved for use in children or adolescents.

Intramuscular: Ziprasidone intramuscular has not been systematically evaluated in elderly patients or in patients with hepatic or renal impairment. As the cyclodextrin excipient is cleared by renal filtration, ziprasidone intramuscular should be administered with caution to patients with impaired renal function. Dosing adjustments are not required on the basis of gender or race [see Use In Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

GEODON Capsules are differentiated by capsule color/size and are imprinted in black ink with “Pfizer and ZDX [dosage strength]” or “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 in the following strengths and package configurations:

GEODON Capsules OR GEODON Capsules
Capsule Strength (mg) Imprint Capsule Strength (mg) Imprint
20 ZDX 20   20 396
40 ZDX 40 40 397
60 ZDX 60 60 398
80 ZDX 80 80 399

GEODON for Injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions). 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).

Storage And Handling

GEODON Capsules are differentiated by capsule color/size and are imprinted in black ink with “Pfizer and ZDX [dosage strength]” or 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 in the following strengths and package configurations:

GEODON Capsules
Package Configuration Capsule Strength (mg) NDC Code Imprint
Bottles of 60 20 0049-0052-60 ZDX 20
Bottles of 60 40 0049-0054-60 ZDX 40
Bottles of 60 60 0049-0056-60 ZDX 60
Bottles of 60 80 0049-0058-60 ZDX 80
Unit dose/80 20 0049-0052-80 ZDX 20
Unit dose/80 40 0049-0054-80 ZDX 40
Unit dose/80 60 0049-0056-80 ZDX 60
Unit dose/80 80 0049-0058-80 ZDX 80

or

Package Configuration Capsule Strength (mg) NDC Code Imprint
Bottles of 60 20 NDC-0049-3960-60 396
Bottles of 60 40 NDC-0049-3970-60 397
Bottles of 60 60 NDC-0049-3980-60 398
Bottles of 60 80 NDC-0049-3990-60 399
Unit dose/80 20 NDC-0049-3960-41 396
Unit dose/80 40 NDC-0049-3970-41 397
Unit dose/80 60 NDC-0049-3980-41 398
Unit dose/80 80 NDC-0049-3990-41 399

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). 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
Package Concentration NDC Code
Single-use Vials (carton of 10 vials) 20 mg/mL NDC-0049-3920-83

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).

Distributed by: Roerig, Division of Pfizer Inc., NY, NY 10017. Revised: October 2012

Last reviewed on RxList: 1/22/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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