Ziprasidone (injection)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];
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Overview
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Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
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 an tipsychotic drugs [ )]. 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 (5.2see WARNINGS AND PRECAUTIONS (5.2)
1.1 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 (14.1)
1.2 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 (14.2).
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 (14.2)
1.3 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 (14.1)
"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
2.1 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 (14.1)
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 [ ]. No additional benefit was demonstrated for doses above 20 mg twice daily. Patients should be periodically reassessed to determine the need for maintenance treatment. see CLINICAL STUDIES (14.1)
2.2 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 (14.2)
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 (14.2).
2.3 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. Single-dose 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.
2.4 Dosing in Special Populations 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. Oral:
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 [ ]. Intramuscular:see USE IN SPECIFIC POPULATIONS (8)
3 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 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). see DOSAGE AND ADMINISTRATION (2.3)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ziprasidone (injection) in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ziprasidone (injection) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Ziprasidone (injection) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Ziprasidone (injection) in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ziprasidone (injection) in pediatric patients.
Contraindications
There is limited information regarding Ziprasidone (injection) Contraindications in the drug label.
Warnings
There is limited information regarding Ziprasidone (injection) Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Ziprasidone (injection) Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Ziprasidone (injection) Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Ziprasidone (injection) Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Ziprasidone (injection) in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ziprasidone (injection) in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ziprasidone (injection) during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ziprasidone (injection) in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Ziprasidone (injection) in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Ziprasidone (injection) in geriatric settings.
Gender
There is no FDA guidance on the use of Ziprasidone (injection) with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ziprasidone (injection) with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ziprasidone (injection) in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ziprasidone (injection) in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ziprasidone (injection) in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ziprasidone (injection) in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ziprasidone (injection) Administration in the drug label.
Monitoring
There is limited information regarding Ziprasidone (injection) Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ziprasidone (injection) and IV administrations.
Overdosage
There is limited information regarding Ziprasidone (injection) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Ziprasidone (injection) Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Ziprasidone (injection) Mechanism of Action in the drug label.
Structure
There is limited information regarding Ziprasidone (injection) Structure in the drug label.
Pharmacodynamics
There is limited information regarding Ziprasidone (injection) Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Ziprasidone (injection) Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Ziprasidone (injection) Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ziprasidone (injection) Clinical Studies in the drug label.
How Supplied
There is limited information regarding Ziprasidone (injection) How Supplied in the drug label.
Storage
There is limited information regarding Ziprasidone (injection) Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Ziprasidone (injection) Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Ziprasidone (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ziprasidone (injection) Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ziprasidone (injection) Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.