Geodon 20 mg/mL
ziprasidone mesylate · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · ROERIG
Geodon is a injection, powder, lyophilized, for solution containing ziprasidone mesylate at 20 mg/mL, taken intramuscular. Manufactured by ROERIG.
Key Facts
- Brand Name
- Geodon
- Generic Name
- ziprasidone mesylate
- NDC Code (Product)
0049-3920- Manufacturer
- ROERIG
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- NDA020919
- Drug Class
- Atypical Antipsychotic [EPC]
- Marketing Start
- 12/23/2003
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 (5.3) ] . 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) ] . Schizophrenia • GEODON is indicated for the treatment of schizophrenia in adults [see Clinical Studies (14.1) ] . Bipolar I Disorder (Acute Mixed o…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Administer capsules orally with food. Do not open, crush, or chew. ( 2.1 ) • 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. ( 2.2 ) • Acute treatment of manic/mixed episodes of bipolar I disorder: Initiate at 40 mg twice daily. Increase to 60 mg or 80 mg twice daily on day 2 of treatment. Subsequent dose adjustments should be based on tolerability and efficacy within the range of 40-80 mg twice daily. ( 2.3 ) • Maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate: Continue treatment at the same dose on which the patient was initially stabilized, within the range of 40-80 mg twice daily. ( 2.3 ) • Acute treatment of agitation associated with schizophrenia (intramuscular administration): 10 mg-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 ) 2.1 Administration Information for GEODON Capsu…
Contraindications
4 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 ) • Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs. ( 4.3 ) 4.1 QT Prolongation Because of ziprasidone’s dose-related prolongation of the QT interval and the known association of fatal arrhythmias with QT prolongation by some other drugs, ziprasidone is contraindicated: • in patients with a known history of QT prolongation (including congenital long QT syndrome) • in patients with recent acute myocardial infarction • in patients with uncompensated heart failure Pharmacokinetic/pharmacodynamic studies between ziprasidone and other drugs that prolong the QT interval have not been performed. An additive effect of ziprasidone and other drugs that prolong the QT interval cannot be excluded. Therefore, ziprasidone should not be given with: • dofeti…
Drug Interactions
7 DRUG INTERACTIONS Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using ziprasidone in combination with other drugs have been evaluated as described below. All interactions studies have been conducted with oral ziprasidone. Based upon the pharmacodynamic and pharmacokinetic profile of ziprasidone, possible interactions could be anticipated: • Ziprasidone should not be used in combination with other drugs that have demonstrated QT prolongation. ( 4.1 , 7.3 ) • The absorption of ziprasidone is increased up to two-fold in the presence of food. ( 7.10 ) • The full prescribing information contains additional drug interactions. ( 7 ) 7.1 Metabolic Pathway Approximately two-thirds of ziprasidone is metabolized via a combination of chemical reduction by glutathione and enzymatic reduction by aldehyde oxidase. There are no known clinically relevant inhibitors or inducers of aldehyde oxidase. Less than one-third of ziprasidone metabolic clearance is mediated by cytochrome P450 catalyzed oxidation. 7.2 In Vitro Studies An in vitro enzyme inhibition study utilizing human liver microsomes showed that…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described in more detail in other sections of the prescribing information: • Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and Warnings and Precautions (5.1) ] • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-Related Psychosis [see Warnings and Precautions (5.2) ] • QT Prolongation and Risk of Sudden Death [see Contraindications (4.2) , Warnings and Precautions (5.3) ] • Serotonin Syndrome [see Contraindications (4.3) , Warnings and Precautions (5.4) , Drug Interactions (7.1) ] • Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.5) ] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6) ] • Tardive Dyskinesia [see Warnings and Precautions (5.7) ] • Metabolic Changes [see Warnings and Precautions (5.8) ] • Rash [see Warnings and Precautions (5.9) ] • Orthostatic Hypotension [see Warnings and Precautions (5.10) ] • Falls [see Warnings and Precautions (5.11) ] • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.12) ] • Seizures [see Warnings and Precautions (5.13) ] • Dysphagia [s…
Frequently Asked Questions
What is Geodon used for?
Geodon contains ziprasidone mesylate. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is Geodon a controlled substance?
Geodon is not classified as a controlled substance by the DEA.
What is the generic name for Geodon?
The generic name for Geodon is ziprasidone mesylate. There are 7 other brand versions of ziprasidone mesylate.
What is the NDC code for Geodon 20 mg/mL?
The NDC (National Drug Code) for Geodon 20 mg/mL is 0049-3920, listed by ROERIG.