Ziprasidone Mesylate 20 mg/mL
Ziprasidone Mesylate · INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION · Fosun Pharma USA Inc.
Ziprasidone Mesylate is a injection, powder, lyophilized, for solution containing ziprasidone mesylate at 20 mg/mL, taken intramuscular. Manufactured by Fosun Pharma USA Inc..
Key Facts
- Brand Name
- Ziprasidone Mesylate
- Generic Name
- Ziprasidone Mesylate
- NDC Code (Product)
72266-160- Manufacturer
- Fosun Pharma USA Inc.
- Strength
- 20 mg/mL
- Dosage Form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- ANDA211908
- Marketing Start
- 06/15/2020
Recall History
Mckesson Medical-Surgical Inc. Corporate Office
cGMP deviations: Temperature abuse
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Ziprasidone mesylate for injection 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. 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) ] . Ziprasidone mesylate for injection is an atypical antipsychotic. In choosing among treatmen…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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 ) 2.4 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 Zipra…
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: dofetilide, sotalol, quinid…
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 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 ziprasidone had little inhibitory effect on CYP1A2, CYP2C9, CYP2C19, CYP2D6 and CYP3A4, and thus …
Adverse Reactions
6 ADVERSE REACTIONS Commonly observed adverse reactions (incidence ≥5% and at least twice the incidence for placebo) were: Schizophrenia : Somnolence, respiratory tract infection. ( 6.1 ) Manic and Mixed Episodes Associated with Bipolar Disorder : Somnolence, extrapyramidal symptoms, dizziness, akathisia, abnormal vision, asthenia, vomiting. ( 6.1 ) Intramuscular administration (≥5% and at least twice the lowest intramuscular ziprasidone group): Headache, nausea, somnolence. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Steriscience at 1-888-278-1784 or www.steri-science.com or FDA at 1-800-332-1088 or www.fda.gov/medwatch. 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…
Frequently Asked Questions
What is Ziprasidone Mesylate used for?
Ziprasidone Mesylate contains Ziprasidone Mesylate. It is a injection, powder, lyophilized, for solution taken intramuscular. Consult your doctor for specific uses.
Is Ziprasidone Mesylate a controlled substance?
Ziprasidone Mesylate is not classified as a controlled substance by the DEA.
What is the generic name for Ziprasidone Mesylate?
The generic name for Ziprasidone Mesylate is Ziprasidone Mesylate. There are 7 other brand versions of Ziprasidone Mesylate.
What is the NDC code for Ziprasidone Mesylate 20 mg/mL?
The NDC (National Drug Code) for Ziprasidone Mesylate 20 mg/mL is 72266-160, listed by Fosun Pharma USA Inc..