Finished product reference

Ziprasidone

Capsule · Oral · 40 mg

List code
52520
Boxed warning

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Ziprasidone is not approved for the treatment of patients with dementia-related psychosis .

What it is and how it works

Mechanism of Action The mechanism of action of ziprasidone in the treatment of the listed indications could be mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism.

Indications

Ziprasidone capsules are 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. 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 . 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 Schizophrenia Ziprasidone capsules are indicated for the treatment of schizophrenia in adults .

Dosage and administration (summary)

Administer capsules orally with food. Do not open, crush, or chew. 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. 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 to 80 mg twice daily.

Contraindications

Do not use in patients with a known history of QT prolongation Do not use in patients with recent acute myocardial infarction Do not use in patients with uncompensated heart failure Do not use in combination with other drugs that have demonstrated QT prolongation Do not use in patients with known hypersensitivity to ziprasidone Concomitant use of monoamine oxidase inhibitors (MAOIs), or use within 14 days of stopping MAOIs.

Warnings and precautions

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack). QT Interval Prolongation : Ziprasidone use should be avoided in patients with bradycardia, hypokalemia or hypomagnesemia, congenital prolongation of the QT interval, or in combination with other drugs that have demonstrated QT prolongation. Serotonin Syndrome : Increased risk when co-administered with other serotonergic agents, but also when taken alone.

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including ziprasidone capsules, during pregnancy.

Storage and supply

Ziprasidone capsules, USP 80 mg (ziprasidone), are light pink to brown granular powder filled in size “2” hard gelatin capsules having LT Turquoise blue opaque cap and Flesh opaque body, imprinted “RDY” on cap and “259” on body with black ink, and are supplied in NDC: 70518-4709-00 NDC: 70518-4709-01 NDC: 70518-4709-02 NDC: 70518-4709-03 OUTER PACK…

Source: Ziprasidone (Ziprasidone) — US FDA prescribing information, 2026-07-27, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Other presentations of the same active ingredient

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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