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ziprasidone hydrochloride

ZIPRASIDONE HCL

Manufacturer: Apotex Corp.

Score: 144.0

Quick Summary

Ziprasidone hydrochloride is an atypical antipsychotic used for the treatment of schizophrenia. It has a unique mechanism of action, involving dopamine and serotonin receptor antagonism. The initial dose is 20 mg twice daily, with possible adjustments up to 80 mg twice daily. Important safety considerations include a warning about increased mortality in elderly patients with dementia-related psychosis, and contraindications such as a known history of QT prolongation. Common adverse reactions include somnolence and respiratory tract infection. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use, with recommendations for careful monitoring and dose adjustments as necessary.

Key Clinical Findings and Indications

  • Treatment of schizophrenia
  • Efficacy demonstrated in short-term and maintenance trials
  • Unique mechanism of action involving dopamine and serotonin receptor antagonism

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

  • Known history of QT prolongation
  • Recent acute myocardial infarction
  • Uncompensated heart failure
  • Hypersensitivity to ziprasidone

Adverse Reactions

  • Somnolence
  • Respiratory tract infection
  • Extrapyramidal symptoms
  • Dystonia

Dosing Recommendations

General Guidance

Dosage adjustments should occur at intervals of not less than 2 days

Schizophrenia

Adult Dose

20 mg twice daily, with possible adjustments up to 80 mg twice daily

Pediatric Dose

Special Population Considerations

Pregnancy

  • Pregnancy Category C
  • Developmental toxicity and teratogenic effects observed in animal studies

Nursing Mothers

  • It is not known whether ziprasidone or its metabolites are excreted in human milk
  • Women receiving ziprasidone should not breastfeed

Pediatric Use

  • The safety and effectiveness of ziprasidone in pediatric patients have not been established

Geriatric Use

  • No overall differences in safety or effectiveness were observed between elderly and younger subjects
  • Greater sensitivity of some older individuals cannot be ruled out

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