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Paliperidone

PALIPERIDONE

Manufacturer: Lupin Pharmaceuticals, Inc.

Score: 148.0

Quick Summary

Paliperidone is an atypical antipsychotic used for the treatment of schizophrenia and schizoaffective disorder. It is available in extended-release tablets and has a dose range of 3-12 mg/day for adults and 1.5-12 mg/day for adolescents. The drug has warnings for increased mortality in elderly patients with dementia-related psychosis, cerebrovascular adverse reactions, neuroleptic malignant syndrome, QT prolongation, and tardive dyskinesia. Contraindications include known hypersensitivity to paliperidone or risperidone. Adverse reactions include extrapyramidal symptoms, somnolence, and increased prolactin levels.

Key Clinical Findings and Indications

  • Treatment of schizophrenia in adults and adolescents
  • Treatment of schizoaffective disorder in adults

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

  • Known hypersensitivity to paliperidone or risperidone

Adverse Reactions

  • Extrapyramidal symptoms
  • Somnolence
  • Increased prolactin levels

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with renal impairment or hepatic impairment

Schizophrenia

Adult Dose

6 mg/day

Pediatric Dose

3 mg/day for adolescents weighing < 51 kg, 3-6 mg/day for adolescents weighing ≥ 51 kg

Schizoaffective disorder

Adult Dose

6 mg/day

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

  • Category C: use during pregnancy only if potential benefit justifies potential risk to fetus

Nursing Mothers

  • Caution advised: paliperidone is excreted in human breast milk

Pediatric Use

  • Safety and efficacy established for schizophrenia in adolescents 12-17 years old
  • Not established for schizoaffective disorder in pediatric patients

Geriatric Use

  • Use with caution in elderly patients with dementia-related psychosis
  • Dose adjustments may be necessary for elderly patients with renal impairment

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