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risperidone

RISPERIDONE

Manufacturer: Major Pharmaceuticals

Score: 144.0

Quick Summary

Risperidone is an atypical antipsychotic used for the treatment of schizophrenia, bipolar mania, and irritability associated with autistic disorder. It has a boxed warning for increased mortality in elderly patients with dementia-related psychosis. The initial dose for adults with schizophrenia is 2 mg per day, and for adolescents it is 0.5 mg per day. The drug has various adverse reactions, including extrapyramidal symptoms, somnolence, and weight gain. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Treatment of schizophrenia
  • Treatment of bipolar mania
  • Treatment of irritability associated with autistic disorder

Important Safety Information

Warning

Increased mortality in elderly patients with dementia-related psychosis

Contraindications

  • Known hypersensitivity to risperidone or paliperidone

Adverse Reactions

  • Extrapyramidal symptoms
  • Somnolence
  • Weight gain
  • Hyperprolactinemia
  • Orthostatic hypotension

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with severe renal or hepatic impairment, and for patients taking enzyme inducers or inhibitors.

Schizophrenia

Adult Dose

2 mg per day

Pediatric Dose

0.5 mg per day for adolescents

Bipolar mania

Adult Dose

2-3 mg per day

Pediatric Dose

0.5 mg per day for children and adolescents

Irritability associated with autistic disorder

Adult Dose

Not applicable

Pediatric Dose

0.25 mg per day for children < 20 kg, 0.5 mg per day for children ≥ 20 kg

Special Population Considerations

Pregnancy

  • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to atypical antipsychotics, including risperidone, during pregnancy.
  • Risperidone may cause extrapyramidal and/or withdrawal symptoms in neonates.

Nursing Mothers

  • Risperidone is excreted in human breast milk, and caution should be exercised when administering to nursing women.

Pediatric Use

  • Risperidone is approved for the treatment of schizophrenia in adolescents aged 13-17 years, and for the treatment of bipolar mania in children and adolescents aged 10-17 years.
  • Risperidone is approved for the treatment of irritability associated with autistic disorder in children and adolescents aged 5-17 years.

Geriatric Use

  • Clinical studies of risperidone in the treatment of schizophrenia did not include sufficient numbers of patients aged 65 and over to determine whether or not they respond differently than younger patients.
  • A lower starting dose is recommended for elderly patients, reflecting a decreased pharmacokinetic clearance in the elderly.