Usual Adult Dose for Psychosis

Moderately disturbed, nonhospitalized patients:

• Recommended dose: 4 to 8 mg orally 3 times a day, with a dose reduction to the minimum effective dose as soon as possible
• Maximum dose: 24 mg/day

Hospitalized patients:

• Recommended dose: 8 to 16 mg orally 2 to 4 times a day
• Maximum dose: 64 mg/day

Comment:

• Nonhospitalized patients should be limited to a daily dose of 24 mg; maximum doses of 64 mg should be used in hospitalized patients.

Use: Treatment of schizophrenia

Usual Adult Dose for Nausea/Vomiting

Recommended dose: 8 to 16 mg orally, in divided doses
Maximum dose: 24 mg/day, in divided doses

Comment:

• The dose should be reduced as early as possible.

Use: Severe nausea and vomiting

Usual Pediatric Dose for Psychosis

12 years and older:
Moderately disturbed, nonhospitalized patients:

• Recommended dose: 4 to 8 mg orally 3 times a day, with a dose reduction to the minimum effective dose as soon as possible
• Maximum dose: 24 mg/day

Hospitalized patients:

• Recommended dose: 8 to 16 mg orally 2 to 4 times a day
• Maximum dose: 64 mg/day

Comments:

• Nonhospitalized patients should be limited to a daily dose of 24 mg; maximum doses of 64 mg should be used in hospitalized patients.

Use: Treatment of schizophrenia

Usual Pediatric Dose for Nausea/Vomiting

12 years and older:

• Recommended dose: 8 to 16 mg orally, in divided doses
• Maximum dose: 24 mg/day, in divided doses

Comment:

• The dose should be reduced as early as possible.

Use: Severe nausea and vomiting

Renal Dose Adjustments

Use with caution.

Liver Dose Adjustments

Patients with liver damage: Contraindicated

Dose Adjustments

Abnormalities in hepatic tests, BUN, and/or signs/symptoms of blood dyscrasias:

• Discontinue treatment and monitor appropriately.

Elderly patients: Lower initial doses are recommended. Clinical benefit may require lower doses for longer periods of time.

Precautions

US BOXED WARNING:

• INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: This drug has an increased risk of mortality when administered to elderly patients with dementia-related psychosis. Elderly patients with dementia-related psychosis treated with antipsychotic drugs have an increased risk of death. This drug is not approved for use in patients with dementia-related psychosis.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For some patients, this drug may be given before bed.

Storage requirements:

• See manufacturer product information.

General:

• All patients on prolonged treatment should be reassessed regularly.
• Patients receiving long-term treatment may have a higher risk of developing liver damage, corneal/lenticular deposits, and/or irreversible dyskinesia.
• Treatment has not been effective for the management of behavioral complications in patients with mental impairments.

Monitoring:

• ECG monitoring for patients at risk of QT prolongation
• Periodic WBC with differential tests, especially in patients with signs/symptoms of infection/sore throat, at increased risk of blood dyscrasias, and/or with a history of low WBCs or drug-induced neutropenia/leukopenia
• Periodic liver function tests
• Blood pressure, especially in patients with impaired cardiovascular systems
• Eye examinations, especially in patients on prolonged treatment
• Heart rate, especially in patients with arrhythmias and/or taking QT prolonging drugs concurrently
• Periodic renal function tests, especially in patients on prolonged treatment

Patient advice:

• Patients should be warned to avoid abrupt discontinuation of this drug.
• Patients should be instructed to immediately report any signs/symptoms of neutropenia/leukopenia, neuroleptic malignant syndrome, or tardive dyskinesia.
• Inform patients that this drug may cause or impair mental/physical abilities, and they should avoid driving or operating machinery until the full effects of the drug are seen.
• Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.