Usual Adult Dose for Nausea/Vomiting

Severe Nausea and Vomiting:
Oral:

• Usual dose: 5 to 10 mg orally 3 to 4 times a day
• Maximum dose: 40 mg/day

• Usual dosage: 5 to 10 mg IM, repeated every 3 to 4 hours as necessary.
• Maximum dose: 40 mg/day

• Usual dose: 2.5 to 10 mg slow IV injection or infusion at a rate not exceeding 5 mg/min
• Maximum dose: 10 mg (single dose); 40 mg/day

• Usual dose: 25 mg rectally 2 times a day

• Usual dose: 5 to 10 mg IM 1 to 2 hours before anesthesia OR to control acute symptoms during/after surgery, repeated once (in 30 minutes) if necessary
• Maximum dose: 40 mg/day

• Usual dose: 5 to 10 mg slow IV injection or infusion (at a rate not exceeding 5 mg/min) 15 to 30 minutes before anesthesia OR to control acute symptoms during/after surgery, repeated once if necessary
• Maximum dose: 10 mg (single dose)

• Resistant cases may require oral doses exceeding 40 mg/day.
• Patients receiving parenteral formulations may be more likely to experience hypotension.
• This drug may be given as an undiluted or diluted IV solution; however, bolus IV injections should be avoided.

Usual Adult Dose for Anxiety

Oral:

• Usual dose: 5 mg orally 3 to 4 times a day
• Maximum dose: 20 mg/day
• Duration of therapy: Up to 12 weeks

Usual Adult Dose for Psychosis

Mild psychotic disorders:

• Usual dose: 5 to 10 mg orally 3 to 4 times a day

• Initial dose: 10 mg orally 3 to 4 times a day, increasing the dose in small increments every 2 to 3 days until symptoms are controlled or side effects become bothersome
• Maintenance dose: 50 to 75 mg/day for some patients; 100 to 150 mg/day for patients with more severe disturbances

• Initial dose: 10 to 20 mg IM, repeated every 2 to 4 hours (or every hour in resistant cases), if necessary
• Prolonged therapy: 10 to 20 mg IM every 4 to 6 hours

• Many patients respond after the first injection; more than 3 to 4 IM doses are seldom required.
• Once patients are controlled on parenteral formulations, oral formulations should be used at the same dose or higher. Prolonged IM therapy should be used in rare cases.

Usual Adult Dose for Schizophrenia

Mild psychotic disorders:

• Usual dose: 5 to 10 mg orally 3 to 4 times a day

• Initial dose: 10 mg orally 3 to 4 times a day, increasing the dose in small increments every 2 to 3 days until symptoms are controlled or side effects become bothersome
• Maintenance dose: 50 to 75 mg/day for some patients; 100 to 150 mg/day for patients with more severe disturbances

• Initial dose: 10 to 20 mg IM, repeated every 2 to 4 hours (or every hour in resistant cases), if necessary
• Prolonged therapy: 10 to 20 mg IM every 4 to 6 hours

• Many patients respond after the first injection; more than 3 to 4 IM doses are seldom required.
• Once patients are controlled on parenteral formulations, oral formulations should be used at the same dose or higher. Prolonged IM therapy should be used in rare cases.

Usual Pediatric Dose for Nausea/Vomiting

Less than 2 years or less than 9 kg: Use is contraindicated

2 years and older:
Oral:
9 to 13 kg: 2.5 mg orally 1 to 2 times a day; maximum dose is 7.5 mg/day
13 to 18 kg: 2.5 mg orally 2 to 3 times a day; maximum dose is 10 mg/day
18 to 39 kg: 2.5 mg orally 3 times a day OR 5 mg orally 2 times a day; maximum dose is 15 mg/day

Parenteral:

• Usual dose: 0.132 mg/kg IM once

• At moderate doses, pediatric patients may be more prone to extrapyramidal reactions. Patients should receive the lowest effective dose.
• Continued oral treatment after day 1, and parenteral treatment after the first dose is usually not necessary.

Usual Pediatric Dose for Schizophrenia

Less than 2 years or less than 9 kg: Use is contraindicated

2 to 12 years:
Oral:

• Initial dose: 2.5 mg orally 2 to 3 times a day
• Maximum dose: 20 mg/day (2 to 5 years); 25 mg/day (6 to 12 years)

• Usual dose: 0.132 mg/kg IM once

• Patients should not receive more than 10 mg of the oral formulation on the first day of treatment. Dose adjustments may be made after the first day.
• At moderate doses, pediatric patients may be more prone to extrapyramidal reactions. Patients should receive the lowest effective dose.
• When symptoms are controlled with the IM formulation, patients should be switched to oral formulations at the same dose or higher.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Liver dysfunction: Data not available

Abnormal liver function tests with grippe-like symptoms and fever: Treatment should be discontinued.

Dose Adjustments

Debilitated, emaciated, and/or elderly patients: Most patients respond to doses in the lower end of the dosing range. If required, dose titration should be performed gradually and patients should be closely monitored for side effects.

Depressed WBC counts with differential: Treatment should be discontinued and appropriate antibiotic therapy should be started.

Precautions

US BOXED WARNING(S): 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 2 years or less than 9 kg.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• IM injections should be administered deeply into the upper, outer quadrant of the buttock. Solutions that are darker than pale yellow should not be administered.
• Buccal tablets should be placed between the top gum and upper lip, and should be allowed to dissolve without chewing and/or swallowing.

• See manufacturer product information.

• See manufacturer product information.

• See manufacturer product information.

• This drug should not be used in pediatric surgery.
• Symptom control is usually achieved after the first dose of a parenteral formulation.
• Effectiveness for non-psychotic anxiety was established in a 4-week trial and included patients with generalized anxiety disorder. It is unknown whether patients with other conditions (e.g., physical illness, organic mental conditions, agitated depression, character pathologies) will experience the same benefits.
• This drug is usually not a first-line agent for the treatment of non-psychotic anxiety due to the risk of severe side effects not observed in other treatment options.
• Treatment has not been shown effective in the management of behavioral complications associated with mental disabilities.

• ECG and heart rate monitoring for patients at risk of QT prolongation (e.g., arrhythmias, concurrent QT prolonging drug use)
• 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, especially in patients with liver dysfunction
• Blood pressure, especially in patients with impaired cardiovascular systems and pediatric patients
• Eye examinations, especially in patients on prolonged treatment
• Blood glucose levels in patients with diabetes mellitus
• Periodic renal function tests, especially in patients on prolonged treatment
• Yearly learning capacity examinations in pediatric patients
• Body temperature measurements, especially in patients at risk of hypothermia

• Patients should be warned to avoid abrupt discontinuation of this drug.
• Patients should be instructed to immediately report any signs/symptoms of neutropenia/leukopenia, liver toxicity, 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.
• Parents of pediatric patients should be told to avoid exceeding the prescribed dosage, and should be instructed to report any signs/symptoms of restlessness and/or excitement.