Drug Detail:Haloperidol (Haloperidol (oral) [ hal-oh-per-i-dol ])
Drug Class: Miscellaneous antipsychotic agents
Usual Adult Dose for Psychosis
Oral Haloperidol Formulations:
Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
- Initial doses of up to 100 mg/day have been necessary in some severely resistant cases.
Haloperidol Lactate for Injection:
Prompt control acute agitation: 2 to 5 mg IM every 4 to 8 hours
- The frequency of IM administration should be determined by patient response and may be given as often as every hour.
Comments:
- Oral formulations should be used as soon as practical.
- The total parenteral dose in the preceding 24 hours may be used to approximate an initial oral total daily dose. Initial oral doses should be given within 12 to 24 hours after the last parenteral dose.
- The safety of prolonged oral doses of 100 mg/day or greater has not been studied.
Haloperidol Decanoate for Injection:
Initial dose of-Maximum initial dose: 100 mg; if greater than 100 mg is needed, the dose should be administered in 2 separate injections (100 mg followed by the balance in 3 to 7 days)
Maintenance dose: 10 to 15 times the previous daily oral dose IM once a month, titrated to response
r patients stabilized on low daily oral doses (up to 10 mg/day): 10 to 15 times the daily oral dose IM once a month
Initial dose for patients stabilized on higher daily oral doses, tolerant to oral treatment, or at risk of relapse: 20 times the daily oral dose IM once a month
- Maximum initial dose: 100 mg; if greater than 100 mg is needed, the dose should be administered in 2 separate injections (100 mg followed by the balance in 3 to 7 days)
- Maximum monthly dose: 450 mg
Comments:
- Patients should be stabilized on antipsychotic medication before starting prolonged parenteral therapy.
- Monitor closely during initiation and stabilization to minimize the risk of overdosage or reappearance of psychotic symptoms; short acting formulations may be used during this period of adjustment.
- Extended-release injections are generally administered once a month or every 4 weeks, however, the dosing interval as well as dose may be adjusted to best suit the patient.
- Clinical experience with doses greater than 450 mg per months is limited.
Uses:
- Treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
- Management of manifestations of psychotic disorders
Usual Adult Dose for Schizophrenia
Oral Haloperidol Formulations:
Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
- Initial doses of up to 100 mg/day have been necessary in some severely resistant cases.
Haloperidol Lactate for Injection:
Prompt control acute agitation: 2 to 5 mg IM every 4 to 8 hours
- The frequency of IM administration should be determined by patient response and may be given as often as every hour.
Comments:
- Oral formulations should be used as soon as practical.
- The total parenteral dose in the preceding 24 hours may be used to approximate an initial oral total daily dose. Initial oral doses should be given within 12 to 24 hours after the last parenteral dose.
- The safety of prolonged oral doses of 100 mg/day or greater has not been studied.
Haloperidol Decanoate for Injection:
Initial dose of-Maximum initial dose: 100 mg; if greater than 100 mg is needed, the dose should be administered in 2 separate injections (100 mg followed by the balance in 3 to 7 days)
Maintenance dose: 10 to 15 times the previous daily oral dose IM once a month, titrated to response
r patients stabilized on low daily oral doses (up to 10 mg/day): 10 to 15 times the daily oral dose IM once a month
Initial dose for patients stabilized on higher daily oral doses, tolerant to oral treatment, or at risk of relapse: 20 times the daily oral dose IM once a month
- Maximum initial dose: 100 mg; if greater than 100 mg is needed, the dose should be administered in 2 separate injections (100 mg followed by the balance in 3 to 7 days)
- Maximum monthly dose: 450 mg
Comments:
- Patients should be stabilized on antipsychotic medication before starting prolonged parenteral therapy.
- Monitor closely during initiation and stabilization to minimize the risk of overdosage or reappearance of psychotic symptoms; short acting formulations may be used during this period of adjustment.
- Extended-release injections are generally administered once a month or every 4 weeks, however, the dosing interval as well as dose may be adjusted to best suit the patient.
- Clinical experience with doses greater than 450 mg per months is limited.
Uses:
- Treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
- Management of manifestations of psychotic disorders
Usual Adult Dose for Agitated State
Oral Haloperidol Formulations:
Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
- Initial doses of up to 100 mg/day have been necessary in some severely resistant cases.
Haloperidol Lactate for Injection:
Prompt control acute agitation: 2 to 5 mg IM every 4 to 8 hours
- The frequency of IM administration should be determined by patient response and may be given as often as every hour.
Comments:
- Oral formulations should be used as soon as practical.
- The total parenteral dose in the preceding 24 hours may be used to approximate an initial oral total daily dose. Initial oral doses should be given within 12 to 24 hours after the last parenteral dose.
- The safety of prolonged oral doses of 100 mg/day or greater has not been studied.
Uses:
- Management of manifestations of psychotic disorders
- Prompt control of acute agitation in patients with schizophrenia with moderately severe to severe symptoms
Usual Adult Dose for Agitation
Oral Haloperidol Formulations:
Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
- Initial doses of up to 100 mg/day have been necessary in some severely resistant cases.
Haloperidol Lactate for Injection:
Prompt control acute agitation: 2 to 5 mg IM every 4 to 8 hours
- The frequency of IM administration should be determined by patient response and may be given as often as every hour.
Comments:
- Oral formulations should be used as soon as practical.
- The total parenteral dose in the preceding 24 hours may be used to approximate an initial oral total daily dose. Initial oral doses should be given within 12 to 24 hours after the last parenteral dose.
- The safety of prolonged oral doses of 100 mg/day or greater has not been studied.
Uses:
- Management of manifestations of psychotic disorders
- Prompt control of acute agitation in patients with schizophrenia with moderately severe to severe symptoms
Usual Adult Dose for Tourette's Syndrome
Oral Haloperidol Formulations:
Initial dose:
- Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
- Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
Haloperidol Lactate for Injection:
Prompt control acute agitation: 2 to 5 mg IM every 4 to 8 hours
- The frequency of IM administration should be determined by patient response and may be given as often as every hour.
Comments:
- Oral formulations should be used as soon as practical.
- The total parenteral dose in the preceding 24 hours may be used to approximate an initial oral total daily dose. Initial oral doses should be given within 12 to 24 hours after the last parenteral dose.
- The safety of prolonged oral doses of 100 mg/day or greater has not been studied.
- Patients with chronic/resistant cases should be given the severe symptom dose.
Use:
- Control of tics and vocal utterances of Tourette's disorder
Usual Geriatric Dose for Schizophrenia
Oral Haloperidol Formulations:
Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
- Initial doses of up to 100 mg/day have been necessary in some severely resistant cases.
Haloperidol Lactate for Injection:
- Recommended dose: 2 to 5 mg IM every 4 to 8 hours
- The frequency of IM administration should be determined by patient response and may be given as often as every hour.
- Maximum dose: 20 mg/day
Comments:
- Oral formulations should be used as soon as practical.
- The total parenteral dose in the preceding 24 hours may be used to approximate an initial oral total daily dose. Initial oral doses should be given within 12 to 24 hours after the last parenteral dose.
- The safety of prolonged oral doses of 100 mg/day or greater has not been studied.
Haloperidol Decanoate for Injection:
- Initial dose: 10 to 15 times the daily oral dose IM once
- Maintenance dose: 10 to 15 times the previous daily oral dose IM once a month
- Maximum initial dose: 100 mg; if greater than 100 mg is needed, the dose should be administered in 2 separate injections (100 mg followed by the balance in 3 to 7 days)
- Maximum monthly dose: 450 mg
Comments:
- Patients should be stabilized on antipsychotic medication before starting prolonged parenteral therapy.
- Monitor closely during initiation and stabilization to minimize the risk of overdosage or reappearance of psychotic symptoms; short acting formulations may be used during this period of adjustment.
- Extended-release injections are generally administered once a month or every 4 weeks, however, the dosing interval as well as dose may be adjusted to best suit the patient.
- Clinical experience with doses greater than 450 mg per months is limited.
Uses:
- Treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
- Treatment of schizophrenia
Usual Pediatric Dose for Psychosis
3 to 12 years and 15 to 40 kg:
Initial dose: 0.5 mg/day orally in 2 to 3 divided doses
- Adjust in increments of 0.5 mg every 5 to 7 days until desired effect is achieved
13 years and older and greater than 40 kg:
Initial dose:
- Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
- Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
Comment:
- Severely disturbed patients may require higher doses.
Use:
- Management of manifestations of psychotic disorders
Usual Pediatric Dose for Tourette's Syndrome
3 to 12 years and 15 to 40 kg:
- Initial dose: 0.5 mg/day orally in 2 to 3 divided doses
- Maintenance dose: 0.05 to 0.075 mg/kg/day
13 years and older and greater than 40 kg
Initial dose:
- Moderate symptomology: 0.5 to 2 mg orally 2 to 3 times a day
- Severe symptomology: 3 to 5 mg orally 2 to 3 times a day
Comment:
- The daily dose may be increased every 5 to 7 days in 0.5 mg increments in patients 3 to 12 years of age and 15 to 40 kg.
Use:
- Control of tics and vocal utterances of Tourette's disorder
Usual Pediatric Dose for Agitated State
3 to 12 years and 15 to 40 kg:
- Initial dose: 0.5 mg/day orally in 2 to 3 divided doses
- Maintenance dose: 0.05 to 0.075 mg/kg/day
Comments:
- The daily dose may be increased every 5 to 7 days in 0.5 mg increments.
- There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
- Limitation of use: Treatment should be reserved for patients with severe behavior problems and/or hyperactive children only after failure to respond to psychotherapy or medications (other than antipsychotics).
Uses:
- Treatment of severe behavior problems in children, including combative, explosive hyperexcitability not accounted for by immediate provocation
- Short-term treatment of hyperactive children with excessive motor activity and accompanying conduct disorder with impulsivity, difficulty sustaining attention, aggressiveness, mood lability, and/or poor frustration tolerance.
Usual Pediatric Dose for Aggressive Behavior
3 to 12 years and 15 to 40 kg:
- Initial dose: 0.5 mg/day orally in 2 to 3 divided doses
- Maintenance dose: 0.05 to 0.075 mg/kg/day
Comments:
- The daily dose may be increased every 5 to 7 days in 0.5 mg increments.
- There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.
- Limitation of use: Treatment should be reserved for patients with severe behavior problems and/or hyperactive children only after failure to respond to psychotherapy or medications (other than antipsychotics).
Uses:
- Treatment of severe behavior problems in children, including combative, explosive hyperexcitability not accounted for by immediate provocation
- Short-term treatment of hyperactive children with excessive motor activity and accompanying conduct disorder with impulsivity, difficulty sustaining attention, aggressiveness, mood lability, and/or poor frustration tolerance.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Dose Adjustments
Switchover Procedure:
- Initial oral daily doses should be determined by the total 24 hour parenteral dose.
- The first oral dose should be given 12 to 24 hours after the last parenteral dose.
- Patients should be monitored for sedation and/or adverse events periodically for the first few days of oral therapy; dose adjustments may be required based on patient response.
Debilitated patients: Lower initial doses recommended in geriatric dosing should be considered.
Precautions
US BOXED WARNING:
- INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. This drug should not be used in the treatment of patients with dementia-related psychosis
Safety and efficacy of oral formulations have not been established in patients younger than 3 years. Parenteral formulations are not recommended for use in children.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- IM formulations should be administered with the Z-track method to prevent leakage from the injection site.
- Haloperidol decanoate for injection should only be administered via deep intramuscular route, preferably into the gluteal region. Injection volumes should not exceed 3 mL.
- Oral solution: Administer with a calibrated dropper.
Storage requirements:
- Protect from light and store at room temperature.
Reconstitution/preparation techniques:
- See manufacturer product information.
General:
- Treatment should be periodically reevaluated to ensure that the lowest possible effective dose is used.
- There is considerable variability in the amount of medication needed to achieve optimum levels.
- Haloperidol decanoate for injection may be given as one-half of the monthly dose IM every 2 weeks in specific patients or situations.
Monitoring:
- Periodic WBC with differential tests, especially in patients with signs/symptoms of infection/sore throat or with a history of low WBCs or drug-induced neutropenia/leukopenia
- Periodic liver function tests, with increased frequency in patients with signs/symptoms of liver impairment
- Blood pressure, especially in patients with impaired cardiovascular systems
- Eye examinations, especially in patients on prolonged treatment
- Periodic electrolyte levels, especially in patients with a high risk of developing cardiovascular events and/or those taking diuretics
- Routine weight, blood glucose, hemoglobin A1C
Patient advice:
- Warn patients to avoid abrupt discontinuation of this drug.
- Tell patients to immediately report any signs/symptoms of neutropenia/leukopenia, neuroleptic malignant syndrome, or tardive dyskinesia.
- Advise patients, and families/caregivers to monitor and report signs/symptoms of unusual behavior immediately to their healthcare provider (e.g., agitation, irritability, anxiety, panic attacks, insomnia, hostility, aggressiveness, impulsivity, akathisia, hypomania/mania).
- Patients should be advised to report all concurrent prescription and nonprescription medications or herbal products they are taking.
- Patients should be advised to speak to a healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding.
- Inform patients that this drug may cause drowsiness, and they should avoid driving or operating machinery until the full effects of the drug are seen.
