HALDOL SOLUTAB

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HALDOL SOLUTAB (HALDOL SOLUTAB).

How it works

Haloperidol is a typical antipsychotic that primarily antagonizes dopamine D2 receptors in the mesolimbic pathway, also blocking alpha-adrenergic, histamine H1, and muscarinic receptors.

What the body does with it

Metabolism	Hepatic via CYP3A4, CYP2D6, and glucuronidation; major metabolite is reduced haloperidol.
Excretion	Renal (approximately 30-40% as metabolites, <1% unchanged); biliary/fecal (approximately 15-20%); significant enterohepatic recirculation.
Half-life	Terminal elimination half-life averages 21 hours (range 12-38 hours) in healthy adults; clinically significant for once-daily dosing.
Protein binding	Approximately 90% bound primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	14-17 L/kg; extensive tissue distribution with high lipophilicity.
Bioavailability	Oral: 60-70% (first-pass metabolism); intramuscular: 100%.
Onset of Action	Oral: 30-60 minutes for initial sedative effect; antipsychotic effect may require several days to weeks.
Duration of Action	Oral: 12-24 hours for single dose; steady-state achieved in 4-6 days; prolonged effects with depot formulations.

Classification & Brands

Dosing & administration

1 to 15 mg orally once daily (tablet or orally disintegrating tablet). For acute agitation, 2.5 to 10 mg intramuscularly every 1 to 8 hours. Maximum oral dose: 100 mg/day; maximum IM dose: 20 mg/day.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild to moderate renal impairment (CrCl >30 mL/min). For severe renal impairment (CrCl <30 mL/min), start at low end of dosing range and titrate cautiously; monitor for excessive sedation and hypotension.
Liver impairment	In Child-Pugh Class A (mild): no adjustment. Child-Pugh Class B (moderate): reduce dose by 50% and titrate slowly. Child-Pugh Class C (severe): avoid use or use with extreme caution at 25% of normal starting dose.
Pediatric use	For agitation or tic disorders: 0.05 to 0.15 mg/kg/day orally in 2 to 3 divided doses; maximum 6 mg/day (for children 3-12 years). Not recommended for children <3 years. For acute psychosis: 0.01 to 0.03 mg/kg intramuscularly every 4 to 8 hours as needed.
Geriatric use	Initiate at 0.5 to 2 mg orally once or twice daily; titrate slowly by 0.5 mg increments. Maximum dose typically 5 mg/day due to increased risk of QTc prolongation, extrapyramidal symptoms, and cognitive impairment.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for HALDOL SOLUTAB (HALDOL SOLUTAB).

Breastfeeding	Haloperidol excreted in breast milk, M/P ratio approximately 0.5-0.7. Relative infant dose ~2-12% of maternal weight-adjusted dose. Monitor infant for sedation, irritability, and abnormal movements. Generally considered compatible with breastfeeding with caution.
Teratogenic Risk	First trimester: Limited data, but haloperidol crosses placenta. Risk of limb malformations and cardiac defects in first trimester exposure, though absolute risk low. Second and third trimesters: Neonatal extrapyramidal symptoms, withdrawal, and sedation reported with third trimester use.

Warnings & precautions

■ FDA Black Box Warning

Increased mortality in elderly patients with dementia-related psychosis.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to haloperidol","Comatose states","Parkinson's disease","Dementia with Lewy bodies","Concomitant use with drugs causing QT prolongation"]

Clinical Precautions

Precautions

["Tardive dyskinesia","Neuroleptic malignant syndrome","QT prolongation","Central nervous system depression","Seizures","Dysphagia","Hepatotoxicity","Leukopenia/neutropenia"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…

HALDOL SOLUTAB

Clinical safety rating: caution

Comprehensive clinical and safety monograph for HALDOL SOLUTAB (HALDOL SOLUTAB).

How it works

Haloperidol is a typical antipsychotic that primarily antagonizes dopamine D2 receptors in the mesolimbic pathway, also blocking alpha-adrenergic, histamine H1, and muscarinic receptors.

What the body does with it

Metabolism	Hepatic via CYP3A4, CYP2D6, and glucuronidation; major metabolite is reduced haloperidol.
Excretion	Renal (approximately 30-40% as metabolites, <1% unchanged); biliary/fecal (approximately 15-20%); significant enterohepatic recirculation.
Half-life	Terminal elimination half-life averages 21 hours (range 12-38 hours) in healthy adults; clinically significant for once-daily dosing.
Protein binding	Approximately 90% bound primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	14-17 L/kg; extensive tissue distribution with high lipophilicity.
Bioavailability	Oral: 60-70% (first-pass metabolism); intramuscular: 100%.
Onset of Action	Oral: 30-60 minutes for initial sedative effect; antipsychotic effect may require several days to weeks.
Duration of Action	Oral: 12-24 hours for single dose; steady-state achieved in 4-6 days; prolonged effects with depot formulations.

Classification & Brands

Dosing & administration

1 to 15 mg orally once daily (tablet or orally disintegrating tablet). For acute agitation, 2.5 to 10 mg intramuscularly every 1 to 8 hours. Maximum oral dose: 100 mg/day; maximum IM dose: 20 mg/day.

Dosage form	TABLET
Renal impairment	No dose adjustment required for mild to moderate renal impairment (CrCl >30 mL/min). For severe renal impairment (CrCl <30 mL/min), start at low end of dosing range and titrate cautiously; monitor for excessive sedation and hypotension.
Liver impairment	In Child-Pugh Class A (mild): no adjustment. Child-Pugh Class B (moderate): reduce dose by 50% and titrate slowly. Child-Pugh Class C (severe): avoid use or use with extreme caution at 25% of normal starting dose.
Pediatric use	For agitation or tic disorders: 0.05 to 0.15 mg/kg/day orally in 2 to 3 divided doses; maximum 6 mg/day (for children 3-12 years). Not recommended for children <3 years. For acute psychosis: 0.01 to 0.03 mg/kg intramuscularly every 4 to 8 hours as needed.
Geriatric use	Initiate at 0.5 to 2 mg orally once or twice daily; titrate slowly by 0.5 mg increments. Maximum dose typically 5 mg/day due to increased risk of QTc prolongation, extrapyramidal symptoms, and cognitive impairment.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for HALDOL SOLUTAB (HALDOL SOLUTAB).

Breastfeeding	Haloperidol excreted in breast milk, M/P ratio approximately 0.5-0.7. Relative infant dose ~2-12% of maternal weight-adjusted dose. Monitor infant for sedation, irritability, and abnormal movements. Generally considered compatible with breastfeeding with caution.
Teratogenic Risk	First trimester: Limited data, but haloperidol crosses placenta. Risk of limb malformations and cardiac defects in first trimester exposure, though absolute risk low. Second and third trimesters: Neonatal extrapyramidal symptoms, withdrawal, and sedation reported with third trimester use.

Warnings & precautions

■ FDA Black Box Warning

Increased mortality in elderly patients with dementia-related psychosis.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to haloperidol","Comatose states","Parkinson's disease","Dementia with Lewy bodies","Concomitant use with drugs causing QT prolongation"]

Clinical Precautions

Precautions

["Tardive dyskinesia","Neuroleptic malignant syndrome","QT prolongation","Central nervous system depression","Seizures","Dysphagia","Hepatotoxicity","Leukopenia/neutropenia"]

Clinical Tips & Counseling

Drug interactions

Loading safety data…