HALDOL 5/MG TAB 25/TAB

Indications

Approved Uses

Schizophrenia and other psychotic disorders; acute mania (as part of bipolar disorder management); Tourette’s syndrome (tics/vocal utterances); severe behavioral disturbance/aggression (including in children, where locally approved).

Dosage & Administration

Dosing by Condition

Schizophrenia/psychosis (adults, oral): start 0.5-2 mg 2-3 times daily (higher initial doses such as 3-5 mg 2-3 times daily may be used in severe cases), then adjust to the minimum effective dose (commonly 5-20 mg/day). Tourette’s/tics: start low (e.g., 0.5 mg/day in divided doses) and titrate; pediatric dosing is weight-based in some labels (e.g., ~0.05-0.075 mg/kg/day in divided doses). Acute agitation (IM, if using injectable product): 2-5 mg IM, repeat as needed per response with appropriate monitoring.

Initial Dose

0.5-5mg 2-3 times daily (oral), depending on severity; 2-5mg IM for acute agitation

Maintenance Dose

1-15 mg/day orally in divided doses.

Maximum Dose

100mg/day (oral); doses above 30mg/day rarely provide additional benefit

Children's Dosage

Children 3-12 years (15-40kg): 0.025-0.05mg/kg/day in 2-3 divided doses for behavioral disorders; 0.05-0.075mg/kg/day for psychosis; 0.05-0.075mg/kg/day for Tourette's. Not recommended under 3 years.

Dose Adjustment Notes

Use the lowest effective dose and titrate gradually; start lower and titrate more slowly in elderly/frail patients; use caution in hepatic impairment (consider reduced initial dose) and monitor closely.

How to Take

Swallow the tablet with water; may be taken with or without food; take exactly as prescribed at the same time(s) each day.

Safety & Warnings

Contraindications

Hypersensitivity to haloperidol/butyrophenones; comatose states; severe CNS depression; Parkinson’s disease; dementia with Lewy bodies; known QT prolongation/congenital long-QT or history of torsades de pointes (and clinically significant arrhythmias).

Warnings & Precautions

Key warnings/precautions: increased mortality in elderly with dementia-related psychosis; QT prolongation/ventricular arrhythmias (consider baseline ECG and correct electrolytes; avoid other QT‑prolongers); NMS (stop if suspected); tardive dyskinesia risk with long-term/high-dose use; EPS and falls risk (esp. elderly); seizure threshold lowering; hyperprolactinemia; caution in hepatic impairment and cardiovascular disease.

Age Restriction

Not recommended in children under 3 years (safety/efficacy not established; specialist use only).

Special Populations

Children

Children 3-12 years (15-40kg): 0.025-0.05mg/kg/day in 2-3 divided doses for behavioral disorders; 0.05-0.075mg/kg/day for psychosis; 0.05-0.075mg/kg/day for Tourette's. Not recommended under 3 years.

Elderly

Start at 0.5-2mg/day; titrate slowly with careful monitoring; use lowest effective dose; increased risk of falls, QT prolongation, extrapyramidal effects, and mortality in dementia patients

Liver Impairment

Use with caution in hepatic impairment; start with a lower initial dose and titrate more slowly (often ~50% lower initial dose) with longer intervals based on response/tolerability.

Storage & Patient Advice

Missed Dose

Take as soon as remembered; skip if it is almost time for the next dose. Do not double the dose.

Stopping the Medicine

Do not stop abruptly-taper gradually under medical supervision.

Patient Counseling

Take exactly as prescribed and do not stop abruptly without medical advice; may cause drowsiness-avoid driving/machinery until effects are known; avoid alcohol and other sedatives unless approved; rise slowly to reduce dizziness; seek urgent care for fever/rigidity/confusion, uncontrolled movements, or palpitations/syncope; keep follow-up for ECG and movement-symptom monitoring.

Monitoring Requirements

ECG/QTc at baseline and as clinically indicated (especially with risk factors/high doses); monitor for EPS/tardive dyskinesia (e.g., AIMS), vital signs/orthostasis, weight/metabolic parameters as clinically appropriate, and labs such as LFTs and CBC if clinically indicated (or if history of leukopenia).

Pharmacology

Duration of Effect

Clinical effect per oral dose is typically consistent with once- or twice-daily dosing; elimination half-life is ~14-37 hours, while full antipsychotic response may take days to weeks.

Half-Life

Approximately 14-37 hours (commonly ~20-24 hours) after oral dosing.

Bioavailability

60-70% (oral).

Product Information

Available Dosage Forms

Tablet (this product); oral solution/concentrate; short-acting IM injection (haloperidol lactate); long-acting IM depot injection (haloperidol decanoate).

Composition per Dose

Each tablet: 5mg haloperidol

Generic Availability

Yes

OTC Alternatives

No OTC alternative

Psych Class

Antipsychotic-Typical

Controlled Substance

No

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