A-Z Drug Facts > Haloperidol

Haloperidol

Pronouncation: (HAL-oh-pehr-i-dahl)
Class: Phenylbutylpiperadine derivative

Trade Names:
Haldol
- Tablets 0.5 mg
- Tablets 1 mg
- Tablets 2 mg
- Tablets 5 mg
- Tablets 10 mg
- Tablets 20 mg
- Concentrate 2 mg (as lactate)/mL
- Injection 5 mg (as lactate)/mL

Apo-Haloperidol (Canada)
Haloperidol-LA Omega (Canada)
Novo-Peridol (Canada)
PMS-Haloperidol LA (Canada)
ratio-Haloperidol (Canada)
Haloperidol Decanoate

Trade Names:
Haldol Decanoate 50
- Injection 50 mg (as 70.5 decanoate)/mL

Trade Names:
Haldol Decanoate 100
- Injection 100 mg (as 141.04 mg decanoate)/mL

Apo-Haloperidol Decanoate Injection (Canada)

Pharmacology

Has antipsychotic effect, apparently caused by dopamine-receptor blockage in CNS.

Pharmacokinetics

Absorption

When administered in sesame oil, it results in the slow and sustained release of haloperidol. T _max is 6 days after injection. Steady-state plasma concentrations are achieved after the third or fourth dose.

Distribution

The relationship between dose of haloperidol decanoate and plasma haloperidol concentration is roughly linear for doses below 450 mg.

Elimination

Apparent t _½ is approximately 3 wk for the decanoate and 18 h for oral.

Indications and Usage

Management of psychotic disorders; control of Tourette disorder in children and adults; management of severe behavioral problems in children; short-term treatment of hyperactive children. Long-term antipsychotic therapy (haloperidol decanoate).

Unlabeled Uses

Treatment of phencyclidine (PCP) psychosis; antiemetic; hiccoughs.

Contraindications

Severe, toxic CNS depression or comatose states from any cause; Parkinson disease; hypersensitive to any component of the product.

Dosage and Administration

Psychotic disorders
Adults

PO Moderate symptoms, geriatric or debilitated patients: 0.5 to 2 mg twice daily to 3 times daily. Severe symptoms, chronic or resistant patients: 3 to 5 mg twice daily to 3 times daily. Dosages up to 100 mg/day may be necessary in some patients. IM 2 to 5 mg for prompt control of acutely agitated schizophrenic patients with moderately severe to very severe symptoms. Depending on response, subsequent doses may be needed within 60 min; although 4 to 8 h intervals may be satisfactory.

Children 3 to 12 yr of age (weight 15 to 40 kg)

PO Initial dose 0.5 mg/day. If needed, increase in 0.5 mg increments at 5 to 7 day intervals up to 0.15 mg/kg/day or until therapeutic effect is obtained. The dose may be divided and given twice daily to 3 times daily. IM Safety and efficacy not established in children.

Tourette disorder
Adults

PO Start with 0.5 to 1.5 mg 3 times daily (max, 10 mg/day).

Children 3 to 12 yr of age (weight 15 to 40 kg)

PO 0.05 to 0.075 mg/kg/day. Severely disturbed psychotic children may require higher doses.

Behavioral disorders/hyperactivity
Children 3 to 12 yr (weight 15 to 40 kg)

PO 0.05 to 0.075 mg/kg/day. Severely disturbed psychotic children may require higher doses. In severely disturbed, nonpsychotic children or in hyperactive children with conduct disorder, short-term administration may suffice. There is little evidence to support dosages greater than 6 mg/day.

Haloperidol decanoate injection

The dose should be individualized under close supervision during initiation and stabilization of therapy. The recommended interval between doses is monthly or every 4 wk, but variations in patient response may dictate a need for adjustments in dose or dosing interval.

Adults

IM (deep injection) Initial dose should not exceed 100 mg. If conversion from oral haloperidol to IM haloperidol decanoate requires more than 100 mg as an initial dose, administer that dose in 2 injections (max, 100 mg initially followed by balance in 3 to 7 days). In patients stabilized on low oral doses (10 mg or less/day), the initial recommended dose of haloperidol decanoate is 10 to 15 times the daily dose. In patients stabilized on higher oral doses, the recommended dose is 20 times the daily dose. Maintenance dosages should be titrated upward or downward based on therapeutic response.

General Advice

• Measure prescribed dose of oral concentrate using calibrated dropper or dosing syringe.
• Oral concentrate can be mixed with semisolid foods (eg, soup, pudding) or diluted with 1 to 2 oz of water, coffee, tea, tomato or fruit juice just prior to administration. Do not prepare dilutions ahead of time and store.
• Injection is for IM administration only. Not for intradermal, subcutaneous, or IV administration.
• Double check injection dose form. Haloperidol decanoate is designed for monthly injection only.
• Inject prescribed dose slowly, deep into outer quadrant of buttock.
• Do not administer injection if particulate matter or marked discoloration noted. A slight yellowish discoloration is normal and will not alter potency.

Storage/Stability

Store tablets, oral concentrate, and injection at controlled room temperature (59° to 86°F) protected from light. Do not freeze oral concentrate or injection.

Drug Interactions

Anesthetics, opiates, alcohol

May increase CNS depressant effects.

Anticholinergics

May increase anticholinergic effects. May worsen schizophrenic symptoms, decrease haloperidol serum concentrations, and lead to tardive dyskinesia.

Azole antifungal agents (eg, itraconazole)

Plasma levels of haloperidol may be elevated, increasing the risk of side effects.

Carbamazepine

May decrease effects of haloperidol.

Lithium

May induce disorientation, unconsciousness, and extrapyramidal symptoms.

Rifamycins (eg, rifampin)

Plasma levels of haloperidol may be reduced, decreasing the clinical effectiveness.

Laboratory Test Interactions

Pregnancy tests

False-positive results may occur; less likely to occur with serum test.

Protein-bound iodine

Increases have been reported.

Adverse Reactions

Cardiovascular

Orthostatic hypotension; hypertension; tachycardia; ECG changes.

CNS

Tardive dyskinesia; tardive dystonia; insomnia; restlessness; anxiety; euphoria; agitation; drowsiness; depression; lethargy; headache; confusion; vertigo; seizures; exacerbation of psychotic symptoms; pseudoparkinsonism (eg, mask-like face, drooling, pill rolling, shuffling gait, inertia, tremors, cogwheel rigidity); muscle spasms; dyskinesia; akathisia; oculogyric crises; opisthotonos; hyperreflexia.

Dermatologic

Maculopapular and acneiform skin reactions; photosensitivity; hair loss.

EENT

Cataracts; retinopathy; visual disturbances; mydriasis; increased IOP; nasal congestion.

GI

Dyspepsia; anorexia; diarrhea; hypersalivation; nausea; vomiting; dry mouth; elevated prolactin levels; adynamic ileus (may lead to death).

Genitourinary

Menstrual irregularities; breast enlargement; lactation; gynecomastia; impotence; sexual dysfunction; priapism; urinary hesitancy or retention.

Hematologic

Agranulocytosis; leukopenia; leukocytosis; anemia.

Hepatic

Jaundice; impaired liver function.

Respiratory

Laryngospasm; bronchospasm; increased depth of respiration; bronchopneumonia.

Miscellaneous

Hyperglycemia; hypoglycemia; hyponatremia.

Precautions

Pregnancy

Safety not established.

Haloperidol decanoate

Category C .

Lactation

Excreted in breast milk.

Children

Do not use in children younger than 3 yr. Safety and efficacy of IM form not established.

Elderly

More susceptible to effects; consider lower dose.

Special Risk Patients

Use drug with caution in patients with CV disease or mitral insufficiency, history of glaucoma, EEG abnormalities or seizure disorders, prior brain damage, or hepatic or renal impairment.

Tartrazine Sensitivity

Note that tartrazine may be a component of this product.

Abrupt withdrawal

Abrupt withdrawal in patients on maintenance therapy has been associated with transient dyskinetic signs, which may be indistinguishable from tardive dyskinesia.

Antiemetic effects

Caused by suppression of cough reflex, aspiration of vomitus possible.

CNS effects

May impair mental or physical abilities, especially during first few days of therapy.

Debilitated patients

More susceptible to effects; consider lower dose.

Hepatic effects

Jaundice usually occurs in 2 to 4 wk of treatment and is considered a hypersensitivity reaction. Usually reversible.

Neuroleptic malignant syndrome (NMS)

Has occurred and is potentially fatal. Signs and symptoms are hyperpyrexia, muscle rigidity, altered mental status, irregular pulse, irregular BP, tachycardia, and diaphoresis.

Sensitivity to neuroleptic drugs

May require lower dosage.

Sudden death

Has been reported; predisposing factors may be seizures or previous brain damage. Flare up of psychotic behavior may precede death.

Tardive dyskinesia

Syndrome of potentially irreversible, involuntary dyskinetic movements may develop. Prevalence is highest in elderly, especially women. Use smallest effective dose for shortest period of time needed.

Overdosage

Symptoms

CNS depression, somnolence, hypotension, extrapyramidal symptoms, hypertension, shock-like state, coma, autonomic reactions, ECG changes associated with torsades de pointes, cardiac arrhythmias.

Patient Information

• Advise patient, family, or caregiver that dose will be adjusted periodically until maximum benefit has been obtained.
• Advise patient, family, or caregiver not to change the dose or stop taking unless advised by health care provider.
• Instruct patient, family, or caregiver to measure prescribed dose of oral concentrate using calibrated dropper or dosing syringe.
• Advise patient, family, or caregiver that oral concentrate can be mixed with semisolid foods (eg, soup, pudding) or diluted with 1 to 2 oz of water, coffee, tea, or tomato or fruit juice prior to administration. Caution patient, family, or caregiver not to prepare dilutions ahead of time and store.
• Instruct patient not to stop taking haloperidol when feeling better.
• Instruct patient, family, or caregiver to immediately report fainting or loss of consciousness, dizziness, high fever, muscle rigidity, or altered mental status to health care provider.
• Advise patient, family, or caregiver to notify health care provider of the following: excessive drowsiness, increased agitation or anxiety, or involuntary body or facial movements.
• Advise patient to avoid strenuous activity during periods of high temperature or humidity.
• Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
• Instruct patient to get up slowly from lying or sitting position and to avoid sudden position changes to prevent postural hypotension. Advise patient to report dizziness with position changes to health care provider. Caution patient that hot tubs and hot showers or baths may make dizziness worse.
• Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
• Advise patient that drug may cause drowsiness and impaired judgment or thinking skills and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Caution patient that medication may cause sensitivity to sunlight and to avoid unnecessary exposure to UV light (sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light until tolerance is determined.

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