haloperidol (ha-loe-per-i-dole) Haldol, Haldol Decanoate

 Indications

Acute and chronic psychotic disorders including:

schizophrenia, manic states, drug-induced psychoses.

Patients with schizophrenia who require long-term parenteral

(IM) antipsychotic therapy. Also useful in managing

aggressive or agitated patients. Tourette’s syndrome.

Severe behavioral problems in children which

may be accompanied by: unprovoked, combative, explosive

hyperexcitability, hyperactivity accompanied by

conduct disorders (short-term use when other modalities

have failed). Considered second-line treatment after

failure with atypical antipsychotic. Unlabeled

Use: Nausea and vomiting from surgery or chemotherapy.

Action

Alters the effects of dopamine in the CNS. Also has anticholinergic

and alpha-adrenergic blocking activity.

Therapeutic Effects: Diminished signs and symptoms

of psychoses. Improved behavior in children with

Tourette’s syndrome or other behavioral problems.

Pharmacokinetics

Absorption: Well absorbed following PO/IM administration.

Decanoate salt is slowly absorbed and has a

long duration of action.

Distribution: Concentrates in liver. Crosses placenta;

enters breast milk.

Protein Binding: 92%.

Metabolism and Excretion: Mostly metabolized

by the liver.

Half-life: 21–24 hr.

TIME/ACTION PROFILE (antipsychotic activity)

ROUTE ONSET PEAK DURATION

PO 2 hr 2–6 hr 8–12 hr

IM 20–30 min 30–45 min 4–8 hr†

IM (decanoate)

3–9 days unknown 1 mo

†Effect may persist for several days.

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Angle-closure

glaucoma; Bone marrow depression; CNS depression;

Parkinsonism; Severe liver or cardiovascular disease

(QT interval prolonging conditions); Some products

contain tartrazine, sesame oil, or benzyl alcohol and

should be avoided in patients with known intolerance

or hypersensitivity.

Use Cautiously in: Debilitated patients (doseprequired);

Cardiac disease (risk of QT prolongation with

high doses); Diabetes; Respiratory insufficiency; Prostatic

hyperplasia; CNS tumors; Intestinal obstruction;

Seizures; Patients at risk for falls; OB: Neonates atq

risk for extrapyramidal symptoms and withdrawal after

delivery when exposed during the 3rd trimester; use

only if benefit outweighs risk to fetus; Lactation: Discontinue

drug or bottle-feed; Geri: Doseprequired due to

qsensitivity;qrisk of mortality in elderly patients

treated for dementia-related psychosis.

Adverse Reactions/Side Effects

CNS: SEIZURES, extrapyramidal reactions, confusion,

drowsiness, restlessness, tardive dyskinesia. EENT:

blurred vision, dry eyes. Resp: respiratory depression.

CV: hypotension, tachycardia, ECG changes (QT prolongation,

torsade de pointes), ventricular arrhythmias.

GI: constipation, dry mouth, anorexia, drug-induced

hepatitis, ileus, weight gain. GU: impotence, urinary

retention. Derm: diaphoresis, photosensitivity, rashes.

Endo: amenorrhea, galactorrhea, gynecomastia. Hemat:

AGRANULOCYTOSIS, anemia, leukopenia, neutropenia.

Metab: hyperpyrexia. Misc: NEUROLEPTIC MALIGNANT

SYNDROME, hypersensitivity reactions.

Interactions

Drug-Drug: May enhance the QTc-prolonging effect

of QTc-prolonging agents.qhypotension with antihypertensives,

nitrates, or acute ingestion of alcohol.

qanticholinergic effects with drugs having anticholinergic

properties, including antihistamines,

antidepressants, atropine, phenothiazines, quinidine,

and disopyramide.qCNS depression with

other CNS depressants, including alcohol, antihistamines,

opioid analgesics, and sedative/hypnotics.

Concurrent use with epinephrine may result in

severe hypotension and tachycardia. Mayptherapeutic

effects of levodopa. Acute encephalopathic syndrome

may occur when used with lithium. Dementia may occur

with methyldopa.

Drug-Natural Products: Kava-kava, valerian,

or chamomile canqCNS depression.

Route/Dosage

Haloperidol

PO (Adults): 0.5–5 mg 2–3 times daily. Patients with

severe symptoms may require up to 100 mg/day. 

PO (Geriatric Patients or Debilitated Patients):

0.5–2 mg twice daily initially; may be graduallyqas

needed.

PO (Children 3–12 yr or 15–40 kg): 0.25–0.5

mg/day given in 2–3 divided doses; increase by 0.25–

0.5 mg every 5–7 days; maximum dose: 0.15 mg/kg/

day (up to 0.75 mg/kg/day for Tourette’s syndrome or

0.15 mg/kg/day for psychoses).

IM (Adults): 2–5 mg q 1–8 hr (not to exceed 100

mg/day).

IM (Children 6–12 yr): 1–3 mg/dose every 4–8

hours to a maximum of 0.15 mg/kg/day.

IV (Adults): 0.5–5 mg, may be repeated q 30 min

(unlabeled).

Haloperidol Decanoate

IM (Adults): 10–15 times the previous daily PO dose

but not to exceed 100 mg initially, given monthly (not

to exceed 300 mg/mo).

Availability (generic available)

Tablets: 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg, 20 mg.

Oral concentrate: 2 mg/mL. Haloperidol lactate

injection: 5 mg/mL. Haloperidol decanoate injection:

50 mg/mL, 100 mg/mL.