• Acute and chronic psychotic disorders including:
  • schizophrenia,
  • manic states,
  • drug-induced psychoses.
• Patients with schizophrenia who require long-term parenteral (IM) antipsychotic therapy.
• Agitation or aggressive behavior.
• 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).

Unlabeled Uses:

• Nausea and vomiting from surgery or chemotherapy.

Contraindicated in:

• Hypersensitivity
• Angle-closure glaucoma
• Bone marrow depression
• CNS depression
• Parkinsonism
• Severe hepatic or cardiovascular disease (↑ risk of QT interval prolongation)
• Some products contain tartrazine, sesame oil, or benzyl alcohol and should be avoided in patients with known intolerance or hypersensitivity
• Lactation: Lactation.

Use Cautiously in:

• Debilitated patients (↓ dose)
• Cardiac disease (↑ risk of QT interval prolongation with high doses)
• Diabetes
• Respiratory disease
• Prostatic hyperplasia
• CNS tumors
• Intestinal obstruction
• Seizures
• Patients at risk for falls
• OB: Neonates at ↑ risk for extrapyramidal symptoms and withdrawal after delivery when exposed during the 3rd trimester; use during pregnancy only if potential maternal benefit justifies potential fetal risk
• Geri: Appears on Beers list. ↑ risk of stroke, cognitive decline, and mortality in older adults with dementia. Avoid use in older adults, except for schizophrenia, bipolar disorder, or for short-term use as an antiemetic.

CV: hypotension, QT interval prolongation, tachycardia, TORSADES DE POINTES, ventricular arrhythmias.

Derm: diaphoresis, photosensitivity, rash.

EENT: blurred vision, dry eyes.

Endo: amenorrhea, galactorrhea, gynecomastia.

GI: constipation, dry mouth, anorexia, hepatitis, ileus.

GU: impotence, urinary retention.

Hemat: AGRANULOCYTOSIS, anemia, leukopenia, neutropenia.

Metab: weight gain.

Neuro: extrapyramidal reactions, confusion, drowsiness, restlessness, SEIZURES, tardive dyskinesia.

Resp: respiratory depression.
Misc: hypersensitivity reactions, NEUROLEPTIC MALIGNANT SYNDROME.

Drug-Drug:

• Concurrent use with QT interval prolonging drugs may ↑ risk of QT interval prolongation.
• ↑hypotension with antihypertensives, nitrates, or acute ingestion of alcohol.
• ↑anticholinergic effects with drugs having anticholinergic properties, including antihistamines, antidepressants, atropine, phenothiazines, quinidine, and disopyramide.
• ↑CNS depression with other CNS depressants, including alcohol, antihistamines, opioid analgesics, and sedative/hypnotics.
• Concurrent use with epinephrine may result in severe hypotension and tachycardia.
• May ↓ therapeutic effects of levodopa.
• Acute encephalopathic syndrome may occur when used with lithium.

Drug-Natural Products:

• Kava-kava, valerian, or chamomile can ↑ CNS depression.

(Generic available)

• Tablets: 0.5 mg; 1 mg; 2 mg; 5 mg; 10 mg; 20 mg;
• Oral concentrate: 2 mg/mL;
• Solution for intramuscular injection (decanoate): 50 mg/mL; 100 mg/mL;
• Solution for intravenous injection (lactate): 5 mg/mL;

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): 0.5–2 mg twice daily initially; may be gradually ↑ as 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): Haloperidol lactate: 2–5 mg every 1–8 hr (not to exceed 100 mg/day).
• IM (Children 6–12 yr): Haloperidol lactate: 1–3 mg/dose every 4–8 hrs to a maximum of 0.15 mg/kg/day.
• IV (Adults): Haloperidol lactate: 0.5–5 mg, may be repeated every 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).

Haldol, Haldol Decanoate

• Alters the effects of dopamine in the CNS.
• Also has anticholinergic and alpha-adrenergic blocking activity.

• Diminished signs and symptoms of psychoses.
• Improved behavior in children with Tourette’s syndrome or other behavioral problems.

Therapeutic Classification: antipsychotics

Pharmacologic Classification: butyrophenones

Absorption: Well absorbed following PO/IM administration. Decanoate salt is slowly absorbed and has a long duration of action.

Distribution: Concentrates in liver.

Protein Binding: 92%.

Metabolism/Excretion: Mostly metabolized by the liver.

Half-life: 21–24 hr.

(antipsychotic activity)

†Effect may persist for several days.

• Advise patient to take medication as directed. Take missed doses as soon as remembered, with remaining doses evenly spaced throughout the day. May require several wk to obtain desired effects. Do not increase dose or discontinue medication without consulting health care professional. Abrupt withdrawal may cause dizziness; nausea; vomiting; GI upset; trembling; or uncontrolled movements of mouth, tongue, or jaw.
• Inform patient of possibility of extrapyramidal symptoms, tardive dyskinesia, and neuroleptic malignant syndrome. Caution patient to report symptoms immediately.
• Advise patient to change positions slowly to minimize orthostatic hypotension. Protect from falls.
• May cause drowsiness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
• Caution patient to avoid taking alcohol or other CNS depressants, including opioids, concurrently with this medication.
• Advise patient to use sunscreen and protective clothing when exposed to the sun to prevent photosensitivity reactions. Extremes of temperature should also be avoided; drug impairs body temperature regulation.
• Instruct patient to use frequent mouth rinses, good oral hygiene, and sugarless gum or candy to minimize dry mouth.
• Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
• Instruct patient to notify health care professional promptly if weakness, tremors, visual disturbances, dark-colored urine or clay-colored stools, sore throat, fever, menstrual abnormalities, galactorrhea, or sexual dysfunction occur.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. Monitor neonates exposed to haloperidol during the third trimester of pregnancy for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Inform patient of the National Pregnancy Registry for Psychiatric Medications that monitors the safety of psychiatric medications taken by women during pregnancy. Encourage patient to contact the registry at womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry or by phone 1-866-961-2388. Monitor breastfed infants for excessive drowsiness, lethargy, and developmental delays.
• Emphasize the importance of routine follow-up exams to monitor response to medication and detect side effects.

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