haloperidol

BEERS REMS

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 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.

Protein Binding: 92%.

Metabolism/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.

Contraind./Precautions ⬆ ⬇

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.

Adv. Reactions/Side Effects ⬆ ⬇

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

Interactions ⬆ ⬇

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.

Route/Dosage ⬆ ⬇

Haloperidol

Haloperidol Decanoate

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).
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
Solution for intramuscular injection (decanoate): 50 mg/mL; 100 mg/mL
Solution for intravenous injection (lactate): 5 mg/mL

Assessment ⬆ ⬇

Assess mental status (orientation, mood, behavior) prior to and periodically during therapy.
Assess positive (hallucination, delusions) and negative (social isolation) symptoms of schizophrenia.
Assess weight and BMI initially and during therapy. Refer as appropriate for nutritional/weight and medical management.
Monitor BP (sitting, standing, lying) and pulse prior to and frequently during the period of dose adjustment. May cause QT interval changes on ECG.
Observe patient carefully when administering medication, to ensure that medication is actually taken and not hoarded.
Monitor intake and output ratios and daily weight. Assess patient for signs and symptoms of dehydration (decreased thirst, lethargy, hemoconcentration), especially in geriatric patients.
Assess fluid intake and bowel function. Increased bulk and fluids in the diet help minimize constipating effects.
Monitor patient for onset of akathisia (restlessness or desire to keep moving), which may appear within 6 hr of 1st dose and may be difficult to distinguish from psychotic agitation. Benztropine may be used to differentiate agitation from akathisia. Observe closely for extrapyramidal side effects (parkinsonian: difficulty speaking or swallowing, loss of balance control, pill rolling of hands, mask-like face, shuffling gait, rigidity, tremors; and dystonic: muscle spasms, twisting motions, twitching, inability to move eyes, weakness of arms or legs). Trihexyphenidyl or benzotropine may be used to control these symptoms. Benzodiazepines may alleviate akathisia.
Monitor for tardive dyskinesia (uncontrolled rhythmic movement of mouth, face, and extremities; lip smacking or puckering; puffing of cheeks; uncontrolled chewing; rapid or worm-like movements of tongue, excessive eye blinking). Report immediately; may be irreversible.
Monitor for symptoms related to hyperprolactinemia (menstrual abnormalities, galactorrhea, sexual dysfunction).
Monitor for development of neuroleptic malignant syndrome (fever, respiratory distress, tachycardia, seizures, diaphoresis, hypertension or hypotension, pallor, tiredness, severe muscle stiffness, loss of bladder control). Report symptoms immediately. May also cause leukocytosis, elevated liver function tests, elevated CK.
Assess for falls risk. Drowsiness, orthostatic hypotension, and motor and sensory instability increase risk. Institute prevention if indicated.

Lab Test Considerations:

Monitor CBC with differential and liver function tests periodically during therapy.
- Monitor serum prolactin prior to and periodically during therapy. May cause ↑ serum prolactin levels.

Implementation ⬆ ⬇

Avoid skin contact with oral solution; may cause contact dermatitis.
PO: Administer with food or full glass of water or milk to minimize GI irritation.
- Use calibrated measuring device for accurate dose. Do not dilute concentrate with coffee or tea; may cause precipitation. May be given undiluted or mixed with water or juice.
IM: Inject slowly, using 2-in, 21-gauge needle into well-developed muscle via Z-track technique. Do not exceed 3 mL per injection site. Slight yellow color does not indicate altered potency. Keep patient recumbent for at least 30 min following injection to minimize hypotensive effects.

IV Administration:

IV: Haloperidol decanoate should not be administered IV.
Diluent: May be administered undiluted for rapid control of acute psychosis or delirium.Concentration: 5 mg/mL.
Rate: Administer at a rate of 5 mg/min.
Intermittent Infusion: Diluent: May be diluted in 30–50 mL of D5W.
Rate: Infuse over 30 min.

Patient/Family Teaching ⬆ ⬇

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.
Rep: 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 https://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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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇