Haloperidol

Haloperidolis used to treat certain mental/mood disorders (e.g.,schizophrenia, schizoaffective disorders). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also help prevent suicide in people who are likely to harm themselves. It also reduces aggression and the desire to hurt others. It can decrease negative thoughts and hallucinations.

Haloperidol can also be used to treat uncontrolled movements and outbursts of words/sounds related to Tourette's disorder. Haloperidol is also used for severe behavior problems in hyperactive children when other treatments or medications have not worked.

• Haloperidol is a psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).
• Haloperidol is available under the following different brand names:Haldol,Haldol Decanoate, Haloperidol LA, and Peridol.

Dosage of Haloperidol:

Adult and Pediatric Dosage Forms and Strengths

Tablets

• 0.5 mg
• 1 mg
• 2 mg
• 5 mg
• 10 mg
• 20 mg

Oral concentrate

• 2 mg/mL

The injectable solution, lactate

• 5 mg/mL

The injectable solution, decanoate

• 50 mg/mL

Dosing Considerations – Should be Given as Follows:

Schizophrenia,Psychosis

Oral

• Moderate disease, 0.5-2 mg every 8-12 hours initially
• Severe disease, 3-5 mg every 8-12 hours initially; not to exceed 30 mg/day

Intramuscular(IM) lactate (prompt-acting)

• 2-5 mg every 4-8 hours as needed; may require every hour in acute agitation; not to exceed 20 mg/day

Intramuscular (IM) decanoate (depot)

• Initial: IM dose 10-20 times daily oral dose administered monthly; not to exceed 100 mg; if conversion requires initial dose greater than 100 mg, administer in 2 injections (e.g., 100 mg initially, then the remainder in 3-7 days)
• Maintenance: Monthly dose 10-15 times daily orally dose

Intravenous (IV) (Off-label)

• May be needed forICUdelirium; use only haloperidol lactate for IV administration; do not use haloperidol decanoate
• 2-10 mg initially, depending on the degree of agitation; if response inadequate, may repeat bolus every 15-30 minutes, sequentially doubling initial bolus dose; when calm achieved, administer 25% of last bolus dose every 6 hours; taper dose after the patient is controlled
• MonitorECGand QT interval (QT prolongation may occur with cumulative doses 35 mg or more; torsades de pointes reported with single doses 20 mg or more)

Pediatric

• Children under 3 years: Safety and efficacy not established
• 3-12 years (15-40 kg): 0.25-0.5 mg/day orally divided every 8-12 hours initially; may be increased by 0.5 mg/day every 5-7 days as needed; maintenance: 0.05-0.15 mg/kg/day orally divided every 8-12 hours
• 6-12 years: Lactate (prompt-acting): 1-3 mg intramuscularly (IM) every 4-8 hours as needed; not to exceed 0.15 mg/kg/day
• Children over 12 years: Moderate disease, 0.5-2 mg orally every 8-12 hours initially; severe disease, 3-5 mg orally every 8-12 hours; not to exceed 30 mg/day

Tourette Disorder

• Adult: 0.5-2 mg orally every 8-12 hours initially; if severe symptoms necessitate increased dosage, titrate upward to 3-5 mg orally every 8-12 hours; if the patient remains inadequately controlled, daily doses up to 100 mg have been used (safety not determined)
• Children under 3 years: Safety and efficacy not established
• 孩子3 - 12年:0.5毫克/天口头最初;dose increased by 0.5 mg every 5-7 days until therapeutic effect achieved, then reduced to a lowest effective maintenance level of 0.05-0.075 mg/kg/day orally divided every 8-12 hours
• Children over 12 years: 0.5-2 mg orally every 8-12 hours initially; if severe symptoms necessitate increased dosage, titrate upward to 3-5 mg orally every 8-12 hours; if the patient remains inadequately controlled, daily doses up to 100 mg have been used (safety not determined)

Behavioral Disorders

Pediatric

• Children under 3 years: Safety and efficacy not established
• 孩子3 - 12年:0.5毫克/天口头最初;dose increased as needed by 0.5 mg every 5-7 days until therapeutic effect achieved, then reduced to a lowest effective maintenance level of 0.05-0.075 mg/kg/day orally divided every 8-12 hours

Acute Agitation, Pediatric

• Children under 12 years: Safety and efficacy not established
• Children over 12 years: 0.5-3 mg orally, repeated in 1 hour as needed; alternatively, 2-5 mg intramuscularly (IM), repeated in 1 hour as needed

Common side effects of haloperidol include:

• Extrapyramidal symptoms
• Restlessness
• Involuntarymuscle contractions
• Muscle stiffness
• Neurolepticmalignantsyndrome (NMS; infrequent but serious)
• Parkinsonism
• Repetitive, involuntary movements
• Anticholinergiceffects (such asdry mouth, blurred vision)
• Drowsiness
• Weight gain
• Erectile dysfunction
• Infrequent or missed menstrual periods

Less common side effects of haloperidol include:

• Dizziness upon standing (after intramuscular injection)
• Fast heart rate
• Agitation
• Anxiety
• Cerebral edema
• Depression
• Dizziness
• Euphoria
• Headache
• Insomnia
• Inability to maintain body temperature
• Weakness
• Confusion
• Loss of appetite
• Constipation
• Indigestion
• Intestinal obstruction
• Decreased gag reflex
• Cataracts (prolonged use)

Uncommon side effects of haloperidol include:

• ECG changes
• Photosensitivity
• Itching
• Diarrhea
• Blooddyscrasia
• Ejaculatory disorder
• Nipple dischargeunrelated to breastfeeding

Rare side effects of haloperidol include:

• Seizure
• Yellowing skin or eyes (jaundice)
• Prolonged erection

Postmarketing side effects of haloperidol reported include:

• Musclewasting(rhabdomyolysis)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

Severe Interactions of haloperidol include:

• amiodarone
• astemizole
• cisapride
• disopyramide
• eliglustat
• flibanserin
• ibutilide
• indapamide
• lomitapide
• pentamidine
• pimozide
• procainamide
• quinidine
• sotalol
• terfenadine

Haloperidol has serious interactions with at least 87 different drugs.

Haloperidol has moderate interactions with at least 336 different drugs.

Haloperidol has mild interactions with at least 42 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

Patients withdementia-related psychosis who are treated with antipsychotic drugs are at an increased risk for death, as shown in short-term controlled trials; deaths in trials appeared to be eithercardiovascular(e.g.,heart failure, sudden death) or infectious (e.g.,pneumonia) in nature

Not approved for the treatment of patients with dementia-related psychosis

This medication contains haloperidol. Do not take Haldol, Haldol Decanoate, Haloperidol LA, or Peridol if you are allergic to haloperidol or any ingredients contained in this drug

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Documented hypersensitivity
• Severe CNS depression (including coma), NMS, poorly controlled seizure disorder, Parkinson disease

Short-Term Effects

• May causecentral nervous system(CNS) depression; may impair the ability to operate heavy machinery or driving
• See "What Are Side Effects Associated with Using Haloperidol?"

Long-Term Effects

• Cataracts (prolonged use)
• Safety of prolonged administration of 100 mg/day orally not established
• See "What Are Side Effects Associated with Using Haloperidol?"

Cautions

• Risk of sudden death, torsades de pointes, and prolonged QT interval from off-label IV administration of higher than recommended dose: monitor ECG if administering intravenously (IV)
• Conditions or drugs that prolong QT interval,congenitallong QT syndrome
• Safety of prolonged administration of 100 mg/day orally not established
• Avoid use in narrow-angleglaucoma,bone marrowsuppression, and severehypotension
• FDA warning regarding off-label use for dementia in elderly
• Leukopenia/neutropeniaandagranulocytosiswere reported; possible risk factors include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia
• If the patient has a history of the clinically significant presence of eitherrisk factor, monitorcomplete blood count(CBC) frequently during the first few months of therapy; discontinue the drug at the first sign of clinically significant WBC decline less than 1000/µL in absence of other causative factors, and continue monitoring WBC count until recovery
• Severe neurotoxicity manifesting as rigidity or inability to walk or talk may occur in patients with thyrotoxicosis also receiving antipsychotics
• If administering intravenously or intramuscularly (IV or IM), watch for hypotension; use with caution in diagnosed CNS depression, subcortical brain damage, or cardiac disease; if the history of seizures, benefits must outweigh risks; a significant increase in body temperature may indicate intolerance to antipsychotics (discontinue if this occurs)
• Use caution in patients at risk of pneumonia (e.g. Alzheimer's patients); antipsychotic use reported to be associated with esophageal dysmotility andaspiration
• Extrapyramidal symptoms may occur including acute dystonic reactions,akathisia,tardive dyskinesia, and pseudoparkinsonism
• Hyperprolactinemia may occur
• Monitor for mental status changes, muscle rigidity, fever, and/or autonomic instability; the neuroleptic malignant syndrome may occur
• May causeorthostatic hypotension
• Association with increased risk of pigmentaryretinopathyreported
• Impairment of core body temperature regulation reported; use caution with activities that may increase body temperature including strenuous exercise, heat exposure, dehydration, and concomitant medications with anticholinergic effects
• Caution in patients receiving anticoagulants; an isolated instance of interference occurred with effects of oneanticoagulant(phenindione)
• When used to controlmaniain cyclic disorders, there may be rapid mood swings to depression
• May cause anticholinergic effects; use caution in patients withxerostomia,尿retention,BPH, decreasedgastrointestinalmotility,paralytic ileus, or visual problems
• May cause central nervous system (CNS) depression; may impair the ability to operate heavy machinery or driving
• Decreased sensation of thirst due to central inhibition may lead to dehydration, hemoconcentration, and reduced pulmonaryventilation; a number of cases of bronchopneumonia, some fatal, reported; if signs and symptoms appear, especially in the elderly, institute remedial therapy promptly
• Use caution in patients with severe cardiovascular disorders, because of the possibility of transient hypotension and/or precipitation of anginal pain; should hypotension occur and a vasopressor be required,epinephrineshould not be used since haloperidol may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur; use metaraminol,phenylephrineor去甲肾上腺素instead
• Use caution in patients receiving抗惊厥的medications, with a history of seizures, or with EEG abnormalities; haloperidol may lower convulsive threshold; if indicated, adequate anticonvulsant therapy should be concomitantly maintained

Pregnancy and Lactation

• Use haloperidol with caution during pregnancy if benefits outweigh risks
• Animal studies show risk and human studies are not available, or neither animal nor human studies were done
• Neonates exposed to antipsychotic drugs such as haloperidol during 3rd trimester of pregnancy are at risk for extrapyramidal orwithdrawal symptomsafter delivery; these complications vary in severity, in some cases being self-limited and in other cases necessitating ICU support and prolonged hospitalization
• Haloperidol enters breast milk; it is not recommended for use while breastfeeding