Classes
DEA Class; Rx
Common Brand Names; Haldol, Haldol Decanoate, Haloperidol LA, Peridol
- Antipsychotics, 1st Generation;
Description
Oral formulation and immediate-release intramuscular injection FDA-approved for treating schizophrenia and Tourette’s Disorder; immediate-release IM formulation is effective for acute agitation in hospitalized settings
An intramuscular depot injection is available for schizophrenic patients requiring prolonged antipsychotic therapy
As with all antipsychotics, there is an increased risk of death in elderly patients treated for dementia-related psychosis; IV administration is not FDA-approved and is associated with an increased risk of QT prolongation and torsade de pointes (TdP)
Indications
Indicated for the treatment of schizophrenia
Contraindications
Documented hypersensitivity
Severe toxic central nervous system depression or comatose states from any cause
Parkinson disease
Dementia with Lewy bodies
Adverse Effects
Extrapyramidal symptoms
Akathisia
Dystonia
Muscle stiffness
Neuroleptic malignant syndrome (NMS; infrequent but serious)
Parkinsonism
Tardive dyskinesia
Common
Anticholinergic effects
Sedation
Weight gain
Erectile dysfunction
Oligomenorrhea or amenorrhea
Less common
Orthostatic hypotension (after IM injection), tachycardia
Agitation, anxiety, cerebral edema, depression, dizziness, euphoria, headache, insomnia, poikilothermia, restlessness, weakness, confusion
Anorexia, constipation, dyspepsia, ileus, decreased gag reflex
Lens opacities (prolonged use)
Uncommon
ECG changes
Photosensitivity
Pruritus
Diarrhea
Blood dyscrasia
Ejaculatory disorder
Galactorrhea
Rare
Seizure
Cholestatic jaundice
Priapism
Warnings
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 IV
Conditions or drugs that prolong QT interval, congenital long QT syndrome
Safety of prolonged administration of 100 mg/day PO not established
Avoid use in narrow-angle glaucoma, bone marrow suppression, and severe hypotension
FDA warning regarding off-label use for dementia in elderly
Cerebrovascular adverse reactions (eg, stroke, transient ischemic attack), including fatalities reported in elderly patients with dementia-related psychosis; mechanism for increased risk is not known; an increased risk cannot be excluded for antipsychotics; use with caution in patients with risk factors for cerebrovascular adverse reactions
Leukopenia/neutropenia and agranulocytosis reported; possible risk factors include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia
If patient has history of clinically significant presence of either risk factor, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of clinically significant WBC decline <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 IV or IM, watch for hypotension; use with caution in diagnosed CNS depression, subcortical brain damage, or cardiac disease; if history of seizures, benefits must outweigh risks; significant increase in body temperature may indicate intolerance to antipsychotics (discontinue if this occurs)
Pregnancy and Lactation
There are no well controlled studies in pregnant women; there are reports of cases of limb malformations observed following maternal use with drug along with other drugs which have suspected teratogenic potential during first trimester of pregnancy
Drug is excreted in human breast milk; infants should not be nursed during drug treatment
Maximum Dosage
100 mg/day PO. 20 mg/day IM of haloperidol lactate. Clinical experience with haloperidol decanoate doses greater than 450 mg/month IM is limited.
100 mg/day PO. 20 mg/day IM of haloperidol lactate. Clinical experience with haloperidol decanoate doses greater than 450 mg/month IM is limited.
Weighing more than 40 kg: 15 mg/day PO for Tourette’s syndrome; there is no stated maximum dosage for adolescents with other indications; dosages exceeding 15 mg/day PO are rarely needed in adults but severely disturbed psychotic adults may require higher dosages; adult dosages up to 100 mg/day PO have been used in severe refractory cases. Safe and effective use of haloperidol injections has not been established (adult haloperidol lactate Max: 20 mg/day IM).
Weighing 40 kg or less: 0.15 mg/kg/day PO for most indications; severely psychotic patients may require higher doses (suggested Max: 6 mg/day PO for non-psychotic behaviors); 15 mg/day PO for Tourette’s syndrome. Safe and effective use of haloperidol injections has not been established (adult haloperidol lactate Max: 20 mg/day IM).
3 to 12 years and weighing 15 to 40 kg: 0.15 mg/kg/day PO for most indications; severely psychotic children may require higher doses (suggested Max: 6 mg/day PO for non-psychotic behaviors); 15 mg/day PO for Tourette’s syndrome. Safe and effective use of haloperidol injections has not been established (adult haloperidol lactate Max: 20 mg/day IM).
1 to 2 years or weighing less than 15 kg: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Haloperidol
tablet
0.5mg
1mg
2mg
5mg
10mg
20mg
oral concentrate
2mg/mL
injectable solution, lactate
5mg/mL
injectable solution, decanoate
50mg/mL
100mg/mL
