haloperidol (Rx) - Haldol, Haldol Decanoate, more..Haloperidol LA, Peridol
Adult Dosing & Uses
Dosing Forms & Strengths
tablets
- 0.5mg
- 1mg
- 2mg
- 5mg
- 10mg
- 20mg
oral concentrate
- 1mg/mL
- 2mg/mL
injectable solution
- 5mg/mL
injectable solution-decanoate
- 50mg/mL
- 100mg/mL
Schizophrenia/Psychosis
PO
- Initial (moderate): 0.5-2 mg BID/TID
- Initial (severe): 3-5 mg BID/TID
- Not to exceed 30 mg/day
Lactate IM injection (prompt-acting)
- 2-5 mg q4-8hr PRN; may require q1hr in some cases
Decanoate IM injection (depot)
- 10-20 x daily PO dose IM qMonth
- Initial dose should not exceed 100 mg
- If conversion requires initial dosage higher than 100 mg, administer in 2 injections (eg, initial dose of 100 mg followed by the balance in 3-7 days)
- Should not be administered IV
IV (Off-label)
- IV administration may be needed for ICU delirium
- Initial dose: 1-2 mg q2-4 hr
- Titrate to response; maximum single dose 50 mg; maximum cumulative daily dose 500 mg
- Alternative: 10 mg IV initial dose followed by 5-10 mg/hr continuous IV infusion
- Use only haloperidol lactate for IV administration
- Monitor: ECG for prolonged QT interval
Tourette Disorder
0.5-2 mg PO BID/TID initially
Severe symptoms may require increased dose; titrate upward to 3-5 mg PO BID/TID initially
Daily doses up to 100 mg have been used if patient remains inadequately controlled (safety not determined)
Geriatric Dosing
Not approved for dementia-related psychosis because of increased risk of cardiovascular or infectious related deaths (see Black Box Warnings)
Elderly at higher risk of tardive dyskinesia associated with higher potency antipsychotic agents such as haloperidol because of higher ratios of dopaminergic blockage to adrenergic/anticholinergic blockade
Schizophrenia/Psychosis
- Lower initial doses and more gradual adjustments are recommended; 0.5-2 mg PO BID/TID initially
- Decanoate injection (depot): Lower initial doses and more gradual adjustments recommended; 10-15 times daily PO dose IM qMonth
- Lactate injection (prompt-acting): Lower adult doses and longer dosing intervals recommended compared with typical adult doses
- IV (Off-label): Use lactate injection only for IV administration and monitor with ECG for prolonged QT interval; 0.25-0.5 mg IV q4hr
Tourette Disorder
- Lower initial doses and more gradual adjustments are recommended; 0.5-2 mg PO BID/TID initially
Pediatric Dosing & Uses
Dosing Forms & Strengths
tablets
- 0.5mg
- 1mg
- 2mg
- 5mg
- 10mg
- 20mg
oral concentrate
- 1mg/mL
- 2mg/mL
injectable solution
- 5mg/mL
injectable solution-decanoate
- 50mg/mL
- 100mg/mL
Schizophrenia
<3 years: Safety and efficacy not established
PO (3-12 years old; 15-40 kg)
- 0.25-0.5 mg/day PO divided BID/TID initially; may increase by 0.5 mg/day at q5-7d intervals PRN
- Maintenance: 0.05-0.15 mg/kg/d PO divided BID/TID
IM (6-12 years old)
- Lactate injection (prompt-acting): 1-3 mg q4-8hr PRN, no more than 0.15 mg/kg/day
>12 years: As adults
Tourette Disorder
Maintenance: 0.05-0.075 mg/kg/day PO div BID/TID
Behavioral Disorders
Maintenance: 0.05-0.075 mg/kg/day PO divided BID/TID PO
Agitation
0.01-0.03 mg/kg PO qDay; not to exceed 0.15 mg/kg/day
IM (6-12 Years Old)
(as Lactate):1-3 mg q4-8hr PRN, no more than 0.15 mg/kg/day
Drug Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
>10%
Akathisia (60%)
Frequency Not Defined
EPS
- Akathisia (60%)
- Dystonia
- Muscle Stiffness
- NMS (infrequent but serious)
- Parkinsonism
- Tardive dyskinesia
Common
- Anticholinergic effects
- Sedation
- Weight gain
- Erectile dysfunction
- Oligomenorrhea/amenorrhea
Less Common
- Orthostatic hypotension (post-IM inj), tachycardia
- Agitation, anxiety, cerebral edema, depression, dizziness, euphoria, headache, insomnia, poikilothermia, restlessness, weakness
- Anorexia, constipation, dyspepsia, ileus
- Lens opacities (prolonged use)
Uncommon
- ECG changes
- Photosensitivity
- Pruritus
- Diarrhea
- Blood dyscrasia
- Ejaculatory d/o
- Galactorrhea
Rare
- Seizure
- Cholestatic jaundice
- Priapism
Frequency Not Specified
- Confusion
- Decreased gag reflex
Contraindications & Cautions
Black Box Warnings
Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials. The deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.
This drug is not approved for the treatment of patients with dementia-related psychosis.
Contraindications
Documented hypersensitivity; narrow angle glaucoma, bone marrow suppression, severe cardiac or liver disease, severe hypotension
CNS depression (incl coma), neuroleptic malignant syndrome (NMS), poorly controlled seizure disorder, Parkinson's disease
Cautions
Risk of sudden death, Torsades and QT Interval prolongation from off-label IV administration/ higher than recommended dose: monitor ECG if given IV
Conditions/drugs that prolong QT Interval or congenital long QT syndrome
Safety of prolonged admin of 100 mg/d PO not established
<3 yo: Safety and efficacy not established
FDA Warning regarding off-label use for dementia in elderly
Leukopenia/neutropenia and agranulocytosis reported; possible risk factors for leukopenia/neutropenia include pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia ( if history of clinically significant low WBC or drug-induced leukopenia/neutropenia, monitor complete blood count (CBC) frequently during first few months of therapy; discontinue drug at first sign of a clinically significant decline <1000/mm3 in WBC in absence of other causative factors and continue monitoring WBC until recovery)
Severe neurotoxicity manifesting as rigidity, or inability to walk or talk may occur in patients with thyrotoxicosis also receiving antipsychotics; if IV/IM, watch for hypotension; 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 occurs)
Pregnancy & Lactation
Pregnancy Category: C
Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery
These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization
Lactation: enters breast milk; not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Half-Life: 10-20 hr; 3 wk (decanoate)
Onset: 30-60 min
Peak Plasma Time: 2-6 hr (PO); 10-20 min (IM); 6-7 d (decanoate)
Bioavailability: 60%
Protein Bound: 92%
Metabolism: hepatic P450 enzyme CYP2D6
Metabolites: hydroxyhaloperidol
Excretion: urine, bile
Enzymes inhibited: CYP2D6
Mechanism of Action
Phenylbutylpiperadine; dopamine D2 receptor antagonist
IV & IM Information
IV/IM Administration
Haloperidol lactate and decanoate are both administered by IM injection. Haloperidol lactate has also been administered IV (off-label). Haloperidol decanoate should NOT be administered IV.
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