Excipient information presented when available (limited, particularly for generics); consult

specific product labeling.

Concentrate, Oral, as lactate [strength expressed as base]:

Generic: 2 mg/mL (5 mL, 15 mL, 120 mL)

Solution, Intramuscular, as decanoate [strength expressed as base]:

Haldol Decanoate: 50 mg/mL (1 mL); 100 mg/mL (1 mL) [contains benzyl alcohol,
sesame oil]

Generic: 50 mg/mL (1 mL, 5 mL); 100 mg/mL (1 mL, 5 mL)

Solution, Injection, as lactate [strength expressed as base]:

Haldol: 5 mg/mL (1 mL)

Generic: 5 mg/mL (1 mL, 10 mL)

Solution, Injection, as lactate [strength expressed as base, preservative free]:

Generic: 5 mg/mL (1 mL)

Tablet, Oral:

Generic: 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg, 20 mg

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult
specific product labeling.

Concentrate, Oral, as lactate [strength expressed as base]:

Generic: 2 mg/mL (15 mL, 100 mL, 500 mL)

Solution, Intramuscular:

Generic: 5 mg/mL (1 mL, 10 mL)

Solution, Intramuscular, as decanoate [strength expressed as base]:

Generic: 50 mg/mL (5 mL); 100 mg/mL (1 ea, 1 mL, 5 mL)

 Solution, Injection, as lactate [strength expressed as base]:

Generic: 5 mg/mL (1 mL)

Tablet, Oral:

Generic: 0.5 mg, 1 mg, 2 mg, 5 mg, 10 mg, 20 mg

Administration: Adult

Injection oil (decanoate): The decanoate injectable formulation should be administered IM

only, do not administer decanoate IV. A 21-gauge needle is recommended. The maximum
volume per injection site should not exceed 3 mL. Z-track injection techniques are
recommended to limit leakage after injections (Baweja 2012; Gillespie 2013; McEvoy 2006).
Experts recommend administering in the gluteal muscle by deep IM injection, however
haloperidol by deltoid injection has been studied with positive results (Baweja 2012;
Gillespie 2013; McEvoy 2014; Sassa 2002; Yasuhara 2012).

Injection solution (lactate): The lactate injectable formulation may be administered IM or IV

(off-label route). Rate of IV administration not well defined; rates of a maximum of 5
mg/minute (Forsman 1976; Lerner 1979) and 0.125 mg/kg over 1 to 2 minutes (Holley 1983;
Magliozzi 1985) have been reported. Note: IV administration has been associated with QT
prolongation and the manufacturer recommends ECG monitoring for QT prolongation and
arrhythmias. Consult individual institutional policies and procedures prior to
administration. Subcutaneous administration has also been reported (usually in the
palliative care setting), either as intermittent administration or as a continuous
subcutaneous infusion (Glare 2008; Hardy 2010; Mercadante 1995).

Administration: Pediatric

Oral: Administer with food or milk to decrease GI distress. Avoid skin contact with oral
suspension or solution; may cause contact dermatitis.

Parenteral:

IM: Lactate (immediate release): May be administered undiluted IM.

IV: Infusion or IVPB: Lactate (immediate release): May be administered undiluted (5

mg/mL), or diluted in D5W. Rate of IV administration is not well defined but should be
slow; in pediatric delirium patients, loading doses have been administered over 30 to
45 minutes (Schieveld 2005; Schieveld 2007); in adults, rates of a maximum of 5
mg/minute (Forsman 1976; Lerner 1979) and 0.125 mg/kg (in 10 mL NS) over 1 to 2
 minutes (Holley 1983; Magliozzi 1985) have been reported. Note: IV administration has
been associated with QT prolongation and the manufacturer recommends ECG
monitoring for QT prolongation and arrhythmias. Consult individual institutional
policies and procedures prior to administration.

Use: Labeled Indications

Behavioral disorders, nonpsychotic (tablet, concentrate): Treatment of severe

behavioral problems in children with combative, explosive hyperexcitability that cannot be
accounted for by immediate provocation. Reserve for use in these children only after failure
to respond to psychotherapy or medications other than antipsychotics.

Hyperactivity (tablet, concentrate): Short-term treatment of hyperactive children who

show excessive motor activity with accompanying conduct disorders consisting of some or
all of the following symptoms: impulsivity, difficulty sustaining attention, aggression, mood
lability, or poor frustration tolerance. Reserve for use in these children only after failure to
respond to psychotherapy or medications other than antipsychotics.

Schizophrenia:

IM lactate: Treatment of schizophrenia.

IM decanoate: Treatment of patients with schizophrenia who require prolonged

parenteral antipsychotic therapy.

Tablet, concentrate: Treatment of manifestations of psychotic disorders such as

schizophrenia.

Tourette syndrome, management of tics (tablet, concentrate, IM lactate): Control of

tics and vocal utterances in Tourette syndrome in adults and children.

Use: Off-Label: Adult

Agitation/Aggression (severe, acute) associated with psychiatric disorders (eg, schizophrenia),

substance intoxication, or other organic causes; Bipolar disorder (acute mania, episodes with
mixed features or acute hypomania); Chemotherapy-induced breakthrough nausea and
vomiting; Delirium, hyperactive (treatment); Nausea and vomiting in advanced or terminal
illness (palliative care); Postoperative nausea and vomiting, prevention, moderate- to high-risk
patients

Medication Safety Issues

Sound-alike/look-alike issues:
 Haldol may be confused with Halcion, Halog, Stadol

Geriatric Patients: High-Risk Medication:

Beers Criteria: Antipsychotics are identified in the Beers Criteria as potentially

inappropriate medications to be avoided in patients 65 years and older due to an
increased risk of cerebrovascular accidents (stroke) and a greater rate of cognitive
decline and mortality in patients with dementia. Antipsychotics may be appropriate for
schizophrenia, bipolar disorder, other mental health conditions, or short-term use as
antiemetic during chemotherapy but should be given in the lowest effective dose for
the shortest duration possible. In addition, antipsychotics should be used with caution
in older adults due to their potential to cause or exacerbate syndrome of inappropriate
antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium closely with
initiation or dosage adjustments in older adults (Beers Criteria [AGS 2019]).

Pediatric patients: High-risk medication:

KIDs List: Dopamine antagonists, when used in pediatric patients <18 years of age, are
identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list; use
should be avoided in infants and used with caution in children and adolescents due to
risk of acute dystonia (dyskinesia), and with intravenous administration an increased
risk of respiratory depression, extravasation, and death (strong recommendation;
moderate quality of evidence) (PPA [Meyers 2020]).

International issues:

Haldol [US and multiple international markets] may be confused with Halotestin brand
name for fluoxymesterone [Great Britain]

Adverse Reactions (Significant): Considerations

Extrapyramidal symptoms

Haloperidol commonly causes extrapyramidal symptoms (EPS), also known as drug-induced

movement disorders. Antipsychotics can cause 4 main EPS: Acute dystonia, drug-induced
parkinsonism, akathisia, and tardive dyskinesia (Ref). EPS presenting as dysphagia,
esophageal dysmotility, or pulmonary aspiration, have also been reported with
antipsychotics, which may not be recognized as EPS (Ref).

Mechanism: EPS: Dose-related; due to antagonism of dopaminergic D2 receptors in

nigrostriatal pathways; high levels of dopamine 2 receptor occupancy have been
observed for haloperidol (Ref). Tardive dyskinesia: Time related (delayed); results from
chronic exposure to dopamine 2 receptor antagonists leading to up-regulation of these
receptors over time (Ref).

Onset:

Antipsychotics in general:

Acute dystonia: Rapid; in the majority of cases, dystonia usually occurs within
the first 5 days after initiating antipsychotic therapy (and even with the first
dose, particularly in patients receiving parenteral antipsychotics) or a dosage
increase (Ref).

Drug-induced parkinsonism: Varied; onset may be delayed from days to

weeks, with 50% to 75% of cases occurring within 1 month and 90% within 3
months of antipsychotic initiation, a dosage increase, or a change in the
medication regimen (such as adding another antipsychotic agent or
discontinuing an anticholinergic medication) (Ref).

Akathisia: Varied; may begin within several days after antipsychotic initiation
but usually increases with treatment duration, occurring within 1 month in up
to 50% of cases, and within 3 months in 90% of cases (Ref).

Tardive dyskinesia: Delayed; symptoms usually appear after 1 to 2 years of

continuous exposure to a dopamine 2 receptor antagonist, and almost never
before 3 months, with an insidious onset, evolving into a full syndrome over
days and weeks, followed by symptom stabilization, and then a chronic waxing
and waning of symptoms (Ref).

Esophageal dysfunction (associated with EPS): Varied; ranges from weeks to

months following initiation (Ref)

Risk factors:

EPS (in general):

• Prior history of EPS (Ref)

• Higher doses (Ref)

• Specific antipsychotic: Haloperidol has a high propensity to cause EPS (Ref)

Acute dystonia: