Get advice for managing Multiple Sclerosis: Watch the video.

Haloperidol Decanoate

Pronunciation

Class: Butyrophenones
Note: This monograph also contains information on Haloperidol, Haloperidol Lactate
VA Class: CN709
CAS Number: 52-86-8
Brands: Haldol

Warning(s)

  • Increased Mortality in Geriatric Patients with Dementia-related Psychosis
  • Geriatric patients with dementia-related psychosis treated with antipsychotic agents are at an increased risk of death.177 178 179 180 181 182 183 184 g

  • Analyses of 17 placebo-controlled trials in geriatric patients mainly receiving atypical antipsychotic agents revealed an approximate 1.6- to 1.7-fold increase in mortality compared with that in patients receiving placebo.177 178 179 180 184 g

  • Most fatalities appeared to result from cardiovascular-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).177 178 179 180 184 g

  • Observational studies suggest that conventional or first-generation antipsychotic agents also may increase mortality in such patients.177 178 179 180 181 182 183 g

  • Antipsychotic agents, including haloperidol, are not approved for the treatment of dementia-related psychosis.177 178 179 180 181 g

Introduction

Butyrophenone derivative;a b c d e conventional (prototypical, first-generation) antipsychotic agent.185

Uses for Haloperidol Decanoate

Schizophrenia

Treatment of schizophrenia.a b d 185

Antipsychotic agents are used for all phases of schizophrenia, including acute psychotic episodes as well for long-term stabilization and to minimize risk of relapse.185

Patients who do not respond to or tolerate one drug may be successfully treated with an agent from a different class or with a different adverse effect profile.136 137 138 185

APA considers certain atypical (second-generation) antipsychotic agents first-line for the acute phase of schizophrenia, principally because of the decreased risk of adverse extrapyramidal effects and tardive dyskinesia, with the understanding that the relative advantages, disadvantages, and cost-effectiveness of atypical antipsychotic agents compared with first-generation antipsychotic agents remain controversial.185

Conventional antipsychotic agents may be considered first-line in patients with acute psychotic episodes who have been treated successfully in the past with, or who prefer, conventional agents.185

Long-acting haloperidol decanoate ester used principally for prolonged antipsychotic therapy (e.g., chronic schizophrenic disorder).100 101 105 106 108 110 111 112 185 Parenteral antipsychotic therapy with a long-acting preparation may be particularly useful in patients with a history of poor compliance.105 106 108 110 111 112 185 However, should not be used in the acute management of severely agitated patients.100 101

Slideshow: 18 Herbal Supplements with Risky Drug Interactions

Herbal and Dietary Supplements Deserve Your Attention

Tourette’s Syndrome

Control of tics and vocal utterances of Tourette’s syndrome (Gilles de la Tourette’s syndrome).b d e

May be used concomitantly with a stimulant for tic disorders (e.g., Tourette’s syndrome) and comorbid attention deficit hyperactivity disorder (ADHD) in children in whom stimulants alone cannot control tics.147 148

Disruptive Behavior Disorder and ADHD

Treatment of severe behavioral problems in children marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations).b d e

Short-term treatment in children with hyperactivity associated with excessive motor activity and accompanying conduct disorders that are manifested as impulsive behavior, difficulty sustaining attention, aggression, mood lability, and/or poor frustration tolerance.b d e

Manufacturers recommend reserving for severe behavioral problems or ADHD, only after failure of psychotherapy or drug therapy other than antipsychotics.d e Some experts recommend use only for comorbid tics in children with ADHD.148

Delirium

Management of delirium.121 130 172

Antipsychotic agents often considered drugs of choice for delirium.121 172 Haloperidol generally is considered the antipsychotic of choice for most patients with delirium because of its relatively low risk of anticholinergic activity and of sedative and hypotensive effects.121 130 132 170

Various antipsychotic agents may be given orally, IM, or IV, but IV administration is considered most effective in emergency situations or where oral access is limited.121 IV administration also may be associated with less severe extrapyramidal effects.121 123 130

Consider risk of QT-interval prolongation, possibly leading to atypical ventricular tachycardia (torsades de pointes), ventricular fibrillation, and sudden death, if haloperidol is used IV for delirium.121 124 125 126 130 131 132 133 134 169 Institute appropriate monitoring (e.g., ECG).121 124 125 126 130 131 132 133 134 162 163 164 (See Delirium under Dosage and Administration and see QT-interval Prolongation and Sudden Death under Cautions.)

Nausea and Vomiting

Has been used in the prevention and control of severe nausea and vomiting (e.g., cancer chemotherapy-induced emesis).a Appears to be as effective as phenothiazines in preventing cancer chemotherapy-induced emesis; additional studies required.a

Haloperidol Decanoate Dosage and Administration

Administration

Administer haloperidol orally as tablets.102 103

Administer haloperidol lactate orally as solution concentrate or IM;102 103 also has been administered by IV injection121 123 124 125 127 128 129 130 131 133 134 135 or infusion.121 129

Administer haloperidol decanoate IM; do not administer IV.100 101

Avoid skin contact with haloperidol lactate oral solution and injection, since contact dermatitis has occurred rarely.a

Oral Administration

Haloperidol or haloperidol lactate: Administer orally 2 or 3 times daily.102 103

IM Administration

Haloperidol decanoate: Administer by deep IM injection into the gluteal region using a 21-gauge needle, usually at monthly intervals;100 101 maximum volume should not exceed 3 mL per IM injection site.100 101 102 103

Haloperidol lactate: Administer IM at intervals based on patient response; may administer as often as every hour, although 4- to 8-hour intervals may be satisfactory.100 101 102 103

IM administration of haloperidol decanoate or lactate in pediatric patients is not recommended by the manufacturers.187 191

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Haloperidol lactate: Has been administered by IV injection121 123 124 125 127 128 129 130 131 133 134 135 or infusion.121 129

ECG monitoring is recommended whenever haloperidol is administered IV.121 125 129 130 132 133 162 163 164 (See Delirium under Dosage and Administration and see QT-interval Prolongation and Sudden Death under Cautions.)

Dosage

Available as the base, decanoate (decanoic acid ester), and lactate salt; dosage is expressed in terms of haloperidol.100 101 102 103

There is considerable interindividual variation in optimum dosage requirements; carefully adjust dosage according to individual requirements and response, using the lowest possible effective dosage.b c d e

Because of risk of adverse reactions associated with cumulative effects of butyrophenones, periodically evaluate patients with a history of long-term therapy with haloperidol and/or other antipsychotic agents to determine whether maintenance dosage can be decreased or drug therapy discontinued.a

Pediatric Patients

Schizophrenia
Oral

Children 3–12 years of age (weighing 15–40 kg): Initially, 0.5 mg daily given in 2 or 3 divided doses.d e Subsequent dosage may be increased by 0.5 mg daily at 5- to 7-day intervals, depending on the patient’s tolerance and therapeutic response; usual dosage range is 0.05–0.15 mg/kg daily given in 2 or 3 divided doses.d e

Severely disturbed psychotic children may require higher dosages.d e

During prolonged maintenance therapy, keep dosage at the lowest possible effective level; once an adequate response has been achieved, gradually reduce dosage and make subsequent adjustments according to patient response and tolerance.d e

Tourette’s Syndrome
Oral

Children 3–12 years of age (weighing 15–40 kg): Initially, 0.5 mg daily given in 2 or 3 divided doses.d e Subsequent dosage may be increased by 0.5 mg daily at 5- to 7-day intervals, depending on the patient’s tolerance and therapeutic response; usual dosage range is 0.05–0.075 mg/kg daily given in 2 or 3 divided doses.d e

Once an adequate response is achieved, gradually reduce dosage and make subsequent adjustments according to patient response and tolerance.d e

Disruptive Behavior Disorder and ADHD
Oral

Children 3–12 years of age (weighing 15–40 kg): Initially, 0.5 mg daily given in 2 or 3 divided doses.d e Subsequent dosage may be increased by 0.5 mg daily at 5- to 7-day intervals, depending on the patient’s tolerance and therapeutic response; usual dosage range is 0.05–0.075 mg/kg daily given in 2 or 3 divided doses.d e

Nonpsychotic or hyperactive behavioral problems in children may be acute, and short-term administration may be adequate.d e

Maximum effective dosage for management of behavioral problems in children not established, but there is little evidence that improvement in behavior is further enhanced at dosages >6 mg daily.d e

Adults

Schizophrenia
Moderate Symptomatology
Oral

Initially, 0.5–2 mg 2 or 3 times daily.d e Carefully adjust subsequent dosage according to the patient’s tolerance and therapeutic response.d e During prolonged maintenance therapy, keep dosage at lowest effective level.d e

Severe Symptomatology
Oral

Initially, 3–5 mg 2 or 3 times daily.d e

To achieve prompt control, higher dosages may be required in some patients.d e Patients who remain severely disturbed or inadequately controlled may require dosage adjustment.d e

Dosages up to 100 mg daily may be required in some severely psychotic patients.d e

Occasionally, dosages >100 mg daily have been used for the management of severely resistant disorders in adults; however, safety of prolonged administration of such dosages has not been demonstrated.d e

Chronic/Resistant Disorders
Oral

Initially, 3–5 mg 2 or 3 times daily.d e

Patients who remain severely disturbed or inadequately controlled may require dosage adjustment.d e

Dosages up to 100 mg daily may be required in some severely psychotic patients.d e

Occasionally, dosages >100 mg daily have been used for the management of severely resistant disorders in adults; however, safety of prolonged administration of such dosages has not been demonstrated.d e

IM (Haloperidol Decanoate)

May consider for patients requiring prolonged antipsychotic therapy (e.g., patients with chronic schizophrenic disorder).100 101 105 106 108 110 111 112 185

Initially, stabilize patient’s condition with an antipsychotic agent prior to attempting conversion to haloperidol decanoate.c If patient is receiving an antipsychotic agent other than haloperidol, initial conversion to oral haloperidol is recommended to minimize risk of an unexpected adverse reaction that might not be readily reversible following use of the decanoate.100 101 c

Base initial IM decanoate dose on patient’s clinical history, physical condition, and response to previous antipsychotic therapy.100 101 110

A precise formula for converting oral haloperidol dosage to IM haloperidol decanoate not established, but an initial IM dose 10–20 times the previous daily oral haloperidol dose, not >100 mg (regardless of previous antipsychotic dosage requirements) is suggested, although limited clinical experience suggests that a lower initial dosage of the decanoate may be adequate.c (See Table: Haloperidol Decanoate Dosage Recommendations under Dosage and Administration.)

If conversion requires an initial haloperidol decanoate dosage >100 mg, administer in 2 injections (i.e., administer a maximum initial dose of 100 mg followed by the balance in 3–7 days); however, some clinicians have converted therapy to decanoate using a higher initial dose.c

Haloperidol Decanoate Dosage Recommendationsc

Patient Population

Initial Therapy

Monthly Maintenance Therapy

Patients stabilized on low daily oral dosages (up to 10 mg daily), or geriatric or debilitated patients

10–15 times daily oral dosage

10–15 times previous daily oral dosage

Patients receiving high-dose oral therapy, at risk for relapse, or tolerant to oral haloperidol

20 times daily oral dosage

10–15 times previous daily oral dosage

Usually, administer at monthly intervals (i.e., every 4 weeks), but individual response may dictate need for adjusting dosing interval as well as the dose.100 101 108 109 110 111

Observe closely during dosage titration to minimize risk of overdosage or emergence of psychotic manifestations prior to next dose; if supplemental antipsychotic therapy is necessary during periods of dosage titration or for control of acute exacerbations of psychotic manifestations, use a short-acting haloperidol preparation.100 101 110

Experience with haloperidol decanoate dosages >450 mg monthly is limited.100 101

Acute Agitation
IM (Haloperidol Lactate)

Initially, 2–5 mg as a single dose for prompt control in patients with moderately severe to very severe symptoms.b Depending on patient response, may repeat dose as often as every hour; however, administration every 4–8 hours may be adequate to control symptoms in some patients.102 103

Conversion from IM to Oral Therapy
Oral

Oral: Replace short-acting parenteral therapy with haloperidol lactate with oral therapy as soon as possible; depending on patient’s clinical status, give first oral dose within 12–24 hours after administration of last parenteral dose.b

Use total parenteral dosage during preceding 24 hours for initial approximation of total daily oral dosage required; since this dosage is only an initial estimate, closely monitor patients being switched to oral therapy, particularly for efficacy, sedation, and adverse effects, for first several days following initiation of oral therapy.b

Increase or decrease subsequent oral dosage according to patient tolerance and therapeutic response, using lowest possible effective dosage.b

Tourette’s Syndrome
Moderate Symptomatology
Oral

Initially, 0.5–2 mg 2 or 3 times daily.d e Carefully adjust subsequent dosage according to patient’s tolerance and therapeutic response.d e

During prolonged maintenance therapy, keep dosage at lowest effective level.d e

Severe Symptomatology and/or Chronic/Resistant Disorder
Oral

Initially, 3–5 mg 2 or 3 times daily.d e

Patients who remain inadequately controlled may require dosage adjustment.d e

Dosages up to 100 mg daily may be required in some patients to achieve optimal response.d e

Occasionally, dosages >100 mg daily have been used for management of severely resistant disorders in adults; however, safety of prolonged administration of such dosages has not been demonstrated.d e

Delirium
IV (Haloperidol Lactate)

Optimum dosage not established.121 However, initiation of IV haloperidol (as the lactate) with dosages of 1–2 mg every 2–4 hours has been suggested; 121 127 severely agitated adults may require titration to higher dosages.121 124 125 127

Although single IV doses up to 50 mg or total daily dosages of 500 mg have been reported,121 125 127 128 132 must consider risk of adverse effects, particularly prolongation of the QT interval and torsades de pointes.125 130 132 162

Some evidence suggests that risk of torsades de pointes increases at total daily dosages of 35–50 mg or more.125 132 162

In patients requiring multiple IV injections of the drug to control delirium (e.g., more than eight 10-mg doses in 24 hours or >10 mg/hour for >5 consecutive hours), may consider continuous IV infusion;121 129 in such patients, an initial 10-mg dose followed by an infusion of 5–10 mg/hour has been suggested.121 129 If agitation persists, can consider repeating 10-mg IV doses at 30-minute intervals, accompanied by a 5-mg/hour increase in the infusion rate.129

Determine ECG at baseline and periodically or continuously thereafter, paying special attention to possible prolongation of the QT interval; reduce dosage or discontinue drug if clinically important QT prolongation (e.g., 15–25% or more over baseline) occurs or the QTc interval exceeds 450 msec.121 125 129 130 132 133 162 163 164 (See QT-interval Prolongation and Sudden Death under Cautions.)

Prescribing Limits

Pediatric Patients

Oral

Maximum effective dosage not established, but there is little evidence that improvement in behavior is further enhanced at dosages >6 mg daily.d e

IM

Safety and efficacy not established in children.b c

Adults

Oral

Safety of prolonged administration of dosages >100 mg not demonstrated.d e

IM

Experience with haloperidol decanoate dosages >450 mg monthly is limited.100 101

IV

Although single IV doses ≤50 mg or total daily dosages of 500 mg of haloperidol (as the lactate) have reportedly been given for delirium,121 125 127 128 132 higher dosages (i.e., total daily dosages of ≥35–50 mg) and IV administration of the drug appear to be associated with a higher risk of QT-interval prolongation and torsades de pointes.121 124 125 128 129 130 132 133 162 163 164 167 168 170 171

Consider continuous IV infusion in patients requiring multiple IV injections to control delirium (e.g., more than eight 10-mg doses in 24 hours or >10 mg/hour for >5 consecutive hours).121 129 (See Delirium under Dosage and Administration and see QT-interval Prolongation and Sudden Death under Cautions.)

Special Populations

Hepatic Impairment

No specific dosage recommendations.a g

Renal Impairment

No specific dosage recommendations.a g

Geriatric/Debilitated Patients

In geriatric or debilitated patients, lower dosages may be required than those in younger adults; optimal response is usually obtained with more gradual dosage adjustments.b (See Geriatric Use under Cautions.)

Initially, 0.5–2 mg orally 2 or 3 times daily; increase dosage more gradually in debilitated, emaciated, or geriatric patients than in younger adults.d e

Lower IV dosages (e.g., 0.25–0.5 mg every 4 hours as haloperidol lactate) have been suggested for geriatric patients with delirium.121

Cautions for Haloperidol Decanoate

Contraindications

  • Severe toxic CNS depression or comatose states from any cause.b c d e

  • Parkinsonian syndrome.a b c d e

  • Hypersensitivity to haloperidol.b c d e

Warnings/Precautions

Warnings

Increased Mortality in Geriatric Patients with Dementia-related Psychosis

Increased risk of death with use of either conventional (first-generation) or atypical (second-generation) antipsychotics in geriatric patients with dementia-related psychosis.177 178 179 180 181 182 183 184 g

Antipsychotic agents, including haloperidol, are not FDA labeled for the treatment of dementia-related psychosis.177 178 179 180 181 g (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis in Boxed Warning.)

QT-interval Prolongation and Sudden Death

Sudden death, QT-interval prolongation, and torsades de pointes reported in patients receiving haloperidol.124 125 126 129 130 132 133 162 163 164 167 168 169 170 171

Use of higher than recommended doses of any haloperidol formulation and IV administration of the drug appear to be associated with an increased risk of QT-interval prolongation and torsades de pointes.124 125 129 130 132 133 162 163 164 167 168 170 171

Although these effects have been reported in the absence of predisposing factors, use haloperidol with particular caution in patients with other conditions that prolong the QT interval, including electrolyte imbalance (particularly hypokalemia and hypomagnesemia), underlying cardiac abnormalities, hypothyroidism, and familial long QT syndrome, as well as in those concurrently receiving other drugs known to prolong the QT interval.130 132 133 162 163 164 170 (See Drugs that Prolong QT Interval under Interactions.)

Monitor ECG whenever haloperidol is administered IV.125 130 162 163 164 (See Delirium under Dosage and Administration.) Prolongation of the QTc interval to >450 msec or to >15–25% over that in previous ECGs may warrant telemetry, cardiology consultation, and dose reduction or discontinuance.121 130 132 133

Monitor serum magnesium and potassium at baseline and periodically in critically ill patients,121 132 133 especially those with baseline QTc interval ≥440 msec, those receiving other drugs known to increase the QT interval, and those who have electrolyte disorders.121

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, reported with use of antipsychotic agents, including haloperidol.b c d e g

Reserve long-term antipsychotic treatment for patients with chronic illness known to be responsive to antipsychotic agents, and for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate.187 g In patients requiring chronic treatment, use smallest dosage and shortest duration of treatment producing a satisfactory clinical response; periodically reassess need for continued therapy.187

APA recommends assessing patients receiving first-generation antipsychotic agents for abnormal involuntary movements every 6 months; for patients at increased risk for tardive dyskinesia, assess every 3 months.185 Consider discontinuance of haloperidol if signs and symptoms of tardive dyskinesia develop;b c d e f g however, some patients may require treatment despite the presence of the syndrome.f g

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome characterized by hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability, reported with antipsychotic agents, including haloperidol.100 102 103 b f g

Immediately discontinue therapy and initiate supportive and symptomatic therapy if NMS occurs.g Careful monitoring recommended if therapy is reinstituted following recovery; the risk that NMS can recur must be considered.f g

Hyperpyrexia and heat stroke not associated with NMS also reported.b c d e

Fetal/Neonatal Morbidity and Mortality

Cases of limb malformations in offspring of women given haloperidol concurrently with other potentially teratogenic drugs during first trimester of pregnancy reported; causal relationship not established.a b Teratogenic and fetotoxic in animals.a b

Risk for extrapyramidal and/or withdrawal symptoms (e.g., agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, feeding disorder) in neonates exposed to antipsychotic agents during the third trimester; monitor neonates exhibiting such symptoms.187 188 189 190 Symptoms were self-limiting in some neonates but varied in severity; some infants required intensive support and prolonged hospitalization.187 188 189 190

Use during pregnancy or in women likely to become pregnant only when potential benefits justify possible risks to fetus.a b

Concomitant Therapy with Lithium

Acute encephalopathic syndrome reported occasionally in patients receiving lithium and an antipsychotic agent concurrently, especially when high serum lithium concentrations were present.a b Observe patients receiving combined therapy for evidence of neurologic effects; promptly discontinue if manifestations appear.a b

Respiratory Effects

Bronchopneumonia, sometimes fatal, reported with use of antipsychotic agents, including haloperidol.a b Consider that lethargy and decreased thirst, resulting from central inhibition, may cause dehydration, hemoconcentration, and reduced pulmonary ventilation; if such manifestations occur, particularly in geriatric patients, promptly institute appropriate therapy.a b

Ocular Effects

Ocular changes reported in patients receiving chemically related drugs, although not reported with haloperidol.a b

Sensitivity Reactions

Hypersensitivity

Skin reactions (i.e., maculopapular, acneiform) and isolated cases of photosensitivity reported;b c d e contact dermatitis reported rarely with skin contact to haloperidol lactate oral solution and injection.a

Use with caution in patients with known allergies or with a history of allergic reactions to drugs.a

General Precautions

Hypotension and Angina

Possible transient hypotension and/or precipitation of angina; use with caution in patients with severe cardiovascular disorders163 164 165 166

If hypotension occurs, may use metaraminol, norepinephrine, or phenylephrine; do not use epinephrine since haloperidol causes a reversal of epinephrine’s vasopressor effects and a further lowering of BP.163 164 165 166

Seizures

Possible risk of seizures; may lower seizure threshold.100 101 103 b c d e Use with caution in patients with a history of seizures or EEG abnormalities or in those receiving anticonvulsant agents.100 101 103 Maintain adequate anticonvulsant therapy.a b

CNS Depression

Possible impairment of ability to perform activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).a b

Possible additive effects or potentiated action when used with alcohol or other CNS depressants.a b c d e (See Specific Drugs under Interactions and also see Advice to Patients.)

Extrapyramidal Symptoms

Extrapyramidal symptoms occur frequently; if concomitant therapy with an antiparkinsonian drug is necessary to manage extrapyramidal symptoms, it may be necessary to continue the antiparkinsonian drug for a period of time after haloperidol discontinuance to prevent emergence of these symptoms.a b

Thyrotoxicosis

Severe neurotoxicity (e.g., rigidity, inability to walk or talk) may occur in patients with thyrotoxicosis who are also receiving antipsychotic agents, including haloperidol.a b

Bipolar Disorder

If used to control mania in patients with bipolar disorder, there may be a rapid mood swing to depression.a b

Abrupt Withdrawal

Possible transient dyskinetic signs after abrupt withdrawal in some patients receiving maintenance therapy; in some cases, dyskinetic movements are indistinguishable from tardive dyskinesia except for duration.b It is not known whether gradual withdrawal will reduce occurrence of withdrawal-emergent neurological signs; pending further evidence, withdraw gradually.b

Endocrine Effects

Elevated prolactin concentrations possible; may persist during long-term therapy.a b c d e g

Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, clinical importance of elevated prolactin concentrations for most patients has not been established.a g

Use with caution in patients with previously diagnosed breast cancer, since in vitro tests indicate that about one-third of such tumors are prolactin dependent.a g

Metabolic Effects

Decreased serum cholesterol concentrations reported in patients receiving chemically related agents.b c d e

Hematologic Effects

Leukopenia and neutropenia temporally related to antipsychotic agents, including haloperidol, reported.187 h Agranulocytosis (including fatal cases) also reported with other antipsychotic agents.187

Possible risk factors for leukopenia and neutropenia include preexisting low WBC count and a history of drug-induced leukopenia or neutropenia.187 h Monitor CBC frequently during the first few months of therapy in patients with such risk factors.187 Discontinue haloperidol at the first sign of a decline in WBC count in the absence of other causative factors.187

Carefully monitor patients with clinically significant neutropenia for fever or other signs and symptoms of infection and treat promptly if observed.187 In patients with severe neutropenia (ANC <1000/mm3), discontinue haloperidol and monitor WBC until recovery occurs.187

Specific Populations

Pregnancy

Category C.c (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk.a b Women receiving haloperidol should not breast-feed.a b

Pediatric Use

Safety and efficacy of IM administration of haloperidol decanoate or lactate not established in pediatric patients.187 191

Safety and efficacy of orally administered haloperidol or haloperidol lactate not established in children <3 years of age.102 103

Hyperammonemia reported during postmarketing surveillance in a 5.5-year old child with citrullinemia, an inherited disorder of ammonia excretion, following haloperidol therapy.100

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.100 103 g Other reported clinical experience has not consistently identified differences in responses between geriatric and younger patients.100 103 g

Prevalence of tardive dyskinesia appears to be highest among geriatric patients, particularly geriatric women.100 103 g

Pharmacokinetics of haloperidol in geriatric patients generally warrant use of reduced dosages.100 103 g (See Geriatric/Debilitated Patients under Dosage and Administration.)

Geriatric patients with dementia-related psychosis treated with either conventional or atypical antipsychotic agents are at an increased risk of death.177 178 179 180 181 182 183 184 g (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis in Boxed Warning.)

Common Adverse Effects

Extrapyramidal reactions (e.g., Parkinson-like symptoms, akathisia, dystonia).b c d e

Interactions for Haloperidol Decanoate

Drugs that Prolong QT Interval

QT-interval prolongation and torsades de pointes reported;124 125 126 129 130 132 133 162 163 164 167 168 169 170 171 patients receiving higher than recommended dosages of any haloperidol preparation and those receiving the drug IV appear to be at higher risk.162 163 164 Particular caution is advised when oral or parenteral haloperidol is used in patients concurrently receiving other drugs that prolong the QT interval.132 162 163 (See Delirium under Uses, Delirium under Dosage and Administration, and QT-interval Prolongation and Sudden Death under Cautions.)

Specific Drugs

Drug

Interaction

Comments

Anticholinergic agents

Increases in intraocular pressure may occur in patients receiving anticholinergic drugs, including antiparkinsonian agents, concurrently with haloperidola b c d e

Anticoagulants

Antagonism of anticoagulant activity of phenindione (no longer commercially available in US) reported in 1 patientb c d e

Further study needed to determine clinical importancea

CNS depressants (e.g., alcohol, anesthetics, barbiturates or other sedatives, opiates or other analgesics)

Possible additive effects or potentiated action of other CNS depressantsa b c d e

Use concomitantly with caution to avoid excessive sedationa

Lithium

An acute encephalopathic syndrome occasionally has occurred, especially when high serum lithium concentrations were presenta b c d e

Observe patients receiving combined therapy for evidence of adverse neurologic effects; promptly discontinue if such signs or symptoms appeara b d e

Methyldopa

Possible dementia in patients receiving haloperidol and methyldopa concomitantlya

Clinical importance of this possible interaction not determined; carefully observe patients for adverse psychiatric symptoms if used concurrentlya

Rifampin

Decreased (70%) mean plasma haloperidol concentrations and decreased antipsychotic efficacy with concomitant use100 103

Following discontinuance of rifampin in other schizophrenic patients treated with oral haloperidol, mean haloperidol concentrations increased 3.3-fold100 103

Careful monitoring of clinical status and appropriate dosage adjustment warranted whenever rifampin is initiated or discontinued in patients stabilized on haloperidol100 103

Haloperidol Decanoate Pharmacokinetics

Absorption

Bioavailability

Well absorbed from GI tract following oral administration, but appears to undergo first-pass metabolism in the liver.102 105 108 111 Oral bioavailability reported to average 60%.102 118

Peak plasma concentrations occur within 2–6 hours after oral administration.102

Following IM administration of haloperidol lactate, peak plasma haloperidol concentrations occur within 10–20 minutes.102

Following IM administration of haloperidol decanoate, plasma haloperidol concentrations are usually evident within 1 day107 112 and peak concentrations generally occur within about 6–7 days (range: 1–9 days).100 101 105 106 107 112

Onset

Following IM administration of haloperidol lactate, peak pharmacologic action occurs within 30–45 minutes;102 in acutely agitated patients, control of psychotic manifestations may become apparent within 30–60 minutes, with substantial improvement often occurring within 2–3 hours.102

Duration

Haloperidol decanoate: Esterification of haloperidol results in slow and gradual release of haloperidol decanoate from fatty tissues, thus prolonging duration of action;101 105 106 107 109 112 administration of the ester in a sesame oil vehicle further delays rate of release.106

Distribution

Extent

Distribution into human body tissues and fluids not fully characterized.a In animals, the drug is distributed mainly into the liver, with lower concentrations being distributed into the brain, lungs, kidneys, spleen, and heart.a

Following IM administration of haloperidol decanoate, the esterified compound is initially distributed into fatty tissue stores, from which the drug is then slowly and gradually released.100 101 105 106 107 109 112

Distributed into milk.a b

Plasma Protein Binding

About 92%.a

Elimination

Metabolism

Exact metabolic fate not clearly established, but appears to be principally metabolized in the liver by oxidative N-dealkylation of the piperidine nitrogen to form fluorophenylcarbonic acids and piperidine metabolites (which appear to be inactive),101 102 117 and by reduction of the butyrophenone carbonyl to the carbinol, forming hydroxyhaloperidol.101 102 106 116

Limited data suggest that the reduced metabolite, hydroxyhaloperidol, has some pharmacologic activity, although its activity appears to be less than that of haloperidol.106 116

After distribution and slow and gradual release from fatty tissue stores following IM administration of haloperidol decanoate, the drug undergoes hydrolysis by plasma and/or tissue esterases to form haloperidol and decanoic acid.100 101 105 106 107 109 112 Subsequent distribution, metabolism, and excretion of haloperidol appear to be similar to those of orally administered drug.101

Elimination Route

Excreted slowly in urine and feces as unchanged drug and metabolites.a Approximately 40% of a single oral dose is excreted in urine within 5 days.a About 15% of an oral dose is excreted in feces via biliary elimination.a Small amounts are excreted for about 28 days following oral administration.a

Half-life

After IM administration of the decanoate, apparent half-life is approximately 3 weeks.100 101 105 106 109

Special Populations

Pharmacokinetics of haloperidol generally warrant the use of reduced dosages in geriatric patients.b c d e g

Stability

Storage

Oral

Solution

Tight, light-resistant containers100 101 102 103 104 at 15–30°C.a Avoid freezing.100 101 103

Tablets

Tight, light-resistant containers100 101 102 103 104 at 20–25°C.a

Parenteral

Injection

Haloperidol decanoate: 15–30°C.c Do not refrigerate or freeze.c Protect from light.c

Haloperidol lactate: 15–30°C.b Do not freeze.b Protect from light.b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Haloperidol Decanoate

Incompatible with sterile water for injection or sodium chloride injection and with other aqueous injections.101

Haloperidol Lactate

May be compatible with some drugs for a short period of time after mixing, but at least one manufacturer recommends that the lactate not be mixed with other drugs.102

Solution Compatibility (haloperidol lactate)HID

Compatible

Dextrose 5% in water

Variable

Dextrose 5% in sodium chloride 0.2%

Ringer’s injection, lactated

Sodium chloride 0.45 or 0.9%

Drug Compatibility
Admixture Compatibility (haloperidol lactate)HID

Compatible

Buprenorphine HCl with glycopyrrolate

Oxycodone HCl

Y-site Compatibility (haloperidol lactate)HID

Compatible

Amifostine

Aztreonam

Bivalirudin

Ceftaroline fosamil

Cisatracurium besylate

Cladribine

Dexmedetomidine HCl

Dobutamine HCl

Docetaxel

Dopamine HCl

Doxorubicin HCl liposome injection

Etoposide phosphate

Famotidine

Fenoldopam mesylate

Fentanyl citrate

Filgrastim

Fludarabine phosphate

Gemcitabine HCl

Granisetron HCl

Hetastarch in lactated electrolyte injection (Hextend)

Hydromorphone HCl

Lidocaine HCl

Linezolid

Lorazepam

Melphalan HCl

Methadone HCl

Midazolam HCl

Morphine sulfate

Nitroglycerin

Norepinephrine bitartrate

Ondansetron HCl

Oxaliplatin

Paclitaxel

Pemetrexed disodium

Phenylephrine HCl

Propofol

Quinupristin-dalfopristin

Remifentanil HCl

Tacrolimus

Teniposide

Theophylline

Thiotepa

Tigecycline

Vinorelbine tartrate

Incompatible

Allopurinol sodium

Amphotericin B cholesteryl sulfate complex

Fluconazole

Foscarnet sodium

Gallium nitrate

Heparin sodium

Piperacillin sodium–tazobactam sodium

Sargramostim

Variable

Sodium nitroprusside

Syringe Compatibility (haloperidol lactate)HID

Compatible

Buprenorphine HCl with glycopyrrolate

Cyclizine lactate with diamorphine HCl

Lorazepam

Incompatible

Diphenhydramine HCl

Heparin sodium

Hydroxyzine HCl

Ketorolac tromethamine

Morphine sulfate

Variable

Benztropine mesylate

Cyclizine lactate

Diamorphine HCl

Hydromorphone HCl

Scopolamine butylbromide

Actions

  • Principal pharmacologic effects are similar to those of piperazine-derivative phenothiazines.a

  • Precise mechanism of antipsychotic action is unclear, but appears to depress the CNS at the subcortical level of the brain, midbrain, and brain stem reticular formation; appears to inhibit the ascending reticular activating system of the brain stem (possibly through the caudate nucleus), thereby interrupting the impulse between the diencephalon and the cortex.a

  • May antagonize actions of glutamic acid within the extrapyramidal system.a Inhibition of catecholamine receptors may also be important in the mode of action; may also inhibit the reuptake of various neurotransmitters in the midbrain.a

  • Appears to have strong central antidopaminergic and weak central anticholinergic activity.a

  • Precise mechanism of antiemetic action is unclear, but has been shown to directly affect the chemoreceptor trigger zone (CTZ), apparently by blocking dopamine receptors in the CTZ.a

  • Like other dopamine receptor antagonists (e.g., phenothiazines), may cause extrapyramidal reactions, and there appears to be a very narrow range between effective therapeutic dosage for management of acute psychotic disorders and that causing extrapyramidal symptoms.a

  • Produces less sedation, hypotension, and hypothermia than chlorpromazine.a

Advice to Patients

  • Importance of advising patients and caregivers that geriatric patients with dementia-related psychoses treated with antipsychotic agents are at an increased risk of death.177 178 179 180 g Inform patients and caregivers that haloperidol is not approved for treating geriatric patients with dementia-related psychosis.177 178 179 180 181 g

  • Potential for drug to impair mental alertness or physical coordination; use caution when driving or operating machinery.c

  • Importance of avoiding alcohol during therapy due to risk of additive effects and hypotension.c

  • Importance of informing patients and caregivers about the risk of NMS, which can cause high fever, stiff muscles, sweating, fast or irregular heart beat, change in BP, and confusion.187

  • Importance of informing patients in whom chronic haloperidol use is contemplated of risk of tardive dyskinesia.187 f g Importance of advising patients to report any muscle movements that cannot be stopped to a healthcare professional.i

  • Risk of leukopenia/neutropenia.187 Importance of advising patients with a preexisting low WBC count or history of drug-induced leukopenia/neutropenia that their CBC count should be monitored during haloperidol therapy.187

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b c d e

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.187 190 Importance of clinicians informing patients about the benefits and risks of taking antipsychotics during pregnancy (see Fetal/Neonatal Morbidity and Mortality under Cautions).187 190 Importance of advising patients not to stop taking haloperidol if they become pregnant without consulting their clinician; abruptly discontinuing antipsychotic agents may cause complications.190 Importance of advising patients not to breast-feed during haloperidol therapy.187

  • Importance of informing patients of other important precautionary information.b c d e (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Haloperidol

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

0.5 mg*

Haloperidol Tablets

1 mg*

Haloperidol Tablets

2 mg*

Haloperidol Tablets

5 mg*

Haloperidol Tablets

10 mg*

Haloperidol Tablets

20 mg*

Haloperidol Tablets

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Haloperidol Decanoate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Parenteral

Injection, for IM use only

50 mg (of haloperidol) per mL*

Haldol Decanoate

Ortho-McNeil-Janssen

Haloperidol Decanoate Injection

100 mg (of haloperidol) per mL*

Haldol Decanoate

Ortho-McNeil-Janssen

Haloperidol Decanoate Injection

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Haloperidol Lactate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Solution

2 mg (of haloperidol) per mL*

Haloperidol Lactate Oral Solution Concentrate

Parenteral

Injection

5 mg (of haloperidol) per mL*

Haldol

Ortho-McNeil-Janssen

Haloperidol Lactate Injection

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Haloperidol 0.5MG Tablets (SANDOZ): 90/$16.99 or 180/$22.97

Haloperidol 1MG Tablets (MYLAN): 90/$19.99 or 180/$27.98

Haloperidol 10MG Tablets (ZYDUS PHARMACEUTICALS (USA)): 60/$72.99 or 180/$202.98

Haloperidol 2MG Tablets (MYLAN): 90/$20.99 or 270/$40.96

Haloperidol 20MG Tablets (SANDOZ): 60/$124.99 or 180/$342.97

Haloperidol 5MG Tablets (MYLAN): 90/$25.99 or 270/$55.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions July 9, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

100. Ortho-McNeil Pharmaceutical. Haldol (haloperidol) decanoate for IM injection prescribing information. Spring House, PA; (dated 2000 Aug). In: Physicians desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:2535-7.

101. McNeil Pharmaceutical. Product information summary on Haldol decanoate. Spring House, PA; 1986 Feb

102. McNeil Pharmaceutical. Product information summary on Haldol. Spring House, PA; 1984 May

103. Ortho-McNeil Pharmaceutical. Haldol (haloperidol) tablets, concentrate, and injection prescribing information. (dated 2000 Aug). In: Physicians desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:2533-5.

104. The United States pharmacopeia, 21st rev, and The national formulary, 15th ed. Rockville, MD: The United States Pharmacopeial Convention, Inc; 1985: 447-8.

105. Ereshefsky L, Saklad SR, Jann MW et al. Future of depot neuroleptic therapy: pharmacokinetic and pharmacodynamic approaches. J Clin Psychiatry. 1984; 45:50-9. [IDIS 185445] [PubMed 6143748]

106. Jann MW, Ereshefsky L, Saklad SR. Clinical pharmacokinetics of the depot antipsychotics. Clin Pharmacokinet. 1985; 10:315-33. [IDIS 203381] [PubMed 2864156]

107. Viukari M, Salo H, Lamminsivu U et al. Tolerance and serum levels of haloperidol during parenteral and oral haloperidol treatment in geriatric patients. Acta Psychiatr Scand. 1982; 65:301-8. [PubMed 7080851]

108. Knudsen P. Chemotherapy with neuroleptics. Acta Psychiatr Scand. 1985; 322(Suppl):51-75.

109. Reyntjens AJM, Heykants JJP, Woestenborghs RJH et al. Pharmacokinetics of haloperidol decanoate. Int Pharmacopsychiatry. 1982; 17:238-46. [PubMed 7185768]

110. Kane JM. Dosage strategies with long-acting injectable neuroleptics, including haloperidol decanoate. J Clin Psychopharmacol. 1986; 1(Suppl):20-3S.

111. Vasavan Nair NP, Suranyi-Cadotte B, Schwartz G et al. A clinical trial comparing intramuscular haloperidol decanoate and oral haloperidol in chronic schizophrenic patients: efficacy, safety, and dosage equivalence. J Clin Psychopharmacol. 1986; 6(Suppl):30-7S.

112. Meco G, Casacchia M, Attenni M et al. Haloperidol decanoate in schizophreniform disorders: clinical and neuroendocrine aspects. Acta Psychiatr Belg. 1983; 83:57-68. [PubMed 6613612]

113. Zee-Cheng CS, Mueller CE, Seifert CF et al. Haloperidol and torsades de pointes. Ann Intern Med. 1985; 102:418. [IDIS 196965] [PubMed 3970495]

114. Roose K. Haloperidol decanoate as a replacement for maintenance therapy with intramuscular fluphenazine decanoate in schizophrenia and other chronic psychoses. Acta Psychiatr Belg. 1982; 82:216-23. [PubMed 7180558]

115. Arap Mengech HNK, Wazome EGM. Intramuscular haloperidol decanoate for neuroleptic maintenance therapy. East Afr Med J. 1984; 61:435-8. [PubMed 6152736]

116. Forsman A, Larsson M. Metabolism of haloperidol. Curr Ther Res. 1978; 24:567-8.

117. Forsman A, Folsch G, Larsson M et al. On the metabolism of haloperidol in man. Curr Ther Res. 1977; 21:606-17.

118. Forsman A, Ohman R. Pharmacokinetic studies on haloperidol in man. Curr Ther Res. 1976; 20:319-36. [PubMed 822989]

119. Matsunaga Y, Nambu K, Oh-e Y et al. Excretion and metabolism of intramuscularly administered [14C]-haloperidol decanoate in rats. Arzneimittelforschung. 1986; 36:453-6. [PubMed 3707664]

120. Reynolds JEF, ed. Martindale: the extra pharmacopoeia. 28th ed. London: The Pharmaceutical Press; 1982:xxv.

121. Trzepacz P, Breitbart W, Levenson J et al for the American Psychiatric Association Working Group on Delirium. Practice guideline for the treatment of patients with delirium. Am J Psychiatry. 1999; 156(Supp 5):1-20.

122. Breitbart W, Marotta R, Platt MM et al. A double-blind trial of haloperidol, chlorpromazine, and lorazepam in the treatment of delirium in hospitalized AIDS patients. Am J Psychiatry. 1996; 153:231-7. [IDIS 362910] [PubMed 8561204]

123. Menza MA, Murray GB, Holmes VF et al. Decreased extrapyramidal symptoms with intravenous haloperidol. J Clin Psychiatry. 1987; 48:278-80. [IDIS 232364] [PubMed 3597329]

124. Wilt JL, Minnema AM, Johnson RF et al. Torsade de pointes associated withe use of intravenous haloperidol. Ann Intern Med. 1993; 119:391-4. [IDIS 319320] [PubMed 8338292]

125. Sharma ND, Rosman HS, Padhi D et al. Torsades de pointes associated with intravenous haloperidol in critically ill patients. Am J Cardiol. 1998; 81:238-40. [IDIS 400827] [PubMed 9591913]

126. Jackson T, Ditmanson L, Phibbs B. Torsades de pointes and low-dose oral haloperidol. Arch Intern Med. 1997; 157:2103-5.

127. Tesar GE, Murray GB, Cassem NH. Use of high-dose haloperidol in the treatment of agitated cardiac patients. J Clin Psychopharmacol. 1985; 5:344-7. [IDIS 208263] [PubMed 4067002]

128. Levenson JL. High-dose intravenous haloperidol for agitated delirium following lung transplantation. Psychosomatics. 1995; 36:66-8. [PubMed 7871137]

129. Riker RR, Fraser GL, Cox PM. Continuous infusion of haloperidol controls agitation in critically ill patients. Crit Care Med. 1994; 22:433-9. [IDIS 326815] [PubMed 8124994]

130. Metzger E, Friedman R. Prolongation of the corrected QT and torsades de pointes cardiac arrhythmia associated with intravenous haloperidol in the medically ill. J Clin Psychopharmacology. 1993; 13:128-32.

131. Hunt N, Stern TA. The association between intravenous haloperidol and torsades de pointes: three cases and a literature review. Psychosomatics. 1995; 36:541-9. [PubMed 7501784]

132. Lawrence KR, Nasraway SA. Conduction disturbances associated with administration of butyrophenone antipsychotics in the critically ill: a review of the literature. Pharmacotherapy. 1997; 17:531-7. [IDIS 387827] [PubMed 9165555]

133. O’Brien JM, Rockwood RP, Suh KI. Haloperidol-induced torsade de pointes. Ann Pharmacother. 1999; 33:1046-50. [IDIS 434359] [PubMed 10534216]

134. Di Salvo TG, O’Gara PT. Torsade de pointes caused by high-dose intravenous haloperidol in cardiac patients. Clin Cardiol. 1995; 18:285-90. [PubMed 7628136]

135. Ortho-McNeil, Raritan, NJ: Personal Communication.

136. Citrome L. New antipsychotic medications: what advantages do they offer? Postgrad Med. 1997; 101:207-210,213,214. (IDIS 380687)

137. Lieberman JA. Atypical antipsychotic drugs as a first-line treatment of schizophrenia: a rationale and hypothesis. J Clin Psychiatry. 1996; 57(Suppl 11):68-71. [IDIS 376650] [PubMed 8941173]

138. Lahti AC, Tamminga CA. Recent developments in the neuropharmacology of schizophrenia. Am J Health-Syst Pharm. 1995; 52(Suppl 1):S5-8. [IDIS 341484] [PubMed 7749964]

139. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia. Am J Psychiatry. 1997; 154(Suppl):1-63.

140. Weller E, Rowan A, Weller R et al. Aggressive behavior associated with attention-deficit/hyperactivity disorder, conduct disorder, and developmental disabilities. J Clin Psychiatry. 1999; 17:2-7.

141. Shapiro AK, Shapiro E, Eisenkraft GJ. Treatment of Gilles de la Tourette syndrome with pimozide. Am J Psychiatry. 1983; 140:1183-6. [IDIS 175638] [PubMed 6351642]

142. Ross MS, Moldofsky H. A comparison of pimozide and haloperidol in the treatment of Gilles de la Tourette’s syndrome. Am J Psychiatry. 1978; 135:585-7. [IDIS 104623] [PubMed 347954]

143. Shapiro AK, Shapiro E. Clinical efficacy of haloperidol, pimozide, penfluridol, and clonidine in the treatment of Tourette syndrome. In: Friedhoff AJ, Chase TN, eds. Gilles de la Tourette syndrome. New York: Raven Press; 1982:383-6.

144. Shapiro E, Shapiro AK. Tic disorders. JAMA. 1981; 245:1583-5. [IDIS 129710] [PubMed 6937691]

145. Bruun RD. Gilles de la Tourette’s syndrome: an overview of clinical experience. J Am Acad Child Psychiatr. 1984; 23:126-33.

146. Reviewers’ comments on pimozide (personal observations); 1986 Aug, Sep.

147. Pliszka SR, Greenhill LL, Crismon ML et al. The Texas Children’s Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part I: special communication. J Am Acad Child Adolesc Psychiatry. 2000; 39:908-19. [IDIS 449214] [PubMed 10892234]

148. Pliszka SR, Greenhill LL, Crismon ML et al. The Texas Children’s Medication Algorithm Project: Report of the Texas Consensus Conference Panel on Medication Treatment of Childhood Attention-Deficit/Hyperactivity Disorder. Part II: Tactics. J Am Acad Child Adolesc Psychiatry. 2000; 39:920-7. [IDIS 449215] [PubMed 10892235]

149. Sallee FR, Nesbitt L, Jackson C et al. Relative efficacy of haloperidol and pimozide in children and adolescents with Tourette’s disorder. Am J Psychiatry. 1997; 154:1057-62. [IDIS 390628] [PubMed 9247389]

150. Shapiro E, Shapiro AK, Fulop G et al. Controlled study of haloperidol, pimozide, and placebo for the treatment of Gilles de la Tourette’s syndrome. Arch Gen Psychiatry. 1989; 46:722-30. [IDIS 263707] [PubMed 2665687]

151. Clarke DJ, Ford R. Treatment of refractory Tourette syndrome with haloperidol decanoate. Acta Psychiatr Scand. 1988; 77:495-6. [PubMed 3164570]

152. Licamele WL, Goldberg RL. Tourette syndrome. Am Fam Physician. 1988; 37:115-9. [PubMed 3162786]

153. Serrano AC. Haloperidol—its use in children. J Clin Psychiatry. 1981; 42:154-6. [IDIS 166139] [PubMed 6937455]

154. Regeur L, Pakkenberg B, Fog R et al. Clinical features and long-term treatment with pimozide in 65 patients with Gilles de la Tourette’s syndrome. J Neurol Neurosurg Psychiatry. 1986; 49:791-5. [PubMed 3462344]

155. Jankovic J. Tourette’s syndrome. N Engl J Med. 2001; 345:1184-92. [IDIS 472398] [PubMed 11642235]

156. Kennedy E, Song F, Hunter R et al. Risperidone versus typical antipsychotic medication for schizophrenia. Cochrane Database Syst Rev. 2000; 1:CD000440.

157. McEvoy JP, Scheifler PL, Frances A. The expert consensus guideline series: treatment of schizophrenia 1999. J Clin Psychiatry. 1999; 60(suppl 11):1-80.

158. Joy CB, Adams CE, Lawrie SM. Haloperidol versus placebo for schizophrenia. Cochran Database Syst Rev. 2001; 2:CD003082.

159. Csernansky JG, Mahmoud R, Brenner R for the risperidone-USA 79 study group. A comparison of risperidone and haloperidol for the prevention of relapse in patients with schizophrenia. N Engl J Med. 2002; 346:16-22. [IDIS 478869] [PubMed 11777998]

160. The Canadian Psychiatric Association. Canadian clinical practice guidelines for the treatment of schizophrenia. Can J Psychiatry. 1998; 43(Suppl 2):25-40S.

161. Geddes J. Prevention of relapse in schizophrenia. N Engl J Med. 2002; 346:56-8. [IDIS 478870] [PubMed 11778005]

162. Food and Drug Administration. Information for healthcare professionals: haloperidol (marketed as Haldol, Haldol Decanoate and Haldol Lactate). Rockville, MD; 2007 September. From the FDA web site.

163. Ortho McNeil Pharmaceutical, Inc. Haldol (haloperidol) injection prescribing information. Raritan, NJ; 2007 Aug.

164. Ortho McNeil Pharmaceutical, Inc. Haldol Decanoate 50 and Haldol Decanoate 100 (haloperidol decanoate) injection prescribing information. Raritan, NJ; 2007 Aug.

165. Sandoz Inc. Haloperidol tablets prescribing information. Princeton, NJ; 2006 Jun.

166. Pharmaceutical Associates, Inc. Haloperidol oral solution (concentrate) prescribing information. Greenville, SC; 2004 Jun.

167. Perrault LP, Denault AY, Carrier M et al. Torsades de pointes secondary to intravenous haloperidol after coronary bypass grafting surgery. Can J Anaesth. 2000; 47:251-4. [PubMed 10730737]

168. O’Brien JM, Rockwood RP, Suh KI. Haloperidol-induced torsade de pointes. Ann Pharmacother. 1999; 33:1046-50.

169. Glassman AH, Bigger JT. Antipsychotic Drugs: Prolonged QTc interval, torsade de pointes, and sudden death. Am J Psychiatry. 2001; 158:1774-82. [PubMed 11691681]

170. Hassaballa HA, Balk RA. Torsade de pointes associated with the administration of intravenous haloperidol: a review of the literature and practical guidelines for use. Expert Opin. Drug Saf. 2003; 2:543-7.

171. Ortho-McNeil Janssen Scientific Affairs, LLC, Titusville, NJ: Personal communication.

172. Cook IA. Guideline watch: Practice guideline for the treatment of patients with delirium. Arlington, VA: American Psychiatric Association, 2004. From the FDA website.

173. Society of Critical Care Medicine and American Society of Health-System Pharmacists. Clinical practice guidelines for sustained use of sedative and analgesics in the critically ill adult.Am J Health-Syst Pharm. 2002; 59:150-78. [PubMed 11826570]

174. Seitz DP, Gill SS, van Zyl LT. Antipsychotics in the treatment of delirium: a systematic review. J Clin Psychiatry. 2007; 68:11-21. [PubMed 17284125]

175. Lonergan E, Britton AM, Luxenberg J. Antipsychotics for delirium (review). Cochrane Database Syst Rev. 2007; 2:CD005594. [PubMed 17443602]

176. Siddiqi N, Stockdale R, Britton AM et al. Interventions for preventing delirium in hospitalised patients (review). Cochrane Database Syst Rev. 2007; 2:CD005563. [PubMed 17443600]

177. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Haldol Decanoate 50 and Haldol Decanoate 100 (haloperidol decanoate) injection prescribing information. Raritan, NJ; 2008 Aug 14.

178. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Haldol (haloperidol) injection prescribing information. Raritan, NJ; 2008 Aug 14.

179. Sandoz Inc. Haloperidol tablets prescribing information. Princeton, NJ; 2008 Sep.

180. Food and Drug Administration. FDA Alert: Information for healthcare professionals: conventional antipsychotics. Rockville, MD; 2008 Jun 16. From the FDA website.

181. Food and Drug Administration. FDA News: FDA requests boxed warnings on older class of antipsychotic drugs. Rockville, MD; 2008 Jun 16. From the FDA website.

182. Schneeweiss S, Setoguchi S, Brookhart A et al. Risk of death associated with the use of conventional versus atypical antipsychotic drugs among elderly patients. CMAJ. 2007; 176:627-32. [PubMed 17325327]

183. Gill SS, Bronskill SE, Normand SL et al. Antipsychotic drug use and mortality in older adults with dementia. Ann Intern Med. 2007; 146:775-86. [PubMed 17548409]

184. Food and Drug Administration. Public health advisory: deaths with antipsychotics in elderly patients with behavioral disturbances. Rockville, MD; 2005 Apr 11. From the FDA website.

185. American Psychiatric Association. Practice guideline for the treatment of patients with schizophrenia, second edition. From the APA website.

186. Teva Pharmaceuticals USA. Haloperidol oral solution (concentrate) prescribing information. Sellersville, PA; 2009 Apr.

187. Ortho-McNeil Pharmaceutical, Inc. Haldol (haloperidol) injection prescribing information. Raritan, NJ; 2011 Feb.

188. Sexson WR, Barak Y. Withdrawal emergent syndrome in an infant associated with maternal haloperidol therapy. J Perinatol. 1989; 9:170-2. [PubMed 2738729]

189. Coppola D, Russo LJ, Kwarta RF Jr. et al. Evaluating the postmarketing experience of risperidone use during pregnancy: pregnancy and neonatal outcomes. Drug Saf. 2007; 30:247-64. [PubMed 17343431]

190. US Food and Drug Administration. FDA drug safety communication: Antipsychotic drug labels updated in use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns. Rockville, MD; 2011 Feb 22. From the FDA website: .

191. Ortho-McNeil -Janssen Pharmaceuticals, Inc. Haldol Decanoate 50 (haloperidol) and Haldol Decanoate 100 (haloperidol) for IM injection only prescribing information. Raritan, NJ; 2010 Dec.

HID. Trissel LA. Handbook on injectable drugs. 17th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2013:579-85.

a. AHFS drug information 2004. McEvoy GK, ed. Haloperidol. Bethesda, MD: American Society of Health-System Pharmacists; 2004: 2296-300.

b. Bedford Laboratories. Haloperidol injection prescribing information. Bedford, OH; 2001 Apr.

c. Ortho-McNeil Pharmaceutical, Inc. Haldol Decanoate 50 and Haldol Decanoate 100 (haloperidol) injection prescribing information. Raritan, NJ; 2001 Sep.

d. Sandoz, Inc. Haloperidol tablets prescribing information. Broomfield, CO; 2003 Nov.

e. Teva Pharmaceuticals USA. Haloperidol oral solution (concentrate) prescribing information. Sellersville, PA; 2009 Apr.

f. AHFS drug information 2007. McEvoy GK, ed. Phenothiazines general statement. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 2439-50.

g. Zydus Pharmaceuticals USA Inc. Haloperidol tablets prescribing information. Princeton, NJ; 2008 Dec 2.

h. Qureshi SU, Rubin E. Risperidone- and aripiprazole-induced leukopenia: a case report. Prim Care Companion J Clin Psychiatry. 2008; 10:482-3. [PubMed 19287562]

i. Food and Drug Administration. Patient information sheet: aripiprazole (marketed as Abilify). 2006 Sep 6.

Hide
(web3)