What you need to know about drugs

haloperidol

haloperidol

Pronunciation Generic Name: haloperidol (HAL oh PER i dol)

Brand Name: Haldol, Haldol Decanoate

OverviewSide EffectsDosageInteractionsFor ProfessionalsMore…

What is haloperidol?

Haloperidol is an antipsychotic medication. It works by changing the actions of chemicals in your brain.

Haloperidol is used to treat schizophrenia. It is also used to control motor and speech tics in people with Tourette’s syndrome.

Haloperidol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about haloperidol?

Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to haloperidol, or have certain conditions. Be sure your doctor knows if you have Parkinson’s disease.

Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

Before taking haloperidol, tell your doctor if you have liver disease, kidney disease, heart disease, angina (chest pain), a thyroid disorder, epilepsy or other seizure disorder, a personal or family history of “Long QT syndrome,” or an electrolyte imbalance such as low potassium or magnesium levels in your blood.

Haloperidol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of haloperidol.

Call your doctor at once if you have tremor (uncontrolled shaking) or restless muscle movements in your eyes, tongue, jaw, or neck.

What should I discuss with my healthcare provider before taking haloperidol?

Haloperidol is not for use in psychotic conditions related to dementia. Haloperidol may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

You should not use this medication if you are allergic to haloperidol, or have certain conditions. Be sure your doctor knows if you have Parkinson’s disease.

To make sure you can safely take haloperidol, tell your doctor if you have any of these other conditions:

  • liver disease;

  • kidney disease;
  • heart disease, angina (chest pain);
  • a thyroid disorder;
  • epilepsy or other seizure disorder;
  • a personal or family history of “Long QT syndrome”; or
  • an electrolyte imbalance such as low potassium or magnesium levels in your blood.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking haloperidol, do not stop taking it without your doctor’s advice.

Haloperidol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take haloperidol?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Taking too much of this medication can cause a serious heart rhythm disorder or sudden death. Never take more than your prescribed dose.

Take haloperidol with a full glass of water.

Haloperidol can be taken with or without food.

It may take several weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Do not stop using haloperidol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to avoid withdrawal symptoms when you stop using haloperidol.

Store at room temperature away from moisture and heat.

See also: Haloperidol dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of haloperidol can be fatal.

Overdose symptoms may include extreme drowsiness, feeling like you might pass out, tremors, and uncontrolled muscle movements in your eyes, tongue, jaw, or neck.

What should I avoid while taking haloperidol?

Haloperidol may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase certain side effects of haloperidol.

Avoid becoming overheated or dehydrated during exercise and in hot weather. You may be more prone to heat stroke while you are taking haloperidol.

Haloperidol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • dizziness, fainting, fast or pounding heartbeat;

  • restless muscle movements in your eyes, tongue, jaw, or neck;
  • tremor (uncontrolled shaking);
  • seizure (convulsions);
  • pale skin, easy bruising or bleeding, flu symptoms;
  • very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
  • stabbing chest pain, feeling short of breath, cough with yellow or green mucus;
  • sudden mood changes, agitation, hallucinations, unusual thoughts or behavior; or
  • jaundice (yellowing of your skin or eyes).

Less serious side effects may include:

  • headache, dizziness, spinning sensation, drowsiness;

  • sleep problems (insomnia);
  • feeling restless or anxious;
  • mild skin rash or itching;
  • breast enlargement, irregular menstrual periods, loss of interest in sex; or
  • dry mouth, blurred vision, urinating less than usual.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: haloperidol side effects (in more detail)

Haloperidol Dosing Information

Usual Adult Dose for ICU Agitation:

Haloperidol lactate:

IV, intermittent: 0.03 to 0.15 mg/kg IV (2 to 10 mg) every 30 minutes to 6 hours.

IV, infusion: 3 to 25 mg/hour by continuous IV infusion, has been used for ventilator patients with agitation and delirium.

Usual Adult Dose for Dementia:

For non-psychotic behavioral problems related to dementia:

Initial dose: 0.5 mg orally 2 to 3 times daily.

Maintenance dose: 0.5 to 3 mg orally 2 times a day.

Usual Adult Dose for Mania:

Oral:

Initial dose: 0.5 to 5 mg orally 2 to 3 times a day

Maintenance dose: 1 to 30 mg/day in 2 or 3 divided doses. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:

Haloperidol Lactate:

2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Usual Adult Dose for Nausea/Vomiting:

Oral:

1 to 5 mg orally every 4 to 6 hours as needed.

Parenteral:

Haloperidol lactate:

1 to 5 mg IM or IV every 4 to 6 hours as needed.

Usual Adult Dose for Psychosis:

Oral:

Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.

Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:

Haloperidol lactate:

2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Haloperidol decanoate:

Initial dose: 10 to 15 times the previous oral daily dose intramuscularly every 3 to 4 weeks. The initial dose should not exceed 100 mg and the balance should be given in 3 to 7 days. There is limited experience with doses greater than 450 mg/month. Do not give IV.

Usual Adult Dose for Tourette’s Syndrome:

Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.

Maintenance dose: May increase every 5 to 7 days to 3 to 5 mg 2 to 3 times daily for more severe or resistant cases.

Usual Geriatric Dose for Psychosis:

Oral:

Initial dose: 0.5 to 2 mg orally 2 to 3 times a day.

Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses. The lowest possible effective dose should be used since geriatric patients are more sensitive to the adverse effects of haloperidol (e.g., tardive dyskinesia).

Parenteral:

Haloperidol Lactate:

2 to 5 mg IM or IV for prompt control. May repeat every 4 to 8 hours. Doses up to 8 to 10 mg may be given intramuscularly. Acutely agitated patients may require hourly injections.

Usual Pediatric Dose for Psychosis:

Oral:

2 years or younger or less than 15 kg: Use is not recommended.

3 to 12 years and 15 to 40 kg:

Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.

Maintenance dose: The daily dose may be increased every 5 to 7 days in 0.25 to 0.5 mg increments. The usual range is 0.05 to 0.15 mg/kg/day in 2 to 3 divided doses. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.

13 to 18 years and greater than 40 kg:

Initial dose: 0.5 to 5 mg orally 2 to 3 times a day.

Maintenance dose: 1 to 30 mg/day in 2 to 3 divided doses. Daily doses of up to 100 mg have been used. Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients; however, the limited clinical usage has not demonstrated the safety of prolonged administration of such doses.

Parenteral:

Haloperidol lactate:

5 years younger: Use is not recommended.

6 to 12 years: 1 to 3 mg IM every 4 to 8 hours as needed (maximum 0.15 mg/kg/day). Patients should be switched to oral therapy as soon as possible.

13 to 18 years: 2 to 5 mg IM every 4 to 8 hours as needed.

Haloperidol decanoate:

17 year or younger: Safety and efficacy have not been established.

Usual Pediatric Dose for Tourette’s Syndrome:

2 years or younger or less than 15 kg: Use is not recommended.

3 to 12 years and 15 to 40 kg:

Initial dose: 0.5 mg/day orally in 2 to 3 divided doses.

Maintenance dose: The daily dose may be increased weekly in 0.25 to 0.5 mg increments up to 0.05 to 0.075 mg/kg/day. There is little evidence that behavior improvement is further enhanced by doses greater than 6 mg/day.

13 to 18 years and greater than 40 kg: 1 to 2 mg orally 2 to 3 times a day.

What other drugs will affect haloperidol?

Before using haloperidol, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for depression or anxiety). They can add to sleepiness caused by haloperidol.

Tell your doctor about all other medicines you use, especially:

  • arsenic trioxide (Trisenox);

  • a blood thinner such as warfarin (Coumadin);
  • lithium (Eskalith, Lithobid, others);
  • seizure medication;
  • rifampin (Rifadin, Rifamate, Rimactane);
  • tacrolimus (Prograf);
  • an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), levofloxacin (Levaquin), moxifloxacin (Avelox), or pentamidine (NebuPent, Pentam);
  • an antidepressant such as amitriptylline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), or desipramine (Norpramin);
  • anti-malaria medications such as chloroquine (Aralen) or mefloquine (Lariam);
  • heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), ibutilide (Corvert), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);
  • medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
  • migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig); or
  • narcotic medication such as methadone (Methadose, Diskets, Dolophine).

This list is not complete and other drugs may interact with haloperidol. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Next Page → Side Effects

More haloperidol resources

  • Side Effects
  • Recommended Dosage
  • Pregnancy Warnings
  • Drug Images
  • Drug Interactions
  • Support Group
  • 16 Reviews - Add your own review/rating
  • haloperidol Advanced Consumer (Micromedex) – Includes Dosage Information
  • haloperidol MedFacts Consumer Leaflet (Wolters Kluwer)
  • Haloperidol Professional Patient Advice (Wolters Kluwer)
  • Haloperidol Prescribing Information (FDA)
  • Haloperidol Monograph (AHFS DI)
  • Haldol Prescribing Information (FDA)
  • Haldol Decanoate Advanced Consumer (Micromedex) – Includes Dosage Information
  • Haldol Decanoate Prescribing Information (FDA)
  • Haldol Decanoate MedFacts Consumer Leaflet (Wolters Kluwer)

Compare haloperidol with other medications

  • Dementia
  • ICU Agitation
  • Mania
  • Nausea/Vomiting
  • Psychosis
  • Tourette’s Syndrome

Where can I get more information?

  • Your pharmacist can provide more information about haloperidol.

Post a Comment

Your email is kept private. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

Haloperidol

Haloperidol

Pronunciation Class: Butyrophenones

Note: This monograph also contains information on Haloperidol Decanoate, Haloperidol Lactate
VA Class: CN709

CAS Number: 52-86-8

Brands: Haldol

For ProfessionalsSide EffectsInteractionsMore…

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

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

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 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 injection†121 123 124 125 127 128 129 130 131 133 134 135 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 injection†121 123 124 125 127 128 129 130 131 133 134 135 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

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

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 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

Alcohol 10% in dextrose 5%

Amifostine

Amsacrine

Aztreonam

Bivalirudin

Cimetidine HCl

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

Sufentanil citrate

Tacrolimus

Teniposide

Theophylline

Thiotepa

Vinorelbine tartrate

Incompatible

Allopurinol sodium

Amphotericin B cholesteryl sulfate complex

Cefepime HCl

Fluconazole

Foscarnet sodium

Gallium nitrate

Heparin sodium

Lansoprazole

Piperacillin sodium–tazobactam sodium

Sargramostim

Variable

Sodium nitroprusside

Syringe Compatibility (haloperidol lactate)HID
Compatible

Buprenorphine HCl with glycopyrrolate

Cyclizine lactate with diamorphine HCl

Hydromorphone HCl

Lorazepam

Morphine HCl

Sufentanil citrate

Incompatible

Diphenhydramine HCl

Heparin sodium

Hydroxyzine HCl

Ketorolac tromethamine

Morphine sulfate

Variable

Benztropine mesylate

Cyclizine lactate

Diamorphine HCl

Hydromorphone HCl

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 02/2013. 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

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug’s actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions January 27, 2012. 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. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:826-33.

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.

Post a Comment

Your email is kept private. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

Haloperidol

Haloperidol

Pronunciation Pronunciation: ha-loe-PER-i-dole

Class: Phenylbutylpiperadine derivative

For ProfessionalsSide EffectsInteractionsMore…

Trade Names

Haldol

– Tablets 0.5 mg

– Tablets 1 mg

– Tablets 2 mg

– Tablets 5 mg

– Tablets 10 mg

– Tablets 20 mg

– Solution, concentrate, oral 2 mg (as lactate)/mL

– Injection, solution 5 mg (as lactate)/mL

Haldol Decanoate

– Injection, oil, extended-release 50 mg (as decanoate 70.5 mg)/mL

– Injection, oil, extended-release 100 mg (as decanoate 141.04 mg)/mL

Apo-Haloperidol (Canada)

Haloperidol LA (Canada)

Pharmacology

Has antipsychotic effect, apparently caused by dopamine-receptor blockage in CNS.

Pharmacokinetics

Absorption

When administered in sesame oil, it results in the slow and sustained release of haloperidol. T max is 6 days after injection. Steady-state plasma concentrations are achieved after the third or fourth dose. When taken orally, haloperidol is readily absorbed from the GI tract.

Distribution

The relationship between dose of haloperidol decanoate and plasma haloperidol concentration is roughly linear for doses below 450 mg. Vd is about 18 L/kg; C max is 9.2 ng/mL and T max about 1.7 h following a single 20 mg oral dose. Haloperidol is widely distributed in the body, including breast milk, and it crosses the blood-brain barrier.

Metabolism

Metabolized by the liver. Because of first-pass metabolism in the liver, plasma concentration after oral doses are lower than those after IM injection.

Elimination

Apparent half-life is approximately 3 wk for the decanoate and 18 h for oral.

Indications and Usage

Oral Management of psychotic disorders; control of Tourette disorder in children and adults; management of severe behavioral disorders in children; short-term treatment of hyperactive children.

Injection Haloperidol lactate Treatment of schizophrenia; control of Tourette disorder.

Haloperidol decanoate Treatment of schizophrenia in patients requiring prolonged parenteral therapy.

Unlabeled Uses

Obsessive-complusive disorder; prevention of chemotherapy-induced nausea or vomiting; treatment of acute agitation in children.

Contraindications

Severe toxic CNS depression or comatose states from any cause; Parkinson disease; hypersensitivity to any component of the product.

Dosage and Administration

Psychotic disorders

Adults Moderate symptoms, elderly or debilitated patients PO 0.5 to 2 mg 2 or 3 times daily.

Severe symptoms, chronic or resistant patients PO 3 to 5 mg 2 or 3 times daily. Dosages up to 100 mg/day may be necessary in some patients.

Children 3 to 12 yr of age (weight, 15 to 40 kg) PO Initial dosage, 0.5 mg/day. If needed, increase dose in 0.5 mg increments at 5- to 7-day intervals up to 0.15 mg/kg/day or until therapeutic effect is obtained (usual dosage range, 0.05 to 0.15 mg/kg/day in 2 or 3 divided doses). IM Safety and efficacy not established in children.

Tourette disorder

Adults Moderate symptoms, elderly or debilitated patients PO 0.5 to 2 mg 2 or 3 times daily.

Severe symptoms, or chronic or resistant patients 3 to 5 mg 2 or 3 times daily. Dosages up to 100 mg/day may be necessary in some patients.

Children 3 to 12 yr of age (weight, 15 to 40 kg) PO Initial dosage, 0.5 mg/day. If needed, increase dose in 0.5 mg increments at 5- to 7-day intervals up to 0.15 mg/kg/day or until therapeutic effect is obtained (usual dosage range, 0.05 to 0.075 mg/kg/day in 2 or 3 divided doses).

Behavioral disorders/hyperactivity

Children 3 to 12 yr of age (weight, 15 to 40 kg) PO Initial dosage, 0.5 mg/day. If needed, increase dose in 0.5 mg increments at 5- to 7-day intervals or until therapeutic effect is obtained (usual dosage range, 0.05 to 0.075 mg/kg/day in 2 or 3 divided doses). In severely disturbed, nonpsychotic children or in hyperactive children with conduct disorder, short-term administration may suffice. There is little evidence to support dosages greater than 6 mg/day.

Haloperidol lactate injection

Schizophrenia Adults IM 2 to 5 mg for prompt control of acutely agitated schizophrenic patients with moderately severe to very severe symptoms. Depending on response, subsequent doses may be needed within 60 min; although 4 to 8 h intervals may be satisfactory.

Haloperidol decanoate injection

The dose should be individualized under close supervision during initiation and stabilization of therapy. The recommended interval between doses is monthly or every 4 wk, but variations in patient response may dictate a need for adjustments in dose or dosing interval.

Schizophrenia Adults IM (deep injection) Initial dose should not exceed 100 mg. If conversion from oral haloperidol to IM haloperidol decanoate requires more than 100 mg as an initial dose, administer that dose in 2 injections (max, 100 mg initially followed by the balance in 3 to 7 days). In patients stabilized on low oral doses (10 mg or less per day), the initial recommended dose of haloperidol decanoate is 10 to 15 times the daily dose. In patients stabilized on higher oral doses, in risk of relapse or tolerant to oral haloperidol, the recommended dose is 20 times the daily dose. Recommended monthly maintenance dose of haloperidol decanoate is 10 to 15 times the previous oral daily dose.

General Advice

  • Measure prescribed dose of oral concentrate using calibrated dropper or dosing syringe.
  • Injection is for IM administration only. Not for intradermal, subcutaneous, or IV administration.
  • Double-check injection doseform. Haloperidol decanoate is designed for monthly injection only.
  • The maximum volume per injection site for haloperidol decanoate should not exceed 3 mL.
  • Do not administer injection if particulate matter or marked discolorations noted. A slight yellowish discoloration is normal and will not alter potency.

Storage/Stability

Store tablets and oral concentrate between 68° and 77°F. Store injection between 59° and 86°F and protect from light. Do not freeze oral concentrate or injection.

Drug Interactions

Anesthetics, opiates, alcohol May increase CNS depressant effects. Use with caution and closely monitor the response of the patient.

Anticholinergics May increase anticholinergic effects. Coadministration may worsen schizophrenic symptoms, decrease haloperidol serum concentrations, and lead to tardive dyskinesia. In addition, the risk for intestinal pseudo-obstruction may be increased. If these agents are coadministered, adjust the dose of both drugs as needed. Monitor for signs and symptoms of GI hypomotility.

Anticonvulsants Use with caution in patients receiving anticonvulsant medications because haloperidol may lower the convulsive threshold. Monitor the response of the patient and adjust the anticonvulsant dose as needed.

Antiparkinson medication (eg, levodopa) Haloperidol is contraindicated in patients with Parkinson disease. Antiparkinson medication may have to be given after haloperidol is discontinued because of the difference in excretion rates. The risk of extrapyramidal symptoms may be increased if both drugs are discontinued simultaneously. In addition, coadministration of haloperidol and antiparkinson medication may increase IOP.

Azole antifungal agents (eg, itraconazole) Plasma levels of haloperidol may be elevated, increasing the risk of adverse effects. Monitor the clinical response to haloperidol when an azole antifungal agent is started or stopped. Adjust the haloperidol dose as needed.

Beta-blockers (eg, propranolol) Coadministration of beta-blockers and haloperidol may cause an unexpected severe hypotensive reaction, which may be because of additive or synergistic pharmacologic effects. If severe hypotension occurs, provide supportive treatment.

Cabergoline Pharmacologic effects of cabergoline may be decreased. Coadministration is not recommended.

Carbamazepine May decrease effects of haloperidol while the effects of carbamazepine may be increased. Monitor plasma concentrations of both drugs and the clinical response of the patient. Adjust the dosage of either drug as needed.

Drugs that prolong the QT interval (eg, antiarrhythmic agents [eg, amiodarone, disopyramide, dofetilide, flecainide, procainamide, quinidine], arsenic trioxide, chloroquine, chlorpromazine, cisapride, dolasetron, droperidol, fluconazole, halofantrine, haloperidol, lapatinib, macrolide and related antibiotics [eg, clarithromycin, telithromycin], maprotiline, mefloquine, mesoridazine, methadone, nilotinib, paliperidone, pentamidine, perflutren, phosphodiesterase type 5 inhibitors [eg, sildenafil], pimozide, propafenone, quinolone antibiotics [ie, gatifloxacin, moxifloxacin], tacrolimus, tetrabenazine, thioridazine, tricyclic antidepressants [eg, doxepin, nortriptyline], tyrosine kinase receptor antagonists [eg, lapatinib], ziprasidone) The risk of cardiovascular toxicity, including, fatal cardiac arrhythmias (torsades de pointes), may be increased. Coadministration is not recommended.

Epinephrine In patients who develop hypotension, do not administer epinephrine because haloperidol may block the vasopressor activity of epinephrine, paradoxically lowering BP.

Guanethidine The antihypertensive effectiveness of guanethidine may be decreased. Avoid this drug combination when possible. If coadministration is required, a larger dose of guanethidine may control BP. Monitor BP and adjust the guanethidine dose as needed.

Lithium May induce disorientation, unconsciousness, extrapyramidal symptoms, and hyperthermia. Monitor neurologic function closely and discontinue immediately if impaired consciousness or hyperthermia develops.

Rifamycins (eg, rifampin) Plasma levels of haloperidol may be reduced, decreasing the clinical effectiveness. Closely monitor the clinical response of the patient when starting or stopping rifamycins. Adjust the haloperidol dose as needed.

Serotonin reuptake inhibitors (eg, fluoxetine) Haloperidol plasma concentrations may be elevated, increasing the pharmacologic effects and risk of toxicity. Additional clinical monitoring is indicated. If toxic signs occur, stop one or both agents.

Tacrine The risk of occurrence of severe extrapyramidal symptoms may be increased. Monitor the patient. If an interaction is suspected, stop one or both drugs.

Tramadol Risk of seizures may be increased. Coadministration is not recommended.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

ECG changes; hypertension; hypotension; QT prolongation; tachycardia; torsades de pointes.

CNS

Agitation; anxiety; confusion; depression; drowsiness; dystonia; euphoria; exacerbation of psychotic symptoms; extrapyramidal symptoms; headache; insomnia; lethargy; restlessness; seizures; tardive dyskinesia; tardive dystonia; vertigo.

Dermatologic

Hair loss; maculopapular and acneiform skin reactions; photosensitivity.

EENT

Blurred vision; cataracts; retinopathy; visual disturbances.

GI

Anorexia; constipation; diarrhea; dry mouth; dyspepsia; hypersalivation; nausea; vomiting.

Genitourinary

Breast engorgement; gynecomastia; impotence; increased libido; lactation; mastalgia; menstrual irregularities; priapism; urinary retention.

Hematologic

Agranulocytosis; anemia; leukocytosis; leukopenia; lymphomonocytosis.

Hepatic

Jaundice; impaired liver function.

Local

Local tissue reactions (haloperidol decanoate).

Metabolic-Nutritional

Hyperglycemia; hypoglycemia; hyponatremia; hyperammonemia (postmarketing).

Respiratory

Bronchospasm; increased depth of respiration; laryngospasm.

Miscellaneous

Diaphoresis; heat stroke; hyperpyrexia; NMS.

Precautions

Warnings

Increased mortality Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with those taking placebo. Although the causes of death were varied, most of the deaths appeared to be either CV (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Haloperidol is not approved for the treatment of dementia-related psychosis.

Monitor

Monitor for improvement in symptoms of psychotic disorders, control of tics and vocal utterances in Tourette disorder, or improvement of behavioral problems or hyperactivity. Monitor for electrolyte imbalances (eg, hypokalemia, hypomagnesemia) as needed. Provide close clinical supervision during initiation and stabilization of therapy.

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Do not use in children younger than 3 yr of age. Safety and efficacy of IM form not established.

Elderly

More susceptible to effects; consider lower dose.

Special Risk Patients

Use drug with caution in patients with CV disease or mitral insufficiency, history of glaucoma, EEG abnormalities or seizure disorders, prior brain damage, or hepatic or renal impairment.

Abrupt withdrawal

Abrupt withdrawal in patients on maintenance therapy has been associated with transient dyskinetic signs, which may be indistinguishable from tardive dyskinesia.

Bronchopneumonia

Has occurred, including fatal cases, in some patients following the use of antipsychotic drugs, including haloperidol.

CNS effects

May impair mental or physical abilities, especially during first few days of therapy.

CV effects

Cases of sudden death, QT prolongation, and torsades de pointes have been reported.

Cyclic disorders

When haloperidol is used to control mania, there may be a rapid mood swing to depression.

Debilitated patients

More susceptible to effects; consider lower dose.

Hyperprolactinemia

Prolactin levels may be elevated.

NMS

Has occurred and is potentially fatal. Signs and symptoms are hyperpyrexia, muscle rigidity, altered mental status, irregular pulse, irregular BP, tachycardia, and diaphoresis.

Severe neurotoxicity

Severe neurotoxicity may occur in patients with thyrotoxicosis who are also receiving antipsychotics, including haloperidol.

Sudden death

Has been reported; predisposing factors may be seizures or previous brain damage. Flare up of psychotic behavior may precede death.

Tardive dyskinesia

Syndrome of potentially irreversible, involuntary dyskinetic movements may develop. Prevalence is highest in elderly patients, especially women. Use smallest effective dose for shortest period of time needed.

Overdosage

Symptoms

Autonomic reactions; cardiac arrhythmias; CNS depression; coma; ECG changes associated with torsades de pointes; extrapyramidal symptoms; hypertension; hypotension; shock-like state; somnolence.

Patient Information

  • Advise patient, family, or caregiver that dose will be adjusted periodically until max benefit has been obtained.
  • Advise patient, family, or caregiver not to change the dose or stop taking unless advised by health care provider.
  • Instruct patient, family, or caregiver to measure prescribed dose of oral concentrate using calibrated dropper or dosing syringe.
  • Instruct patient not to stop taking haloperidol when feeling better.
  • Instruct patient, family, or caregiver to immediately report fainting or loss of consciousness, dizziness, high fever, muscle rigidity, or altered mental status to health care provider.
  • Advise patient, family, or caregiver to notify health care provider of the following: excessive drowsiness, increased agitation or anxiety, or involuntary body or facial movements.
  • Advise patient to avoid strenuous activity during periods of high temperature or humidity.
  • Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.
  • Instruct patient to get up slowly from lying or sitting position and to avoid sudden position changes to prevent postural hypotension. Advise patient to report dizziness with position changes to health care provider. Caution patient that hot tubs and hot showers or baths may make dizziness worse.
  • Advise patient to take sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
  • Advise patient that drug may cause drowsiness and impaired judgment or thinking skills and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Caution patient that medication may cause sensitivity to sunlight and to avoid unnecessary exposure to UV light (sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light until tolerance is determined.

Copyright © 2009 Wolters Kluwer Health.

Post a Comment

Your email is kept private. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

Haloperidol

Haloperidol

Pronunciation Generic Name: Haloperidol lactate

Dosage Form: injection

For ProfessionalsSide EffectsInteractionsMore…

Haloperidol Injection USP

(For Immediate Release)

Rx Only

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10 week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Haloperidol Injection is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).

Haloperidol Description

Haloperidol USP is the first of the butyrophenone series of major antipsychotics. The chemical designation is 4-[4-(p-chlorophenyl)-4-hydroxypiperidino]-4’-fluorobutyrophenone and it has the following structural formula:

Haloperidol injection USP is available as a sterile parenteral form for intramuscular injection. The injection provides 5 mg Haloperidol (as the lactate) USP with 1.8 mg methylparaben and 0.2 mg propylparaben per mL, and lactic acid for pH adjustment between 3 to 3.6.

ACTIONS

The precise mechanism of action has not been clearly established.

INDICATIONS

Haloperidol USP is indicated for use in the treatment of schizophrenia.

Haloperidol USP is indicated for the control of tics and vocal utterances of Tourette’s Disorder.

Contraindications

Haloperidol is contraindicated in severe toxic central nervous system depression or comatose states from any cause and in individuals who are hypersensitive to this drug or have Parkinson’s disease.

Warnings

Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol Injection is not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING).

Cardiovascular Effects

Cases of sudden death, QT-prolongation, and torsades de pointes have been reported in patients receiving Haloperidol injection. Higher than recommended doses of any formulation and intravenous administration of Haloperidol injection appear to be associated with a higher risk of QT-prolongation and torsades de pointes. Although cases have been reported even in the absence of predisposing factors, particular caution is advised in treating patients with other QT-prolonging conditions (including electrolyte imbalance [particularly hypokalemia and hypomagnesemia], drugs known to prolong QT, underlying cardiac abnormalities, hypothyroidism, and familial long QT-syndrome). Haloperidol INJECTION IS NOT APPROVED FOR INTRAVENOUS ADMINISTRATION. If Haloperidol injection is administered intravenously, the ECG should be monitored for QT-prolongation and arrhythmias.

Tardive Dyskinesia

A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.

Both the risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment, itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.

Given these considerations, antipsychotic drugs should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are not available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.

If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.

(For further information about the description of tardive dyskinesia and its clinical detection, please refer to ADVERSE REACTIONS.)

Neuroleptic Malignant Syndrome (NMS)

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status (including catatonic signs) and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis) and acute renal failure.

The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever and primary central nervous system (CNS) pathology.

The management of NMS should include 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.

If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.

Hyperpyrexia and heat stroke, not associated with the above symptom complex, have also been reported with Haloperidol.

Usage in Pregnancy

Rodents given 2 to 20 times the usual maximum human dose of Haloperidol by oral or parenteral routes showed an increase in incidence of resorption, reduced fertility, delayed delivery and pup mortality. No teratogenic effect has been reported in rats, rabbits or dogs at dosages within this range, but cleft palate has been observed in mice given 15 times the usual maximum human dose.

Cleft palate in mice appears to be a nonspecific response to stress or nutritional imbalance as well as to a variety of drugs, and there is no evidence to relate this phenomenon to predictable human risk for most of these agents.

There are no well controlled studies with Haloperidol in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of Haloperidol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to Haloperidol, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus. Infants should not be nursed during drug treatment.

Nonteratogenic Effects Neonates exposed to antipsychotic drugs (including Haloperidol) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Haloperidol decanoate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Combined Use of Haloperidol and Lithium

An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, elevated serum enzymes, BUN, and fasting blood sugar) followed by irreversible brain damage has occurred in a few patients treated with lithium plus Haloperidol. A causal relationship between these events and the concomitant administration of lithium and Haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely for early evidence of neurological toxicity and treatment discontinued promptly if such signs appear.

General

A number of cases of bronchopneumonia, some fatal, have followed the use of antipsychotic drugs, including Haloperidol. It has been postulated that lethargy and decreased sensation of thirst due to central inhibition may lead to dehydration, hemoconcentration and reduced pulmonary ventilation. Therefore, if the above signs and symptoms appear, especially in the elderly, the physician should institute remedial therapy promptly.

Although not reported with Haloperidol, decreased serum cholesterol and/or cutaneous and ocular changes have been reported in patients receiving chemically-related drugs.

Precautions

Leukopenia, Neutropenia, and Agranulocytosis

Class Effect In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including Haloperidol. Agranulocytosis has also been reported.

Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia. Patients with a history of a clinically significant low WBC or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of Haloperidol should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur. Patients with severe neutropenia (absolute neutrophil count < 1000/mm3) should discontinue Haloperidol and have their WBC followed until recovery.

Other

Haloperidol should be administered cautiously to 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, epinephrine should not be used since Haloperidol may block its vasopressor activity and paradoxical further lowering of the blood pressure may occur. Instead, metaraminol, phenylephrine or norepinephrine should be used.
  • receiving anticonvulsant medications, with a history of seizures, or with EEG abnormalities, because Haloperidol may lower the convulsive threshold. If indicated, adequate anticonvulsant therapy should be concomitantly maintained.
  • with known allergies, or with a history of allergic reactions to drugs.
  • receiving anticoagulants, since an isolated instance of interference occurred with the effects of one anticoagulant (phenindione).

When Haloperidol is used to control mania in cyclic disorders, there may be a rapid mood swing to depression.

Severe neurotoxicity (rigidity, inability to walk or talk) may occur in patients with thyrotoxicosis who are also receiving antipsychotic medication, including Haloperidol.

Drug Interactions

Drug-drug interactions can be pharmacodynamic (combined pharmacologic effects) or pharmacokinetic (alteration of plasma levels). The risks of using Haloperidol in combination with other drugs have been evaluated as described below.

Pharmacodynamic Interactions Since QT-prolongation has been observed during Haloperidol treatment, caution is advised when prescribing to patient with QT-prolongation conditions (long QT-syndrome, hypokalemia, electrolyte imbalance) or to patients receiving medications known to prolong the QT-interval or known to cause electrolyte imbalance.

If concomitant antiparkinson medication is required, it may have to be continued after Haloperidol is discontinued because of the difference in excretion rates. If both are discontinued simultaneously, extrapyramidal symptoms may occur. The physician should keep in mind the possible increase in intraocular pressure when anticholinergic drugs, including antiparkinson agents, are administered concomitantly with Haloperidol.

As with other antipsychotic agents, it should be noted that Haloperidol may be capable of potentiating CNS depressants such as anesthetics, opiates and alcohol.

Ketoconazole is a potent inhibitor of CYP3A4. Increases in QTc have been observed when Haloperidol was given in combination with the metabolic inhibitors ketoconazole (400 mg/day) and paroxetine (20 mg/day). It may be necessary to reduce the Haloperidol dosage.

Pharmacokinetic Interactions The Effect of Other Drugs on Haloperidol

Haloperidol is metabolized by several routes, including the glucuronidation and the cytochrome P450 enzyme system. Inhibition of these routes of metabolism by another drug may result in increased Haloperidol concentrations and potentially increase the risk of certain adverse events, including QT-prolongation.

Drugs Characterized as Substrates, Inhibitors or Inducers of CYP3A4, CYP2D6 or Glucuronidation

In pharmacokinetic studies, mild to moderately increased Haloperidol concentrations have been reported when Haloperidol was given concomitantly with drugs characterized as substrates or inhibitors of CYP3A4 or CYP2D6 isoenzymes, such as, itraconazole, nefazodone, buspirone, venlafaxine, alprazolam, fluvoxamine, quinidine, fluoxetine, sertraline, chlorpromazine, and promethazine.

When prolonged treatment (1 to 2 weeks) with enzyme-inducing drugs such as rifampin or carbamazepine is added to Haloperidol therapy, this results in a significant reduction of Haloperidol plasma levels.

Rifampin

In a study of 12 schizophrenic patients coadministered oral Haloperidol and rifampin, plasma Haloperidol levels were decreased by a mean of 70% and mean scores on the Brief Psychiatric Rating Scale were increased from baseline. In 5 other schizophrenic patients treated with Haloperidol and rifampin, discontinuation of rifampin produced a mean 3.3 fold increase in Haloperidol concentrations.

Carbamazepine

In a study in 11 schizophrenic patients coadministered Haloperidol and increasing doses of carbamazepine, Haloperidol plasma concentrations decreased linearly with increasing carbamazepine concentrations.

Thus, careful monitoring of clinical status is warranted when enzyme inducing drugs such as rifampin or carbamazepine are administered or discontinued in Haloperidol-treated patients. During combination treatment, the Haloperidol dose should be adjusted, when necessary. After discontinuation of such drugs, it may be necessary to reduce the dosage of Haloperidol.

Valproate

Sodium valproate, a drug known to inhibit glucuronidation, does not affect Haloperidol plasma concentrations.

Information for Patients

Haloperidol may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. The ambulatory patient should be warned accordingly.

The use of alcohol with this drug should be avoided due to possible additive effects and hypotension.

Carcinogenesis, Mutagenesis, and Impairment of Fertility 

No mutagenic potential of Haloperidol was found in the Ames Salmonella microsomal activation assay. Negative or inconsistent positive findings have been obtained in in vitro and in vivo studies of effects of Haloperidol on chromosome structure and number. The available cytogenetic evidence is considered too inconsistent to be conclusive at this time.

Carcinogenicity studies using oral Haloperidol were conducted in Wistar rats (dosed at up to 5 mg/kg daily for 24 months) and in Albino Swiss mice (dosed at up to 5 mg/kg daily for 18 months). In the rat study survival was less than optimal in all dose groups, reducing the number of rats at risk for developing tumors. However, although a relatively greater number of rats survived to the end of the study in high-dose male and female groups, these animals did not have a greater incidence of tumors than control animals. Therefore, although not optimal, this study does suggest the absence of a Haloperidol related increase in the incidence of neoplasia in rats at doses up to 20 times the usual daily human dose for chronic or resistant patients.

In female mice at 5 and 20 times the highest initial daily dose for chronic or resistant patients, there was a statistically significant increase in mammary gland neoplasia and total tumor incidence; at 20 times the same daily dose there was a statistically significant increase in pituitary gland neoplasia. In male mice, no statistically significant differences in incidences of total tumors or specific tumor types were noted.

Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.

There are no well controlled studies with Haloperidol in pregnant women. There are reports, however, of cases of limb malformations observed following maternal use of Haloperidol along with other drugs which have suspected teratogenic potential during the first trimester of pregnancy. Causal relationships were not established in these cases. Since such experience does not exclude the possibility of fetal damage due to Haloperidol, this drug should be used during pregnancy or in women likely to become pregnant only if the benefit clearly justifies a potential risk to the fetus.

Nursing Mothers

Since Haloperidol is excreted in human breast milk, infants should not be nursed during drug treatment with Haloperidol.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Haloperidol did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not consistently identified differences in responses between the elderly and younger patients. However, the prevalence of tardive dyskinesia appears to be highest among the elderly, especially elderly women (seeWARNINGS, Tardive Dyskinesia). Also, the pharmacokinetics of Haloperidol in geriatric patients generally warrants the use of lower doses (seeDOSAGE AND ADMINISTRATION).

Adverse Reactions

Cardiovascular Effects

Tachycardia, hypotension, and hypertension have been reported. QT-prolongation and/or ventricular arrhythmias have also been reported, in addition to ECG pattern changes compatible with the polymorphous configuration of torsade de pointes, and may occur more frequently with high doses and in predisposed patients (seeWARNINGS and PRECAUTIONS).

Cases of sudden and unexpected death have been reported in association with the administration of Haloperidol. The nature of the evidence makes it impossible to determine definitively what role, if any, Haloperidol played in the outcome of the reported cases. The possibility that Haloperidol caused death cannot, of course, be excluded, but it is to be kept in mind that sudden and unexpected death may occur in psychotic patients when they go untreated or when they are treated with other antipsychotic drugs.

CNS Effects

Extrapyramidal Symptoms (EPS) EPS during the administration of Haloperidol have been reported frequently, often during the first few days of treatment. EPS can be categorized generally as Parkinson-like symptoms, akathisia, or dystonia (including opisthotonos and oculogyric crisis). While all can occur at relatively low doses, they occur more frequently and with greater severity at higher doses. The symptoms may be controlled with dose reductions or administration of antiparkinson drugs such as benztropine mesylate USP or trihexyphenidyl hydrochloride USP. It should be noted that persistent EPS have been reported; the drug may have to be discontinued in such cases.

Dystonia

Class Effect

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Withdrawal Emergent Neurological Signs Generally, patients receiving short-term therapy experience no problems with abrupt discontinuation of antipsychotic drugs. However, some patients on maintenance treatment experience transient dyskinetic signs after abrupt withdrawal. In certain of these cases the dyskinetic movements are indistinguishable from the syndrome described below under “Tardive Dyskinesia” except for duration. It is not known whether gradual withdrawal of antipsychotic drugs will reduce the rate of occurrence of withdrawal emergent neurological signs but until further evidence becomes available, it seems reasonable to gradually withdraw use of Haloperidol.

Tardive Dyskinesia As with all antipsychotic agents Haloperidol has been associated with persistent dyskinesias. Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear irreversible. The syndrome is characterized by rhythmical involuntary movements of tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities and the trunk.

There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, this syndrome may be masked.

It has been reported that fine vermicular movement of the tongue may be an early sign of tardive dyskinesia and if the medication is stopped at that time the full syndrome may not develop.

Tardive Dystonia Tardive dystonia, not associated with the above syndrome, has also been reported. Tardive dystonia is characterized by delayed onset of choreic or dystonic movements, is often persistent, and has the potential of becoming irreversible.

Other CNS Effects Insomnia, restlessness, anxiety, euphoria, agitation, drowsiness, depression, lethargy, headache, confusion, vertigo, grand mal seizures, exacerbation of psychotic symptoms including hallucinations, and catatonic-like behavioral states which may be responsive to drug withdrawal and/or treatment with anticholinergic drugs.

Body as a Whole

Neuroleptic malignant syndrome (NMS), hyperpyrexia and heat stroke have been reported with Haloperidol (seeWARNINGS for further information concerning NMS).

Hematologic Effects

Reports have appeared citing the occurrence of mild and usually transient leukopenia and leukocytosis, minimal decreases in red blood cell counts, anemia, or a tendency toward lymphomonocytosis. Agranulocytosis has rarely been reported to have occurred with the use of Haloperidol, and then only in association with other medication (see PRECAUTIONS, Leukopenia, Neutropenia, and Agranulocytosis).

Liver Effects

Impaired liver function and/or jaundice have been reported.

Dermatologic Reactions

Maculopapular and acneiform skin reactions and isolated cases of photosensitivity and loss of hair.

Endocrine Disorders

Lactation, breast engorgement, mastalgia, menstrual irregularities, gynecomastia, impotence, increased libido, hyperglycemia, hypoglycemia and hyponatremia.

Gastrointestinal Effects

Anorexia, constipation, diarrhea, hypersalivation, dyspepsia, nausea and vomiting.

Autonomic Reactions

Dry mouth, blurred vision, urinary retention, diaphoresis and priapism.

Respiratory Effects

Laryngospasm, bronchospasm and increased depth of respiration.

Special Senses

Cataracts, retinopathy and visual disturbances.

Postmarketing Events

Hyperammonemia has been reported in a 5½-year-old child with citrullinemia, an inherited disorder of ammonia excretion, following treatment with Haloperidol.

Overdosage

Manifestations

In general, the symptoms of overdosage would be an exaggeration of known pharmacologic effects and adverse reactions, the most prominent of which would be: 1) severe extrapyramidal reactions, 2) hypotension, or 3) sedation. The patient would appear comatose with respiratory depression and hypotension which could be severe enough to produce a shock-like state. The extrapyramidal reactions would be manifested by muscular weakness or rigidity and a generalized or localized tremor as demonstrated by the akinetic or agitans types respectively. With accidental overdosage, hypertension rather than hypotension occurred in a two-year-old child. The risk of ECG changes associated with torsade de pointes should be considered. (For further information regarding torsade de pointes, please refer to ADVERSE REACTIONS.)

Treatment

Since there is no specific antidote, treatment is primarily supportive. A patent airway must be established by use of an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy. Respiratory depression may be counteracted by artificial respiration and mechanical respirators. Hypotension and circulatory collapse may be counteracted by use of intravenous fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine. Epinephrine should not be used. In case of severe extrapyramidal reactions, antiparkinson medication should be administered. ECG and vital signs should be monitored especially for signs of Q-T prolongation or dysrhythmias and monitoring should continue until the ECG is normal. Severe arrhythmias should be treated with appropriate anti-arrhythmic measures.

Haloperidol Dosage and Administration

There is considerable variation from patient to patient in the amount of medication required for treatment. As with all drugs used to treat schizophrenia, dosage should be individualized according to the needs and response of each patient. Dosage adjustments, either upward or downward, should be carried out as rapidly as practicable to achieve optimum therapeutic control.

To determine the initial dosage, consideration should be given to the patient’s age, severity of illness, previous response to other antipsychotic drugs, and any concomitant medication or disease state. Debilitated or geriatric patients, as well as those with a history of adverse reactions to antipsychotic drugs, may require less Haloperidol. The optimal response in such patients is usually obtained with more gradual dosage adjustments and at lower dosage levels.

Parenteral medication, administered intramuscularly in doses of 2 to 5 mg, is utilized for prompt control of the acutely agitated schizophrenic patient with moderately severe to very severe symptoms. Depending on the response of the patient, subsequent doses may be given, administered as often as every hour, although 4 to 8 hour intervals may be satisfactory.

Controlled trials to establish the safety and effectiveness of intramuscular administration in children have not been conducted.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Switchover Procedure

An oral form should supplant the injectable as soon as practicable. In the absence of bioavailability studies establishing bioequivalence between these two dosage forms the following guidelines for dosage are suggested. For an initial approximation of the total daily dose required, the parenteral dose administered in the preceding 24 hours may be used. Since this dose is only an initial estimate, it is recommended that careful monitoring of clinical signs and symptoms, including clinical efficacy, sedation, and adverse effects, be carried out periodically for the first several days following the initiation of switchover. In this way, dosage adjustments, either upward or downward, can be quickly accomplished. Depending on the patient’s clinical status, the first oral dose should be given within 12 to 24 hours following the last parenteral dose.

How is Haloperidol Supplied

NDC Number Haloperidol Injection USP Volume
0703-7041-04 5 mg/mL (as the lactate) 1 mL fill in a 2 mL vial (amber vial)
0703-7045-01 5 mg/mL (as the lactate) 10 mL (amber vial)

2 mL single dose vials are packaged 25 vials per shelf pack.

10 mL multiple dose vials are packaged in single unit cartons.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Protect from light. Do not freeze.

Rev. A 10/2011

Teva Pharmaceuticals USA

Sellersville, PA 18960

PRINCIPAL DISPLAY PANEL

Haloperidol Injection USP 5 mg/mL Single Dose Vial Tray Label Text

NDC 0703-7041-04 Rx only

Haloperidol

Injection USP

5 mg/mL

(For Immediate Release)

For IM Use Only

1 mL Single Dose Vial

Sterile

25 Vials

TEVA

PRINCIPAL DISPLAY PANEL

Haloperidol Injection USP 5 mg/mL Multiple Dose Vial Carton Label Text

NDC 0703-7045-01 Rx only

Haloperidol

Injection USP

5 mg/mL

(For Immediate Release)

For Intramuscular Use Only.

10 mL Multiple Dose Vial

Sterile

TEVA

Haloperidol 

Haloperidol injection

Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0703-7041
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Haloperidol LACTATE (Haloperidol) Haloperidol 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN  
PROPYLPARABEN  
LACTIC ACID  
Packaging
# Item Code Package Description
1 NDC:0703-7041-04 25 VIAL, SINGLE-DOSE in 1 TRAY
1 NDC:0703-7041-01 1 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076035 03/01/2002
Haloperidol 

Haloperidol injection

Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0703-7045
Route of Administration INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Haloperidol LACTATE (Haloperidol) Haloperidol 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN  
PROPYLPARABEN  
LACTIC ACID  
Packaging
# Item Code Package Description
1 NDC:0703-7045-01 1 VIAL, MULTI-DOSE in 1 CARTON
1 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076035 03/01/2002
Labeler - Teva Parenteral Medicines, Inc. (794362533)

Revised: 08/2012   Teva Parenteral Medicines, Inc.

Post a Comment

Your email is kept private. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>

Haloperidol

Haloperidol

Pronunciation Generic Name: haloperidol (HAL-oh-PER-i-dol)

Brand Name: Haldol

Haloperidol is an antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Haloperidol is not approved to treat mental problems caused by dementia.

OverviewSide EffectsInteractionsFor ProfessionalsMore…

Haloperidol is used for:

Treating schizophrenia. It is also used to control symptoms associated with Tourette disorder. It may also be used for other conditions as determined by your doctor.

Haloperidol is an antipsychotic agent. Exactly how it works is not known, but it may work by blocking certain chemicals in the brain.

Do NOT use haloperidol if:

  • you are allergic to any ingredient in haloperidol
  • you are in a coma, have Parkinson disease, or have severe central nervous system depression (eg, severe drowsiness, slow or shallow breathing)
  • you have severely low levels of certain white blood cells (neutrophils)
  • you are taking astemizole, dofetilide, dronedarone, nilotinib, propafenone, sodium oxybate (GHB), terfenadine, or tetrabenazine

Contact your doctor or health care provider right away if any of these apply to you.

Video: Treatment for Depression Treatments for depression are getting better everyday and there are things you can start doing right away.

Before using haloperidol:

Some medical conditions may interact with haloperidol. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have the blood disease porphyria, low white blood cell levels, electrolyte problems (eg, low blood magnesium, low blood potassium), or high or low blood pressure
  • if you have a history of dementia, Alzheimer disease, seizures, an abnormal electroencephalogram (EEG), thyroid problems, neuroleptic malignant syndrome (NMS), or low white blood cell levels caused by a medicine
  • if you have heart problems or irregular heartbeat (eg, QT prolongation, long QT syndrome), or if a member of your family has a history of these conditions
  • if you have had high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk of breast cancer
  • if you are dehydrated, drink alcohol, or if you are regularly exposed to extreme heat
  • if you are taking medicine that may increase the risk of a certain type of irregular heartbeat (QT prolongation) or the risk of electrolyte problems (eg, low blood potassium). Check with your doctor if you are unsure if any of your medicines may increase these risks

Some MEDICINES MAY INTERACT with haloperidol. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Antiarrhythmics (eg, amiodarone, disopyramide, dofetilide, dronedarone, flecainide, procainamide, quinidine, propafenone, sotalol), antipsychotics (eg, iloperidone, paliperidone, ziprasidone), arsenic, astemizole, bepridil, chloroquine, cisapride, dolasetron, domperidone, droperidol, halofantrine, ketolides (eg, telithromycin), kinase inhibitors (eg, lapatinib, nilotinib), macrolides (eg, erythromycin), maprotiline, methadone, phenothiazines (eg, thioridazine), pimozide, quinolone antibiotics (eg, levofloxacin, moxifloxacin), terfenadine , or tetrabenazine because the risk of serious heart-related side effects may be increased
  • Lithium because unexpected toxic effects, including weakness, severe tiredness, confusion, unusual muscle movements, and brain damage, have occurred in a few patients taking this combination. It is not known whether the combination of haloperidol and lithium may have caused this reaction. Discuss any questions or concerns with your doctor
  • Tramadol because the risk of seizures may be increased
  • Anticholinergics (eg, benztropine) or carbamazepine because they may increase the risk of haloperidol’s side effects or decrease haloperidol’s effectiveness
  • Azole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of haloperidol’s side effects
  • Rifampin because it may decrease haloperidol’s effectiveness
  • Anticoagulants (eg, warfarin), narcotic pain medicines, or sodium oxybate (GHB) because the risk of their side effects may be increased by haloperidol

This may not be a complete list of all interactions that may occur. Ask your health care provider if haloperidol may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use haloperidol:

Use haloperidol as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Haloperidol is usually given as an injection at your doctor’s office, hospital, or clinic. If you will be using haloperidol at home, a health care provider will teach you how to use it. Be sure you understand how to use haloperidol. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use haloperidol if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of haloperidol, use it as soon as possible. Use the remaining doses for the day at evenly spaced intervals. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use haloperidol.

Important safety information:

  • Haloperidol may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use haloperidol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do NOT drink alcohol while you are using haloperidol.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using haloperidol; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT use more than the recommended dose or suddenly stop using haloperidol without checking with your doctor.
  • Haloperidol may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to haloperidol. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
  • Do not become overheated in hot weather or while you are being active; heatstroke may occur.
  • Tell your doctor or dentist that you take haloperidol before you receive any medical or dental care, emergency care, or surgery.
  • NMS is a possibly fatal syndrome that can be caused by haloperidol. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.
  • Some patients who take haloperidol may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take haloperidol in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking haloperidol.
  • Diabetes patients – Haloperidol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Haloperidol may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • Haloperidol may increase the amount of a certain hormone (prolactin) in your blood. Symptoms may include enlarged breasts, missed menstrual period, decreased sexual ability, or nipple discharge. Contact your doctor right away if you experience any of these symptoms.
  • Haloperidol may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.
  • Lab tests, including complete blood cell counts, may be performed while you use haloperidol. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use haloperidol with caution in the ELDERLY; they may be more sensitive to its effects, especially uncontrolled muscle movements.
  • Haloperidol should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking haloperidol while you are pregnant. Using haloperidol during the third trimester may result in uncontrolled muscle movements or withdrawal symptoms in the newborn. Discuss any questions or concerns with your doctor. Haloperidol is found in breast milk. Do not breast-feed while taking haloperidol.

Possible side effects of haloperidol:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; loss of appetite; nausea; restlessness; stomach upset; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; dark urine; decreased or difficult urination; decreased sexual ability; dehydration; difficulty speaking or swallowing; drooling; enlarged breasts; excessive or unusual sweating; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; hallucinations; mental or mood changes (eg, abnormal thinking, agitation, anxiety, depression); missed menstrual period or other menstrual changes; nipple discharge; prolonged, painful erection; rigid or stiff muscles; seizures; severe or persistent dizziness, headache, or vomiting; shortness of breath or unusual cough; shuffling walk; uncontrolled muscle movements (eg, of the arms, legs, tongue, jaw, cheeks; tremors; twitching); yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; muscle rigidity, tremor, or weakness; rapid or irregular pulse; slow or shallow breathing; unusual drowsiness or deep sleep; very dry mouth.

Proper storage of haloperidol: Store haloperidol at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not freeze. Keep haloperidol out of the reach of children and away from pets.

General information:

  • If you have any questions about haloperidol, please talk with your doctor, pharmacist, or other health care provider.
  • Haloperidol is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take haloperidol or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about haloperidol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to haloperidol. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using haloperidol.

Issue Date: March 6, 2013 Database Edition 13.1.1.003 Copyright © 2013 Wolters Kluwer Health, Inc.

Post a Comment

Your email is kept private. Required fields are marked *

You may use these HTML tags and attributes: <a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <strike> <strong>