Haloperidol

What is Haloperidol?

• Haloperidol (Haldol) is the first of the butyrophenone series of major tranquilizers, a conventional antipsychotic agent used in the management of manifestations of psychotic disorders.

Haloperidol

Haloperidol3Dan2

What are the uses of this medicine?

Haloperidol (Haldol) is used:

• to treat psychotic disorders.
• for the control of tics and vocal utterances of Tourette’s Disorder in children and adults.
• for the treatment of severe behavior problems in children of combative, explosive hyperexcitability.

Haloperidol tablets are also effective in the short-term treatment of hyperactive children who show the following symptoms:

• impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.

Limitations of use:

• Haloperidol tablets are used in children only after failure to respond to psychotherapy or medications other than antipsychotics.

How does this medicine work?

• Haloperidol (hal" oh per' i dol) is a butyrophenone derivative which appears to act as a dopamine type 2 (D2) receptor antagonist, but has other central and peripheral effects.
• Haloperidol is indicated for the therapy of acute and chronic psychoses and for controlling tics and vocal utterances in Tourette syndrome.
• Haloperidol is also used for short-term treatment of severe behavior problems in children with hyperactivity.
• The precise mechanism of action has not been clearly established.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have severe toxic central nervous system depression or comatose states.
• are hypersensitive to this drug.
• have Parkinson’s disease.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you take:

• amiodarone (Cordarone)
• anticoagulants (blood thinners)
• antihistamines
• disopyramide (Norpace)
• dofetilide (Tikosyn)
• epinephrine (Epipen)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• ipratropium (Atrovent)
• lithium (Eskalith, Lithobid)
• medications for anxiety, depression, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems
• methyldopa
• moxifloxacin (Avelox)
• narcotic medications for pain
• pimozide (Orap)
• procainamide
• quinidine
• rifampin (Rifater, Rifadin)
• sedatives
• sotalol (Betapace, Betapace AF)
• sparfloxacin (Zagam) (not available in the US)
• sleeping pills
• thioridazine
• tranquilizers

Is this medicine FDA approved?

• Haloperidol was approved for use in the United States in 1967, but is currently infrequently used, having been replaced in large part by the atypical antipsychotics, which have fewer extrapyramidal side effects.

How should this medicine be used?

Recommended dosage:

Adult dosage:

• With Moderate Symptomatology:
• 0.5 mg to 2 mg b.i.d. or t.i.d.

Severe Symptomatology:

• 3 mg to 5 mg b.i.d. or t.i.d.

In Geriatric or Debilitated Patients:

• 0.5 mg to 2 mg b.i.d. or t.i.d.

Chronic or Resistant Patients:

• 3 mg to 5 mg b.i.d. or t.i.d.

• Patients who remain severely disturbed or inadequately controlled may require dosage adjustment.
• Daily dosages up to 100 mg may be necessary in some cases to achieve an optimal response.
• Infrequently, haloperidol has been used in doses above 100 mg for severely resistant patients.

Pediatric dosage ages of 3 and 12 years (weight range 15 kg to 40 kg):

• Therapy should begin at the lowest dose possible (0.5 mg per day).
• If required, the dose should be increased by an increment of 0.5 mg at 5 to 7 day intervals until the desired therapeutic effect is obtained.

Psychotic Disorders:

• 0.05 mg/kg/day to 0.15 mg/kg/day.

Nonpsychotic Behavior Disorders and Tourette’s Disorder:

• 0.05 mg/kg/day to 0.075 mg/kg/day.

Maintenance Dosage:

• Upon achieving a satisfactory therapeutic response, dosage should then be gradually reduced to the lowest effective maintenance level.

Administration:

• Haloperidol comes as a tablet and concentrated liquid to take by mouth.
• It is usually taken two or three times a day.
• Take haloperidol at around the same times every day.
• Your doctor will probably start you on a low dose of haloperidol and gradually increase your dose.
• Your doctor may decrease your dose once your condition is controlled.
• Be sure to tell your doctor how you are feeling during your treatment with haloperidol.
• Haloperidol may help control your condition, but will not cure it.
• Continue to take haloperidol even if you feel well.
• Do not stop taking haloperidol without talking to your doctor.
• Your doctor will probably decrease your dose gradually.
• If you suddenly stop taking haloperidol, you may experience difficulty controlling your movements.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a tablet and concentrated liquid

This medicine is available in fallowing brand namesː

• Haldol

What side effects can this medication cause?

The most common side effects of this medicine include:

• Tachycardia
• hypotension
• hypertension
• QT prolongation
• ventricular arrhythmias
• Torsades de pointes
• Extrapyramidal Symptoms
• abnormal contractions of muscle
• spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue
• Tardive Dyskinesia
• Tardive Dystonia
• Insomnia
• restlessness
• anxiety
• euphoria
• agitation
• drowsiness
• depression
• lethargy
• headache
• confusion
• vertigo
• grand mal seizures
• hallucinations
• Neuroleptic malignant syndrome (NMS)
• hyperpyrexia
• heat stroke
• leukopenia
• leukocytosis
• minimal decreases in red blood cell counts
• anemia
• lymphomonocytosis
• Agranulocytosis
• Impaired liver function and/or jaundice
• Maculopapular
• acneiform skin reactions
• photosensitivity
• loss of hair
• Lactation
• breast engorgement
• mastalgia
• menstrual irregularities
• gynecomastia
• impotence
• increased libido
• hyperglycemia
• hypoglycemia
• hyponatremia
• Anorexia
• constipation
• diarrhea
• hypersalivation
• dyspepsia
• nausea and vomiting
• Dry mouth
• blurred vision
• urinary retention
• diaphoresis
• priapism
• Laryngospasm
• bronchospasm
• increased depth of respiration
• Cataracts
• retinopathy
• visual disturbances

What special precautions should I follow?

• Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Haloperidol is not approved for the treatment of patients with dementia-related psychosis.
• Cases of sudden death, QT-prolongation, and Torsades de pointes have been reported in patients receiving haloperidol. Caution is advised in treating patients with other QT-prolonging conditions.
• A syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered.
• A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs.
• 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.
• Hyperpyrexia and heat stroke, not associated with the above symptom complex, have also been reported with haloperidol.
• Haloperidol tablets may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. Haloperidol tablets may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.
• A number of cases of bronchopneumonia, some fatal, have followed the use of antipsychotic drugs, including haloperidol.
• Although not reported with haloperidol, decreased serum cholesterol and/or cutaneous and ocular changes have been reported in patients receiving chemically-related drugs.
• 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.
• Haloperidol therapy is commonly associated with minor serum aminotransferase elevations and in very rare instances has been linked to clinically apparent acute liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• extrapyramidal reactions
• hypotension
• sedation
• comatose with respiratory depression and hypotension
• hypertension rather than hypotension
• Torsades de pointes

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• Gastric lavage or induction of emesis should be carried out immediately followed by administration of activated charcoal.
• 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 antiarrhythmic measures.

Can this medicine be used in pregnancy?

• Haloperidol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

Can this medicine be used in children?

• Haloperidol is not intended for children under 3 years old.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Haloperidol

Inactive ingredients:

• colloidal silicon dioxide, FD&C Yellow No. 6 Aluminum Lake, magnesium stearate, microcrystalline cellulose, pregelatinized starch (corn) and sodium lauryl sulfate. In addition, the 10 mg and 20 mg tablets also contain FD&C Blue No. 1 Aluminum Lake.

Who manufactures and distributes this medicine?

Manufactured for:

• Mylan Pharmaceuticals Inc.
• Morgantown, WV U.S.A.

Manufactured by:

• Mylan Laboratories Limited
• Hyderabad, India

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Protect from light.
• Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Haloperidol
• FDA Haloperidol

Haloperidol Resources
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