Haloperidol

(ha loe per' i dole)

PCaution when used during lactation : Caution when used during pregnancy

LCI  : Contraindicated in lactation

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |
WARNING

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 is not approved for the treatment of patients with dementia-related psychosis.

Indication(s) & Dosage

Haloperidol is indicated for use in the management of manifestations of psychotic disorders. Haloperidol is indicated for the control of tics and vocal utterances of Tourette’s Disorder in children and adults. Haloperidol is as well effective for the treatment of severe behavior problems in children of combative, explosive hyperexcitability (which cannot be accounted for by immediate provocation). Haloperidol is also effective in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance. Haloperidol should be reserved for these two groups of children only after failure to respond to psychotherapy or medications other than antipsychotics.

Oral route
Psychoses
Adult: 0.5-5 mg bid/tid, may increase up to 100 mg daily in severe or resistant cases. Usual maintenance: 3-10 mg daily. 
Child: >3 yr: Initially, 25-50 mcg/kg daily in 2 divided doses, increased gradually if necessary. Max: 10 mg/day.

Tourette's syndrome
Adult: Initially, 0.5-1.5 mg tid. Up to 30 mg daily may be required in Tourette's syndrome; adjust dose carefully to obtain optimum response; usual maintenance: 4 mg daily. 

Severe tics
Adult: Initially, 0.5-1.5 mg tid. Up to 30 mg daily may be required in Tourette's syndrome; adjust dose carefully to obtain optimum response; usual maintenance: 4 mg daily. 

Short-term adjunct in severe anxiety or behavioral disturbances
Adult: 0.5 mg bid. 

Restlessness and confusion
Adult: 1-3 mg every 8 hr.

Intractable hiccup
Adult: 1.5 mg tid, adjust according to response. 

Intramuscular route
Acute psychosis
Adult: Doses range from 2-10 mg, may be given every hr or at intervals of 4-8 hr, until symptoms are controlled. Max: 18 mg/day. For emergency control of severely disturbed patients: Up to 18 mg may be given IV/IM. 

Nausea and vomiting
Adult: 0.5-2 mg daily. In palliative care, 1.5 mg 1-2 times daily via oral admin or 2.5-10 mg over 24 hr by SC infusion (via a syringe driver).

Subcutaneous route
Restlessness and confusion
Adult: 5-15 mg via SC infusion over 24 hr.

Administration May be taken with or without food. May be taken w/ meals to minimise GI irritation.
Overdosage Symptoms of overdosage in children include drowsiness, restlessness, confusion, marked extrapyramidal symptoms and hypothermia. Torsade de pointes may occur in adults. Supportive treatment is recommended. Maintain a patent airway by using an oropharyngeal airway or endotracheal tube or, in prolonged cases of coma, by tracheostomy. Counteract respiratory depression by artificial respiration and mechanical respirators. Hypotension and circulatory collapse may be counteracted by using IV fluids, plasma, or concentrated albumin, and vasopressor agents such as metaraminol, phenylephrine and norepinephrine. Epinephrine should not be used. For severe extrapyramidal reactions, antiparkinson medication should be admin. Monitor ECG and vital signs especially for signs of QT prolongation or dysrhythmias. Continue monitoring until ECG is normal. Treat severe arrhythmias with appropriate anti-arrhythmic measures.
Contraindications Severe toxic CNS depression; preexisting coma; Parkinson's disease; lactation.
Special Precautions Parkinsonism; epilepsy, allergy, angle-closure glaucoma, benign prostatic hyperplasia; severe cardiac or hepatic disease; extremes in temp (hot and cold weather); presence of acute infections or leucopenia; hyperthyroidism; pregnancy, elderly, children. Patients receiving anticoagulants. Discontinue upon signs of neurological toxicity in patients taking haloperidol and lithium.
Adverse Drug Reaction(s) Tardive dyskinesia; extrapyramidal reactions. Anxiety, drowsiness, depression, anorexia, transient tachycardia, postural hypotension, leukopenia; anticholinergic side effects.
Potentially Fatal: Neuroleptic malignant syndrome.
Drug Interactions Carbamazepine and rifampicin reduce plasma concentrations. Symptoms of CNS depression may be enhanced by CNS depressants e.g. alcohol, hypnotics, general anaesthetics, anxiolytics and opioids. May reduce antihypertensive action of guanethidine. May increase risk of arrhythmia when used with drugs that prolong QT interval or diuretics that can cause electrolyte imbalance. May increase plasma levels of haloperidol when used with clozapine or chlorpromazine.
Potentially Fatal: Increases lithium blood levels and may predispose to neuroleptic malignant syndrome. Please consult detailed drug interactions before prescribing.
Pregnancy Category (FDA) Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.
Storage Intramuscular: Store at 15-30°C. Oral: Store at 15-30°C. Subcutaneous: Store at 15-30°C.
Pharmacology Haloperidol blocks postsynaptic dopamine D1 and D2 receptors in the mesolimbic system and decreases the release of hypothalamic and hypophyseal hormones. It produces calmness and reduces aggressiveness with disappearance of hallucinations and delusions.
Absorption: Readily absorbed from the GI tract (oral).
Distribution: Crosses the blood-brain barrier; enters breast milk. Protein-binding: 92%.
Metabolism: Hepatic via oxidative N-dealkylation and reduction of the ketone group; undergoes enterohepatic recycling.
Excretion: Urine and faeces; 12-38 hr (elimination half-life).
ATC Classification N05AD01 - haloperidol; Belongs to the class of butyrophenone derivatives antipsychotics. Used in the management of psychosis.

Brand/Product Info


Total Products : 7       
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
HALOP Opsonin Pharma Limited Haloperidol 5mg Tablet 100's: 50.00 MRP
Halopid 5 Incepta Pharmaceuticals Limited Haloperidol BP 5 mg Tablet 10x10's:MRP 100 Tk
Halopid Injection Incepta Pharmaceuticals Limited Haloperidol BP 5 mg/ml Injection 10x1's:MRP 108 Tk
PERIDOL 5 Square Pharmaceuticals Ltd. Haloperidol 5mg Tablet 10x10's: 101.00 MRP
PERIGEN General Pharmaceuticals Ltd Haloperidol 5mg Tablet 100's: 100.00 MRP
PEROL Ambee Pharmaceuticals Ltd. Haloperidol 5mg Tablet 100's: 51.00 MRP
PEROL Injection Ambee Pharmaceuticals Ltd. Haloperidol 5mg/1ml Injection 10 amps: 100.40 MRP

Gen. MedInfo

IMPORTANT WARNING:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as haloperidol have an increased chance of death during treatment.

Haloperidol is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed Haloperidol if you, a family member, or someone you care for has dementia and is taking haloperidol. For more information, visit the FDA website: http://www.fda.gov/Drugs

 

Why is Haloperidol prescribed?

Haloperidol is used to treat psychotic disorders (conditions that cause difficulty telling the difference between things or ideas that are real and things or ideas that are not real). Haloperidol is also used to control motor tics (uncontrollable need to repeat certain body movements) and verbal tics (uncontrollable need to repeat sounds or words) in adults and children who have Tourette's disorder (condition characterized by motor or verbal tics). Haloperidol is also used to treat severe behavioral problems such as explosive, aggressive behavior or hyperactivity in children who cannot be treated with psychotherapy or with other medications. Haloperidol is in a group of medications called conventional antipsychotics. It works by decreasing abnormal excitement in the brain.

How should Haloperidol be used? 

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. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take haloperidol exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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 inform 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.

Other uses for Haloperidol 

Haloperidol is also used to treat confusion and difficulty thinking and understanding that is caused by severe physical or mental illness. Talk to your doctor about the possible risks of using Haloperidol for your condition.

Haloperidol may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions to follow? 

Before taking haloperidol, 

  • inform your doctor if you are allergic to haloperidol or any other medications.
  • inform your doctor what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone); anticoagulants (blood thinners); antihistamines; disopyramide; dofetilide; epinephrine; erythromycin; ipratropium; lithium; medications for anxiety, depression, irritable bowel disease, mental illness, motion sickness, Parkinson's disease,seizures, ulcers, or urinary problems; methyldopa; moxifloxacin; narcotic medications for pain; pimozide; procainamide; quinidine; rifampin; sedatives; sotalol; sparfloxacin ; sleeping pills; thioridazine; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • inform your doctor if you have or have ever had Parkinson's disease (PD; a disorder of the nervous system that causes difficulties with movement, muscle control, and balance). Your doctor will probably tell you not to take haloperidol.
  • inform your doctor if you or anyone in your family has or has ever had prolonged QT syndrome (condition that increases the risk of developing an irregular heartbeat that may cause loss of consciousness, or sudden death). Also inform your doctor if you have or have ever had breast cancer; bipolar disorder (condition that causes episodes of depression, episodes of mania, and other abnormal moods); citrullinemia (condition that causes build-up of ammonia in the blood); an abnormal electroencephalogram (EEG; a test that records electrical activity in the brain); seizures; an irregular heartbeat; low levels of calcium or magnesium in your blood; chest pain; or heart or thyroid disease. Also inform your doctor if you have ever had to stop taking a medication for mental illness due to severe side effects.
  • inform your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking haloperidol, call your doctor. Haloperidol may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking haloperidol.
  • you should know that Haloperidol may make you drowsy and may affect your thinking and movements. Do not drive a car or operate machinery until you know how Haloperidol affects you.
  • ask your doctor about the safe use of alcohol during your treatment with haloperidol. Alcohol can make the side effects of haloperidol worse.

What special dietary instructions to follow? 

Unless your doctor tells you otherwise, continue your normal diet.

What to do if I forget a dose? 

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can Haloperidol cause? 

Haloperidol may cause side effects. inform your doctor if any of these symptoms are severe or do not go away: 

  • drowsiness

  • dry mouth

  • increased saliva

  • blurred vision

  • loss of appetite

  • constipation

  • diarrhea

  • heartburn

  • nausea

  • vomiting

  • difficulty falling asleep or staying asleep

  • blank facial expression

  • uncontrollable eye movements

  • unusual, slowed, or uncontrollable movements of any part of the body

  • restlessness

  • agitation

  • nervousness

  • mood changes

  • dizziness

  • headache

  • breast enlargement or pain

  • breast milk production

  • missed menstrual periods

  • decreased sexual ability in men

  • increased sexual desire

  • difficulty urinating

If you experience any of the following symptoms, call your doctor immediately: 

  • fever

  • muscle stiffness

  • confusion

  • fast or irregular heartbeat

  • sweating

  • decreased thirst

  • neck cramps

  • tongue that sticks out of the mouth

  • tightness in the throat

  • difficulty breathing or swallowing

  • fine, worm-like tongue movements

  • uncontrollable, rhythmic face, mouth, or jaw movements

  • seizures

  • eye pain or discoloration

  • decreased vision, especially at night

  • seeing everything with a brown tint

  • rash

  • yellowing of the skin or eyes

  • erection that lasts for hours

Haloperidol may cause other side effects. inform your doctor if you have any unusual problems while you are taking Haloperidol.

What to know about storage and disposal of Haloperidol? 

Keep Haloperidol in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Protect the liquid from light and do not allow it to freeze. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose 

In case of overdose, consult your doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include: 

  • unusual, slowed, or uncontrollable movements of any part of the body

  • stiff or weak muscles

  • slowed breathing

  • sleepiness

  • loss of consciousness

What other information to know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to Haloperidol.

Do not let anyone else use your medication. If you still have symptoms and need further treatment, consult your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ref:  U.S. National Library of Medicine.


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.

| See FDA approved Prescribing Information from Manufacturer | Tablet | Injection |    Manufacturer's 
     
| Latest mph edition: 09 Dec 2013 |
  | Back to top |