Haloperidol

Before taking haloperidol,

• tell your doctor and pharmacist if you are allergic to haloperidol or any other medications.
• tell your doctor and pharmacist 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 (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; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell 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.
• tell 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 tell 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; trouble keeping your balance; chest pain; or heart or thyroid disease. Also tell your doctor if you have ever had to stop taking a medication for mental illness due to severe side effects.
• tell 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 this medication may make you drowsy and may affect your thinking and movements. Do not drive a car or operate machinery until you know how this medication 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.
• you should know that haloperidol may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

Keep this medication 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.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

• Haldol^®

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Less serious side effects of Haldol include:

• Drowsiness
• Dizziness or fainting
• Anxiety
• Headaches
• Trouble urinating
• Trouble sleeping
• Sun sensitivity
• Dry mouth

More serious side effects of Haldol may demand immediate emergency medical attention and include:

• Shaking (tremors)
• Stiffness, muscle spasms
• Drooling
• Unwanted breast milk in females
• Decreased sexual ability in males
• Tongue and facial muscle twitches
• Fever
• Dark urine
• Irregular heart beat
• Persistent vomiting
• Sore throat
• Chest pain
• Severe allergic reactions, rash, itching

Haloperidol is part of the drug class:

• Butyrophenone derivatives

Serious side effects have been reported with haloperidol. See the “Haloperidol Precautions” section.

Common side effects of haloperidol include the following:

• 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
• local tissue reactions (injection formulations)
• Tachycardia (fast heartbeat)
• Low blood pressure
• High blood pressure

This is not a complete list of haloperidol side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• 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.)

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Difficulty with speaking or swallowing
• inability to move the eyes
• loss of balance control
• mask-like face
• muscle spasms, especially of the neck and back
• restlessness or need to keep moving (severe)
• shuffling walk
• stiffness of the arms and legs
• trembling and shaking of the fingers and hands
• twisting movements of the body
• weakness of the arms and legs

• Decreased thirst
• difficulty in urination
• dizziness, lightheadedness, or fainting
• hallucinations (seeing or hearing things that are not there)
• lip smacking or puckering
• puffing of the cheeks
• rapid or worm-like movements of the tongue
• skin rash
• uncontrolled chewing movements
• uncontrolled movements of the arms and legs

• Confusion
• convulsions (seizures)
• difficult or fast breathing
• fast heartbeat or irregular pulse
• fever (high)
• hot, dry skin, or lack of sweating
• increased blinking or spasms of the eyelid
• increased sweating
• loss of bladder control
• muscle stiffness (severe)
• muscle weakness
• sore throat and fever
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions
• unusual tiredness or weakness
• unusually pale skin
• yellow eyes or skin

• Continuing nausea or vomiting
• increase in the frequency of seizures
• loss of appetite
• swelling of the face
• tiredness and weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

• Difficulty with breathing (severe)
• dizziness (severe)
• drowsiness (severe)
• muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
• unusual tiredness or weakness (severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision
• changes in menstrual period
• constipation
• dryness of the mouth
• swelling or pain in the breasts (in females)
• unusual secretion of milk
• weight gain

• Decreased sexual ability
• drowsiness
• increased sensitivity of the skin to sun (skin rash, itching, redness or other discoloration of skin, or severe sunburn)
• nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The precise mechanism of action has not been clearly established.

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 torsade 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 torsade 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.

Falls

Motor instability, somnolence, and orthostatic hypotension have been reported with the use of antipsychotics, including Haloperidol, which may lead to falls and, consequently, fractures or other fall-related injuries. For patients, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects, assess the risk of falls when initiating antipsychotic treatment and recurrently for patients receiving repeated doses.

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 injection 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.

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 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.

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.