There may be a slightly increased risk of serious, possibly fatal side effects (e.g., pneumonia, heart failure) when this medication is used in older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

Haloperidol decanoate is used for long-term treatment of a certain mental/mood disorder (schizophrenia). It may be used in people who have trouble remembering to take medication every day. This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can also prevent suicide in people who are likely to harm themselves. It also reduces aggression and the desire to hurt others. It can decrease negative thoughts and hallucinations.

Haloperidol decanoate is a long-acting form of psychiatric medication (antipsychotic-type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Haloperidol is also used for severe behavior problems in hyperactive children when other treatments or medications have not worked.

Most likely, you have used the form of haloperidol that is taken by mouth. Your doctor is using this form of haloperidol so that you won't have to remember to take this medication every day.

This medication is the long-acting form of haloperidol. It is injected deep into a muscle (usually the buttocks) by a healthcare professional. This medication should not be injected into a vein. Your first dose may be divided and given in separate injections given 3-7 days apart. After your doctor has found the best dose for you, this medication is usually given once every 3-4 weeks. Your dosage is based on your condition and response to therapy.

Before injecting each dose, clean the injection site with rubbing alcohol. Before using, check this medication visually for particles. If any are present, do not use the liquid.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist.

This medication takes a while to start working, so you will need to continue to take your other medication by mouth until your doctor tells you to stop.

This medication must be used as prescribed. Do not suddenly stop using this drug without consulting your doctor. Some conditions may worsen if the medication is suddenly stopped.

Inform your doctor if your symptoms do not improve or if they worsen.

Dizziness, drowsiness, difficulty urinating, trouble sleeping, headache, anxiety, and pain at the injection site may occur. If these effects persist or worsen, notify your doctor or pharmacist promptly.

Tell your doctor promptly if any of these side effects occur: muscle spasm/stiffness, shaking (tremor), restlessness, mask-like facial expression, drooling. Your doctor may prescribe another medication for you to take with haloperidol to decrease these side effects.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

In rare cases, haloperidol may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.

For males, in the unlikely event you have a painful or prolonged erection (lasting more than 4 hours), stop using this drug and seek immediate medical attention, or permanent problems may occur.

This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any facial/muscle twitching such as tongue thrusting, chewing movements, puffing or puckering of your mouth, or uncontrollable shaking.

This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop any of the following symptoms: fever, muscle stiffness, severe confusion, increased sweating, fast/irregular heartbeat.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea/vomiting, stomach/abdominal pain, yellowing of eyes/skin, seizures.

Seek immediate medical attention if any of these rare but very serious side effects occur: slow/fast/irregular heartbeat, severe dizziness, chest pain, fainting.

A very severe allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using haloperidol, tell your doctor or pharmacist if you are allergic to it; if you are allergic to sesame; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: a certain severe nervous system problem (severe CNS depression), Parkinson's disease.

This medication should not be given to a patient who is unconscious.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bipolar disorder, difficulty urinating (e.g., due to prostate problems), glaucoma, heart problems (e.g., angina), overactive thyroid (hyperthyroidism), seizures.

Haloperidol decanoate may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using haloperidol decanoate, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using haloperidol decanoate safely.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, be sure to tell your doctor or dentist that you are using haloperidol.

This medication can reduce sweating, making you more likely to get heatstroke. Avoid hard work and exercise in hot weather.

Caution is advised when using this drug in elderly people because they may be more sensitive to the effects of the drug, especially drowsiness, difficulty urinating, and the effects on the heart.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: cabergoline, pergolide, sibutramine.

Many drugs besides haloperidol decanoate may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, quinidine, sotalol, procainamide, and macrolide antibiotics (such as erythromycin), among others. Therefore, before using haloperidol, report all medications you are currently using to your doctor or pharmacist.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting haloperidol.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergic medications (e.g., antispasmodics such as belladonna alkaloids, scopolamine), "blood thinners" (e.g., anticoagulants such as warfarin and heparin), carbamazepine, lithium, methyldopa, drugs for Parkinson's disease (e.g., levodopa and carbidopa, selegiline), quinupristin-dalfopristin, rifampin.

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with haloperidol such as: bupropion, isoniazid (INH), phenothiazines (e.g., chlorpromazine, fluphenazine, thioridazine), theophylline, tramadol, or tricyclic antidepressants (e.g., amitriptyline, nortriptyline), among others. Consult your pharmacist or doctor for more information.

Tell your doctor of pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure medications (e.g., phenytoin, valproic acid), medicine for sleep or anxiety (alprazolam, clonazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medications (e.g., risperidone, trazodone).

Check the labels on all your medicines (e.g., allergy, cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly.

Do not share this medication with others.

If you miss an appointment, call your doctor as soon as possible to set up an appointment. It is important that you stay on schedule with this medication.

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from moisture and sunlight. Do not refrigerate or freeze. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.