Haldol Decanoate contains haloperidol decanoate as the active ingredient, which is a decanoate ester of haloperidol, a butyrophenone. This medication is formulated as an intramuscular injection available in two strengths: 50 mg/mL and 100 mg/mL. Each injection uses a sesame oil vehicle and includes 1.2% benzyl alcohol as a preservative. It is intended for use in settings where an extended duration of effect is beneficial.

How should I use this medication?

This medication is for injection into a muscle. It is given in a hospital or clinic setting.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

Where should I keep my medication?

This medication is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• High fever, stiff muscles, increased sweating, fast or irregular heartbeat, and confusion, which may be signs of neuroleptic malignant syndrome
• High prolactin level—unexpected breast tissue growth, discharge from the nipple, change in sex drive or performance, irregular menstrual cycle
• Infection—fever, chills, cough, or sore throat
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Seizures
• Trouble passing urine
• Uncontrolled and repetitive body movements, muscle stiffness or spasms, tremors or shaking, loss of balance or coordination, restlessness, shuffling walk, which may be signs of extrapyramidal symptoms (EPS)

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Change in sex drive or performance
• Constipation
• Drowsiness
• Dry mouth
• Headache
• Stomach pain
• Weight gain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Dementia
• Diabetes
• Difficulty swallowing
• Have trouble controlling your muscles
• Heart disease
• History of irregular heartbeat
• If you often drink alcohol
• Liver disease
• Low blood counts, like white blood cell, platelet, or red cell counts
• Low levels of potassium or magnesium in the blood
• Lung or breathing disease, like asthma
• Parkinson's disease
• Seizures
• Thyroid disease
• An unusual or allergic reaction to haloperidol, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Metoclopramide
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough, and cold
• Atropine
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Droperidol
• Epinephrine
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Levodopa or other medications for Parkinson's disease
• Lithium
• Medications for blood pressure
• Medications for seizures
• Medications that relax muscles for surgery
• Narcotic medications for pain
• Other medications that prolong the QT interval (an abnormal heart rhythm)
• Phenothiazines like chlorpromazine, prochlorperazine
• Rifampin
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Your condition will be monitored carefully while you are receiving this medication.

You may get dizzy or drowsy or have blurred vision. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medication affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol can increase dizziness and drowsiness. Avoid alcoholic drinks.

This medication may increase blood sugar. Ask your care team if changes in diet or medications are needed if you have diabetes.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your care team if the problem does not go away or is severe.

This medication can cause problems with controlling your body temperature. It can lower the response of your body to cold temperatures. If possible, stay indoors during cold weather. If you must go outdoors, wear warm clothes. It can also lower the response of your body to heat. Do not overheat. Do not over-exercise. Stay out of the sun when possible. If you must be in the sun, wear cool clothing. Drink plenty of water. If you have trouble controlling your body temperature, call your care team right away.

This medication can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

What are the most serious risks of this medication?

This medication should not be used to treat mood and behavior changes caused by dementia. It may increase the risk of death in older adults with dementia.