Generic name: haloperidol (intramuscular route) [ hal-oh-PER-i-dol ]
Drug class: Miscellaneous antipsychotic agents
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with placebo-treated patients. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that conventional antipsychotic drugs may also increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Haloperidol decanoate is not approved for the treatment of patients with dementia-related psychosis .Intramuscular route(Solution)
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Haloperidol injection is not approved for the treatment of patients with dementia-related psychosis .
Commonly used brand name(s)
In the U.S.
- Haldol Decanoate
Available Dosage Forms:
Therapeutic Class: Antipsychotic
Pharmacologic Class: Dopamine Antagonist
Chemical Class: Butyrophenone
Uses for Haldol Decanoate
Haloperidol injection is used to treat schizophrenia. This medicine should not be used to treat behavior problems in older adult patients who have dementia-related psychosis.
This medicine is available only with your doctor’s prescription.
Before using Haldol Decanoate
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of haloperidol injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of haloperidol injection in the elderly. However, elderly women are more likely to have an unwanted side effect called tardive dyskinesia, and elderly patients are more likely to have age-related heart problems, which may require an adjustment in the dose for patients receiving haloperidol injection.
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Interactions with medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Calcium Oxybate
- Chloral Hydrate
- Gabapentin Enacarbil
- Inotuzumab Ozogamicin
- Magnesium Oxybate
- Morphine Sulfate Liposome
- Potassium Oxybate
- Ropeginterferon Alfa-2b-njft
- Sodium Oxybate
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Betel Nut
Interactions with food/tobacco/alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Breast cancer, prolactin-dependent, history of or
- Chest pain or
- Heart or blood vessel disease, severe or
- Hyperprolactinemia (high prolactin in the blood) or
- Hypotension (low blood pressure) or
- Mania or
- Neuroleptic malignant syndrome, history of or
- Seizures or epilepsy, history of—Use with caution. May make these conditions worse.
- Central nervous system depression, severe or
- Coma or
- Dementia in the elderly or
- Lewy body dementia or
- Parkinson’s disease—Should not be used in patients with these conditions.
- Heart rhythm problems (eg, familial long QT syndrome), history of or
- Hypokalemia (low potassium in the blood) or
- Hypomagnesemia (low magnesium in the blood) or
- Hypothyroidism (underactive thyroid) or
- Lung disease (eg, bronchopneumonia) or
- Thyrotoxicosis (overactive thyroid)—May increase risk for more serious side effects.
- Liver disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.
Proper use of Haldol Decanoate
This section provides information on the proper use of a number of products that contain haloperidol. It may not be specific to Haldol Decanoate. Please read with care.
A nurse or other trained health professional will give you this medicine in a medical facility. It is given as a shot into one of your muscles.
Your doctor may give you a few doses of this medicine until your condition improves, and then switch you to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.
Detailed Haldol Decanoate dosage information
Precautions while using Haldol Decanoate
It is very important that your doctor check your progress while you receive this medicine to allow for changes in your dose and help reduce any unwanted effects.
Do not stop receiving Haldol® suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
This medicine may cause serious allergic reactions (eg, anaphylaxis, angioedema, dermatitis exfoliative), which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a cracks in the skin, loss of heat from the body, rash, itching, hoarseness, red, swollen skin, scaly skin, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.
Contact your doctor as soon as possible if you have chest pain or discomfort, a fast heartbeat, trouble with breathing, or fever and chills. These may be symptoms of a very serious problem with your heart.
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have a lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
Check with your doctor right away if you have seizures, difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine will often make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are receiving this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are receiving this medicine.
This medicine may cause some people to become dizzy, drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are receiving this medicine.
Haloperidol can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, a cough or hoarseness, lower back or side pain, or painful or difficult urination.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Haldol Decanoate side effects
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 or nurse immediately if any of the following side effects occur:
- Excessive muscle tone
- inability to move the eyes
- increase in body movements
- increased blinking or spasms of the eyelid
- muscle stiffness, tension, or tightness
- sleepiness or unusual drowsiness
- sticking out of the tongue
- trouble with breathing, speaking, or swallowing
- uncontrolled twisting movements of the neck, trunk, arms, or legs
- unusual facial expressions
- Difficulty swallowing
- fixed position of the eye
- loss of balance control
- mask-like face
- shuffling walk
- slowed movements
- slurred speech
- stiffness of the arms and legs
- tic-like or jerky movements of the head, face, mouth, and neck
- trembling and shaking of the fingers and hands
- Slow movement and reflexes
- Absence of or decrease in body movement
- inability to sit still
- need to keep moving
- Blurred vision
- difficulty opening the mouth
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- high fever
- high or low blood pressure
- increased sweating
- loss of bladder control
- muscle spasm, especially of the neck and back
- muscle twitching
- severe muscle stiffness
- uncontrolled eye movements
- unusual tiredness or weakness
- unusually pale skin
Incidence not known (both)
- black, tarry stools
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, or warmth at the injection site
- chest pain or tightness
- clay-colored stools
- cold sweats
- continuing nausea or vomiting
- cool, pale skin
- dark urine
- decrease in the frequency of urination
- deep or fast breathing with dizziness
- difficulty in passing urine (dribbling)
- dry mouth
- eye pain
- false or unusual sense of well-being
- fever with or without chills
- flushed, dry skin
- fruit-like breath odor
- general feeling of illness, tiredness, or weakness
- hot, dry skin
- increase in the frequency of seizures
- increased hunger
- increased thirst
- increased urination
- irregular heartbeat, recurrent
- itching, skin rash
- lack of sweating
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
- lip smacking or puckering
- loss of appetite
- loss of consciousness
- lower back or side pain
- muscle weakness
- muscle pain or cramps
- muscle trembling or jerking
- noisy breathing
- numbness of the feet, hands, and around the mouth
- painful or difficult urination
- pale skin
- pounding in the ears
- puffing of the cheeks
- rapid or worm-like movements of the tongue
- shuffling walk
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- swelling of the face, ankles, or hands
- swollen glands
- total body jerking
- trouble breathing
- trouble with sleeping
- twisting movements of the body
- uncontrolled chewing movements
- unexplained weight loss
- unpleasant breath odor
- unusual bleeding or bruising
- unusual dullness, tiredness, weakness, or feeling of sluggishness
- vomiting of blood
- weakness of the arms and legs
- yellow eyes or skin
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:
- increased watering of the mouth
- Absent, missed, or irregular menstrual periods
- acne, pimples
- breast discomfort
- decreased interest in sexual intercourse
- heavy bleeding
- inability to have or keep an erection
- increased weight
- loss in sexual ability, desire, drive, or performance
- medium to heavy, irregular vaginal bleeding between regular monthly periods, which may require the use of a pad or a tampon
- stopping of menstrual bleeding
- swelling of the breasts or unusual milk production
Incidence not known (both)
- changes in vision
- decreased vision
- difficulty having a bowel movement
- disturbed color perception
- double vision
- feeling of constant movement of self or surroundings
- fullness or swelling of the breasts
- halos around lights
- increased in sexual ability, desire, drive, or performance
- increased interest in sexual intercourse
- increased sensitivity of the skin to sunlight
- loss of hair
- night blindness
- overbright appearance of lights
- pain or tenderness of the breasts
- painful or prolonged erection of the penis
- redness or other discoloration of the skin
- sensation of spinning
- severe sunburn
- stomach discomfort or upset
- tunnel vision
- weight loss
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.