Generic Name: haloperidol (Oral route)
Elderly patients with dementia-related psychosis treated with atypical 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 is not approved for the treatment of patients with dementia-related psychosis .
Commonly used brand name(s)
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antipsychotic
Pharmacologic Class: Dopamine Antagonist
Chemical Class: Butyrophenone
Uses For Apo-Haloperidol
Haloperidol is used to treat nervous, emotional, and mental conditions (eg, schizophrenia). It is also used to control the symptoms of Tourette's disorder. This medicine should not be used to treat behavior problems in older adult patients who have dementia.
Haloperidol is also used to treat severe behavioral problems (eg, aggressive, impulsive behavior) or hyperactivity in children who have already been treated with psychotherapy or other medicines that did not work well.
This medicine is available only with your doctor's prescription.
Before Using Apo-Haloperidol
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 in children younger than 3 years of age. 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 in the elderly. However, elderly women are more likely to have a side effect called tardive dyskinesia, and elderly patients are more likely to have age-related heart or lung problems, which may require an adjustment in the dose for patients receiving haloperidol.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
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 taking 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
- Chloral Hydrate
- Morphine Sulfate Liposome
- 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:
- Angina (severe chest pain) or
- Breast cancer, history of or
- Encephalopathy or
- Heart or blood vessel disease, severe or
- Hyperprolactinemia (high prolactin in the blood) or
- Hypotension (low blood pressure) or
- Lung or breathing problems (eg, bronchopneumonia) or
- Mania or
- Neuroleptic malignant syndrome, history of or
- Seizures, history of—Use with caution. May make these conditions worse.
- Central nervous system depression, severe or
- Coma or
- Dementia in elderly 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
- Thyroid problems—May increase risk for more serious side effects.
Proper Use of haloperidol
This section provides information on the proper use of a number of products that contain haloperidol. It may not be specific to Apo-Haloperidol. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is particularly important for elderly patients, since they may react very strongly to this medicine.
For patients taking the liquid form of this medicine:
- This medicine is to be taken by mouth and it comes in a dropper bottle. Each dose is to be measured with the specially marked dropper provided with your bottle. Do not use other droppers since they may not deliver the correct amount of medicine.
- This medicine should be mixed with water or a beverage, such as orange juice, apple juice, tomato juice, or cola, and taken immediately after mixing.
Continue taking this medicine for the full time of treatment. Sometimes haloperidol must be taken for several days to several weeks before its full effect is reached.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage forms (solution or tablets):
- For nervous, emotional, or mental conditions:
- Adults and children 13 years of age and older—At first, 0.5 to 5 milligrams (mg) 2 or 3 times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 100 mg per day.
- Older adults—At first, 0.5 to 2 mg 2 or 3 times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 100 mg per day.
- Children 3 to 12 years of age and weighs 15 to 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor.
- Children younger than 3 years of age—Use and dose must be determined by the doctor.
- For Tourette's disorder:
- Children 3 to 12 years of age and weighs 15 to 40 kilograms (kg)—Dose is based on body weight and must be determined by your doctor. The dose is usually 0.05 to 0.075 milligram (mg) per kilogram (kg) of body weight per day.
- Children younger than 3 years of age—Use and dose must be determined by the doctor.
- For nervous, emotional, or mental conditions:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using Apo-Haloperidol
Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. The amount of haloperidol you take may be changed to meet the needs of your condition and to prevent side effects.
Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely. This will allow your body time to adjust and help avoid a worsening of your medical condition.
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 using 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. Even if you take haloperidol at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.
Dizziness, lightheadedness, or fainting may occur, especially when you get up 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 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 taking this medicine, since overheating may result in heat stroke. Also, hot baths or saunas may make you feel dizzy or faint while you are using this medicine.
Haloperidol may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:
- Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
- Wear protective clothing, including a hat or sunglasses.
- Apply a sun block product that has a sun protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your doctor.
- Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
- Do not use a sunlamp or tanning bed or booth.
If you have a severe reaction from the sun, check with your doctor.
Haloperidol may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
Contact your doctor as soon as possible if you have chest pain or discomfort, a fast heartbeat, trouble breathing, or fever and chills. These can 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 any of the following symptoms while taking this medicine: 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 any of the following symptoms while using this medicine: convulsions, 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).
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.
Apo-Haloperidol 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 immediately if any of the following side effects occur:More common
- 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
- 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:Symptoms of overdose
- 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:More common
- Blurred vision
- changes in menstrual period
- dryness of the mouth
- swelling or pain in the breasts (in females)
- unusual secretion of milk
- weight gain
- Decreased sexual ability
- 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.
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