Pronunciation:

ha-loe-PER-i-dole

Brand Names:

• Haldol
• Haldol Decanoate
• Alti-Haloperidol
• Apo-Haloperidol
• Novo-Peridol
• Peridol
• Pms-Haloperidol
• Ratio-Haloperidol

Dosage Forms:

• Solution
• Tablet
• Injectable
• Suspension
• Oil

Classifications:

Therapeutic—

Antipsychotic

Pharmacologic—

Dopamine Antagonist

Chemical—

Butyrophenone

Uses of This Medicine:

Haloperidol is used to treat nervous, mental, and emotional conditions. It is also used to control the symptoms of Tourette's disorder. Haloperidol may also be used for other conditions as determined by your doctor.

Haloperidol is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, haloperidol is used in certain patients with the following medical conditions:

• Huntington's chorea (an hereditary movement disorder)
• Infantile autism
• Nausea and vomiting caused by cancer chemotherapy

Before Using This Medicine:

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:

Allergies—

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.

Children—

Side effects, especially muscle spasms of the neck and back, twisting movements of the body, trembling of fingers and hands, and inability to move the eyes are more likely to occur in children, who usually are more sensitive than adults to the effects of haloperidol.

Older adults—

Constipation, dizziness or fainting, drowsiness, dryness of mouth, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) are especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of haloperidol.

Pregnancy—

	Pregnancy Category	Explanation
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.

Breast-feeding—

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.

Other medicines—

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.

• Bepridil
• Cisapride
• Levomethadyl
• Mesoridazine
• Pimozide
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Other interactions—

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. Discuss with your healthcare professional the use of your medicine with 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:

• Alcohol abuse—The risk of heat stroke may be increased

• Difficult urination or
• Glaucoma or
• Heart or blood vessel disease or
• Lung disease or
• Parkinson's disease—Haloperidol may make the condition worse

• Epilepsy—The risk of seizures may be increased

• Kidney disease or
• Liver disease—Higher blood levels of haloperidol may occur, increasing the chance of side effects

• Overactive thyroid—Serious unwanted effects may occur

Proper Use of This Medicine:

If this medicine upsets your stomach, it may be taken with food or milk to lessen stomach irritation.

For patients taking the liquid form of this medicine :

• This medicine is to be taken by mouth even if it comes in a dropper bottle. Each dose is to be measured with the specially marked dropper provided with your prescription. 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. Haloperidol should not be mixed with tea or coffee, since they cause the medicine to separate out of solution.

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 children or elderly patients, since they may react very strongly to this medicine.

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.

Dosing—

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 and tablets):
  • Adults and adolescents: To start, 500 micrograms to 5 milligrams two or three times a day. Your doctor may increase your dose if needed. However, the dose is usually not more than 100 milligrams a day.
  • Children 3 to 12 years of age or weighing 15 to 40 kilograms (33 to 88 pounds): Dose is based on body weight. The usual dose is 25 to 150 micrograms per kilogram (11 to 68 micrograms per pound) a day, taken in smaller doses two or three times a day.
  • Children up to 3 years of age: Dose must be determined by the doctor.
  • Older adults: To start, 500 micrograms to 2 milligrams two or three times a day. The doctor may increase your dose if needed.
• For short-acting injection dosage form:
  • Adults and adolescents: To start, 2 to 5 milligrams, usually injected into a muscle. The dose may be repeated every one to eight hours, depending on your condition.
  • Children: Dose must be determined by the doctor.
• For long-acting or depot injection dosage form:
  • Adults and adolescents: To start, the dose is usually 10 to 15 times the daily oral dose you were taking, injected into a muscle once a month. The doctor may adjust how much of this medicine you need and how often you will need it, depending on your condition.
  • Children: Dose must be determined by the doctor.

Missed dose—

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.

Storage—

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.

Precautions While Using This Medicine:

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 often to meet the needs of your condition. This also helps prevent side effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually 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 slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally, especially as the amount of medicine is increased. 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 are not alert.

Although not a problem for many patients, dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. However, if the 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 taking this medicine.

Before using any prescription or over-the-counter (OTC) medicine for colds or allergies, check with your doctor. These medicines may increase the chance of heat stroke or other unwanted effects, such as dizziness, dry mouth, blurred vision, and constipation, while you are taking haloperidol.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using this medicine. Taking haloperidol together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

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. Also, wear sunglasses.
• Apply a sun block product that has a skin 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 health care professional.
• 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 dryness of the 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.

If you are taking the liquid form of this medicine , avoid getting it on your skin because it may cause a skin rash or other irritation.

If you are receiving this medicine by injection:

• The effects of the long-acting injection form of this medicine may last for up to 6 weeks. The precautions and side effects information for this medicine applies during this time.

Side Effects of This Medicine:

Along with its needed effects, haloperidol can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures (neuroleptic malignant syndrome). You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Stop taking this medicine and get emergency help immediately if any of the following effects occur:

Rare

Convulsions (seizures)

difficult or fast breathing

fast heartbeat or irregular pulse

fever (high)

high or low blood pressure

increased sweating

loss of bladder control

muscle stiffness (severe)

unusually pale skin

unusual tiredness or weakness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

Difficulty in speaking or swallowing

inability to move 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 arms and legs

trembling and shaking of fingers and hands

twisting movements of body

weakness of arms and legs

Less common

Decreased thirst

difficulty in urination

dizziness, lightheadedness, or fainting

hallucinations (seeing or hearing things that are not there)

lip smacking or puckering

puffing of cheeks

rapid or worm-like movements of tongue

skin rash

uncontrolled chewing movements

uncontrolled movements of arms and legs

Rare

Confusion

hot, dry skin, or lack of sweating

increased blinking or spasms of eyelid

muscle weakness

sore throat and fever

uncontrolled twisting movements of neck, trunk, arms, or legs

unusual bleeding or bruising

unusual facial expressions or body positions

yellow eyes or skin

Symptoms of overdose

Difficulty in 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

constipation

dryness of mouth

swelling or pain in breasts (in females)

unusual secretion of milk

weight gain

Less common

Decreased sexual ability

drowsiness

increased sensitivity of skin to sun (skin rash, itching, redness or other discoloration of skin, or severe sunburn)

nausea or vomiting

Some side effects, such as trembling of fingers and hands, or uncontrolled movements of the mouth, tongue, and jaw, may occur after you have stopped taking this medicine. If you notice any of these effects, check with your doctor as soon as possible.

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