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|Peridol

HALOPERIDOL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Haldol
• Haldol Decanoate

In Canada—

• Apo-Haloperidol
• Haldol
• Haldol LA
• Novo-Peridol
• Peridol
• PMS Haloperidol

Generic name product may be available in the U.S. and Canada.

Category

• Antidyskinetic, Gilles de la Tourette"s syndrome
• Antidyskinetic, Huntington"s chorea
• Antiemetic
• Antipsychotic

Description

Haloperidol (ha-loe-PER-i-dole) 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, in the following dosage forms:

• Oral
• Solution (U.S. and Canada)
• Tablets (U.S. and Canada)

• Parenteral
• Injection (U.S. and Canada)

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 haloperidol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to haloperidol. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Haloperidol has not been studied in pregnant women. However, studies in animals given 2 to 20 times the usual maximum human dose of haloperidol have shown reduced fertility, delayed delivery, cleft palate, and an increase in the number of stillbirths and newborn deaths.

Breast-feeding—Haloperidol passes into breast milk. Animal studies have shown that haloperidol in breast milk causes drowsiness and unusual muscle movements in the nursing offspring. Breast-feeding is not recommended during treatment with haloperidol.

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.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 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 haloperidol, it is especially important that your health care professional know if you are taking any of the following:

• Amoxapine (e.g., Asendin) or
• Metoclopramide (e.g., Reglan) or
• Metyrosine (e.g., Demser) or
• Other antipsychotics (medicine for mental illness) or
• Pemoline (e.g., Cylert) or
• Pimozide (e.g., Orap) or
• Promethazine (e.g., Phenergan) or
• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil]) or
• Trimeprazine (e.g., Temaril)—Taking these medicines with haloperidol may increase the frequency and severity of certain side effects

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Taking these medicines with haloperidol may result in increased CNS and other depressant effects, and in an increased chance of low blood pressure (hypotension)

• Epinephrine (e.g., Adrenalin)—Severe low blood pressure or irregular heartbeat may occur

• Levodopa (e.g., Dopar, Larodopa)—Haloperidol may interfere with the effects of this medicine

• Lithium (e.g., Eskalith, Lithane)—Although lithium and haloperidol are sometimes used together, their use must be closely monitored by your doctor, who may change the amount of medicine you need to take

Other medical problems—The presence of other medical problems may affect the use of haloperidol. 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 haloperidol 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 haloperidol. If your dose is different, do not change it unless your doctor tells you to do so.

The number of tablets or dropperfuls of solution that you take or injections that you receive 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 haloperidol .

• 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. Then take any remaining doses for that day at regularly spaced intervals. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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 haloperidol and get emergency help immediately if any of the following side effects occur:

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

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

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 08/24/1998

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