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 usedto control the symptoms of Tourette's disorder. Haloperidol may also be usedfor other conditions as determined by your doctor.

Haloperidol is available only with your doctor's prescription, in the followingdosage 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 willdo. This is a decision you and your doctor will make. For haloperidol, thefollowing should be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to haloperidol. Also tell your health care professionalif 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 doseof 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 studieshave shown that haloperidol in breast milk causes drowsiness and unusual musclemovements in the nursing offspring. Breast-feeding is not recommended duringtreatment with haloperidol.

Children?Side effects, especially muscle spasms of the neckand 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 usuallyare 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 tardivedyskinesia (such as rapid, worm-like movements of the tongue or any otheruncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs)are especially likely to occur in elderly patients, who are usually more sensitivethan younger adults to the effects of haloperidol.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases 2 different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takinghaloperidol, it is especially important that your health care professionalknow 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 haloperidolmay increase the frequency and severity of certain side effects

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

• Epinephrine (e.g., Adrenalin)?Severe low blood pressure orirregular heartbeat may occur

• Levodopa (e.g., Dopar, Larodopa)?Haloperidol may interferewith the effects of this medicine

• Lithium (e.g., Eskalith, Lithane)?Although lithium and haloperidolare 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 medicalproblems may affect the use of haloperidol. Make sure you tell your doctorif 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 medicineupsets 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 dropperbottle. Each dose is to be measured with the specially marked dropper providedwith your prescription. Do not use other droppers since they may not deliverthe correct amount of medicine.
• This medicine should be mixed with water or a beverage such as orangejuice, apple juice, tomato juice, or cola and taken immediately after mixing.Haloperidol should not be mixed with tea or coffee, since they cause the medicineto 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 takeit for a longer time than your doctor ordered. This is particularly importantfor children or elderly patients, since they may react very strongly to thismedicine.

Continue taking this medicine for the full time of treatment. Sometimes haloperidol must be taken for several days to several weeks beforeits full effect is reached.

Dosing?The dose of haloperidol will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 injectionsthat you receive depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, andthe length of time you take the medicine depend on the medical problem forwhich you are using haloperidol.

• For oral dosage forms (solution and tablets):
  • Adults and adolescents: To start, 500 micrograms to 5 milligramstwo 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 (33to 88 pounds): Dose is based on body weight. The usual dose is 25 to 150 microgramsper kilogram (11 to 68 micrograms per pound) a day, taken in smaller dosestwo 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 threetimes 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 injectedinto a muscle. The dose may be repeated every one to eight hours, dependingon your condition.
  • Children: Dose must be determined by the doctor.
• For long-acting or depot injection dosageform:
  • Adults and adolescents: To start, the dose is usually 10 to 15 timesthe 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 youwill 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 assoon as possible. Then take any remaining doses for that day at regularlyspaced 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, nearthe kitchen sink, or in other damp places. Heat or moisture may cause themedicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Yourdoctor should check your progress at regular visits, especially during thefirst few months of treatment with this medicine. The amount of haloperidolyou take may be changed often to meet the needs of your condition. This alsohelps prevent side effects.

Do not stop taking this medicine without first checkingwith your doctor. Your doctor may want you to reduce gradually theamount you are taking before stopping completely. This will allow your bodytime 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 whileyou are taking this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alertthan they are normally, especially as the amount of medicine is increased.Even if you take haloperidol at bedtime, you may feel drowsy or less alerton arising. Make sure you know how you react to thismedicine before you drive, use machines, or do anything else that could bedangerous if you are dizzy or are not alert.

Although not a problem for many patients, dizziness, lightheadedness, orfainting 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 temperatureto increase. Use extra care not to become overheatedduring exercise or hot weather while you are taking this medicine, since overheatingmay result in heat stroke. Also, hot baths or saunas may make you feeldizzy or faint while you are taking this medicine.

Before using any prescription or over-the-counter (OTC) medicine for coldsor allergies, check with your doctor. These medicines may increase the chanceof heat stroke or other unwanted effects, such as dizziness, dry mouth, blurredvision, 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 thatyou are using this medicine. Taking haloperidol together with medicinesthat are used during surgery or dental or emergency treatments may increasethe CNS depressant effects.

Haloperidol may cause your skin to be more sensitive to sunlight than itis normally. Exposure to sunlight, even for brief periods of time, may causea skin rash, itching, redness or other discoloration of the skin, or a severesunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00a.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 aboutthis, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protectyour lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check withyour doctor.

Haloperidol may cause dryness of the mouth. For temporary relief, use sugarlesscandy 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, checkwith your medical doctor or dentist. Continuing dryness of the mouth may increasethe chance of dental disease, including tooth decay, gum disease, and fungusinfections.

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

If you are receiving this medicine by injection:

• The effects of the long-acting injection form of this medicine maylast for up to 6 weeks. The precautions and side effectsinformation 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 (amovement disorder) may occur and may not go away after you stop using themedicine. Signs of tardive dyskinesia include fine, worm-like movements ofthe 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 andyour doctor should discuss the good this medicine will do as well as the risksof taking it.

Stop taking haloperidoland get emergency help immediately if any of the following side effectsoccur:

Rare

Convulsions (seizures); difficult orfast breathing; fast heartbeat or irregular pulse; fever (high); high orlow 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 possibleif 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, especiallyof the neck and back; restlessness or need to keepmoving (severe); shuffling walk; stiffness of arms and legs; trembling and shakingof 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 oftongue; skin rash; uncontrolledchewing movements; uncontrolled movements of armsand legs

Rare

Confusion; hot, dry skin, or lack ofsweating; increased blinking or spasms of eyelid; muscle weakness; sorethroat and fever; uncontrolled twisting movementsof neck, trunk, arms, or legs; unusual bleeding orbruising; 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)

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

More common

Blurred vision; changes in menstrualperiod; constipation; drynessof 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 sideeffects, such as trembling of fingers and hands, or uncontrolled movementsof the mouth, tongue, and jaw, may occur after you have stopped taking thismedicine. If you notice any of these effects, check with your doctor as soonas possible.

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although these uses are not included in productlabeling, haloperidol is used in certain patients with the following medicalconditions:

• 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 relatingto proper use, precautions, or side effects for these uses.