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Drugs (Haloperidol)*
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)
It is very important that you read and understand the following information. If any of it
causes you special concern, check with your doctor. Also, if you have any questions or if
you want more information about this medicine or your medical problem, ask your doctor,
nurse, or pharmacist.
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 doctor and pharmacist 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.
Age Groups
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:
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 Therapy
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:
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 doctor
and pharmacist 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
Before you begin using any new medicine (prescription or nonprescription) or if you
develop any new medical problem while you are using this medicine, check with your doctor,
nurse, or pharmacist.
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 is best taken alone. However, if necessary, it may be mixed with
water. If this is done, the mixture should be taken immediately after mixing. Haloperidol
should not be taken in 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.
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.
Dosing
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 teaspoonfuls 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.
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 doctor or
pharmacist.
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 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:
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)
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:
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 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.
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