Artane

ARTANE (trihexyphenidyl) may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that ARTANE (trihexyphenidyl) therapy does not adversely affect their ability to engage in such activities.

Because of increased sedative effects, patients should be cautioned to avoid the use of alcohol or other CNS depressants while taking ARTANE (trihexyphenidyl) .

Since this medication may increase the susceptibility to heat stroke (gastrointestinal (GI) problems, fever, heat intolerance), use with caution during hot weather. (See WARNINGS.)

Patients should be advised to report the occurrence of GI problems, fever, or heat intolerance promptly since paralytic ileus, hyperthermia, or heat stroke may occur.

If GI upset occurs, ARTANE (trihexyphenidyl) may be taken with food.

Patients should have close monitoring of intraocular pressure. (See WARNINGS.)

Serious side effects have been reported with Artane. See the “Drug Precautions” section.

Common side effects of Artane include dryness of the mouth, blurry vision, dizziness, mild nausea or nervousness.

This is not a complete list of Artane side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use caution when driving, operating machinery, or performing other hazardous activities. Trihexyphenidyl may cause dizziness or blurred vision. If you experience dizziness or blurred vision, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking trihexyphenidyl.

Avoid becoming overheated. Trihexyphenidyl may cause decreased sweating. This could lead to heat stroke in hot weather or with vigorous exercise.

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.

Pediatric

No information is available on the relationship of age to the effects of trihexyphenidyl in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of trihexyphenidyl in geriatric patients. However, elderly men are more likely to have age-related prostate problems, and all elderly patients are more likely to have age-related kidney, liver, or heart problems. These conditions may require caution or an adjustment in the dose for patients receiving trihexyphenidyl.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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.

• Potassium

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.

• Tiotropium

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
• Chlorpromazine
• Haloperidol
• Perphenazine

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. 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:

• Bowel or stomach blockage or
• Enlarged prostate or
• Glaucoma or
• Hypertension (high blood pressure) or
• Urinary blockage—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

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:

• Abdominal or stomach cramps or pain
• bloating
• constipation
• delusions of persecution, mistrust, suspiciousness, or combativeness
• excessive dryness of the mouth
• false beliefs that cannot be changed by facts
• loss of appetite
• nausea or vomiting
• seeing, hearing, or feeling things that are not there
• skin rash
• stomach pain
• swollen, painful, or tender lymph glands on the side of the face or neck

• Anxiety
• blurred vision
• change in vision
• decrease in frequency of urination
• decrease in urine volume
• difficult urination
• difficulty in passing urine (dribbling)
• disturbed behavior
• dry mouth
• enlarged pupils
• eye pain
• fast, pounding, or irregular heartbeat or pulse
• hyperventilation
• irritability
• loss of vision
• mental confusion
• nervousness
• painful urination
• restlessness
• shaking
• shortness of breath
• trouble sleeping

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:

• Dizziness
• mild nausea
• nervousness

• Drowsiness
• weakness

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.

Use caution when driving, operating machinery, or performing other hazardous activities. Trihexyphenidyl may cause dizziness or blurred vision. If you experience dizziness or blurred vision, avoid these activities.

Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking trihexyphenidyl.

Avoid becoming overheated. Trihexyphenidyl may cause decreased sweating. This could lead to heat stroke in hot weather or with vigorous exercise. Try to keep as cool as possible and watch for signs of heat stroke such as decreased sweating, nausea, and dizziness.

Applies to trihexyphenidyl: oral capsule extended release, oral elixir, oral tablet

Along with its needed effects, trihexyphenidyl (the active ingredient contained in Artane) 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 while taking trihexyphenidyl:

• Abdominal or stomach cramps or pain
• bloating
• constipation
• delusions of persecution, mistrust, suspiciousness, or combativeness
• excessive dryness of the mouth
• false beliefs that cannot be changed by facts
• loss of appetite
• nausea or vomiting
• seeing, hearing, or feeling things that are not there
• skin rash
• stomach pain
• swollen, painful, or tender lymph glands on the side of the face or neck

• Anxiety
• blurred vision
• change in vision
• decrease in frequency of urination
• decrease in urine volume
• difficult urination
• difficulty in passing urine (dribbling)
• disturbed behavior
• dry mouth
• enlarged pupils
• eye pain
• fast, pounding, or irregular heartbeat or pulse
• hyperventilation
• irritability
• loss of vision
• mental confusion
• nervousness
• painful urination
• restlessness
• shaking
• shortness of breath
• trouble sleeping

Some side effects of trihexyphenidyl 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:

• Dizziness
• mild nausea
• nervousness

• Drowsiness
• weakness

Applies to trihexyphenidyl: oral elixir, oral tablet

General

Most adverse effects of trihexyphenidyl (the active ingredient contained in Artane) are extensions of its pharmacologic activity and are anticholinergic in nature. Between 30% and 50% of all patients experience minor side effects (dry mouth, nausea, blurred vision, dizziness, nervousness). Elderly patients and those with underlying organic brain disease tend to be the most susceptible, especially to the central effects.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth, difficulty swallowing, anorexia, constipation, nausea, and vomiting. A reduction in dosage will sometimes help alleviate these problems. Paralytic ileus may develop, particularly in patients on concomitant phenothiazine or tricyclic antidepressant therapy, and may occasionally be fatal. Upon withdrawal of medication, nausea and vomiting may occur due to a cholinergic rebound.[Ref]

Nervous system

Bucco-linguo-masticatory dyskinesias and chorea have been reported mostly in elderly patients being treated for Parkinson's disease with various anticholinergic agents, including trihexyphenidyl (the active ingredient contained in Artane) [Ref]

Nervous system side effects have included depression, anxiety, listlessness, drowsiness, numbness of fingers and dyskinesia. Chorea has been reported at higher dosages (>=15 mg/day). Trihexyphenidyl may also aggravate symptoms of tardive dyskinesia or elicit previously suppressed symptoms. Sleepwalking has been attributed to drugs or combination of drugs with anticholinergic activity.

Cognitive deficits, such as impairment of recent and short-term memory and inability to concentrate, may occur with clinical doses of anticholinergic agents and may be dose-related.[Ref]

Psychiatric

Psychiatric side effects have included toxic psychosis which manifested as confusion, disorientation, agitation, excitation, memory impairment, delusions and hallucinations (usually visual, but may be auditory or tactile or all three), at toxic and therapeutic dosages (2% to 4%, up to 19% in elderly patients). Psychiatric deterioration and psychotic flare-ups have also been reported following withdrawal of therapy. Symptoms include delusions, hallucinations, aggression or violent behavior, and suicidal tendencies. In high dosages, trihexyphenidyl (the active ingredient contained in Artane) may sometimes produce euphorigenic effects. For this reason, it can be a drug of abuse.[Ref]

Toxic psychosis, when present, tends to occur quickly, generally within several days to a week of initiating trihexyphenidyl therapy or within hours after an acute overdose. However, occasionally the onset may be delayed by months. Symptoms generally resolve spontaneously within a few days after the discontinuation of medication.[Ref]

Ocular

Ocular side effects have included blurred vision, mydriasis, and cycloplegia. Trihexyphenidyl (the active ingredient contained in Artane) may also cause angle-closure glaucoma, which has rarely led to blindness.[Ref]

Cardiovascular

Cardiovascular side effects have included tachycardia, although an isolated case of bradycardia has also been described. Orthostatic hypotension has been reported during withdrawal syndromes following discontinuation of long-term trihexyphenidyl (the active ingredient contained in Artane) therapy.[Ref]

Genitourinary

Genitourinary side effects have included urinary retention and dysuria.[Ref]

Metabolic

Metabolic side effects have included alterations in thermal homeostasis as a result of trihexyphenidyl (the active ingredient contained in Artane) s inhibition of the body's sweating mechanism. Heat stroke, hyperthermia, and fever have occurred with anticholinergic agents, most commonly in patients on concomitant neuroleptic or tricyclic antidepressant therapy.[Ref]

Other

Anticholinergic poisoning syndrome may persist for more than a week's duration following trihexyphenidyl (the active ingredient contained in Artane) overdose. Most patients with anticholinergic intoxication require only supportive therapy of vital functions and/or discontinuation of medications. However, severely agitated, delirious, or comatose patients may be treated with physostigmine salicylate, an acetylcholinesterase inhibitor with both central and peripheral effects.[Ref]

Anticholinergic intoxication may present with central and peripheral symptoms including those listed above, in addition to warm and dry skin, EKG abnormalities, insomnia, twitching or jerking movements, pantomime activity with nonexistent objects, hyperactivity, hyperreflexia, respiratory arrest, delirium, convulsions, shock and coma.[Ref]

Some side effects of Artane may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Summary of Use during Lactation

Limited information indicates that maternal doses of trihexyphenidyl up to 4 mg daily together with haloperidol did not produce any adverse effects in breastfed infants. Long-term use of trihexyphenidyl might reduce milk production or milk letdown, but a single dose is not likely to interfere with breastfeeding. During long-term use, observe for signs of decreased lactation (e.g., insatiety, poor weight gain).

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

One woman with schizophrenia took trihexyphenidyl and haloperidol during 3 pregnancies and postpartum. The trihexyphenidyl dose was 4 mg daily in all 3 pregnancies. She breastfed (extent not stated) all 3 children for 6 to 8 months using the same doses. Development was age-appropriate in all children aged 16 months at 8 years of age at the time of assessment.[1]

Effects on Lactation and Breastmilk

Anticholinergics can inhibit lactation in animals, apparently by inhibiting growth hormone and oxytocin secretion.[2][3][4][5][6] Anticholinergic drugs can also reduce serum prolactin in nonnursing women.[7] The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

One woman with schizophrenia took trihexyphenidyl and haloperidol during 3 pregnancies and postpartum. She was able to breastfeed (extent not stated) all 3 children for 6 to 8 months.[1] The prolactin elevating effect of haloperidol might have counteracted any prolactin lowering effect of trihexyphenidyl.

References

1. Mendhekar DN, Andrade C. Uneventful use of haloperidol and trihehexyphenidyl during three consecutive pregnancies. Arch Womens Ment Health. 2011;14:83-4. PMID: 21116668

2. Aaron DK, Ely DG, Deweese WP et al. Reducing milk production in ewes at weaning using restricted feeding and methscopolamine bromide. J Anim Sci. 1997;75:1434-42. PMID: 9250502

3. Powell MR, Keisler DH. A potential strategy for decreasing milk production in the ewe at weaning using a growth hormone release blocker. J Anim Sci. 1995;73:1901-5. PMID: 7592071

4. Daniel JA, Thomas MG, Powell MR, Keisler DH. Methscopolamine bromide blocks hypothalmic-stimulated release of growth hormone in ewes. J Anim Sci. 1997;75:1359-62. PMID: 9159285

5. Bizzarro A, Iannucci F, Tolino A et al. Inhibiting effect of atropine on prolactin blood levels after stimulation with TRH. Clin Exp Obstet Gynecol. 1980;7:108-11. PMID: 6788407

6. Svennersten K, Nelson L, Juvnas-Moberg K. Atropinization decreases oxytocin secretion in dairy cows. Acta Physiol Scand. 1992;145:193-4. PMID: 1636447

7. Masala A, Alagna S, Devilla L et al. Muscarinic receptor blockade by pirenzepine: effect on prolactin secretion in man. J Endocrinol Invest. 1982;5:53-5. PMID: 6808052

LactMed Record Number

769

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.