Trihexyphenidyl

If you experience any of the following serious side effects, stop taking trihexyphenidyl and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
• fever;
• fast or irregular heartbeats;
• anxiety, hallucinations, confusion, agitation, hyperactivity, or loss of consciousness;
• seizures;
• eye pain; or
• a rash.

Other, less serious side effects may be more likely to occur. Continue to take trihexyphenidyl and talk to your doctor if you experience

• dryness of the mouth;
• large pupils or blurred vision;
• drowsiness or dizziness;
• difficulty urinating or constipation;
• nervousness or anxiety;
• upset stomach; or
• decreased sweating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Try to keep your regular appointments with your doctor. This is so your doctor can check on your progress.
• If you buy any medicines, check with a pharmacist that they are safe to take with trihexyphenidyl. Some antihistamines and some strong painkillers can interfere with trihexyphenidyl and increase the risk of side-effects.
• If you are having an operation or any dental treatment, tell the person carrying out the treatment that you are taking trihexyphenidyl.
• If you have been taking trihexyphenidyl for some time, do not stop taking it without speaking with your doctor first. Stopping suddenly can cause problems so your doctor will want to reduce your dose gradually if this becomes necessary.
• Ask your doctor for advice before drinking alcohol while you are on trihexyphenidyl. Your doctor may recommend you do not drink alcohol because it increases the possibility of side-effects such as feeling sleepy.

Minor side effects, such as dryness of the mouth, blurred vision, dizziness, mild nausea or nervousness, will be experienced by 30 to 50 percent of all patients. These sensations, however, are much less troublesome with ARTANE (trihexyphenidyl) than with belladonna alkaloids and are usually less disturbing than unallenated parkinsonism. Such reactions tend to become less pronounced, and even to disappear, as treatment continues. Even before these reactions have remitted spontaneously, they may often be controlled by careful adjustment of dosage form, amount of drug, or interval between doses.

Isolated instances of suppurative parotitis secondary to excessive dryness of the mouth, skin rashes, dilatation of the colon, paralytic ileus, and certain psychiatric manifestations such as delusions, hallucinations, and paranoia, all of which may occur with any of the atropine-like drugs, have been reported rarely with ARTANE® (trihexyphenidyl)

Potential side effects associated with the use of any atropine-like drugs, including Artane (trihexyphenidyl) , include cognitive dysfunctions, including confusion and memory impairment; constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intraocular pressure, choreiform movements, weakness, vomiting, and headache. Exacerbation of parkinsonism with abrupt treatment withdrawal has been reported. Neuroleptic malignant syndrome with abrupt treatment withdrawal has been reported (see WARNINGS, Neuroleptic Malignant Syndrome).

The occurrence of angle-closure glaucoma in patients receiving trihexyphenidyl HCl has been reported (blindness has been reported in some cases). Paradoxical sinus bradycardia, dry skin, and cycloplegia have been reported.

In addition to adverse events seen in adults, the following adverse events have been reported in the literature in pediatric patients: hyperkinesia, psychosis, forgetfulness, weight loss, restlessness, chorea, and sleep alterations.

Drug Abuse And Dependence

Although ARTANE (trihexyphenidyl) is not classified as a controlled substance, the possibility of abuse should be borne in mind due to its stimulant and euphoriant properties.

Read the entire FDA prescribing information for Artane (Trihexyphenidyl)

Do not use trihexyphenidyl without first talking to your doctor if you have

• ever had an allergic reaction to it;

• narrow-angle glaucoma;

• an obstruction in the bowel or a complication of bowel disease known as megacolon; or

• myasthenia gravis.

Before taking this medication, tell your doctor if you have

• enlargement of the prostate or difficulty urinating;

• epilepsy or another seizure disorder;

• heart disease or an irregular heartbeat;

• depression or any other psychiatric illness;

• kidney disease; or

• liver disease.

You may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

It is not known whether trihexyphenidyl will be harmful to an unborn baby. Do not take this medication without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether trihexyphenidyl passes into breast milk. Do not take this medication without first talking to your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and only take the next regularly scheduled dose. Do not take a double dose of this medication.

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.

Minor side effects, such as dryness of the mouth, blurring of vision, dizziness, mild nausea or nervousness, will be experienced by 30 to 50 percent of all patients. These sensations, however, are much less troublesome with Trihexyphenidyl HCl than with belladonna alkaloids and are usually less disturbing than unalleviated parkinsonism. Such reactions tend to become less pronounced, and even to disappear, as treatment continues. Even before these reactions have remitted spontaneously, they may often be controlled by careful adjustment of dosage form, amount of drug, or interval between doses.

Isolated instances of suppurative parotitis secondary to excessive dryness at the mouth, skin rashes, dilatation of the colon, paralytic ileus, and certain psychiatric manifestations such as delusions and hallucinations, plus one doubtful case of paranoia all of which may occur with any of the atropine-like drugs, have been reported rarely with Trihexyphenidyl hydrochloride.

Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Such patients should be allowed to develop a tolerance through the initial administration of a small dose and gradual increase in dose until an effective level is reached. If a severe reaction should occur, administration of the drug should be discontinued for a few days and then resumed at a lower dosage. Psychiatric disturbances can result from indiscriminate use (leading to overdosage) to sustain continued euphoria.

Potential side effects associated with the use of any atropine-like drugs include constipation, drowsiness, urinary hesitancy or retention, tachycardia, dilation of the pupil, increased intraocular tension, weakness, vomiting, and headache.

The occurrence of angle-closure glaucoma due to long-term treatment with Trihexyphenidyl has been reported.

Trihexyphenidyl HCl tablets are available as follows:

2 mg – round, flat, scored, white tablets; debossed "5971" above the score and "V" below the score. Available in bottles of 100, 500 and 1000.

5 mg – round, flat, scored, white tablets; debossed "5972" above the score and "V" below the score. Available in bottles of 100, 500, and 1000.

Dispense in a tight, light-resistant container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Manufactured for:
QUALITEST PHARMACEUTICALS
Huntsville, AL 35811

8181446
Rev 2/08
R2

(trye heks ee FEN i dil)

Oral: May be administered before or after meals (if excessive dry mouth develops, consider administering before meals unless it causes nausea; postencephalitic patients who are prone to excessive salivation may prefer to take after meals); tolerated best if given in 3 daily doses and with food. High doses (>10 mg/day) may be divided into 4 doses (at each meal and at bedtime).

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

Along with its needed effects, trihexyphenidyl 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