ARTANE trihexyphenidyl HCl is a synthetic antispasmodic drug available in the following forms:

Tablets

Containing 2 mg and 5 mg ARTANE trihexyphenidyl HCl, each strength also containing as inactive ingredients: Corn Starch, Dibasic Calcium Phosphate, Magnesium Stearate and Pregelatinized Starch.

Elixir

Containing 2 mg/5 mL ARTANE trihexyphenidyl HCl in a clear, colorless, lime-mint flavored preparation, also containing as inactive ingredients: Alcohol 5%, Citric Acid, Flavorings, Methylparaben, Propylparaben, Sodium Chloride and Sorbitol Solution.

This drug is indicated as an adjunct in the treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic and idiopathic). It is often useful as adjuvant therapy when treating these forms of parkinsonism with levodopa. Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as the dibenzoxazepines, phenothiazines, thioxanthenes, and butyrophenones.

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether ARTANE trihexyphenidyl HCl may best be given before or after meals should be determined by the way the patient reacts. Postencephalitic patients who are usually more prone to excessive salivation, may prefer to take it after meals and may, in addition, require small amounts of atropine which, under such circumstances is sometimes an effective adjuvant. It ARTANE tends to dry the mouth excessively, it may be better to take it before meals, unless it causes nausea. If taken after meals, the thirst sometimes induced can be allayed by mint candies, chewing gum or water.

As initial therapy for parkinsonism, 1 mg of ARTANE in tablet or elixir form may be administered the first day. The dose may then be increased by 2 mg increments at intervals of three to five days, until a total of 6 to 10 mg is given daily. The total daily dose will depend upon what is found to be the optimal level. Many patients derive maximum benefit from this daily total of 6 to 1 0 mg but some patients, chiefly those in the postencephalitic group, may require a total daily dose of 12 to 15 mg.

The size and frequency of dose of ARTANE needed to control extrapyramidal reactions to commonly employed tranquilizers, notably the phenothiazines, thioxanthenes, and butyrophenones, must be determined empirically. The total daily dosage usually ranges between 5 and 15 mg although in some cases these reactions have been satisfactorily controlled on as little as 1 mg daily. It may be advisable to commence therapy with a single 1 mg dose. If the extrapyramidal manifestations are not controlled in a few hours, the subsequent doses may be progressively increased until satisfactory control is achieved. Satisfactory control may sometimes be more rapidly achieved by temporarily reducing the dosage of the tranquilizer on instituting ARTANE trihexyphenidyl HCl therapy and then adjusting dosage of both drugs until the desired ataractic effect is retained without onset of extrapyramidal reactions.

It is sometimes possible to maintain the patient on a reduced ARTANE dosage after the reactions have remained under control for several days. Instances have been reported in which these reactions have remained in remission for long periods after ARTANE therapy was discontinued.

When ARTANE is used concomitantly with levodopa, the usual dose of each may need to be reduced. Careful adjustment is necessary, depending on side effects and degree of symptom control. ARTANE dosage of 3 to 6 mg daily, in divided doses, is usually adequate.

Concomitant Use of ARTANE Trihexyphenidyl HCl with Other Parasympathetic Inhibitors

ARTANE TABLETS: Trihexyphenidyl HCl may be substituted in whole or in part, for other parasympathetic inhibitors. The usual technique is partial substitution initially, with progressive reduction in the other medication as the dose of trihexyphenidyl HCl is increased.

ARTANE TABLETS and ELIXIR: The total daily intake of ARTANE tablets or elixir is tolerated best if divided into 3 doses and taken at mealtimes. High doses (> 10 mg daily) may be divided into 4 parts, with 3 doses administered at mealtimes and the fourth at bedtime.

ARTANE® trihexyphenidyl HCl is available as follows:

TABLETS

2 mg - round, flat, scored, white tablets; engraved ARTANE above 2 on one side and LL above A11 below the score on the other side, supplied as follows:

NDC 0005-4434-23 - Bottle of 100
NDC 0005-4434-34 - Bottle of 1000
NDC 0005-4434-60 - Unit Dose 10 (2 X 5) Strips

5 mg - round, flat scored, white tablets; engraved ARTANE above 5 on one side and LL above A12 below the score on the other side, supplied as follows:

NDC 0005-4436-23 - Bottle of 100
NDC 0005-4436-34 - Bottle of 1000
NDC 0005-4436-60 - Unit Dose 10 (2 X 5) Strips

Store at controlled room temperature 20°- 25° C (68°- 77° F).

Dispense in tight containers as defined in the USP

ELIXIR

2 mg/5 ml - NDC 0005-4440-65 - Bottle of 16 fl o

Store at controlled room temperature 20°- 25° C (68°- 77° F).

DO NOT FREEZE.

Dispense in tight containers as defined in the USP.

Updated Sep 30, 2003

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 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 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.

Potential side effects associated with the use of any atropine-like drugs, including Artane, 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 is not classified as a controlled substance, the possibility of abuse should be borne in mind due to its stimulant and euphoriant properties.

Cannabinoids, barbiturates, opiates, and alcohol may have additive effects with ARTANE, and thus, an abuse potential exists.

Concurrent use of alcohol or other CNS depressants with ARTANE may cause increased sedative effects.

Monoamine oxidase inhibitors and tricyclic antidepressants possessing significant anticholinergic activity may intensify the anticholinergic effects of antidyskinetic agents because of the secondary anticholinergic activities of these medications.

Prophylactic administration of anticholinergic agents, such as trihexyphenidyl, as a prevention of drug-induced parkinsonism during neuroleptic therapy is not recommended. There may be an increased risk for the development of tardive dyskinesia during concomitant administration of anticholinergics and neuroleptics (see PRECAUTIONS, General).

The usual dose of either trihexyphenidyl or levodopa may need to be reduced during concomitant therapy, since concomitant administration may increase drug-induced involuntary movements (see DOSAGE AND ADMINISTRATION).

Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ARTANE is administered to a nursing woman. As with other anticholinergics, trihexyphenidyl may cause suppression of lactation. Therefore, trihexyphenidyl should only be used if the expected benefit to the mother outweighs the potential risk to the infant.

Pediatric Use
Safety and effectiveness in pediatric patients have not been established. (See also ADVERSE REACTIONS.)

Patients to be treated with ARTANE should have a gonioscope evaluation prior to initiation of therapy and close monitoring of intraocular pressures. The use of anticholinergic drugs may precipitate angle closure with an increase in intraocular pressure. If blurring of vision occurs during therapy, the possibility of narrow angle glaucoma should be considered. Blindness has been reported due to aggravation of narrow angle glaucoma (see CONTRAINDICATIONS and
ADVERSE REACTIONS).

ARTANE should be administered with caution in hot weather, especially when given concomitantly with other atropine-like drugs to the chronically ill, alcoholics, those who have central nervous system disease, or those who do manual labor in a hot environment. Anhidrosis may occur more readily when some disturbance of sweating already exists. If there is evidence of anhidrosis, the possibility of hyperthermia should be considered. Dosage should be decreased so that the ability to maintain body heat equilibrium via perspiration is not impaired. Severe anhidrosis and fatal hyperthermia have occurred with the use of anticholinergics under the conditions described above.

Neuroleptic Malignant Syndrome
A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with dose reduction or discontinuation of trihexyphenidyl. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmias). The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (eg, pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.

General
Patients with cardiac, liver, or kidney disorders, or with hypertension, should be closely monitored.

Since ARTANE has atropine-like properties, patients on long-term treatment should be carefully monitored for untoward reactions.

Since ARTANE has parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Incipient glaucoma may be precipitated by parasympatholytic drugs such as ARTANE.

Tardive dyskinesia may appear in some patients on long-term therapy with antipsychotic drugs or may occur after therapy with these drugs has been discontinued. Antiparkinsonism agents do not alleviate the symptoms of tardive dyskinesia, and in some instances may aggravate them. However, parkinsonism and tardive dyskinesia often coexist in patients receiving chronic neuroleptic treatment, and anticholinergic therapy with ARTANE may relieve some of these parkinsonism symptoms. ARTANE is not recommended for use in patients with tardive dyskinesia unless they have concomitant Parkinson's disease.

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. (See DRUG ABUSE AND DEPENDENCE.) Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided (see DOSAGE AND ADMINISTRATION).

Information for Patients

ARTANE 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 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.

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 may be taken with food.

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

The mean oral LD50 of ARTANE has been reported to be 365 mg/kg (range, 325 to 410 mg/kg) in mice and 1660 mg/kg (1420 to 1940 mg/kg) in rats. At a dose of 40 mg/kg, dogs have exhibited emesis, restlessness followed by drowsiness, equilibrium disturbances, and mydriasis. In humans, doses up to 300 mg (5 mg/kg) have been ingested without fatalities or sequelae. However, rare cases of death associated with trihexyphenidyl overdosages taken in conjunction with other CNS-depressant agents have been reported or in patients with a compromised respiratory condition. Trihexyphenidyl blood concentrations associated with the fatalities ranged from 0.03 to 0.80 mg/l.

Signs and Symptoms
Overdosage with ARTANE produces typical central symptoms of atropine intoxication (the central anticholinergic syndrome). Correct diagnosis depends upon recognition of the peripheral signs of parasympathetic blockade, including dilated and sluggish pupils; warm, dry skin; facial flushing; decreased secretions of the mouth, pharynx, nose, and bronchi; foul-smelling breath; elevated temperature; tachycardia, cardiac arrhythmias; decreased bowel sounds; and urinary retention. Neuropsychiatric signs such as delirium, disorientation, anxiety, hallucinations, illusions, confusion, incoherence, agitation, hyperactivity, ataxia, lip smacking and tasting movements, loss of memory, paranoia, combativeness, and seizures may be present. The condition can progress to stupor, coma, paralysis, cardiac and respiratory arrest, and death.

Treatment
Treatment of acute overdose involves symptomatic and supportive therapy. Gastric lavage or other methods to limit absorption should be instituted. A small dose of diazepam or a short-acting barbiturate may be administered if CNS excitation is observed. Phenothiazines are contraindicated because the toxicity may be intensified due to their antimuscarinic action, causing coma. Respiratory support, artificial respiration or vasopressor agents may be necessary. Hyperpyrexia must be reversed, fluid volume replaced and acid-balance maintained. Urinary catheterization may be necessary. It is not known if ARTANE is dialyzable.

ARTANE is contraindicated in patients with hypersensitivity to trihexyphenidyl HCl or to any of the tablet or elixir ingredients. Artane is also contraindicated in patients with narrow angle glaucoma. Blindness after long-term use due to narrow angle glaucoma has been reported.

ACTIONS

ARTANE trihexyphenidyl HCl is the substituted piperidine salt, 3-(1-piperidyl)-1-phenyl-cyclohexyl-1-propanol hydrochloride, which exerts a direct inhibitory effect upon the parasympathetic nervous system. It also has a relaxing effect on smooth musculature; exerted both directly upon the muscle tissue itself and indirectly through an inhibitory effect upon the parasympathetic nervous system. Its therapeutic properties are similar to those of atropine although undesirable side effects are ordinarily less frequent and severe than with the latter.

ARTANE 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 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.

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 may be taken with food.

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

Please also refer to the WARNINGS and PRECAUTIONS sections.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

TRIHEXYPHENIDYL - ORAL

(try-hex-ee-FEH-nih-dill)

USES: Trihexyphenidyl is used to treat symptoms of Parkinson's disease or involuntary movements due to the side effects of certain psychiatric drugs (antipsychotics such as chlorpromazine/haloperidol). Trihexyphenidyl belongs to a class of medication called anticholinergics that work by blocking a certain natural substance (acetylcholine). This helps decrease muscle stiffness, sweating, and the production of saliva, and helps improve walking ability in people with Parkinson's disease.

Anticholinergics can stop severe muscle spasms of the back, neck, and eyes that are sometimes caused by psychiatric drugs. It can also decrease other side effects such as muscle stiffness/rigidity (extrapyramidal signs-EPS). It is not helpful in treating movement problems caused by tardive dyskinesia and may worsen them.

HOW TO USE: Take this medication by mouth, usually 3 to 4 times a day with meals and at bedtime, or as directed by your doctor. Your doctor may start you at a low dose and increase your dose slowly to find the best dose for you. The dosage is based on your medical condition and response to therapy.

If you are using the liquid form of this medication, measure your dose with a special measuring spoon or device. Do not use a household spoon because it may not provide the correct dose.

Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same times each day.

Take this medication at least 1 hour before antacids containing magnesium, aluminum, or calcium. Allow at least 1-2 hours between doses of trihexyphenidyl and certain drugs for diarrhea (adsorbent antidiarrheals such as kaolin, pectin, attapulgite). Take this medication at least 2 hours after ketoconazole. Antacids and some drugs for diarrhea may prevent the full absorption of trihexyphenidyl, and this product may prevent the complete absorption of ketoconazole when these products are taken together.

If you are taking this medication for side effects from another medication, your doctor may instruct you to take it on a regular schedule or only as needed. If you are taking this medication for Parkinson's disease, your doctor may change the dose of your other medications (e.g., levodopa). Follow your doctor's instructions closely.

Rarely, abnormal drug-seeking behavior (addiction) is possible with this medication. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. Properly stop the medication when so directed. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.

When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well. Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Drowsiness, dizziness, constipation, flushing, nausea, nervousness, blurred vision, or dry mouth may occur. These effects usually lessen as your body gets used to the medicine. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: decreased sexual ability, severe stomach/abdominal pain, difficult/painful swallowing, difficulty urinating, vision changes, weakness.

Seek immediate medical attention if any of these very unlikely but very serious side effects occur: chest pain, severe dizziness/fainting, high fever, fast/irregular/slow heartbeat, mental/mood changes (e.g., confusion, hallucinations, memory problems).

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking trihexyphenidyl, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain eye problem (narrow-angle glaucoma), blockage of the bladder/esophagus/stomach/intestines (e.g., bowel obstruction), severe ulcerative colitis.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol use, breathing problems (e.g., asthma, emphysema), diarrhea caused by an infection, certain eye problem (open-angle glaucoma), heart problems (e.g., angina, heart attack, heart failure, fast/irregular heartbeat), high/low blood pressure, intestinal problems (e.g., chronic constipation, ileus, ulcerative colitis), kidney disease, liver disease, mental/mood problems (e.g., anxiety, dementia, psychosis), certain muscle disease (myasthenia gravis), certain nerve disease (autonomic neuropathy), seizure, stomach problems (e.g., acid reflux, hiatal hernia, ulcer), stroke, overactive thyroid (hyperthyroidism), problems urinating (e.g., due to enlarged prostate, neurogenic bladder).

This drug may make you dizzy/drowsy or cause blurred vision; use caution while engaging in activities requiring alertness or clear vision such as driving or using machinery. Avoid alcohol beverages.

To minimize dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

This medication decreases saliva production, an effect that can increase gum and tooth problems (e.g., cavities, gum disease). Take special care with your dental hygiene (e.g., brushing, flossing) and have regular dental check-ups.

Liquid forms of this product may contain alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Some medications (e.g., disulfiram, metronidazole) may cause a serious reaction when combined with alcohol. Tell your doctor if you are taking any medication that should not be used with alcohol. Ask your doctor or pharmacist about using this product safely.

This drug can cause decreased sweating, which could cause a severe rise in your body temperature (hyperthermia). The risk of this serious side effect is greater in hot weather, during vigorous exercise, and/or if you drink alcohol. Drink plenty of fluids and dress lightly while in hot weather and when exercising. If you experience signs of hyperthermia such as mental/mood changes, headache, or dizziness, promptly seek cool or air-conditioned shelter and/or stop exercising, and seek immediate medical attention. Consult your doctor for more details.

The elderly may be more sensitive to the effects of this drug, especially dizziness, heatstroke, memory problems, and constipation.

Children may be more sensitive to the effects of this drug, especially effects on heart rate.

This drug should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medication because very serious interactions may occur: pramlintide.

If you are currently using the medication listed above, tell your doctor or pharmacist before starting trihexyphenidyl.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: amantadine, anticholinergics/antispasmodics (e.g., belladonna alkaloids, clidinium), certain antiarrhythmics (e.g., disopyramide, procainamide, quinidine), cholinesterase inhibitors (e.g., donepezil, galantamine), corticosteroids (e.g., prednisone), monoamine oxidase inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, selegiline, tranylcypromine), motion sickness medication (e.g., meclizine, scopolamine), narcotic pain relievers (e.g., meperidine), potassium tablets/capsules, tricyclic antidepressants (e.g., amitriptyline, doxepin).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., risperidone, trazodone).

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain anticholinergics or drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: unusually fast/slow heartbeat, slow/shallow breathing, unconsciousness, seizures, loss of coordination, fever, hot/dry/flushed skin, widened pupils, change in vision, change in the amount of urine, confusion, hallucinations.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., eye exams) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2008 Copyright(c) 2008 First DataBank, Inc.