BENTYL is an antispasmodic and anticholinergic (antimuscarinic) agent available in the following forms:

1. BENTYL capsules for oral use contain 10 mg dicyclomine hydrochloride USP. BENTYL 10 mg capsules also contain inactive ingredients: calcium sulfate, corn starch, FD&C Blue No. 1, FD&C Red No. 40, gelatin, lactose, magnesium stearate, pregelatinized corn starch, and titanium dioxide.
2. BENTYL tablets for oral use contain 20 mg dicyclomine hydrochloride USP. BENTYL 20 mg tablets also contain inactive ingredients: acacia, dibasic calcium phosphate, corn starch, FD&C Blue No. 1, lactose, magnesium stearate, pregelatinized corn starch, and sucrose.
3. BENTYL syrup for oral use contains 10 mg dicyclomine hydrochloride USP in each 5 mL (1 teaspoonful). BENTYL syrup also contains inactive ingredients: citric acid, D&C Red No. 33, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavors, glucose, methylparaben, propylene glycol, propylparaben, saccharin sodium, and water.
4. BENTYL injection is a sterile, pyrogen-free, aqueous solution for intramuscular injection (NOT FOR INTRAVENOUS USE).

Ampule. 20 mg/2 mL (10 mg/mL) -Each mL contains 10 mg dicyclomine hydrochloride USP in sterile water for injection, made isotonic with sodium chloride.

Chemically, BENTYL (dicyclomine hydrochloride) is [bicyclohexyl]-1-carboxylic acid, 2-(diethylamino) ethyl ester, hydrochloride with the following chemical structure:

Dicyclomine hydrochloride occurs as a fine, white, crystalline, practically odorless powder with a bitter taste. It is soluble in water, freely soluble in alcohol and chloroform, and very slightly soluble in ether.

Last updated on RxList: 11/16/2007

For the treatment of functional bowel/irritable bowel syndrome.

DOSAGE MUST BE ADJUSTED TO INDIVIDUAL PATIENT NEEDS (See CLINICAL PHARMACOLOGY.)

Adults-Oral. The only oral dose clearly shown to be effective is 160 mg per day (in 4 equally divided doses). Since this dose is associated with a significant incidence of side effects, it is prudent to begin with 80 mg per day (in 4 equally divided doses). Depending upon the patient's response during the first week of therapy, the dose should be increased to 160 mg per day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.

Adults-Intramuscular Injection. NOT FOR INTRAVENOUS USE.

The intramuscular dosage form is to be used temporarily when the patient cannot take oral medication. Intramuscular injection is about twice as bioavailable as oral dosage forms; consequently, the recommended intramuscular dose is 80 mg daily (in 4 equally divided doses). Oral dicyclomine hydrochloride should be started as soon as possible and the intramuscular form should not be used for periods longer than 1 or 2 days.

ASPIRATE THE SYRINGE BEFORE INJECTING TO AVOID INTRAVASUCLAR INJECTION, SINCE THROMBOSIS MAY OCCUR IF THE DRUG IS INADVERTENTLY INJECTED INTRAVASCULARLY. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Elderly: In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See PRECAUTIONS Geriatric Use)

10 mg blue capsules, imprinted BENTYL 10, NDC 58914-012-10: bottles of 100. Store at room temperature, preferably below 86°F (30°C).

20 mg compressed, light blue, round tablets, debossed BENTYL 20, NDC 58914-013-10: bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).

10 mg/5 mL pink syrup, NDC 58914-015-16: 16 ounce bottle.
Store at room temperature, preferably below 86°F (30°C). Protect from excessive heat.

20 mg/2 mL (10 mg/mL) injection (for intramuscular use only, NOT FOR INTRAVENOUS USE)
NDC 58914-080-52: Boxes of five 20 mg/2 mL ampules (10 mg/mL).

Store at room temperature, preferably below 86°F (30°C). Protect from freezing.

Rev. March 2005. Bentyl Capsules, Bentyl Tablets and Bentyl Syrup Manufactured by: Patheon Pharmaceuticals Inc. Cincinnati, OH 45215. Bentyl Injection Manufactured by: Akorn Inc. Decatur, IL 62522. FDA Rev date: 2/2/2007

Last updated on RxList: 11/16/2007

Controlled clinical trials have provided frequency information for reported adverse effects of dicyclomine hydrochloride listed in a decreasing order of frequency. (See CLINICAL PHARMACOLOGY.)

Not all of the following adverse reactions have been reported with dicyclomine hydrochloride.

Adverse reactions are included here that have been reported for pharmacologically similar drugs with anticholinergic/antispasmodic action.

Gastrointestinal: dry mouth, nausea, vomiting, constipation, bloated feeling, abdominal pain, taste loss, anorexia

Central Nervous System: dizziness, light-headedness, tingling, headache, drowsiness, weakness, nervousness, numbness, mental confusion and/or excitement (especially in elderly persons), dyskinesia, lethargy, syncope, speech disturbance, insomnia

Ophthalmologic: blurred vision, diplopia, mydriasis, cycloplegia, increased ocular tension

Dermatologic/Allergic: rash, urticaria, itching, and other dermal manifestations; severe allergic reaction or drug idiosyncrasies including anaphylaxis

Genitourinary: urinary hesitancy, urinary retention

Cardiovascular: tachycardia, palpitations

Respiratory: dyspnea, apnea, asphyxia (see WARNINGS)

Other: decreased sweating, nasal stuffiness or congestion, sneezing, throat congestion, impotence, suppression of lactation (see PRECAUTIONS: Nursing Mothers)

With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the I.M. injection of the drug.

Drug Abuse And Dependence

Abuse of and/or dependence on dicyclomine for anticholinergic effects have been rarely reported.

The following agents may increase certain actions or side effects of anticholinergic drugs: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.

Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. (See also CONTRAINDICATIONS.)

Anticholinergic agents may affect gastrointestinal absorption of various drugs, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result. Anticholinergic drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide. Because antacids may interfere with the absorption of anticholinergic agents, simultaneous use of these drugs should be avoided. The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.

Last updated on RxList: 11/16/2007

In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and supportive measures instituted.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients withileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.

BENTYL may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Psychosis has been reported in sensitive individuals given anticholinergic drugs. CNS signs and symptoms include confusion, disorientation, short-term memory loss, hallucinations, dysarthria, ataxia, coma, euphoria, decreased anxiety, fatigue, insomnia, agitation and mannerisms, and inappropriate affect.

These CNS signs and symptoms usually resolve within 12 to 24 hours after discontinuation of the drug.

There are reports that administration of dicyclomine hydrochloride syrup to infants has been followed by serious respiratory symptoms (dyspnea, shortness of breath, breathlessness, respiratory collapse, apnea, asphyxia), seizures, syncope, pulse rate fluctuations, muscular hypotonia, and coma. Death has been reported. No causal relationship between these effects observed in infants and dicyclomine administration has been established. BENTYL IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE AND IN NURSING MOTHERS. (See CONTRAINDICATIONS and PRECAUTIONS: Nursing Mothers and Pediatric Use.)

Safety and efficacy of dicyclomine hydrochloride in pediatric patients have not been established.

General

Use with caution in patients with:

1. Autonomic neuropathy
2. Hepatic or renal disease
3. Ulcerative colitis-large doses may suppress intestinal motility to the point of producing a paralytic ileus and the use of this drug may precipitate or aggravate the serious complication of toxic megacolon (see CONTRAINDICATIONS)
4. Hyperthyroidism
5. Hypertension
6. Coronary heart disease
7. Congestive heart failure
8. Cardiac tachyarrhythmia
9. Hiatal hernia (see CONTRAINDICATIONS: Reflux esophagitis)
10. Known or suspected prostatic hypertrophy.

Investigate any tachycardia before administration of dicyclomine hydrochloride, since it may increase the heart rate.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

Carcinogenesis, Mutagenesis, Impairment of Fertility

There are no known human data on long-term potential for carcinogenicity or mutagenicity. Long-term studies in animals to determine carcinogenic potential are not known to have been conducted. In studies in rats at doses of up to 100 mg/kg/day, BENTYL produced no deleterious effects on breeding, conception, or parturition.

Pregnancy

Teratogenic Effects. Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at doses up to 33 times the maximum recommended human dose based on 160 mg/day (3 mg/kg) and have revealed no evidence of impaired fertility or harm to the fetus due to dicyclomine. Epidemiologic studies in pregnant women with products containing dicyclomine hydrochloride (at doses up to 40 mg/day) have not shown that dicyclomine increases the risk of fetal abnormalities if administered during the first trimester of pregnancy. There are, however, no adequate and well-controlled studies in pregnant women at the recommended doses (80-160 mg/day). Because animal reproduction studies are not always predictive of human response, BENTYL as indicated for functional bowel/irritable bowel syndrome should be used during pregnancy only if clearly needed.

Nursing Mothers

Since dicyclomine hydrochloride has been reported to be excreted in human milk, BENTYL IS CONTRAINDICATED IN NURSING MOTHERS. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS: Pediatric Use and ADVERSE REACTIONS.)

Pediatric Use

(See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Nursing Mothers.) BENTYL IS CONTRAINDICATED IN INFANTS LESS THAN 6 MONTHS OF AGE. Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of Bentyl did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. (See DOSAGE AND ADMINISTRATION)

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Last updated on RxList: 11/16/2007

Signs and Symptoms

The signs and symptoms of overdosage are headache; nausea; vomiting; blurred vision; dilated pupils; hot, dry skin; dizziness; dryness of the mouth; difficulty in swallowing; and CNS stimulation. A curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).

A 37-year-old female reported numbness on the left side, cold fingertips, blurred vision, abdominal and flank pain, decreased appetite, dry mouth, and nervousness following ingestion of 320 mg daily (four 20 mg tablets QID) for four days. These events resolved after discontinuing the dicyclomine.

Oral LD₅₀

The acute oral LD₅₀ of the drug is 625 mg/kg in mice.

Minimum Human Lethal Dose/Maximum Human Dose Recorded

The amount of drug in a single dose that is ordinarily associated with symptoms of overdosage or that is likely to be life-threatening, has not been defined. The maximum human oral dose recorded was 600 mg by mouth in a 10-month-old child and approximately 1500 mg in an adult, each of whom survived. In three of the infants who died following administration of dicyclomine hydrochloride (see WARNINGS), the blood concentrations of drug were 200, 220, and 505 ng/mL, respectively.

Dialysis

It is not know if BENTYL is dialyzable.

Treatment

Treatment should consist of gastric lavage, emetics, and activated charcoal. Sedatives (e.g., short-acting barbiturates, benzodiazepines) may be used for management of overt signs of excitement. If indicated, an appropriate parenteral cholinergic agent may be used as an antidote.

1. Obstructive uropathy
2. Obstructive disease of the gastrointestinal tract
3. Severe ulcerative colitis (See PRECAUTIONS)
4. Reflux esophagitis
5. Unstable cardiovascular status in acute hemorrhage
6. Glaucoma
7. Myasthenia gravis
8. Evidence of prior hypersensitivity to dicyclomine hydrochloride or other ingredients of these formulations
9. Infants less than 6 months of age (See WARNINGS and PRECAUTIONS: Information for Patients.)
10. Nursing Mothers (See WARNINGS and PRECAUTIONS: Information for Patients.)

Last updated on RxList: 11/16/2007

Dicyclomine relieves smooth muscle spasm of the gastrointestinal tract. Animal studies indicate that this action is achieved via a dual mechanism: (1) a specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites with approximately 1/8 the milligram potency of atropine (in vitro, guinea pig ileum); and (2) a direct effect upon smooth muscle (musculotropic) as evidenced by dicyclomine's antagonism of bradykinin- and histamine-induced spasms of the isolated guinea pig ileum. Atropine did not affect responses to these two agonists. In vivo studies in cats and dogs showed dicyclomine to be equally potent against acetylcholine (ACh)- or barium chloride (BaCI₂)-induced intestinal spasm while atropine was at least 200 times more potent against effects of ACh than BaCI₂. Tests for mydriatic effects in mice showed that dicyclomine was approximately 1/500 as potent as atropine; antisialagogue tests in rabbits showed dicyclomine to be 1/300 as potent as atropine.

In man, dicyclomine is rapidly absorbed after oral administration, reaching peak values within 60-90 minutes. The principal route of elimination is via the urine (79.5% of the dose). Excretion also occurs in the feces, but to a lesser extent (8.4%). Mean half-life of plasma elimination in one study was determined to be approximately 1.8 hours when plasma concentrations were measured for 9 hours after a single dose. In subsequent studies, plasma concentrations were followed for up to 24 hours after a single dose, showing a secondary phase of elimination with a somewhat longer half-life. Mean volume of distribution for a 20 mg oral dose is approximately 3.65 L/kg suggesting extensive distribution in tissues.

In controlled clinical trials involving over 100 patients who received drug, 82% of patients treated for functional bowel/irritable bowel syndrome with dicyclomine hydrochloride at initial doses of 160 mg daily (40 mg q.i.d.) demonstrated a favorable clinical response compared with 55% treated with placebo (p<.05). In these trials most of the side effects were typically anticholinergic in nature (see table) and were reported by 61% of the patients.

Side Effect	Dicyclomine Hydrochloride (40 mg q.i.d.) %	Placebo %
Dry Mouth	33	5
Dizziness	29	2
Blurred Vision	27	2
Nausea	14	6
Light-Headedness	11	3
Drowsiness	9	1
Weakness	7	1
Nervousness	6	2

Nine percent (9%) of patients were discontinued from the drug because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated. (See ADVERSE REACTIONS.)

Last updated on RxList: 11/16/2007

BENTYL may produce drowsiness or blurred vision. The patient should be warned not to engage in activities requiring mental alertness, such as operating a motor vehicle or other machinery or to perform hazardous work while taking this drug.

BENTYL is contraindicated in infants less than 6 months of age and in nursing mothers. (See CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS: Nursing Mothers and Pediatric Use.) In the presence of a high environmental temperature, heat prostration can occur with drug use (fever and heat stroke due to decreased sweating). If symptoms occur, the drug should be discontinued and a physician contacted.

Last updated on RxList: 11/16/2007

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.

DICYCLOMINE - ORAL

(dye-SYE-klo-meen)

COMMON BRAND NAME(S): Bentyl

USES: This medication is used to treat a certain intestinal problem (irritable bowel syndrome) when other treatments have not worked (e.g., diet changes, anxiety treatment). Dicyclomine belongs to a class of drugs known as anticholinergics/antispasmodics. It works by decreasing intestinal cramping.

This medication should not be used in children younger than 6 months.

HOW TO USE: Take this medication by mouth, usually 4 times daily or exactly as directed by your doctor. To decrease side effects, your doctor will usually direct you to start taking a lower dose of this medication, then gradually increase it to a dose that relieves your symptoms. If you are also taking an antacid, do not take it with dicyclomine because the antacid may interfere with how your body absorbs this drug. Take dicyclomine at least 1 hour before or 2 hours after the antacid.

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.

Dosage of dicyclomine is based on your age, medical condition, and response to treatment. It is usually used for only 2 weeks at a time.

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

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.

Tell your doctor if your condition persists or worsens during the first 1 to 2 weeks of treatment.

SIDE EFFECTS: Drowsiness, dry mouth, dizziness, blurred vision, dry eyes, tiredness, and trouble sleeping may occur. Less common side effects may also include lightheadedness, nausea, vomiting, headache, loss of appetite, temporary loss of the ability to taste, constipation, abdominal bloating/pain, problems sleeping, unusually fast heartbeat, and stuffy nose. If any of these effects persist or worsen, tell 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. To relieve dry eyes, consult your pharmacist for an appropriate eye lubricant.

To prevent constipation, maintain a diet adequate in fiber, and drink plenty of water. If you become constipated while using this drug, tell your doctor immediately.

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 sweating, sudden fast/irregular heartbeat, speaking problems, mental/mood changes (e.g., confusion, unusual behavior, aggressive behavior, excitability, nervousness), problems starting the flow of urine, shortness of breath, decreased sexual ability, diarrhea if you have a colostomy or ileostomy.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 dicyclomine, 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: glaucoma, urine blockage due to narrowing of the urination tube (urethra), enlarged prostate, blockage or narrowing in the stomach/intestines, severe slowing or stoppage of the intestines (e.g., intestinal atony, paralytic ileus), any condition that causes immobility (being bedridden), severe bleeding, a certain severe intestinal disease (severe ulcerative colitis), a certain muscle disease (myasthenia gravis), severe and persistent heartburn, severe bleeding with fainting.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, kidney problems, enlarged prostate, ulcerative colitis, heart disease (e.g., angina, previous heart attack, chronic heart failure, heart rhythm problems), overactive thyroid (hyperthyroidism), high blood pressure, nerve problems that cause slowing of the intestines (autonomic neuropathy), hiatal hernia with heartburn, drug/alcohol abuse, previous heatstroke, sleep apnea.

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages.

This drug may make you sweat less, causing you to be more likely to develop a severe condition caused by becoming overheated (heatstroke). Use caution in hot temperatures and during strenuous exercise. Drink plenty of fluids, and dress lightly while in hot weather or when exercising. Check carefully for signs of decreased sweating. If this occurs, stop exercising and promptly seek cooler shelter. Seek immediate medical attention if your body temperature is above normal or if you have mental/mood changes, headache, or dizziness.

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness, confusion, and urination problems.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast milk production may also be decreased by this medication. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your 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 your doctor or pharmacist first.

This drug should not be used with the following medications because very serious interactions may occur: pramlintide, potassium tablets/capsules.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting dicyclomine.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of drugs that have similar drying side effects such as: certain antihistamines (e.g., diphenhydramine), amantadine, tricyclic antidepressants (e.g., amitriptyline), psychiatric medicines (e.g., chlorpromazine, risperidone, clozapine, trazodone), certain heart rhythm medications (e.g., disopyramide, quinidine), narcotic pain medicines (e.g., meperidine, morphine).

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants (e.g., methocarbamol), among others.

Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

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. Canada residents can call a provincial poison control center. Symptoms of overdose may include: headache, nausea, vomiting, blurred vision, large pupils, hot/dry skin, severe dizziness, severely dry mouth, difficulty swallowing, excitability, muscle weakness, paralysis, slowed breathing, fainting, seizures.

NOTES: Do not share this medication with others.

Keep all medical appointments so that your doctor can periodically 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 below 86 degrees F (30 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.