CANTIL tablets for oral administration contain 25 mg mepenzolate bromide USP. The anticholinergic agent mepenzolate bromide USP chemically is 3-[(hydroxydiphenylacetyl)oxy]-1,1-dimethylpiperidinium bromide and has the following structure: Mepenzolate bromide occurs as a white or light cream-colored powder, which is freely soluble in methanol, slightly soluble in water and chloroform, and practically insoluble in ether. Each yellow tablet contains 25 mg mepenzolate bromide USP. This tablet also contains inactive ingredients: confectioners' sugar, corn starch, corn syrup solids, FD&C Yellow No. 5 (tartrazine), (see PRECAUTIONS, General), lactose, magnesium stearate and microcrystalline cellulose.

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Precise frequency data from controlled clinical studies with CANTIL (mepenzolate bromide) are not available. Gastrointestinal System: vomiting, nausea, constipation, loss of taste, bloated feeling, dry mouth Central Nervous System: mental confusion, dizziness, weakness, drowsiness, headache, nervousness Ophthalmologic: increased ocular tension, cycloplegia, blurred vision, dilation of the pupil Dermatologic-Hypersensitivity: anaphylaxis, urticaria Cardiovascular: tachycardia, palpitations Genitourinary: urinary retention, urinary hesitancy Miscellaneous: decreased sweating, drowsiness, insomnia, impotence, suppression of lactation Drug Abuse And Dependence Tolerance, abuse, or dependence has not been reported with CANTIL (mepenzolate bromide) . Read the Cantil (mepenzolate bromide) Side Effects Center for a complete guide to possible side effectsLearn More »

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The usual adult dose is 1 or 2 tablets (25 or 50 mg) 4 times a day preferably with meals and at bedtime. Begin with the lower dosage when possible and adjust subsequently according to the patient's response. Safety and efficacy in pediatric patients have not been established. 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.)

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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 CONTRAINDICATIONS.) Anticholinergic agents may affect gastrointestinal absorption of various drugs, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentrations 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. Read the Cantil Drug Interactions Center for a complete guide to possible interactions Learn More »

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CANTIL (mepenzolate bromide) is indicated for use as adjunctive therapy in the treatment of peptic ulcer. It has not been shown to be effective in contributing to the healing of peptic ulcer, decreasing the rate of recurrence, or preventing complications.

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1. Glaucoma
2. Obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy)
3. Obstructive disease of the gastrointestinal tract (for example, pyloroduodenal stenosis, achalasia)
4. Paralytic ileus
5. Intestinal atony of the elderly or debilitated patient (See PRECAUTIONS, Geriatric Use)
6. Unstable cardiovascular status in acute gastrointestinal hemorrhage
7. Toxic megacolon complicating ulcerative colitis
8. Myasthenia gravis
9. Allergic or idiosyncratic reactions to CANTIL (mepenzolate bromide) or related compounds

Last reviewed on RxList: 5/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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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). Oral LD50 The oral LD50 is greater than 750 mg/kg in mice and greater than 1000 mg/kg in rats. Maximum Human Dose Recorded The maximum human dose recorded is 375 to 500 mg in a 4-year-old child (no adverse effects reported) and 500 to 750 mg in a 30-year-old adult (resulted in death). Dialysis It is not known if the drug 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.

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25 mg mepenzolate bromide, compressed yellow tablets debossed MERRELL 37. NDC 0068-0037-01: bottles of 100 Keep tightly closed. Store at room temperature, preferably below 86°F. Protect from excessive heat. Dispense in tight containers with child-resistant closure. Rev. February 2006. Manufactured for: sanofi-aventis U.S. LLC Bridgewater, NJ 08807. Last reviewed on RxList: 5/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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General Use CANTIL (mepenzolate bromide) with caution in the elderly (see PRECAUTIONS, Geriatric Use) and in all 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 for this reason precipitate or aggravate "toxic megacolon," a serious complication of the disease.
4. Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.
5. Coronary heart disease
6. Congestive heart failure
7. Cardiac arrhythmias
8. Tachycardia
9. Hypertension
10. Prostatic hypertrophy
11. Hyperthyroidism

Investigate any tachycardia before giving anticholinergic (atropine-like) drugs since they may increase the heart rate. This product contains FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin sensitivity. Carcinogenesis, Mutagenesis, Impairment of Fertility No data are available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility in animals or humans. Pregnancy Teratogenic Effects.Pregnancy Category B.Reproduction studies have been performed in rats and rabbits at doses up to 30 times the human dose (based on 50 kg weight) and have shown no evidence of impaired fertility or harm to the animal fetus. There are, however, no adequate and well-controlled studies with CANTIL (mepenzolate bromide) in pregnant women. Because animal reproduction studies are not always predictive of human response, CANTIL (mepenzolate bromide) should be used during pregnancy only if clearly needed. Nonteratogenic Effects. No data are available on nonteratogenic effects in the fetus or newborn infant. Nursing Mothers It is not known whether CANTIL (mepenzolate bromide) is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CANTIL (mepenzolate bromide) is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Studies in newborn animals (rats) show that younger animals are more sensitive to the toxic effects of CANTIL (mepenzolate bromide) than are older animals. Geriatric Use Clinical studies of CANTIL (mepenzolate bromide) 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 (See DOSAGE AND ADMINISTRATION), reflecting the greater frequency of decreased hepatic, renal or cardiac function (see PRECAUTIONS, General), and of concomitant disease or other drug therapy. (See PRECAUTIONS: DRUG INTERACTIONS.) CANTIL (mepenzolate bromide) is contraindicated in intestinal atony of the elderly. (See CONTRAINDICATIONS.) CANTIL (mepenzolate bromide) should be used with caution in the elderly. (See PRECAUTIONS, General.) Last reviewed on RxList: 5/6/2009
This monograph has been modified to include the generic and brand name in many instances.

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