Data from FDA - Curated by EPG Health - Last updated 19 December 2016

Indication(s)

INDICATIONS AND USAGE CANTIL 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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Advisory information

contraindications

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

Special warnings and precautions

PRECAUTIONS General Use CANTIL with caution in the elderly (see PRECAUTIONS, Geriatric Use) and in all patients with: Autonomic neuropathy Hepatic or renal disease 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.

Hiatal hernia associated with reflux esophagitis, since anticholinergic drugs may aggravate this condition.

Coronary heart disease Congestive heart failure Cardiac arrhythmias Tachycardia Hypertension Prostatic hypertrophy 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.

Information for Patients CANTIL may produce drowsiness or blurred vision.

The patient should be cautioned regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work while taking this drug.

Drug Interactions 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.

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 in pregnant women.

Because animal reproduction studies are not always predictive of human response, CANTIL 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 is secreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when CANTIL 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 than are older animals.

Geriatric Use Clinical studies of CANTIL 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 is contraindicated in intestinal atony of the elderly.

(See CONTRAINDICATIONS.)

CANTIL should be used with caution in the elderly.

(See PRECAUTIONS, General.)

Adverse reactions

ADVERSE REACTIONS Precise frequency data from controlled clinical studies with CANTIL 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

Usage information

Dosing and administration

DOSAGE AND ADMINISTRATION 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.)

Pregnancy and lactation
Nursing Mothers It is not known whether CANTIL is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when CANTIL is administered to a nursing woman.

Interactions

Drug Interactions 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.

More information

Category Value
Authorisation number NDA010679
Orphan designation No
Product NDC 0068-0037
Date Last Revised 20-03-2012
Type HUMAN PRESCRIPTION DRUG
RXCUI 104044
Marketing authorisation holder sanofi-aventis U.S. LLC