"The U.S. Food and Drug Administration today allowed marketing of the Eclipse System for the treatment of fecal incontinence (FI) in adult women.
Fecal incontinence is the inability to control bowel movements and is a common problem, espec"...
Diarrhea may be an early symptom of incomplete intestinal obstruction especially in patients with ileostomy or colostomy. In this instance, treatment with this drug would be inappropriate and possibly harmful.
CANTIL (mepenzolate bromide) 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.
It should be noted that the use of anticholinergic drugs in the treatment of gastric ulcer may produce a delay in gastric emptying time and may complicate such therapy (antral stasis). 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 medication.
Use CANTIL (mepenzolate bromide) 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
- Prostatic hypertrophy
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.
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.
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.
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.
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.)This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/6/2009
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