Bentyl (Dicyclomine) Drug Information: Overdosage and Contraindications

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May 25, 2012

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Irritable Bowel Syndrome (IBS) »

What is irritable bowel syndrome (IBS)?

Irritable bowel syndrome (IBS) is one of the most common ailments of the bowel (intestines) and affects an estimated 15% of people in the US. The term, irritable bowel, is not a particularly accurate one since it implies that the bowel is responding irritably to normal stimuli, and this may or may not be the case. The several terms used for IBS, including spastic colon, spastic colitis, and mucous colitis, attest to the difficulty of getting a descriptive handle on the ailment. Moreover, each of the other names is itself as problematic as the term IBS.

IBS is best described as a functional disease. The concept of functional disease is particularly useful when discussing diseases of the gastrointestinal tract. The concept applies to the muscular organs of the gastrointestinal tract; the esophagus, stomach, small intestine, gallbladder, and colon. What is meant by the term, functional, is that either th...

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OVERDOSE

In case of an overdose, patients should contact a physician, poison control center (1-800-222-1222), or emergency room.

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

One reported event included a 37-year-old who 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 four times daily). These events resolved after discontinuing the dicyclomine.

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

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 AND PRECAUTIONS], the blood concentrations of drug were 200, 220, and 505 ng/mL.

It is not known if BENTYL is dialyzable.

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.

CONTRAINDICATIONS

BENTYL is contraindicated in infants less than 6 months of age [see Use in Specific Populations], nursing mothers [see Use In Specific Populations], and in patients with: