FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with use of CANTIL.
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 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.
With overdosage, a curare-like action may occur i.e., neuromuscular blockage leading to muscular weakness and possible paralysis.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources
Cantil Manufacturers
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Sanofi-aventis U.s. Llc
Cantil | Sanofi-aventis U.s. Llc
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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