Methscopolamine Drug Information

Adjunctive therapy for the treatment of peptic ulcer. METHSCOPOLAMINE BROMIDE HAS NOT BEEN SHOWN TO BE EFFECTIVE IN CONTRIBUTING TO THE HEALING OF PEPTIC ULCER, DECREASING THE RATE OF RECURRENCE OR PREVENTING COMPLICATIONS.

The average dosage of Methscopolamine Bromide Tablets is 2.5 mg one-half hour before meals and 2.5 to 5 mg at bedtime. A starting dose of 12.5 mg daily will be clinically effective in most patients without the production of appreciable side effects. If the patient is experiencing symptoms such as severe abdominal pain or cramping which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5 mg one- half hour before meals and at bedtime.

If very unpleasant side effects develop promptly, the daily dosage should be reduced. If neither symptomatic relief nor side effects appear, the daily dosage may be increased. Some patients have tolerated 30 mg daily with no unpleasant reactions.

Patients whose dosage has been reduced to eliminate or modify side effects often continue to show adequate response both subjectively in relief of symptoms and objectively as measured by antisecretory effects. The ultimate aim of therapy is to arrive at a dosage which provides maximal clinical effectiveness with a minimum of unpleasant side effects. Many patients report no side effects on a dosage which gives complete relief of symptoms.

On the other hand, some patients have reported severe side effects without appreciable symptomatic relief. Such patients must be considered unsuited for this therapy. Usually they have been or will prove to be similarly intolerant to other anticholinergic drugs.

If methscopolamine bromide is to be used in a patient who gives a history of such intolerance, it should be started at a low dosage.

The following adverse reactions have been observed, but there is not enough data to support an estimate of frequency. Cardiovascular : Tachycardia, palpitation. Allergic : Severe allergic reaction or drug idiosyncrasies including anaphylaxis.

CNS : Headaches, nervousness, mental confusion, drowsiness, dizziness. Special Senses : Blurred vision, dilation of the pupil, cycloplegia, increased ocular tension, loss of taste. Renal : Urinary hesitancy and retention.

Gastrointestinal : Nausea, vomiting, constipation, bloated feeling. Dermatologic : Decreased sweating, urticaria and other dermal manifestations. Miscellaneous : Xerostomia, weakness, insomnia, impotence, suppression of lactation.

4. Drug interactions Additive anticholinergic effects may result from concomitant use with antipsychotics, tricyclic antidepressants, and other drugs with anticholinergic effects. Concomitant administration with antacids may interfere with the absorption of methscopolamine bromide.

6. Pregnancy Teratogenic effects Animal reproduction studies have not been conducted with methscopolamine bromide. It is also not known whether methscopolamine bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methscopolamine bromide should be given to a pregnant woman only if clearly needed.

8. Pediatric use Safety and efficacy in children have not been established.

Glaucoma; obstructive uropathy (e.g., bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (e.g., pyloroduodenal stenosis); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. Methscopolamine Bromide Tablets, 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.

The symptoms of overdosage with Methscopolamine Bromide Tablets, 2.5 mg and 5 mg progress from intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma. Measures to be taken are induction of emesis and injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically (alcohol sponging, ice packs). Excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly intravenously or chloral hydrate (100 to 200 mL of a 2% solution) by rectal infusion.

In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns. The oral LD 50 in rats is 1,352 to 2,617 mg/kg. No data is available on the dialyzability of methscopolamine bromide.