FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
In the presence of high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with drug use. 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. Methscopolamine 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. With overdosage, a curare-like action may occur, i.e., neuromuscular blockade leading to muscular weakness and possible paralysis.
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
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.
History
There is currently no drug history available for this drug.
Other Information
Methscopolamine Bromide Tablets USP, 2.5 mg and 5mg contain methscopolamine bromide, an anticholinergic, which occurs as white crystals, or as a white odorless crystalline powder. Methscopolamine bromide melts at about 225°C with decomposition. The drug is freely soluble in water, slightly soluble in alcohol, and insoluble in acetone and in chloroform.
The chemical name for methscopolamine bromide is 3-Oxa-9-azoniatricyclo [3.3.1.02,1ronane, 7-(3-hydroxy-1-000-2-phenyl-propoxy)-9, 9-dimethyl-, bromide, [7(5)-(1., 26, 46, 5., 76) ]-and the molecular weight is 398.30.
The structural formula is represented below:
Methscopolamine Bromide Tablets USP, 2.5 mg for oral administration contain 2.5 mg of methscopolamine bromide.
Methscopolamine Bromide Tablets USP, 5 mg for oral administration contain 5mg of methscopolamine bromide.
Inactive ingredients: microcrystalline cellulose, pregelatinized starch, magnesium stearate.
Contains no lactose.
Sources
Methscopolamine Manufacturers
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Golden State Medical Supply, Inc.
Methscopolamine | Golden State Medical Supply, Inc.
The average dosage of methscopolamine bromide tablets USP is 2.5 mg one-half hour before meals and 2.5 to 5mg 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 having severe symptoms which demand prompt relief, the drug may be started on a daily dosage of 20 mg, administered in doses of 5mg 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.
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