methscopolamine bromide

FDA Drug Profile — Methscopolamine Bromide, METHSCOPOLAMINE BROMIDE

Drug Details

Generic Name
methscopolamine bromide
Brand Names
Methscopolamine Bromide, METHSCOPOLAMINE BROMIDE
Application Number
ANDA040642
Sponsor
Breckenridge Pharmaceutical, Inc.
NDC Codes
10
Dosage Forms
TABLET
Routes
ORAL
Active Ingredients
METHSCOPOLAMINE BROMIDE

Indications and Usage

INDICATIONS AND USAGE 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.

Warnings

WARNINGS 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.