FDA
Methscopolamine Bromide
The FDA lists this product in 9 strengths and forms.
Indications
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.
Contraindications
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, USP 2.5 mg and 5 mg is contraindicated in patients who are hypersensitive to methscopolamine bromide or related drugs.
Warnings and precautions
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.
Adverse reactions
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.
At a glance
- Brand name
- Methscopolamine Bromide
- Route
- Oral
- Dosage form
- Tablet
- Applicant
- Unichem
- Status
- Prescription
- FDA approval
- 24 Sept 2012
- Application
- ANDA200602-002



