FDA records indicate that there are no current recalls for this drug.
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Propantheline Bromide Recall
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Questions & Answers
Side Effects & Adverse Reactions
In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of propantheline.
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.
With overdose, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis). Propantheline may cause increased heart rate and therefore, should be used with caution in patients with heart disease.
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
Propantheline bromide is effective as adjunctive therapy in the treatment of peptic ulcer.
History
There is currently no drug history available for this drug.
Other Information
Each tablet for oral administration contains:
Propantheline bromide.................................................. 15 mg
Propantheline bromide, a synthetic quaternary ammonium compound, occurs as white or nearly white crystals. It is odorless and has a bitter taste, and is very soluble in water and chloroform; practically insoluble in ether, acetone and ethyl acetate. It is designated chemically as (2-Hydroxyethyl) diisopropylmethyl-ammonium bromide xanthene-9-carboxylate.
The structural formula is:
The tablets contain hydroxypropyl methylcellulose, lactose, magnesium stearate, starch, sterotex, and other ingredients.
Sources
Propantheline Bromide Manufacturers
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Roxane Laboratories, Inc.
Propantheline Bromide | Roxane Laboratories, Inc.
The usual initial adult dose of propantheline bromide tablets is 15 mg taken 30 minutes before each meal and 30 mg at bedtime (a total of 75 mg daily). Subsequent dosage adjustment should be made according to the patient’s individual response and tolerance.
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