Propantheline bromide
- Content
- 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 patients individual response and tolerance.
- 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.

# Precautions
- Propantheline should be used with caution in the elderly and in all patients with autonomic neuropathy, hepatic or renal disease, hyperthyroidism, coronary heart disease, congestive heart failure, cardiac tachyarrhythmias, hypertension, or hiatal hernia associated with reflux esophagitis, since anticholinergics may aggravate this condition.
- In patients with ulcerative colitis, large doses of propantheline may suppress intestinal motility to the point of producing paralytic ileus and, for this reason, may precipitate or aggravate toxic megacolon, a serious complication of the disease.
- Concurrent use of propantheline with slow-dissolving tablets of digoxin may cause increased serum digoxin levels. This interaction can be avoided by using only those digoxin tablets that rapidly dissolve by USP standards
- Animal reproduction studies have not been conducted with propantheline. It is also not known whether propantheline can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Propantheline should be given to a pregnant woman only if clearly needed.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Propantheline bromide in women who are pregnant.
- Measures to be taken are (1) immediate induction of emesis or lavage of the stomach and (2) injection of physostigmine 0.5 to 2 mg intravenously, and repeated as necessary up to a total of 5 mg, and (3) monitoring of vital signs and managing as necessary.
- Fever may be treated symptomatically (cooling blanket or alcohol sponging). Excitement of a degree which demands attention may be managed with thiopental sodium 2% solution given slowly intravenously or diazepam, 5 to 10 mg intravenously or 10 mg intramuscularly. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, mechanical respiration should be instituted and maintained until effective respiratory action returns.
- The oral LD50 of propantheline bromide is 780 mg/kg in the mouse and 370 mg/kg in the rat.
- 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.
- The plasma elimination half-life of propantheline is about 1.6 hours. Approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of propantheline is about 3% after oral tablet administration.
- No long-term fertility, carcinogenicity, or mutagenicity studies have been done with propantheline.
- 15 mg white film-coated tablets
- (Identified 54 303).
- NDC 0054-4721-25: Bottles of 100 tablets.
- Dispense in tight, light-resistant container as defined in the USP/NF.
- Store at 20 to 25C (68 to 77F)