Rx Drugs Info

pro-banthine (propantheline bromidetablet 
[Shire US Manufacturing Inc]

DESCRIPTION

Pro-Banthine®(propantheline bromide) oral tablets contain 15 mg or 7.5 mg of the anticholinergic propantheline bromide, (2-hydroxyethyl) diisopropylmethylammonium bromide xanthene-9-carboxylate.

The structural formula of propantheline bromide is:

Image from Drug Label Content

Propantheline bromide is very soluble in water, alcohol, and chloroform, but it is practically insoluble in ether and in benzene. Its molecular weight is 448.40.

Inactive Ingredients: include calcium carbonate, castor oil, corn starch, lactose anhydrous, light mineral oil, magnesium carbonate, magnesium stearate, saccharin sodium, sucrose, talc, titanium dioxide, and waxes. The 15-mg tablet also contains cosmetic ochre and cosmetic red as coloring agents.

CLINICAL PHARMACOLOGY

Propantheline bromide inhibits gastrointestinal motility and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the post-ganglionic nerve endings of the parasympathetic nervous system.

Propantheline bromide is extensively metabolized in man primarily by hydrolysis to the inactive compounds xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. After a single 30-mg oral dose given as two 15-mg tablets, the mean peak plasma concentration of propantheline was 21 ng/mL at 1 hour in 6 healthy subjects.

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.

INDICATIONS AND USAGE

Pro-Banthine® (propantheline bromide) tablets are as effective as adjunctive therapy in the treatment of peptic ulcer.

CONTRAINDICATIONS

Propantheline bromide is contraindicated in patients with:

  1. Glaucoma, since mydriasis is to be avoided.
  2. Obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus, etc.)
  3. Obstructive uropathy (e.g., bladder-neck obstruction due to prostatic hypertrophy).
  4. Intestinal atony of elderly or debilitated patients.
  5. Severe ulcerative colitis or toxic megacolon complicating ulcerative colitis.
  6. Unstable cardiovascular adjustment in acute hemorrhage.
  7. Myasthenia gravis.

WARNINGS

In the presence of a high environmental temperature, heat prostration (fever and heat stroke due to decreased sweating) can occur with the use of Pro-Banthine®.

Diarrhea may be an early symptom of incomplete intestinal obstruction, especially in patients with ileostomy or colostomy. In this instance treatment with propantheline bromide would be inappropriate and possibly harmful.

With overdosage, a curare-like action may occur (i.e., neuromuscular blockage leading to muscular weakness and possible paralysis).

Propantheline bromide may cause increased heart rate and, therefore, should be used with caution in patients with heart disease.

PRECAUTIONS

General

Propantheline bromide 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 bromide 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.

Information for patients

Propantheline 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 product.

Drug Interactions

Anticholinergics may delay absorption of other medication given concomitantly.

Excessive cholinergic blockade may occur if propantheline bromide is given concomitantly with belladonna alkaloids, synthetic or semisynthetic anticholinergic agents, narcotic analgesics such as meperidine, Type 1 antiarrhythmic drugs (e.g. disopyramide, procainamide or quinidine), antihistamines, phenothiazines, tricyclic antidepressants, or other psychoactive drugs. Propantheline bromide may also potentiate the sedative effect of phenothiazines. Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Concurrent use of propantheline bromide 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.

Carcinogenesis, mutagenesis, impairment of fertility

No long-term fertility, carcinogenicity, or mutagenicity studies have been done with propantheline bromide.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with propantheline bromide. It is also not known whether propantheline bromide can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Propantheline bromide should be given to a pregnant woman only if clearly needed.

Nursing mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when propantheline bromide is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

Varying degrees of drying of salivary secretions may occur as well as decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia and increased ocular tension. Other reported adverse reactions include urinary hesitancy and retention, tachycardia, palpitations, loss of the sense of taste, headache, nervousness, mental confusion, drowsiness, weakness, dizziness, insomnia, nausea, vomiting, constipation, bloated feeling, impotence, suppression of lactation, and allergic reactions or drug idiosyncrasies, including anaphylaxis, urticaria, and other dermal manifestations.

OVERDOSAGE

The symptoms of overdosage with propantheline bromide progress from an intensification of the usual side effects to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis, and coma.

Measures to be taken are (1) immediate induction of emesis or lavage of the stomach, (2) injection of physostigmine 0.5 to 2 mg intravenously, 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.

DOSAGE AND ADMINISTRATION

The usual initial adult dosage of Pro-Banthine®tablets is 15 mg taken 30 minutes before each meal (3 times daily), 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. The administration of one 7.5-mg tablet 30 minutes before each meal (3 times daily) is convenient for patients with mild manifestations, for geriatric patients, and for those of small stature.

HOW SUPPLIED

Pro-Banthine®15-mg tablets are round, peach-colored, sugar-coated, with RPC imprinted on one side and 074 on the other side. Bottles of 100 (NDC 54092-074-01).

Pro-Banthine® 7.5-mg tablets are round, white, sugar-coated, with RPC imprinted on one side and 073 on the other side. Bottles of 100 (NDC 54092-073-01).

Store below 25°C (77°F).

Rev. 2/00 073 0117 004


Pro-Banthine (propantheline bromide)
PRODUCT INFO
Product Code 54092-074 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
propantheline bromide (propantheline) Active 15 MILLIGRAM  In 1 TABLET
calcium carbonate Inactive  
castor oil Inactive  
corn starch Inactive  
lactose anhydrous Inactive  
light mineral oil Inactive  
magnesium carbonate Inactive  
magnesium stearate Inactive  
saccharin sodium Inactive  
sucrose Inactive  
talc Inactive  
titanium dioxide Inactive  
waxes Inactive  
cosmetic ochre Inactive  
cosmetic red Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color PINK (PEACH) Score 1
Shape ROUND Symbol false
Imprint Code RPC;074 Coating true
Size 6mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 54092-074-01 100 TABLET In 1 BOTTLE None

Pro-Banthine (propantheline bromide)
PRODUCT INFO
Product Code 54092-073 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule
INGREDIENTS
Name (Active Moiety) Type Strength
propantheline bromide (propantheline) Active 7.5 MILLIGRAM  In 1 TABLET
calcium carbonate Inactive  
castor oil Inactive  
corn starch Inactive  
lactose anhydrous Inactive  
light mineral oil Inactive  
magnesium carbonate Inactive  
magnesium stearate Inactive  
saccharin sodium Inactive  
sucrose Inactive  
talc Inactive  
titanium dioxide Inactive  
waxes Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color WHITE Score 1
Shape ROUND Symbol false
Imprint Code RPC;073 Coating true
Size 6mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 54092-073-01 100 TABLET In 1 BOTTLE None

Revised: 03/2007Shire US Manufacturing Inc

Data are from FDA and U.S. National Library of Medicine.