COMPOSITION: Each tablet contains 15 mg propantheline bromide.
PHARMACOLOGICAL CLASSIFICATION: A 11.2 Gastro-intestinal antispasmodics
PHARMACOLOGICAL ACTION: Pro-Banthine, an anticholinergic agent, inhibits neural impulses at the effector sites of the parasympathetic system and at the ganglia of the sympathetic and parasympathetic nervous system.
INDICATIONS: Pro-Banthine is indicated for adjunctive therapy of peptic ulcer for symptomatic treatment of the irritable bowel syndrome; inneurogenic bladder, enuresis, urinary incontinence due to detrusor hyperactivity and renal colic; in hyperhidrosis; as adjunctive therapy in ulcerative colitis; diverticulitis, cholecystitis and pancreatitis, and for certain gastrointestinal diagnostic procedures.
CONTRA-INDICATIONS: Pro-Banthine is contra-indicated in patients with glaucoma, obstructive disease of the gastrointestinal or urinary tract, intestinal atony, sever ulcerative colitis or toxic megacolon, unstable cardiovascular adjustment in acute haemorrhage, and myaesthenia gravis.
DOSAGE AND DIRECTIONS FOR USE:
For peptic ulcer, the recommended initial adult dosage is 15 mg (1 tablet) 30 minutes before each meal and 30 mg (2 tablets) at bedtime 175 mg daily).
Subsequent dosage adjustment should be made according to the patients individual response and tolerance. For patients with mild manifestations, and for geriatric patients and those of small stature, a lower total daily dose may be appropriate.
For contrast radiology, 30 mg (2 tablets) should be given 45 minutes before the procedure.
For other indications, the dose is 15 to 30 mg (1 - 2 tablets) four times daily.
SIDE EFFECTS AND SPECIAL PRECAUTIONS: In some patients, especially those with ileostomy or colostomy, diarrhoea may be a symptom of incomplete intestinal obstruction. Pro-Banthine therapy should be avoided in such patients.
Pro-Banthine may cause increased heart rate and, therefore, should be used with caution in patients with heart disease. In the presence of a high environmental temperature, heat prostration can occur with the use of Pro-Banthine. Patients with prostatic hypertrophy may experience urinary hesitancy. Urinary retention may be minimised if such patients are advised to micturate at the time the medication is taken.
Pro-Banthine 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 arrhythmias or hypertension, or hiatal hernia associated with reflux oesophagitis, as these conditions may be aggravated.
Caution is required in patients with ulcerative colitis, since in these patients Pro-Banthine may suppress intestinal motility, to the point of producing paralytic ileus, thus precipitating or aggravating toxic megacolon.
Safe use of Pro-Banthine in pregnancy has not been established. Therefore, the use of this drug in women of childbearing potential requires that the benefits be weighed against any possible risks.
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 Pro-Banthine is administered to a nursing woman. Suppression of lactation may occur with anticholinergic drugs. Safety and efficacy of Pro-Banthine in children have not been established.
Pro-Banthine may produce drowsiness or blurred vision. Patients should be cautioned regarding operating machinery or motor vehicles during treatment with this drug.
Drug Interactions: Anticholinergics may delay absorption of other medication given concomitantly.
Excessive cholinergic blockade may occur if Pro-Banthine is given concomitantly with belladonna alkaloids, synthetic or semisynthetic, anticholinergic agents, narcotic analgesics such as meperidine, Type 1 antiarrhythmic drugs (eg. disopyramide, procainamide or quinidine, antihistamines, phenothiazines, tricyclic antidepressants, or other psychoactive drugs. Pro-Banthine may also potentiate the sedative effect of phenothiazines. Increased intra-ocular pressure may result from concurrent administration of anticholinergics and corticosteroids. Concurrent use of Pro-Banthine with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.
Adverse Reactions: Varying degrees of drying of salivary secretions may occur, as well as mydriasis, blurred vision, cycloplegia, increased ocular tension, heat stroke and decreased sweating. In addition, the following adverse reactions have been reported: nervousness, drowsiness, dizziness, insomnia, headache, tachycardia, loss of the sense of taste, nausea, vomiting, constipation, urinary hesitancy and retention, suppression of lactation, impotence, and allergic reactions, including urticaria and anaphylaxis.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT: The symptoms of overdosage with Pro-Banthine progress from an intensification of the usual side effects to central nervous system disturbances, circulatory changes, respiratory failure, paralysis and coma.
Measures to be taken are:
immediate induction of emesis or lavage of the stomach,
injection of physostigmine 0,5 to 2 mg intravenously repeated as necessary up to a total of 5 mg and
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.
IDENTIFICATION: PRO-BANTHINE 15 Tablets:
Pink, sugar-coated tablets, 6,4 mm in diameter, printed Searleon one side and plain on reverse.
PRESENTATION: Bottles containing 100 and 1 000 tablets and foil packs of 10 tablets.
STORAGE INSTRUCTIONS: Store in a dry place below 30°C.
Keep out of reach of children.
REFERENCE NUMBER: E921 (Act 101/1965)
NAME AND ADDRESS OF THE APPLICANT: G D Searle (South Africa) (Pty) Ltd.
14 Mandy Road
DATE OF PUBLICATION OF THIS PACKAGE INSERT: 5 August 1972.