Pro-Banthine (Propantheline)

PRO-BANTHINE®

Roberts

Propantheline Bromide

Anticholinergic

Action And Clinical Pharmacology: Propantheline bromide is a synthetic quaternary ammonium anticholinergic agent which inhibits gastrointestinal motility and spasm and diminishes gastric acid secretion. The drug also inhibits the action of acetylcholine at the postganglionic nerve endings of the parasympathetic nervous system. Its effects are similar to those of atropine although they last longer (6 hours). The antispasmodic effects on the gastrointestinal tract may occur at doses causing other less marked antimuscarinic effects. Propantheline is extensively metabolized in man primarily by hydrolysis to the inactive materials xanthene-9-carboxylic acid and (2-hydroxyethyl) diisopropylmethylammonium bromide. Approximately half of the hydrolysis of the drug occurs in the gastrointestinal tract prior to its absorption. After a single 15 mg oral dose of carbon-14 labeled drug given to a healthy man, 390 ng/mL peak plasma concentration of total 4 material is attained at 6 hours. Unmetabolized drug represents only a small proportion of the total 4 material. The plasma half-life of the total 4 material is about 9 hours and approximately 70% of the dose is excreted in the urine, mostly as metabolites. The urinary excretion of the intact propantheline is about 5%. tag_IndicationsIndications

Indications And Clinical Uses: Adjunctive therapy of peptic ulcer, symptomatic treatment of the irritable bowel syndrome (irritable colon, spastic colon, mucous colitis); renal colic and hyperhidrosis; adjunctive therapy of ulcerative colitis, diverticulitis, cholecystitis and pancreatitis.

Contra-Indications: Propantheline is contraindicated in patients with: glaucoma since mydriasis is to be avoided; obstructive disease of the gastrointestinal tract (pyloroduodenal stenosis, achalasia, paralytic ileus); obstructive uropathy due to prostatism; intestinal atony of elderly or debilitated patients; severe ulcerative colitis or toxic megacolon complicating ulcerative colitis; unstable cardiovascular adjustment in acute hemorrhage; myasthenia gravis.

Manufacturers’ Warnings In Clinical States: Heat Prostration: 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.

Intestinal Obstruction: 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.

Occupational Hazards: Propantheline may produce drowsiness or blurred vision. Caution the patient regarding activities requiring mental alertness, such as operating a motor vehicle or other machinery or performing hazardous work, while taking the drug.

Severe Cardiac Disease: Give this medication with caution to patients with severe cardiac disease if even a slight increase in heart rate is undesirable.

Pregnancy: Reproduction studies have not been performed in animals. Information on possible adverse effects to the fetus is limited to uncontrolled data derived from marketing experience. Such experience has revealed no evidence of toxicity to mother or fetus. There are no controlled studies in animals or humans to determine whether this drug affects fertility in human males or females, has teratogenic potential, or has other adverse effects on the fetus. It should be used during pregnancy only when, in the opinion of the physician, the benefits outweigh any possible risk.

Lactation: Documentation is lacking or conflicting regarding the excretion of anticholinergics (especially atropine) in milk and the reduction in breast milk production by these drugs. Problems in humans have not been documented. Propantheline is considered to be compatible with breast-feeding; however, it is recommended to monitor closely the possible anticholinergic side effects to the infant.

Children: Since there is inadequate experience with the use of propantheline in children, safety and efficacy have not been established. Keep out of reach of children.

Precautions: Varying degrees of urinary hesitancy may occur in patients with prostatic hypertrophy. Urinary retention may be minimized if patients are advised to micturate just before taking the medication.

Propantheline should be used with caution in hiatal hernia associated with reflux esophagitis since it may lower esophageal sphincter pressure and aggravate this condition.

Elderly and Disease States: 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 or hypertension, as these conditions may be aggravated.

Ulcerative Colitis: 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.

Bronchial Secretion: A decrease in bronchial secretion may lead to inspissation of these secretions and formation of bronchial mucous plugs especially in the elderly or debilitated with chronic pulmonary disease.

Drug Interactions: Anticholinergics may delay absorption of other medication given concomitantly.

Excessive cholinergic blockage may occur if propantheline 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 may also potentiate the sedative effect of phenothiazines. Increased intraocular pressure may result from concurrent administration of anticholinergics and corticosteroids.

Concurrent use of propantheline with slow-dissolving tablets of digoxin may cause increased serum digoxin levels.

Adverse Reactions: Varying degrees of drying of salivary secretions, decreased sweating. Ophthalmic side effects include blurred vision, mydriasis, cycloplegia, and increased ocular tension. In addition the following adverse reactions have been reported: 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 dermatoses.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: The symptoms of overdosage with propantheline 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 lavage of the stomach, and (2) injection of physostigmine 0.5 to 2 mg i.v., and repeated as necessary up to a total of 5 mg. Fever may be treated symptomatically.

Excitement of a degree which demands attention may be managed with sodium thiopental 2% solution given slowly i.v. or chloral hydrate (100 to 200 mL of a 2% solution) by rectal infusion. In the event of progression of the curare-like effect to paralysis of the respiratory muscles, artificial respiration should be instituted and maintained until effective respiratory action returns.

Dosage And Administration: Dosage should be individualized.

The usual initial adult dosage is 15 mg 30 minutes before each meal and 30 mg at bedtime (i.e., 75 mg daily).

Subsequent dosage adjustments should be made according to the patient’s individual response and tolerance. The administration of one 7.5 mg tablet 3 times a day may be sufficient for patients with mild manifestations, for geriatric patients, and for those of small stature.

When used in contrast radiology, 30 mg should be given 45 minutes before the procedure.

For other indications, the dose is 15 to 30 mg 4 times daily.

Availability And Storage: 7.5 mg: Each white, convex, sugar-coated tablet, printed in red ink, 073 on one side and RPC on the other side, contains: propantheline bromide 7.5 mg. Nonmedicinal ingredients: beeswax white, calcium carbonate, carnauba wax, castor oil, cornstarch, lactose, light mineral oil, magnesium carbonate, magnesium stearate, sodium saccharin, sucrose, talc and titanium dioxide. Energy: 1.4 kJ (0.33 kcal). Bottles of 100.

15 mg: Each peach-colored, convex, sugar-coated tablet, printed in red ink, 074 on one side and RPC on the other side, contains: propantheline bromide 15 mg. Nonmedicinal ingredients: beeswax white, calcium carbonate, carnauba wax, castor oil, cornstarch, iron oxides, lactose, light mineral oil, magnesium carbonate, magnesium stearate, sodium saccharin, sucrose, talc and titanium dioxide. Energy: 1 kJ (0.24 kcal). Bottles of 100.

PRO-BANTHINE® Roberts Propantheline Bromide Anticholinergic

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