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Generic Name

Propantheline Bromide
Therapeutic Class: Anti Spasmodic / Anticholinergics (antimuscarinics)

Indications:
Propantheline Bromide is indicated in the treatment of-

• Adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal)
• Relief of the symptoms of gastritis (stomach upset, gastrointestinal bleeding, blood in vomit, blood in stool, persistent pain)
• Symptomatic treatment of the diarrhea-related irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, functional GI disorders, etc)
• Urinary incontinence
• Control of salivation and enuresis
• Improves lactose intolerance
• Prevents excessive sweating (Hyperhidrosis)

Presentation:
Each film-coated tablet contains Propantheline Bromide BP 15 mg

Description:
Propantheline Bromide acts by a dual mechanism of action.

• Specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites
• The direct effect upon smooth muscle (musculotropic). 

This medication is a muscarinic antagonist having antispasmodic properties. It reduces the effect of acetylcholine, a chemical released from nerves that stimulate muscles, by blocking the receptors for acetylcholine on smooth muscle. It also has a direct relaxing effect on smooth muscle. In addition, Propantheline inhibits gastrointestinal motility and decreases gastric acid secretion, and controls excessive pharyngeal, tracheal, and bronchial secretions. Other secretions like pancreatic juice, sweat, and saliva are also reduced.
Dosage & Administration:
The usual initial adult dose of Propantheline Bromide is 75 mg daily.
One tablet 30 min before each meal (15 mg three times daily)
Two tablets at bedtime
Dosage adjustment should be made according to the patient's individual response and tolerance. But the maximum daily dosage should not exceed 120 mg.

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

Side Effects:
The adverse effects of Propantheline Bromide are usually dose-related and are usually reversible when the therapy is discontinued. Variable degrees of dry mouth, dry skin, mydriasis might be noted. Other reported adverse effects include urinary retention, nausea, vomiting, constipation, headache, nervousness, mental confusion, etc.

Precautions:
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, since anticholinergics may aggravate this condition.

Use in Pregnancy & Lactation:
Propantheline Bromide is in the Pregnancy Category C. Animal reproduction studies have not been conducted with propantheline bromide. Propantheline bromide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in milk. Because many drugs are excreted in 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

Interaction:
Antacids or Absorbent Antidiarrhoeals may reduce the absorption of propantheline bromide, therefore resulting in a reduction of its therapeutic effectiveness. Therefore, take two to three hours apart from doses of propantheline bromide. Anticholinergics may delay the absorption of other medication given concomitantly. Significant drug interaction also occurs with concomitant use of digoxin, haloperidol,
corticosteroids, ketoconazole, levodopa, opioid analgesics, phenothiazines, urinary alkalizer.

OverDose:
The symptoms of overdosage with Propantheline Bromide progress from an intensification of the usual side effects (from nausea and vomiting) to CNS disturbances (from restlessness and excitement to psychotic behavior), circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis.

Storage:
Do not store above 30°C. Keep away from light and out of the reach of children.