Thelin 15 mg

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 diarrhoea related irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, functional Gl disorders etc)
Urinary incontinence
Control of salivation and enuresis
Improves lactose intolerance
Prevents excessive sweating (Hyperhidrosis)

PHARMACOLOGY

Propantheline Bromide acts by dual mechanism of action.

Specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites
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 stimulates 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.

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 absorption of other medication given concomitantly. Significant drug interaction also occurs with concomitant use of digoxin, haloperidol, corticosteroides, ketoconazole, levodopa, opioid analgesics, phenothiazines, urinary alkalizers.

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.

PREGNANCY & LACTATION

Propantheline Bromide is in 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.

PRECAUTIONS & WARNINGS

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.

THERAPEUTIC CLASS

Anticholinergics (antimuscarinics)/ Anti-spasmodics

STORAGE CONDITIONS

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