Thelin(Propantheline Bromide)
Therapeutic Group: Anti Spasmodic
Presentation
Each film coated tablet contains Propantheline Bromide BP 15 mg
Description
Propantheline Bromide acts by dual mechanism of action.
(1) Specific anticholinergic effect (antimuscarinic) at the acetylcholine-receptor sites
(2) 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.
Indications
Propantheline Bromide is indicated in the treatment of-
1. Adjunctive therapy in the treatment of peptic ulcer (gastric and duodenal)
2. Relief of the symptoms of gastritis (stomach upset, gastrointestinal bleeding, blood in vomit, blood in stool, persistent pain)
3. Symptomatic treatment of the diarrhoea related irritable bowel syndrome (irritable colon, spastic colon, acute enterocolitis, functional GI disorders etc)
4. Urinary incontinence
5. Control of salivation and enuresis
6. Improves lactose intolerance
Prevents excessive sweating (Hyperhidrosis)
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 patient's individual response and tolerance. But the maximum daily dosage should not exceed 120 mg.
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 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.
Paediatric use
Safety and effectiveness in pediatric patients have not been established
Drug 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.
Over Dose
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 behaviour), circulatory changes, (flushing, fall in blood pressure, circulatory failure), respiratory failure, paralysis.
Storage
Do not store above 30 0C. Keep away from light and out of the reach of children.
Commercial Pack
Thelin 15 Tablet: Each box contains 5 blister strips of 10 tablets.