Generic
Propantheline Bromide
6 brands available in the market
At a glance
Propantheline Bromide is a quaternary ammonium antimuscarinic with antisecretory and antispasmodic effects. It is used for adjunctive therapy in peptic ulcer, relief of gastritis symptoms, symptomatic treatment of diarrhea related irritable bowel syndrome, urinary incontinence, control of salivation and enuresis, improvement of lactose intolerance, and prevention of excessive sweating (hyperhidrosis).
Description
Propantheline Bromide acts by dual mechanism: specific anticholinergic (antimuscarinic) effect at acetylcholine-receptor sites and direct effect upon smooth muscle (musculotropic). It reduces the effect of acetylcholine on smooth muscle and has a direct relaxing effect on smooth muscle. It inhibits gastrointestinal motility, decreases gastric acid secretion, and controls excessive pharyngeal, tracheal, and bronchial secretions.
Indications
- Adjunctive therapy in peptic ulcer (gastric and duodenal)
- Relief of gastritis symptoms
- Symptomatic treatment of diarrhea related irritable bowel syndrome
- Urinary incontinence
- Control of salivation and enuresis
- Improvement of lactose intolerance
- Prevention of excessive sweating (hyperhidrosis)
Therapeutic class
Anticholinergics (antimuscarinics)/ Anti-spasmodics
Pharmacological class
Quaternary Ammonium Antimuscarinic
Pharmacology
Propantheline Bromide acts through anticholinergic effect at acetylcholine receptors and direct effect on smooth muscle. It reduces acetylcholine effects on smooth muscle, inhibits gastrointestinal motility, decreases gastric acid secretion, and reduces other secretions (pancreatic juice, sweat, saliva).
Mechanism of action
Reduces gastric acid secretion and GI motility by blocking acetylcholine receptors.
Dosage
Adult Dose (Oral):
- Peptic ulcer/GI spasm: 15 mg three times daily (30 min before meals) + 30 mg at bedtime; up to 120 mg daily
- Elderly: 7.5 mg three times daily; max 30 mg three times daily
- Urinary incontinence/Enuresis/Hyperhidrosis: 15-30 mg 2-3 times daily
Pediatric Dose (Oral):
- GI spasm (1 month-12 years): 300 mcg/kg (max 15 mg) 3-4 times daily
Administration
- Take on an empty stomach (30 minutes before meals)
- Swallow tablet whole; do not chew, crush, or break
- Maintain 2-3 hour interval with other medications
Missed dose
If you miss a dose, take it as soon as you remember; skip if it's almost time for next dose; do not double the dose.
Side effects
Side Effects (>10%):
- Constipation
- Dry mouth
- Dry skin
- Decreased sweating
Side Effects (Frequency Not Defined):
- Blurred vision
- Sedation
- Tachycardia
- Dysphagia
- Urinary retention
- Potentially fatal: Toxic megacolon due to preexisting ulcerative colitis
Precautions & warnings
- Caution in hyperthyroidism, congestive heart failure, coronary heart disease, cardiac arrhythmias, hypertension
- Caution in elderly, pregnancy, and lactation
- Caution in fever, diarrhea, GI reflux disease, or ulcerative colitis
- Caution in hepatic or renal impairment
- Caution in Down's syndrome
Contraindications
- Glaucoma
- Obstructive diseases of GI or urinary tract
- Severe ulcerative colitis or toxic megacolon
- Intestinal atony
- Hiatus hernia associated with reflux esophagitis
- Prostatic enlargement
- Myasthenia gravis
- Paralytic ileus
- Pyloric stenosis
- Angle-closure glaucoma
Drug interactions
- MAOIs, TCAs, phenothiazines, antihistamines, disopyramide: Additive anticholinergic effects
- Domperidone, cisapride, metoclopramide: May antagonize GI effects
- Ketoconazole, levodopa: May reduce absorption
- Nitrofurantoin: May increase absorption
- Digoxin: May increase serum levels
- Haloperidol, sublingual nitrates: May reduce effects
- Antacids/absorbent antidiarrheals: Reduce propantheline absorption (2-3 hour interval)
Food interactions
Take on an empty stomach (to avoid interactions with food); it is not known whether it is safe to consume alcohol.
Use in pregnancy
Use in Pregnancy: Pregnancy Category C; use only if clearly needed; animal reproduction studies not conducted.
Pregnancy Category: C — always consult a doctor before taking during pregnancy.
Use in lactation
Use in Lactation: Unknown if excreted in human milk; caution required; lactation suppression may occur.
Pediatric use
Safety and effectiveness not established in pediatric patients.
Geriatric use
Caution in elderly (intestinal atony, prostatic hypertrophy); anticholinergics may aggravate these conditions.
Renal / hepatic impairment
Renal Impairment: Caution in kidney disease; anticholinergics may aggravate this condition; consult your doctor.
Hepatic Impairment: Caution in liver disease; anticholinergics may aggravate this condition; consult your doctor.
Overdose effects
Overdose: Progression from usual side effects to CNS disturbances (restlessness, psychotic behavior), circulatory changes, respiratory failure, paralysis.
Storage conditions
Do not store above 30°C; keep away from light; keep out of reach of children.
Chemical structure
Propantheline Bromide