BUSCOPAN 10/MG SUGAR COATED TAB 20/TAB

Indications

Approved Uses

Symptomatic relief of smooth-muscle spasm of the gastrointestinal tract (including IBS-related cramping) and genitourinary tract; may also be used for biliary tract spasm.

Off-Label Uses

Off-label: reduction of GI spasm during diagnostic procedures (e.g., endoscopy/radiology) and management of colicky pain (e.g., biliary/renal colic) where not specifically labeled.

Dosage & Administration

Dosing by Condition

Adults and adolescents ≥12 years: 10-20 mg per dose (1-2 tablets) up to 4 times daily as needed for GI/GU spasm (including IBS-related cramping); do not exceed 80 mg/day without medical advice.

Initial Dose

10mg three times daily for Irritable Bowel Syndrome.

Maintenance Dose

10mg three times daily up to 20mg four times daily.

Maximum Dose

80mg per day (oral)

Dose Adjustment Notes

No specific renal/hepatic dose adjustment is established; use with caution in renal or hepatic impairment.

How to Take

Swallow the tablet whole with water; may be taken with or without food.

Side Effects

Common Side Effects

Dry mouth, tachycardia, urinary retention, constipation, decreased sweating, flushing, blurred vision

Safety & Warnings

Contraindications

Myasthenia gravis, megacolon, narrow-angle glaucoma, mechanical stenosis in the gastrointestinal tract, paralytic or obstructive ileus, tachycardia, prostatic hypertrophy with urinary retention, hypersensitivity to hyoscine butylbromide.

Warnings & Precautions

Use caution/avoid in: narrow-angle glaucoma risk, prostatic hypertrophy/urinary retention, tachyarrhythmias/cardiac disease; stop and seek urgent medical advice if abdominal pain is severe/persistent/worsening or accompanied by fever, vomiting, blood in stool, or other alarm features; not recommended under 6 years.

Drug Interactions

Interaction Severity

MODERATE: additive anticholinergic effects with other anticholinergics (e.g., TCAs, first-generation antihistamines, antipsychotics) and increased tachycardia with beta-agonists; MODERATE: antagonism of prokinetic effect with metoclopramide.

Special Populations

Pregnancy

Consult Doctor

Storage & Patient Advice

Stopping the Medicine

Safe to stop anytime; no tapering required, but do not use continuously without medical evaluation of persistent/recurrent abdominal pain.

Patient Counseling

Swallow with water (with/without food); use as needed up to 10-20 mg per dose, max 4 doses/day unless advised. Possible anticholinergic effects (dry mouth, blurred vision, constipation, urinary retention, palpitations); avoid driving if vision is affected. Seek urgent care for painful red eye/vision changes (possible acute glaucoma), inability to pass urine, or severe/worsening abdominal pain, fever, vomiting, or blood in stool; if symptoms persist, seek medical advice.

Monitoring Requirements

For parenteral administration, monitor blood pressure and heart rate. For oral use, no routine monitoring required for short-term use.

Pharmacology

Mechanism of Action

Competitive muscarinic receptor antagonist (antimuscarinic) that relaxes smooth muscle in the GI, biliary, and genitourinary tracts; as a quaternary ammonium compound it acts mainly peripherally.

Onset of Action

About 15-30 minutes after oral administration.

Duration of Effect

Approximately 3-6 hours (commonly ~4 hours) after an oral dose.

Bioavailability

Very low; <1% oral bioavailability (often cited around ~1%).

Excretion

Oral: predominantly fecal excretion (unabsorbed drug) with a smaller urinary component; IV: both renal and fecal excretion, with ~42-61% renally and ~28-37% fecally reported.

Protein Binding

Approximately 4.4% plasma protein binding (very low).

Product Information

Available Dosage Forms

Tablet (this product: 10 mg sugar-coated tablet); hyoscine butylbromide is also available in some markets as solution for injection.

Composition per Dose

Each tablet: 10mg hyoscine butylbromide

Generic Availability

Yes

OTC Alternatives

OTC alternatives for crampy abdominal pain/IBS-type symptoms may include peppermint oil (enteric-coated) and, where locally OTC, mebeverine or alverine; non-drug options include heat and dietary trigger management.

Gi Condition

IBS

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