Schedule H

Oral, Intramuscular (IM), Intravenous (IV)

Oral:

• Tablets: 10 mg

• Oral solution/Syrup: 5 mg/5 mL (60 mL, 100 mL bottles)

Parenteral:

• Injection: 20 mg/mL (1 mL ampoule)

Fixed-Dose Combinations (FDCs) commonly available:

• Hyoscine butylbromide + Paracetamol

• Hyoscine butylbromide + Diclofenac

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Gastrointestinal Smooth Muscle Spasm

Includes irritable bowel syndrome (IBS), functional bowel disorders, gastric/intestinal colic

Oral Route (Adults):

Parameter Dosing Details

Starting dose 10 mg three times daily

Titration Increase to 20 mg per dose if inadequate response after 2–3 days

Usual maintenance dose 10–20 mg three to four times daily

Maximum dose 80 mg/day (20 mg QID)

Parenteral Route (Adults) — For Acute Spasm:

Parameter Dosing Details

Starting dose 20 mg IM or slow IV as single dose

Titration Not applicable

Usual maintenance dose 20 mg every 8 hours if needed

Maximum dose 100 mg/day parenterally (under supervision)

Key Clinical Notes:

• Administer oral doses 30 minutes before meals for optimal effect

• Parenteral route preferred when oral not feasible or for acute severe spasm

• Does NOT cross blood-brain barrier (quaternary ammonium structure) — no central anticholinergic effects

• IV injection should be given slowly to avoid hypotension

1. Genitourinary Tract Spasm

Includes renal colic, ureteric colic, bladder spasm

Oral Route:

Parameter Dosing Details

Starting dose 20 mg three times daily

Titration Not applicable

Usual maintenance dose 20 mg TID–QID

Maximum dose 80 mg/day

Parenteral Route (Acute Colic):

Parameter Dosing Details

Starting dose 20 mg IM/IV as single dose

Titration Repeat after 30 minutes if inadequate relief (max 2 doses initially)

Usual maintenance dose 20 mg every 8 hours if needed

Maximum dose 100 mg/day

Key Clinical Notes:

• Use as adjunct to analgesics (NSAIDs, opioids) in acute colic

• Not a substitute for definitive management of obstructive uropathy

• Consider imaging to rule out mechanical obstruction before repeated dosing

1. Biliary Colic / Biliary Tract Spasm

Parameter Dosing Details

Starting dose 20 mg IM/IV as single dose

Titration Repeat after 8 hours if severe spasm persists

Usual maintenance dose 20 mg every 8 hours (parenteral) or 20 mg TID (oral after acute phase)

Maximum dose 100 mg/day parenterally; 80 mg/day orally

Key Clinical Notes:

• Combine with NSAIDs (diclofenac) or opioids for optimal pain relief

• Rule out acute cholecystitis, cholangitis, or biliary obstruction requiring intervention

• Switch to oral route once acute episode controlled

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Pre-procedural bowel relaxation (GI endoscopy, barium studies) (OFF-LABEL) 20 mg IV immediately before procedure Single dose Specialist/Radiologist use. Reduces bowel motility artifacts. Evidence: Standard practice in Indian radiology and endoscopy centres.

Primary Dysmenorrhoea (OFF-LABEL) 10–20 mg TID orally, starting 1–2 days before expected menses 3–5 days per cycle Limited RCT evidence; used in Indian gynaecology practice. Consider mefenamic acid as preferred first-line.

Post-operative abdominal cramps (OFF-LABEL) 20 mg IM/IV every 8 hours PRN 24–48 hours post-surgery Specialist only. Commonly used in surgical wards.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Gastrointestinal Colic / Abdominal Spasm

⚠️ NOT recommended in infants <6 months

Oral Route (Syrup):

6 months – 2 years 2.5–5 mg (2.5–5 mL) Three times daily 15 mg/day

2–6 years 5 mg (5 mL) Three times daily 30 mg/day

6–12 years 10 mg (tablet or 10 mL syrup) Three times daily 30–40 mg/day

12 years Adult dosing — 80 mg/day

Parenteral Route (IM/IV) — Specialist Use Only:

6 months – 12 years 0.3–0.5 mg/kg per dose Every 6–8 hours PRN 1.5 mg/kg/day (max 40 mg/day)

12 years Adult dosing (20 mg) Every 8 hours 100 mg/day

Key Clinical Notes:

• Minimum age: 6 months (absolute minimum)

• Use for short duration only (3–5 days); reassess if symptoms persist

• Preferred over dicyclomine in infants 6 months to 2 years due to lack of CNS penetration

• IV administration should be slow in children

Safety Monitoring in Children:

• Monitor for anticholinergic effects: dry mouth, flushing, urinary retention, constipation

• Watch for paradoxical irritability or fever (may indicate anticholinergic toxicity)

• Ensure adequate hydration

Secondary Indications — Paediatric (Off-label)

Indication Dose Duration Notes

Pre-procedural bowel relaxation (imaging/endoscopy) (OFF-LABEL) 0.3–0.5 mg/kg IV (max 20 mg) as single dose Single pre-procedure dose Specialist/Radiologist only. Used in paediatric imaging centres.

Clear Statement: NOT recommended below 6 months of age. Use between 6 months and 2 years only under paediatric specialist supervision with short-term therapy.

Dialysis Limited dialysability; use with caution

• Known hypersensitivity to hyoscine butylbromide or other belladonna alkaloids

• Mechanical gastrointestinal obstruction or ileus

• Paralytic ileus

• Megacolon (including toxic megacolon)

• Mechanical urinary tract obstruction

• Myasthenia gravis

• Narrow-angle (angle-closure) glaucoma

• Tachyarrhythmias (severe)

• Infants less than 6 months of age

• Elderly patients — increased sensitivity to anticholinergic effects (urinary retention, constipation)

• Prostatic hypertrophy without obstruction — risk of urinary retention

• Cardiac disease, tachycardia — may cause transient increase in heart rate

• Conditions predisposing to glaucoma (monitor intraocular pressure)

• Autonomic neuropathy (e.g., diabetic neuropathy)

• Hyperthyroidism

• Fever or high ambient temperature — impaired thermoregulation

• Down syndrome — increased sensitivity to anticholinergics

• Chronic constipation — may worsen

• Ulcerative colitis — use cautiously; may precipitate toxic megacolon

• Hiatal hernia with reflux oesophagitis

Parameter Details

Risk Category Limited human data; use with caution. No adequate controlled studies in pregnant women.

Preferred alternatives Paracetamol for pain; mebeverine may be considered for spasm (consult obstetrician)

When may be used May be used if benefit outweighs risk; avoid in first trimester unless essential

Monitoring Monitor fetal movements if used in second/third trimester; maternal heart rate

Parameter Details

Compatibility Likely compatible with breastfeeding

Preferred alternatives None specifically required; hyoscine butylbromide acceptable

Drug levels in milk Low (minimal transfer due to quaternary ammonium structure — poorly lipid soluble, low oral bioavailability)

Infant monitoring Monitor for feeding difficulty, constipation, decreased urine output (rare)

Parameter Recommendation

Starting dose 10 mg twice daily (lower than standard adult dose)

Titration Increase cautiously based on tolerability; reassess after 3–5 days

Special risks Urinary retention (especially males with prostatic enlargement); constipation; tachycardia; dry mouth. CNS effects (confusion, delirium) unlikely as drug does not cross BBB, but still monitor.

Monitoring Assess urinary output and bowel function; heart rate if cardiac disease present

Interacting Drug Mechanism & Effect Management

Other anticholinergics (atropine, dicyclomine, tricyclic antidepressants, antihistamines with anticholinergic effects) Additive anticholinergic toxicity: dry mouth, constipation, urinary retention, tachycardia, paralytic ileus Avoid routine combination; if essential, use lowest doses and monitor closely

Metoclopramide / Domperidone Functional antagonism — opposing effects on GI motility Avoid concurrent use; therapeutic conflict

Beta-adrenergic agonists (salbutamol, terbutaline — systemic) Additive tachycardia Monitor heart rate; use with caution in cardiac patients

Interacting Drug Effect Management

Opioid analgesics (tramadol, morphine, codeine) Enhanced risk of constipation and paralytic ileus Monitor bowel function; use laxatives if needed

First-generation antihistamines (chlorpheniramine, diphenhydramine, promethazine) Additive anticholinergic and sedative effects Monitor for excessive dry mouth, constipation

Amantadine Additive anticholinergic effects Monitor for toxicity

Antacids May reduce absorption of oral hyoscine butylbromide Separate administration by 1–2 hours

Digoxin Delayed gastric emptying may alter digoxin absorption Monitor digoxin levels if symptoms suggest toxicity

• Dry mouth (most common)

• Constipation

• Tachycardia (transient, dose-related)

• Blurred vision (accommodation disturbance)

• Flushing

• Urinary hesitancy/retention (especially in elderly males)

• Dizziness

• Nausea

Adverse Effect Clinical Notes

Anaphylaxis / Severe hypersensitivity Rare; discontinue immediately; emergency management required

Angle-closure glaucoma (precipitation) May occur in predisposed individuals; presents with eye pain, visual halos, headache. Ophthalmology emergency.

Severe urinary retention Particularly in elderly males with prostatic hypertrophy; may require catheterisation

Paralytic ileus Risk if used in undiagnosed mechanical obstruction; discontinue immediately if bowel obstruction suspected

Severe tachyarrhythmia Rare; discontinue; cardiac monitoring required

During treatment Bowel sounds and abdominal examination (especially in acute presentations); heart rate (if cardiac risk factors); urinary output (elderly, prostatic hypertrophy)

Long-term Not recommended for prolonged use (>2 weeks). If continued, periodic reassessment of indication; bowel and bladder function

Plain Hyoscine Butylbromide:

• Buscopan® (Boehringer Ingelheim) — most widely recognised

• Spasmindon® (Elder)

• Hyosafe® (Alkem)

• Kolibri® (various)

• Scopan® (Torrent)

• Buscowin® (Win-Medicare)

Fixed-Dose Combinations:

• Buscopan Plus® (Hyoscine + Paracetamol)

• Spasmindon-P® (Hyoscine + Paracetamol)

• Various generic FDCs with NSAIDs

Note: Hyoscine butylbromide plain is NOT listed in NLEM 2022. Not under NPPA price control as of 2024.

1. Preferred antispasmodic in infants >6 months — unlike dicyclomine, hyoscine butylbromide does not cross the blood-brain barrier, making it safer with no CNS side effects (no respiratory depression, seizure risk)

1. Does NOT cross BBB — quaternary ammonium structure ensures peripheral-only action; ideal for elderly patients where CNS anticholinergic effects (confusion, delirium) are a concern

1. Rule out obstruction first — never use in suspected mechanical GI or urinary obstruction; always confirm with clinical/radiological assessment before repeated dosing in acute abdomen

1. Useful pre-procedure agent — commonly used IV before endoscopy, colonoscopy, or barium studies to reduce motility and improve imaging quality

1. Effective combination in colic — combine with NSAIDs (diclofenac) or paracetamol for renal/biliary colic; antispasmodic alone often insufficient for complete pain relief

1. IV administration must be slow — rapid IV injection can cause transient hypotension; inject over 1–2 minutes

1. Short-term use preferred — not recommended for chronic daily use beyond 2 weeks; reassess underlying cause if symptoms persist

antispasmodic; GI-colic; renal-colic; biliary-colic; IBS; peripheral-anticholinergic; does-not-cross-BBB; safe-in-infants-6months; injectable; endoscopy-pre-medication; Hyoscine Butylbromide

RxIndia v1.0 — 06 Jun 2025

• CDSCO Drug Database

• Indian Pharmacopoeia 2022

• National Formulary of India (NFI) 2021

• API Textbook of Medicine (11th Edition)

• AIIMS Standard Treatment Guidelines

• IAP Drug Formulary — Paediatric Use Guidance

• AIIMS Radiology Procedural Protocols

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (14th Edition)

• Product package inserts (Buscopan®)