Schedule H

Oral, Intramuscular (IM)

Oral:

• Tablets: 10 mg, 20 mg

• Syrup/Oral solution: 10 mg/5 mL (60 mL, 100 mL bottles)

Parenteral:

• Injection: 10 mg/mL (1 mL ampoule), 20 mg/2 mL (2 mL ampoule)

Fixed-Dose Combinations (FDCs) commonly available:

• Dicyclomine + Paracetamol

• Dicyclomine + Mefenamic acid

• Dicyclomine + Simethicone

• Dicyclomine + Paracetamol + Simethicone

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Irritable Bowel Syndrome (IBS) — Abdominal Pain and Cramping

Parameter Dosing Details

Starting dose 10–20 mg orally three times daily

Titration Increase by 10 mg per dose every 2–3 days based on response and tolerability

Usual maintenance dose 20 mg three to four times daily

Maximum dose 40 mg four times daily (160 mg/day) — rarely required

Key Clinical Notes:

• Administer 30 minutes before meals for optimal efficacy

• Assess response after 1–2 weeks; discontinue if no benefit

• Short-term use preferred; reassess need periodically

• Not effective for diarrhoea-predominant symptoms without pain

1. Functional Gastrointestinal Disorders with Spasm/Colic

Includes functional dyspepsia with spasm, biliary colic (adjunctive), renal colic (adjunctive)

Parameter Oral Route Intramuscular Route

Starting dose 10–20 mg TID 10–20 mg single dose

Titration Based on symptom response Not applicable

Usual maintenance dose 20 mg TID–QID Repeat IM after 4–6 hours if needed

Maximum dose 160 mg/day 80 mg/day

Key Clinical Notes:

• IM route reserved for acute/severe spasm when oral not feasible

• IV administration is NOT recommended — risk of thrombosis, respiratory arrest

• Switch to oral therapy as soon as patient can tolerate

• Rule out organic causes before attributing symptoms to functional disorder

Secondary Indications — Adults Only (Off-label)

Indication Dose Duration Notes

Bladder spasm (post-urological procedures) (OFF-LABEL) 10–20 mg TID orally Short-term (3–5 days) Specialist only. Limited evidence; extrapolated from anticholinergic class effects. Use with caution in urinary retention risk.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. Infantile Colic / Functional Abdominal Pain

⚠️ CONTRAINDICATED in infants <6 months due to risk of respiratory depression, seizures, and apnoea

6 months – 2 years Syrup 5 mg (2.5 mL) three to four times daily 20 mg/day

2–12 years Syrup or tablet 10 mg (5 mL) three to four times daily 40 mg/day

12 years Tablet/syrup Adult dosing 80 mg/day initially

Key Clinical Notes:

• Minimum age: 6 months (absolute minimum; paediatrician supervision mandatory below 2 years)

• Use only when non-pharmacological measures (feeding changes, anti-gas drops) have failed

• Duration: Short-term only (5–7 days); reassess if symptoms persist

• Avoid prolonged use due to anticholinergic accumulation risk

Safety Monitoring in Children:

• Monitor for excessive sedation, feeding difficulty, respiratory changes

• Watch for signs of anticholinergic toxicity: flushing, dry skin, fever, dilated pupils, irritability

• Discontinue immediately if any concerning symptoms develop

Secondary Indications — Paediatric (Off-label)

Not applicable — no established off-label paediatric indications in Indian practice.

Clear Statement: ABSOLUTELY CONTRAINDICATED below 6 months of age. Use in infants 6 months to 2 years only under direct paediatric specialist supervision.

Severe impairment (eGFR <30) Use with caution; start at lower dose. Anticholinergic metabolites may accumulate.

Dialysis Not significantly dialysed; use with caution

• Known hypersensitivity to dicyclomine or any formulation excipient

• Infants less than 6 months of age (absolute contraindication)

• Obstructive uropathy or urinary retention (e.g., benign prostatic hyperplasia with obstruction)

• Gastrointestinal obstruction or ileus

• Severe ulcerative colitis or toxic megacolon

• Myasthenia gravis

• Narrow-angle (angle-closure) glaucoma

• Unstable cardiovascular status (for parenteral use)

• Reflux oesophagitis with significant obstruction

• Paralytic ileus

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

• Mild-moderate hepatic or renal impairment

• Autonomic neuropathy

• Hyperthyroidism — may exacerbate tachycardia

• Cardiac arrhythmias, tachycardia, ischaemic heart disease, congestive heart failure

• Chronic constipation — may worsen

• Hiatal hernia with reflux oesophagitis

• Prostatic hypertrophy without obstruction — monitor for retention

• Pyrexia or high ambient temperature — impaired thermoregulation risk

• Driving or operating machinery — may cause drowsiness and blurred vision

• Lactating women — may reduce milk production

• Concurrent use of other anticholinergic drugs — additive toxicity

Parameter Details

Risk Category Limited human data; animal studies inconclusive. Not formally classified.

Preferred alternatives Hyoscine butylbromide (minimal systemic absorption); Mebeverine (better safety profile in obstetric practice)

When may be used Avoid in first trimester. May be used in second/third trimester only if clearly indicated and alternatives not suitable.

Monitoring Monitor fetal movements if prolonged use; maternal heart rate

Parameter Details

Compatibility NOT recommended during breastfeeding

Preferred alternatives Hyoscine butylbromide (poorly absorbed, minimal milk transfer); Mebeverine

Drug levels in milk Dicyclomine is excreted in breast milk at levels sufficient to cause infant toxicity

Infant risks Apnoea, seizures, syncope, muscular hypotonia, cyanosis reported in breastfed infants

Recommendation Avoid use in breastfeeding women; if essential, discontinue breastfeeding during treatment

Parameter Recommendation

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

Titration Slow titration over 1–2 weeks; assess tolerability before each increase

Special risks Increased anticholinergic burden leading to: confusion, delirium, cognitive impairment; urinary retention; constipation (may precipitate impaction); dry mouth, dental problems; blurred vision, falls risk; heat stroke in hot weather

Monitoring Assess cognitive function, urinary output, bowel habits; review anticholinergic burden from all medications

Recommendation Avoid if possible in elderly with dementia, cognitive impairment, or high anticholinergic load from other drugs

Interacting Drug Mechanism & Effect Management

Other anticholinergics (atropine, hyoscine, antihistamines with anticholinergic effects, TCAs, phenothiazines) Additive anticholinergic toxicity: confusion, urinary retention, ileus, hyperthermia Avoid combination; if essential, use lowest doses and monitor closely

Slow-release potassium preparations (solid oral forms) Delayed GI transit increases contact time → risk of potassium-induced GI ulceration/perforation Avoid solid potassium preparations; use liquid formulations if potassium supplementation needed

Antiglaucoma medications (pilocarpine, cholinergic agonists) Antagonism of glaucoma treatment → worsening of intraocular pressure Contraindicated in narrow-angle glaucoma; use with caution in open-angle glaucoma

Interacting Drug Effect Management

Antihistamines (diphenhydramine, chlorpheniramine, promethazine) Enhanced anticholinergic and sedative effects Monitor for excessive sedation, dry mouth, urinary retention

Tricyclic antidepressants (amitriptyline, imipramine) Additive anticholinergic effects Use with caution; monitor for toxicity

Opioid analgesics (tramadol, morphine, codeine) Additive constipation; enhanced sedation Monitor bowel function; avoid prolonged combination

Benzodiazepines Enhanced sedation Caution with driving/machinery

Antacids May reduce dicyclomine absorption Separate administration by 1–2 hours

Metoclopramide, Domperidone Antagonistic effects on GI motility Avoid combination; therapeutic conflict

Digoxin Delayed gastric emptying may increase digoxin absorption Monitor digoxin levels if initiating or stopping dicyclomine

• Dry mouth (most common)

• Constipation

• Blurred vision

• Dizziness

• Drowsiness/sedation

• Nausea

• Bloating

• Urinary hesitancy

• Tachycardia

• Reduced sweating

Adverse Effect Clinical Notes

Anticholinergic toxicity syndrome Hyperthermia, flushing, dilated pupils, delirium, tachycardia, urinary retention, ileus. Requires supportive care; consider physostigmine in severe cases.

Heat stroke Impaired thermoregulation; higher risk in hot weather or during fever

Toxic megacolon Risk in patients with ulcerative colitis — contraindicated

Seizures (especially in infants) Discontinue immediately; supportive care

Respiratory depression/Apnoea (infants) Life-threatening; dicyclomine absolutely contraindicated <6 months

Angioedema/Urticaria Rare hypersensitivity; discontinue permanently

Psychosis/Delirium (elderly) Discontinue; usually reversible

Paralytic ileus Discontinue; exclude mechanical obstruction

After initiation (1–2 weeks) Symptom response; anticholinergic side effects (dry mouth, constipation, blurred vision, urinary symptoms); sedation

Long-term Reassess indication periodically (short-term use preferred); monitor anticholinergic burden in elderly; cognitive assessment if prolonged use in elderly

Paediatric-specific Respiratory rate, feeding pattern, alertness, hydration status

Plain Dicyclomine:

• Cyclopam® (Indoco Remedies)

• Spasmonil® (Cadila Healthcare)

• Meftal-Spas® (component — Blue Cross)

• Cyclorin® (Ind-Swift)

• Kolispas® (Shreya Life Sciences)

• Dicymine® (various generics)

Common Fixed-Dose Combinations:

• Cyclopam® Plus (Dicyclomine + Paracetamol)

• Spasmonil® Plus (Dicyclomine + Simethicone)

Note: Dicyclomine plain is NOT listed in NLEM 2022. Some FDCs may be under NPPA price control.

1. Rule out organic disease first — dicyclomine treats functional symptoms only. Red flags (weight loss, GI bleeding, fever, obstruction) require investigation before initiating antispasmodic therapy.

1. Absolutely avoid in infants <6 months — serious respiratory depression, seizures, and deaths have been reported. This is a hard contraindication.

1. Timing matters — administer 30 minutes before meals for best absorption and pre-emptive effect on post-prandial symptoms.

1. Short-term use preferred — efficacy tends to diminish with prolonged use; reassess need after 2–4 weeks. Consider behavioural/dietary interventions for IBS.

1. Anticholinergic burden in elderly — avoid if possible; if used, assess total anticholinergic load from all medications. Prefer mebeverine (non-anticholinergic) in elderly patients.

1. IM only, never IV — intravenous administration can cause thrombosis, hypotension, respiratory arrest, and fatal arrhythmias.

1. Avoid in breastfeeding — documented infant toxicity (apnoea, seizures); use alternatives like hyoscine butylbromide or mebeverine.

IBS; antispasmodic; anticholinergic; abdominal-colic; functional-GI-disorders; contraindicated-infants; elderly-caution; lactation-avoid; short-term-use; IM-only; Dicyclomine

RxIndia v1.0 — 06 Jun 2025

• CDSCO Drug Database

• National Formulary of India (NFI) 2021

• Indian Pharmacopoeia 2022

• API Textbook of Medicine (11th Edition)

• AIIMS Standard Treatment Guidelines — Gastroenterology

• IAP Drug Formulary (Paediatric Use Guidance)

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

• NPPA Ceiling Price List

• Product package inserts (Cyclopam®, Spasmonil®)