DRUG NAME: Mebeverine

Therapeutic Class: Musculotropic Smooth Muscle Relaxant

Subclass: Antispasmodic

Speciality: Gastroenterology

Schedule (India): H

Route(s): Oral

Formulations Available in India:

Formulation	Strengths Available
Mebeverine hydrochloride tablets (immediate-release)	135 mg
Mebeverine hydrochloride extended-release capsules	200 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Irritable Bowel Syndrome (IBS) and Functional Bowel Disorders

Immediate-Release Tablets (135 mg):

Parameter	Recommendation
Starting dose	135 mg orally three times daily
Titration	Not applicable
Usual maintenance dose	135 mg orally three times daily
Maximum dose	405 mg/day (135 mg TDS)

Extended-Release Capsules (200 mg):

Parameter	Recommendation
Starting dose	200 mg orally twice daily
Titration	Not applicable
Usual maintenance dose	200 mg orally twice daily
Maximum dose	400 mg/day (200 mg BD)

Clinical Notes:

Administer 20 minutes before meals for optimal effect
Reassess response after 2 weeks; discontinue if no improvement
ER formulation may improve compliance with equivalent efficacy

2. Spastic Colitis / Mucous Colitis

Parameter	Recommendation
Starting dose	135 mg orally three times daily (IR) OR 200 mg orally twice daily (ER)
Titration	Not applicable
Usual maintenance dose	Same as starting dose
Maximum dose	405 mg/day (IR) or 400 mg/day (ER)

Clinical Notes:

Duration guided by clinical response
Reassess necessity after 4 weeks of therapy

Secondary Indications – Adults (Off-label)

Indication	Dose	Duration	Notes
Biliary colic / Functional biliary dyskinesia (OFF-LABEL)	135 mg orally 2–3 times daily	Short-term (5–7 days)	Specialist only; based on Indian specialist practice

Evidence Basis: Indian gastroenterology specialist prescribing practice; limited controlled trial data

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not applicable — Mebeverine is not approved for routine paediatric use in India.

Secondary Indications – Paediatrics (Off-label)

Functional Abdominal Pain / IBS in Older Children (OFF-LABEL)

Age Group	Dose	Maximum Dose	Duration
≥10 years	135 mg orally twice daily	270 mg/day	2–4 weeks; reassess need
<10 years	NOT RECOMMENDED	—	—

Safety Monitoring:

Monitor for changes in bowel habits
Assess symptom response at 2 weeks
Rule out organic pathology before initiating

Age Restriction:

NOT recommended below 10 years of age except under paediatric gastroenterology specialist supervision

Evidence Basis: Limited paediatric data; Indian paediatric gastroenterology specialist practice

RENAL ADJUSTMENT

Renal Function	Recommendation
Mild-to-moderate impairment	No dose adjustment required
Severe impairment (eGFR <30 mL/min)	Use with caution; limited pharmacokinetic data
Dialysis	No specific data available

HEPATIC ADJUSTMENT

Hepatic Function	Recommendation
Mild impairment	No specific adjustment required; monitor clinical response
Moderate impairment	Use with caution; monitor for adverse effects
Severe impairment	Avoid or use with caution under specialist supervision; no pharmacokinetic data available

CONTRAINDICATIONS

Known hypersensitivity to mebeverine hydrochloride or any excipients
Paralytic ileus
Intestinal obstruction

CAUTIONS

Organic bowel disease: Rule out structural GI pathology (malignancy, IBD) before initiating empiric therapy
Chronic constipation: Monitor bowel pattern; not ideal for constipation-predominant IBS
Elderly patients: Monitor for constipation
Non-response: Reassess diagnosis if no improvement after 2–4 weeks; may mask progression of underlying conditions
Lactose intolerance: Some formulations contain lactose as excipient

PREGNANCY

Aspect	Recommendation
Overall safety	Limited human data; animal studies show no teratogenicity
Risk category	No definitive classification; not known to be teratogenic
First trimester	Generally avoided due to limited data
When use may be considered	If benefit outweighs risk; short-term use with specialist advice
Preferred alternatives	Non-pharmacological measures first; dicyclomine used cautiously by some Indian obstetricians
Monitoring	Fetal growth; maternal GI symptom resolution

LACTATION

Aspect	Recommendation
Compatibility	Likely compatible; minimal systemic absorption expected
Expected drug levels in milk	Low (based on pharmacokinetic profile)
Human data	Limited
Preferred alternatives	Hyoscine butylbromide if antispasmodic needed
Infant monitoring	Feeding adequacy, bowel habits, any GI discomfort

ELDERLY

Aspect	Recommendation
Starting dose	Same as adults (135 mg TDS or 200 mg ER BD)
Titration	Not typically required; may start with twice daily dosing if concerned
Key risks	Constipation; reassess necessity periodically
Monitoring	Bowel function; symptom response
Special notes	No anticholinergic effects — preferred over dicyclomine in elderly; no confusion/falls risk

MAJOR DRUG INTERACTIONS

None of major clinical significance documented.

Mebeverine undergoes extensive first-pass metabolism with minimal systemic bioavailability
No significant CYP-mediated interactions reported
No QT prolongation risk

MODERATE DRUG INTERACTIONS

Interacting Drug/Class	Effect	Management
Other anticholinergic agents	Theoretical additive effect on GI motility (though mebeverine is not anticholinergic)	Monitor for constipation
Loperamide	Potential increased risk of reduced bowel motility	Monitor bowel movement patterns; avoid prolonged concurrent use
Opioid analgesics	Additive constipation risk	Ensure adequate hydration and fibre intake

COMMON ADVERSE EFFECTS

Nausea
Headache
Mild GI discomfort or bloating
Dizziness
Constipation (uncommon)

Note: Mebeverine is generally well-tolerated with a low incidence of adverse effects due to minimal systemic absorption.

SERIOUS ADVERSE EFFECTS

Adverse Effect	Clinical Notes
Hypersensitivity reactions (urticaria, angioedema, anaphylaxis)	Rare; discontinue immediately; supportive management
Severe skin reactions	Very rare; discontinue if rash develops

MONITORING REQUIREMENTS

Phase	Parameters
Baseline	Assess for red flag symptoms (weight loss, rectal bleeding, anaemia, family history of GI malignancy); rule out organic pathology
After initiation	Symptom response at 2 weeks
Long-term	Reassess periodically (every 3–6 months) to avoid unnecessary chronic use; monitor bowel habits

BRANDS AVAILABLE IN INDIA

Brand Name	Manufacturer	Formulation
Colospa®	Abbott	135 mg tablets, 200 mg SR capsules
Mebex®	Intas	135 mg tablets
Mebaspa®	Macleods	135 mg tablets
Colofac®	Abbott	135 mg tablets
Meva®	Sun Pharma	135 mg tablets, 200 mg SR

FDC Products (if relevant):

Mebeverine + Chlordiazepoxide combinations available for IBS with anxiety component

PRICE RANGE (INR)

Formulation	Approximate Price
135 mg tablet	₹3–₹8 per tablet
200 mg ER capsule	₹8–₹15 per capsule

NLEM Status: Not included in NLEM 2022
NPPA Control: Not price-controlled
Government supply: Limited; primarily available through private pharmacies

CLINICAL PEARLS

No anticholinergic effects: Unlike dicyclomine and hyoscine, mebeverine does not cause dry mouth, urinary retention, or CNS effects — making it preferred in elderly, glaucoma, and prostatic hypertrophy patients.
Rule out red flags first: Always exclude organic pathology (weight loss, bleeding, anaemia, family history of malignancy) before initiating empiric therapy for presumed functional bowel disorder.
Not ideal for constipation-predominant IBS: Mebeverine does not stimulate motility; consider alternatives or combination therapy for IBS-C.
Compliance tip: Extended-release 200 mg BD formulation may improve adherence compared to 135 mg TDS.
Reassess chronic use: If symptoms persist beyond 4 weeks or recur frequently, reassess diagnosis rather than continuing indefinitely.
Safe in special populations: Low systemic absorption makes it suitable for patients where anticholinergic agents are contraindicated or poorly tolerated.

VERSION

RxIndia v1.0 — 03 Feb 2026

REFERENCES

CDSCO Product Database
Indian Pharmacopoeia / National Formulary of India
API Textbook of Medicine, 11th Edition
AIIMS Drug Formulary
Indian Gastroenterology Association practice patterns
Goodman & Gilman’s The Pharmacological Basis of Therapeutics

Anti Spasmodic

Sub-classifications

Cumulative Drug Index

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