Loperamide Schedule (India)

Schedule H

Loperamide Routes

Oral

Loperamide Formulations

2 mg tablets

2 mg capsules

1 mg/5 mL oral suspension

Loperamide Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

Acute Non-specific Diarrhoea (Adults)

Parameter Recommendation

Starting dose 4 mg (2 tablets/capsules) initially

Titration 2 mg after each unformed stool

Usual maintenance dose 4–8 mg/day

Maximum dose 16 mg/day

Clinical Notes:

Do not exceed 48 hours of treatment without clinical reassessment

Discontinue if no improvement within 48 hours

Ensure adequate oral rehydration alongside antimotility therapy

Chronic Diarrhoea (e.g., IBS-D, Short Bowel Syndrome)

Parameter Recommendation

Starting dose 4 mg/day in divided doses

Titration Increase by 2 mg/day based on response

Usual maintenance dose 4–8 mg/day in 2–4 divided doses

Maximum dose 16 mg/day

Clinical Notes:

If no improvement after 10 days, reassess diagnosis and management

Long-term use may help reduce stool frequency but does not address bloating or abdominal discomfort

Consider specialist referral for persistent symptoms

Diarrhoea Associated with Ileostomy

Parameter Recommendation

Starting dose 4 mg/day in divided doses

Titration Adjust based on stoma output

Usual maintenance dose 4–8 mg/day

Maximum dose 16 mg/day

Clinical Notes:

Aim to reduce excessive stoma output and fluid losses

Gastroenterology or surgical specialist supervision recommended

Monitor hydration and electrolyte status regularly

Secondary Indications — Adults (Off-label, if any)

Indication Dose Duration Label Status Evidence Basis

Traveller's Diarrhoea Starting: 2–4 mg stat; then 2 mg after each loose stool; Max: 16 mg/day Short-term only (≤48 hours) OFF-LABEL Indian specialist practice; limited RCT data

Cautions for Off-label Use:

Avoid in presence of fever, bloody stools, or suspected invasive bacterial infection (Shigella, Salmonella, EHEC)

Risk of ileus increases with invasive pathogens

Use only as adjunct to rehydration and antimicrobials where indicated

Loperamide Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: Acute Diarrhoea

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

<2 years Any NOT RECOMMENDED —

2–5 years 13–20 kg 1 mg (5 mL) twice daily 6 mg/day

6–8 years 20–30 kg 2 mg/day in 2 divided doses 8 mg/day

9–12 years >30 kg 2 mg three times daily 8 mg/day

Duration: Not more than 2–3 days without clinical reassessment

Safety Monitoring:

Discontinue immediately if abdominal distension or reduced bowel sounds develop

Monitor hydration status and serum electrolytes

Exercise extra caution in malnourished or significantly dehydrated children

Oral rehydration remains the cornerstone of diarrhoea management in children

Secondary Indications — Paediatrics (Off-label, if any)

Indication Dose Duration Label Status Evidence Basis

Chronic diarrhoea in short bowel syndrome Titrated individually Long-term under supervision OFF-LABEL; Specialist only Limited paediatric case series; Indian GI specialist practice

Age Restriction:

Not recommended in children below 2 years due to risk of paralytic ileus and fatal respiratory depression

Loperamide Renal Adjustments

No dose adjustment required.

Loperamide Hepatic adjustment

Severity	Recommendation
Mild impairment	Use lowest effective dose; monitor for CNS effects
Moderate impairment	Use with caution; consider reduced dosing frequency
Severe impairment	Avoid use — risk of CNS toxicity due to reduced first-pass hepatic metabolism

Loperamide Contraindications

Age below 2 years

Acute dysentery (bloody or mucoid stools)

Febrile diarrhoea or suspected invasive bacterial enteritis

Pseudomembranous colitis (Clostridioides difficile infection)

Known hypersensitivity to loperamide or any excipients

Severe hepatic impairment

Loperamide Cautions

HIV-positive patients with diarrhoea (risk of toxic megacolon if underlying infectious colitis)

Elderly patients (increased risk of constipation and bowel distension)

Dehydrated or malnourished patients

Prolonged or repeated use may delay diagnosis of underlying pathology

Extended use can cause rebound constipation

Loperamide Pregnancy

Parameter Recommendation

Risk category Generally considered safe based on available data; limited human studies

Preferred alternative Oral rehydration therapy is first-line

When may be used Short-term use under obstetric guidance if rehydration alone is insufficient

Monitoring Watch for signs of constipation and reduced gut motility

Loperamide Lactation

Parameter Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Very low

Preferred status Preferred over diphenoxylate-atropine combinations

Infant monitoring Observe for constipation, reduced feeding, or unusual drowsiness

Loperamide Elderly

Starting dose: Begin at 2 mg; titrate cautiously

Titration: Slower than in younger adults

Extra risks: Increased susceptibility to constipation, paralytic ileus, and abdominal distension

Monitoring: Regularly assess bowel sounds and abdominal examination

Loperamide Major drug interactions

Interacting Drug/Class Mechanism/Effect Recommendation

P-glycoprotein inhibitors (quinidine, ritonavir, verapamil) Increased CNS penetration of loperamide Avoid combination; CNS depression risk

Strong CYP3A4/CYP2C8 inhibitors (ketoconazole, itraconazole, gemfibrozil) Elevated loperamide plasma levels Avoid or use with extreme caution

QT-prolonging drugs (at high loperamide doses) Additive QT prolongation Risk of torsades de pointes; avoid supratherapeutic dosing

Loperamide Moderate drug interactions

Interacting Drug/Class Mechanism/Effect Recommendation

CNS depressants (benzodiazepines, opioids) Additive sedation (mainly at abuse-level doses) Monitor for excessive drowsiness

Anticholinergic drugs Increased risk of paralytic ileus Use cautiously; monitor bowel function

Oral cholera vaccine Reduced vaccine immunogenicity Avoid concurrent administration

Loperamide Common Adverse effects

Constipation

Abdominal cramps

Nausea

Flatulence

Dizziness

Dry mouth

Loperamide Serious Adverse effects

Toxic megacolon (especially if used in infectious colitis)

Paralytic ileus

CNS depression (particularly in hepatic impairment or overdose/abuse)

QT prolongation and ventricular arrhythmias (reported with supratherapeutic doses or abuse)

Anaphylaxis (rare)

Loperamide Monitoring requirements

Timing	Parameters
Baseline	Hydration status, serum electrolytes, clinical assessment for invasive infection

After initiation Bowel sounds, abdominal distension, stool frequency

Chronic use Bowel pattern, CNS symptoms (if hepatic dysfunction suspected), electrolyte balance

Loperamide Brands in India

Lopedim® (Cipla)

Imodium® (Janssen)

Lopamide®

Lomedon®

Note: Lomotil® contains diphenoxylate-atropine — it is a different drug.

Loperamide Price range (INR)

Formulation	Approximate Price (per tablet)
Tablets (2 mg) ₹1–₹3 per tablet
Capsules (2 mg) ₹1–₹3 per capsule
Oral suspension (30 mL) ₹20–₹35 per bottle

NLEM Status: Not included in NLEM 2022; price variation exists across brands.

Loperamide Clinical pearls

Always exclude invasive bacterial diarrhoea (fever, blood/mucus in stool) before prescribing — loperamide is contraindicated in such cases

In acute diarrhoea, treatment beyond 48 hours without reassessment is inappropriate

For IBS-D, low-dose loperamide may reduce stool frequency but has limited effect on bloating or pain

Avoid in patients with hepatic impairment — reduced first-pass metabolism increases CNS toxicity risk

Contraindicated below age 2 years due to risk of serious respiratory and GI complications

Be vigilant for loperamide abuse (high doses for opioid effects) — associated with fatal cardiac arrhythmias

Loperamide Tags

diarrhoea; antimotility; opioid-receptor agonist; IBS-D; short bowel; paediatric-caution; hepatic-risk; not for infectious diarrhoea; Schedule H

Loperamide Version

RxIndia v1.0 — 28 May 2025

Loperamide Reference

CDSCO product listings

Indian Pharmacopoeia

AIIMS Formulary

API Textbook of Medicine

ICMR Guidelines on Diarrhoeal Management

National Treatment Guidelines for Acute Diarrhoea (Government of India)

WHO Model List of Essential Medicines (supportive reference)

NLEM 2022 (drug status verified — not listed)

RxIndia

The Drug Registry

Loperamide

Racecadotril