Schedule H

Oral

• 2 mg tablets

• 2 mg capsules

• 1 mg/5 mL oral suspension

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. 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

1. 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

1. 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

PAEDIATRIC DOSING (Specialist Only)

Primary Indication: Acute Diarrhoea

<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

No dose adjustment required.

• 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

• 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

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

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

• 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

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

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

• Constipation

• Abdominal cramps

• Nausea

• Flatulence

• Dizziness

• Dry mouth

• 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)

After initiation Bowel sounds, abdominal distension, stool frequency

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

• Lopedim® (Cipla)

• Imodium® (Janssen)

• Lopamide®

• Lomedon®

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

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

• 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

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

RxIndia v1.0 — 28 May 2025

• 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)