Olsalazine Schedule (India)

Schedule H

Olsalazine Routes

Oral

Olsalazine Formulations

Capsules: 250 mg (Olsalazine sodium)

Note: Limited availability in India; mesalazine and sulfasalazine are more widely stocked

Olsalazine Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

Ulcerative Colitis — Maintenance of Remission

Parameter Recommendation

Starting dose 500 mg orally twice daily (with meals)

Titration May adjust after 4–6 weeks based on symptom control and tolerance

Usual maintenance dose 500 mg orally twice daily

Maximum dose 1.5 g/day in divided doses (specialist discretion)

Clinical notes:

Initiated after achieving remission with corticosteroids or other induction agents

Not suitable for acute exacerbations — may worsen diarrhoea due to pro-secretory effects

Prodrug converted to mesalazine in the colon by bacterial azo-reductases

Take with food to reduce GI intolerance

Secondary Indications – Adults Only (Off-label, if any):

Indication Dose Duration Evidence Basis Notes

Crohn's Colitis (OFF-LABEL) Starting: 500 mg BD; Maintenance: 500 mg BD; Max: 1.5 g/day Specialist-guided Limited observational studies; extrapolated from mesalazine class Specialist only; consider if mesalazine not tolerated

Radiation Proctitis (OFF-LABEL) Starting: 500 mg BD; Maintenance: 500 mg BD Minimum 4 weeks; assess response Indian specialist practice; extrapolated from mesalazine data Specialist only

Olsalazine Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications:

Ulcerative Colitis — Maintenance of Remission

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

Below 12 years Not recommended — — Use mesalazine preferred per IAP guidance

12–18 years 250 mg orally twice daily 500 mg orally twice daily if tolerated 1.5 g/day Gastroenterology supervision required

Safety Monitoring:

Monitor for diarrhoea and weight loss

Baseline and periodic CBC, renal function, LFTs

Mesalazine is preferred first-line agent in paediatric IBD per Indian IAP guidelines

Safety Statement: Not recommended below 12 years of age except under specialist supervision.

Secondary Indications – Paediatric Doses (Off-label, if any):

Not applicable — no well-validated off-label uses in Indian paediatric practice.

Olsalazine Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation

Mild impairment (eGFR 60–89) Use with caution; monitor renal function

Moderate impairment (eGFR 30–59) Avoid use; consider mesalazine alternatives with closer monitoring

Severe impairment (eGFR <30) Contraindicated

Haemodialysis Avoid use; insufficient data

Monitor serum creatinine every 3 months if prolonged use in patients with any degree of renal impairment

Olsalazine Hepatic adjustment

Hepatic Impairment	Recommendation
Mild impairment (Child-Pugh A)	Use with caution; monitor LFTs
Moderate impairment (Child-Pugh B)	Reduce dose if tolerated; close LFT monitoring
Severe impairment (Child-Pugh C)	Avoid use; limited safety data; consider specialist alternatives

Olsalazine Contraindications

Known hypersensitivity to olsalazine, salicylates, or other 5-ASA derivatives

Severe renal impairment (eGFR <30 mL/min/1.73 m²)

Severe hepatic impairment

Acute flare of ulcerative colitis (may exacerbate diarrhoea)

Known salicylate hypersensitivity

Olsalazine Cautions

History of bronchial asthma — increased risk of hypersensitivity reactions

Sulfonamide allergy — cross-reactivity possible though olsalazine is sulfa-free

Elderly patients — higher susceptibility to diarrhoea and dehydration

Pre-existing renal impairment — monitor function closely

Paradoxical worsening of diarrhoea in 10–20% of patients — may require drug discontinuation

Blood dyscrasias — monitor CBC periodically

Concomitant nephrotoxic drugs — increased renal risk

Olsalazine Pregnancy

Parameter Information

Safety category Likely safe (based on 5-ASA class experience); limited olsalazine-specific human data

Preferred alternatives Mesalazine (broader safety data in pregnancy)

Use recommendation May be used if mesalazine not tolerated and benefit clearly outweighs risk; specialist input essential

Monitoring Fetal growth monitoring if used long-term; maternal renal function

Olsalazine Lactation

Parameter Information

Compatibility Compatible with breastfeeding

Drug levels in milk Low to negligible (parent drug poorly absorbed systemically)

Preferred alternatives Mesalazine generally preferred in nursing mothers

Infant monitoring Observe for loose stools, feeding intolerance

Olsalazine Elderly

Parameter Recommendation

Starting dose 250 mg twice daily

Titration Slow titration over 2–4 weeks to 500 mg twice daily if tolerated

Extra risks Diarrhoea (dose-limiting), dehydration, electrolyte imbalance, reduced renal reserve

Monitoring Renal function, hydration status, electrolytes; higher sensitivity to GI adverse effects

Olsalazine Major drug interactions

Drug Interaction Mechanism Management

Azathioprine / 6-Mercaptopurine Increased myelotoxicity risk Inhibition of TPMT enzyme by 5-ASA metabolites Requires regular CBC monitoring; consider dose reduction of thiopurines

Methotrexate Increased methotrexate toxicity Competition for renal tubular secretion Avoid combination or use with extreme caution; monitor methotrexate levels

Warfarin Enhanced anticoagulant effect Possible displacement from protein binding Monitor INR closely; adjust warfarin dose as needed

Olsalazine Moderate drug interactions

Drug Interaction Management

NSAIDs Increased nephrotoxicity risk Monitor renal function; use lowest effective NSAID dose

Diuretics Additive risk of renal impairment and volume depletion Monitor hydration and renal function

Antacids May impair GI absorption of olsalazine Space doses by at least 2 hours

Digoxin Possible reduced digoxin absorption Monitor digoxin levels if clinically indicated

Olsalazine Common Adverse effects

Diarrhoea (dose-related; occurs in 10–20%)

Abdominal cramps

Nausea

Headache

Dyspepsia

Rash

Olsalazine Serious Adverse effects

Severe diarrhoea (secretory) Uncommon Discontinue drug; rehydrate

Interstitial nephritis Rare Discontinue immediately; nephrology referral

Hepatitis (idiosyncratic) Rare Discontinue; monitor LFTs; hepatology input

Blood dyscrasias (agranulocytosis, thrombocytopenia) Rare Discontinue; urgent haematology referral

Hypersensitivity reactions (systemic, cutaneous) Rare Discontinue immediately

Pancreatitis Very rare Discontinue; supportive care

Olsalazine Monitoring requirements

Phase Parameters

Baseline CBC, serum creatinine, LFTs, urinalysis

After initiation (2–4 weeks) Renal function, LFTs; assess for diarrhoea

Long-term (every 3–6 months) CBC, renal function, LFTs

Clinical monitoring Stool frequency, weight, signs of dehydration or drug intolerance

Olsalazine Brands in India

Dipentum (imported; limited availability)

Note: Olsalazine has very limited availability in India. Mesalazine and sulfasalazine are more commonly available and widely used alternatives.

Olsalazine Price range (INR)

Formulation	Approximate Price (per tablet)
250 mg capsule ₹12–₹18 per capsule (estimated) Private retail; limited availability

NPPA Status Not under NLEM price control —

Government supply Limited; mesalazine more commonly stocked —

Olsalazine Clinical pearls

Prodrug mechanism: Olsalazine consists of two mesalazine molecules linked by azo bond — cleaved by colonic bacteria to release active drug locally

Diarrhoea risk: Paradoxical secretory diarrhoea occurs in 10–20% of patients; if persistent, switch to mesalazine or sulfasalazine

Acute flare avoidance: Not indicated for acute ulcerative colitis — pro-secretory effect may worsen symptoms

Sulfasalazine alternative: Consider olsalazine in patients intolerant to sulfasalazine (headache, nausea) or mesalazine

Renal vigilance: Essential to monitor renal function in long-term use — interstitial nephritis is a class effect

Limited availability: In India, mesalazine is preferred and more accessible; olsalazine may require special procurement

Olsalazine Tags

Olsalazine; ulcerative colitis; IBD; 5-ASA; mesalazine alternative; diarrhoea risk; renal monitoring; maintenance therapy; sulfa-free; gastroenterology

Olsalazine Version

RxIndia v1.0 — 10 Jan 2025

Olsalazine Reference

CDSCO Product Database

National Formulary of India (NFI)

Indian Pharmacopoeia (IP)

API Textbook of Medicine

Indian Society of Gastroenterology Practice Guidelines

AIIMS Formulary and IBD protocols

IAP Guidelines (paediatric IBD)

Goodman & Gilman's The Pharmacological Basis of Therapeutics, 14th edition

Harrison's Principles of Internal Medicine, 21st edition

NLEM (checked for inclusion status — not currently included)

RxIndia

The Drug Registry

Olsalazine