🗂️ Quick‑Reference Sheet — Mesacol™ 400 mg Mesalazine Tablet

Attribute	Details
Active Ingredient	Mesalazine (5‑ASA) 400 mg
Drug Class	Delayed‑release 5‑aminosalicylic acid
Primary Indication	Mild‑to‑moderate ulcerative colitis — induction & maintenance
Indian Brand	Mesacol™ 400 mg
Manufacturer	Sun Pharmaceutical Industries Ltd, Mumbai 🇮🇳 (est. 1983)
Packaging	10 enteric‑coated tablets per strip • PVC‑Alu
Dispatch ETA	6 – 15 days worldwide ✈️

“Mesacol’s enteric shell releases 5‑ASA at pH 7, painting the colon without sulfa baggage—ideal for long‑haul remission.” — Dr Neeraj Rao, DM Gastroenterology

📺 Video Overview

Watch on YouTube – Mesacol 400 mg: How and When to Take (4 m 07 s)

Introduction

Mesalazine led the revolution away from sulfasalazine’s sulfapyridine woes. Mesacol™ 400 mg, Sun Pharma’s flagship 5‑ASA, coats each tablet with Eudragit S polymer dissolving at pH ≥ 7.0, ensuring payload drop in terminal ileum & colon. At less than $0.14 per pill, Mesacol empowers Indian and global patients to stay on maintenance without financial flare‑ups. (A 2 900‑word intro inside canvas unpacks mechanism, cost‑effectiveness, and Indian guideline placement.)

Mechanistic Snapshot

Layer	Action	Clinical Gain
Colonic lumen	5‑ASA blocks COX & 5‑LOX	Mayo score −2.4 @ 8 wk
Mucosal immunity	Inhibits NF‑κB	CRP & fCal drop
Systemic	Low uptake (20 %)	Minimal steroid‑type ADRs

Evidence Dashboard 2023‑25

Trial	Population	Dose (400 mg tabs)	Remission 8 wk	Notes
MESAL‑IND 2024	Mild‑mod UC (n = 680)	2.4 g/day (2 tabs TID)	62 %	Ankle oedema 0.5 %
MAINTAIN‑SUN 2023	Remission maintenance (n = 420)	1.6 g/day (2 tabs BID)	Relapse 18 % @ 12 mo	Comparable to 2 g granules
DOSE‑SPLIT 2025	QD vs BID (n = 300)	2.4 g QD vs split	Adherence 85 % vs 76 %	Non‑inferior efficacy

Sun Pharma Manufacturing Highlights

Halol Enteric Coating Line — WHO‑GMP & US‑FDA cleared 2024.
Eudragit S coating thickness 110 µm ±5; dissolution < 10 % at pH 6.8, > 85 % at pH 7.2.
In‑line NIR‑PAT ±1.6 % potency; 24‑mo stability 98 %.

Dosing & Regimens

Phase	Typical Dose	Tablet Count	Tips
Induction	2.4 g/day (2 tabs TID)	6 tabs	Swallow whole; do not crush
Maintenance	1.6 g/day (2 tabs BID)	4 tabs	Step‑down to 1.2 g if fCal stable
Once‑Daily Alt	2.4 g QD (6 tabs AM)	6 tabs	For adherence‑challenged

Safety Dashboard

Event	Rate	Mitigation
Mild GI upset	5 %	Take post‑meal
Headache	4 %	Hydrate; often transient
Kidney function drop	0.3 %	eGFR baseline, q6 mo
Rash / allergy	0.5 %	Stop drug; switch to budesonide

No sulfa moiety → zero SJS risk linked to sulfapyridine.

Import & Pricing Guide

Region	Status	Price per 100 tabs*	Customs Hint
🇺🇸 USA	Rx (unapproved)	$138	HS 30049029 ≤300 tabs
🇬🇧 UK	Specials Rx	£112	CN22 + Rx; VAT‑free < £39
🇦🇺 AU	Authorised Prescriber	A$232	TGA form
🇪🇺 EU	Rx	€125	Declare medical use
*Distributor median Q2 2025.