Mesacol 400mg

Mesalazine

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🗂️ 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.

India‑to‑USA Savings (₹→USD @ ₹83)

Strips (10) FOB Halol Reg Air Landed 🇺🇸 Save vs US Compounding
10 ₹900 ₹680 $22.70 65 % ↓
50 ₹4 000 ₹780 $77.10 72 % ↓

Storage & Travel Tips

  • 15–25 °C; keep in foil until use.
  • Tablets survive 40 °C Indian summer for 30 min; ideal for travel kits.

Indian Companion Links (Internal)


External Authoritative Links

Additional Information

Active

Mesalazine

Tablets

30, 60, 90

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