Product image of Mesalazine supplied by GNH India

Mesalazine

Active Ingredient:
Mesalazine
Origin:
EU

Mesalazine

Mesalazine, the active ingredient in this product, is a 5-aminosalicylic acid (5-ASA) presented as a rectal formulation for rectal use. It reduces inflammation in the colon and is prescribed for ulcerative colitis and Crohn's disease with colonic involvement in patients who need local anti‑inflammatory therapy.

GNH India supplies Mesalazine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Dr. Falk Pharma Uk Ltd

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Indications & Clinical Uses

Mesalazine acts locally in the colon to control inflammatory bowel disease.

  • Ulcerative colitis: induces remission and reduces mucosal inflammation.
  • Crohn's disease (colonic involvement): controls colonic inflammation and helps maintain remission.
  • Maintenance therapy for ulcerative colitis: sustains remission after induction treatment.

How It Works

  • Mesalazine releases 5‑aminosalicylic acid in the colon where it inhibits cyclooxygenase and lipoxygenase pathways, decreasing prostaglandin and leukotriene synthesis. It also modulates cytokine production and reduces neutrophil activation, resulting in localized anti‑inflammatory effects without significant systemic absorption.

Side Effects

Mesalazine may cause a range of adverse reactions, most of which are mild and related to its rectal administration.

Common Side Effects

  • Rectal irritation or burning sensation.
  • Abdominal pain or cramping.
  • Nausea or mild headache.
  • Flatulence and loose stools.

Serious or Rare Side Effects

  • Severe allergic reaction (anaphylaxis, rash, swelling).
  • Blood in stool or severe colitis.
  • Hepatotoxicity or elevated liver enzymes.
  • Pancreatitis or Stevens‑Johnson syndrome.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety aspects.

  • Renal function: assess baseline and monitor periodically.
  • Hepatic function: check liver enzymes before and during treatment.
  • Severe ulcerative colitis: use with caution and monitor response closely.
  • Known hypersensitivity: avoid in patients with allergy to mesalazine or related compounds.
  • Pregnancy and breastfeeding: safety not established; weigh benefits against potential risks.
  • Store at room temperature: keep in the original package, protect from moisture and direct sunlight.

Avoid Interactions

Mesalazine can interact with other medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Azathioprine: increased risk of bone marrow suppression.
  • Warfarin: potentiation of anticoagulant effect, may raise INR.
  • Live vaccines: reduced efficacy, consider postponing vaccination.

Moderate Interactions (Monitor Closely)

  • NSAIDs: heightened gastrointestinal irritation.
  • Oral contraceptives: possible reduction in hormonal effectiveness.
  • Lithium: potential for increased lithium serum levels.

Frequently Asked Questions

Mesalazine is prescribed for inflammatory bowel diseases, specifically ulcerative colitis and Crohn's disease when the colon is involved. It works locally in the gut to reduce inflammation, help induce remission, and maintain disease control.

Mesalazine releases 5‑aminosalicylic acid in the colon where it blocks cyclooxygenase and lipoxygenase enzymes, lowering prostaglandin and leukotriene production. It also modulates cytokine release and neutrophil activity, providing a targeted anti‑inflammatory effect.

The exact dose and frequency of Mesalazine are determined by the prescribing clinician based on the severity of disease, patient weight, and response to therapy. Dosage instructions are provided on the prescription label.

Safety data for Mesalazine in pregnancy and lactation are limited, and the product is classified as having an unknown pregnancy category. Healthcare providers must weigh potential benefits against possible risks before prescribing to pregnant or nursing patients.

To request Mesalazine, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Mesalazine is a 5‑ASA agent similar to sulfasalazine and olsalazine but is delivered rectally, providing higher local concentrations in the distal colon. This can result in faster symptom relief for distal disease, while systemic exposure remains low compared with oral formulations.

Mesalazine rectal formulations should be stored at room temperature, below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and ensure the container is tightly closed when not in use.

Mesalazine is supplied as a rectal preparation, such as an enema or suppository. The patient inserts the dose into the rectum according to the prescribing information, usually once or twice daily, allowing the drug to coat the colonic mucosa.

Serious adverse events, though rare, include severe allergic reactions (anaphylaxis, rash), significant gastrointestinal bleeding, hepatotoxicity, pancreatitis, and severe colitis. Patients should seek immediate medical attention if they experience any of these symptoms.

Mesalazine is contraindicated in individuals with known hypersensitivity to mesalazine or any component of the formulation. Caution is also advised for patients with severe renal or hepatic impairment, and it should be avoided in those with active severe ulcerative colitis without close monitoring.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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