Product image of Mesalazine Aurobindo (Mesalazine) supplied by GNH India

Mesalazine Aurobindo

Active Ingredient:
Mesalazine
Origin:
EU

Mesalazine Aurobindo (Mesalazine)

Mesalazine, the active ingredient in Mesalazine Aurobindo, is an aminosalicylate presented as a rectal formulation for rectal use. It treats ulcerative colitis and colonic Crohn's disease in adult patients, helping to induce and maintain remission.
GNH India supplies Mesalazine Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aurobindo Pharma B.V.

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Indications & Clinical Uses

Mesalazine is an aminosalicylate used to manage inflammatory bowel disease.

  • Ulcerative colitis: induction of remission and control of disease activity.
  • Ulcerative colitis (maintenance): helps maintain remission after induction therapy.
  • Colonic Crohn's disease: used for maintenance therapy to reduce flare frequency.

How It Works

  • Mesalazine exerts its anti‑inflammatory effect by inhibiting cyclooxygenase and lipoxygenase pathways within the colonic mucosa, thereby decreasing prostaglandin and leukotriene synthesis. The drug acts locally in the colon, reducing inflammatory cell activation and cytokine release, which contributes to symptom relief and mucosal healing in inflammatory bowel disease.

Side Effects

Mesalazine may cause a range of adverse reactions, from mild to severe.

Common Side Effects

  • Abdominal pain or cramping.
  • Diarrhea or loose stools.
  • Nausea or mild vomiting.
  • Headache.
  • Rectal irritation or burning.
  • Flatulence.

Serious or Rare Side Effects

  • Severe allergic reactions such as rash, angioedema, or anaphylaxis.
  • Hepatotoxicity manifested by elevated liver enzymes.
  • Blood dyscrasias including neutropenia or thrombocytopenia.
  • Pancreatitis.
  • Worsening of colitis or new onset colonic ulceration.
  • Interstitial nephritis or renal impairment.

Precautions & Warnings

Before initiating therapy, clinicians should consider several safety measures.

  • Renal function monitoring: assess baseline creatinine and periodically re‑check.
  • Hepatic function monitoring: evaluate liver enzymes before and during treatment.
  • Hypersensitivity assessment: avoid use in patients with known salicylate allergy.
  • Severe disease caution: use with care in patients with fulminant ulcerative colitis.
  • Concomitant anticoagulant use: monitor for increased bleeding risk.
  • Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mesalazine can interact with several drug classes, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid)

  • Warfarin or other anticoagulants: increased risk of bleeding.
  • Live vaccines: potential for reduced vaccine efficacy and infection.
  • Sulfasalazine: additive toxicity, especially hematologic effects.

Moderate Interactions (Monitor Closely)

  • Non‑steroidal anti‑inflammatory drugs (NSAIDs): may heighten renal toxicity.
  • Azathioprine or 6‑mercaptopurine: possible additive bone‑marrow suppression.
  • Oral contraceptives: mesalazine may reduce hormonal efficacy, requiring alternative contraception.

Frequently Asked Questions

Mesalazine Aurobindo is a prescription‑only rectal formulation of mesalazine, an aminosalicylate indicated for the induction and maintenance of remission in ulcerative colitis and for maintenance therapy in colonic Crohn's disease. It works by reducing local inflammation in the colon.

Mesalazine inhibits the cyclooxygenase and lipoxygenase pathways in the colonic mucosa, leading to decreased production of prostaglandins and leukotrienes. This local anti‑inflammatory action reduces immune cell activation and cytokine release, helping to control inflammation associated with inflammatory bowel disease.

The specific dose and dosing schedule of Mesalazine Aurobindo are determined by the prescribing clinician based on the patient’s disease severity, location, and response to therapy. Healthcare professionals tailor the regimen to each individual’s clinical needs.

Safety data for mesalazine in pregnancy and lactation are limited, and the product’s pregnancy category is listed as unknown. Clinicians should weigh potential benefits against risks and consider alternative therapies when treating pregnant or nursing patients.

To place an order, submit an enquiry on the Mesalazine Aurobindo product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, and will request trade or institutional credentials before providing pricing, availability, shipping details (including any cold‑chain requirements), and import documentation.

Mesalazine belongs to the aminosalicylate class, offering a topical anti‑inflammatory effect directly in the colon. Compared with systemic immunosuppressants or biologics, it generally has a more favorable safety profile but may be less potent for severe disease. Choice of therapy depends on disease severity, location, and patient-specific factors.

Mesalazine Aurobindo should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture, excessive heat, and direct sunlight to maintain stability and potency.

The product is supplied as a rectal formulation, typically in the form of suppositories or enemas. Administration is performed by inserting the dose into the rectum according to the prescriber’s instructions, usually after bowel evacuation and before bedtime for optimal contact time.

Serious adverse events include severe allergic reactions (e.g., anaphylaxis), hepatotoxicity, blood dyscrasias such as neutropenia or thrombocytopenia, pancreatitis, and interstitial nephritis. Patients should be monitored regularly for signs of these conditions, and therapy should be discontinued if they occur.

Mesalazine Aurobindo is contraindicated in individuals with known hypersensitivity to mesalazine, salicylates, or any component of the formulation. It should also be avoided in patients with severe renal or hepatic impairment unless closely monitored, and in those with acute fulminant ulcerative colitis where systemic therapy is required.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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