Product image of Mesalazin Orion (Mesalazine) supplied by GNH India

Mesalazin Orion

Active Ingredient:
Mesalazine
Origin:
EU

Mesalazin Orion (Mesalazine)

Mesalazine, the active ingredient in Mesalazin Orion, is an aminosalicylate (5‑ASA) presented as a rectal formulation for local use. It is employed to reduce inflammation in the colon of patients with ulcerative colitis and related disorders.

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

Manufacturer / TM Owner

Faes Farma, S.A.

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Indications & Clinical Uses

Mesalazin Orion belongs to the aminosalicylate class and is used to manage inflammatory conditions of the colon.

  • Ulcerative colitis: reduces mucosal inflammation and helps achieve clinical remission.
  • Ulcerative proctitis: targets distal colonic inflammation to control symptoms.
  • Maintenance therapy: supports sustained remission in patients with ulcerative colitis after induction of response.

How It Works

  • Mesalazine exerts its anti‑inflammatory effect by inhibiting cyclooxygenase and lipoxygenase pathways, thereby reducing prostaglandin and leukotriene synthesis. It also scavenges reactive oxygen species and modulates immune cell activity, leading to decreased cytokine release and attenuation of colonic mucosal inflammation.

Side Effects

Mesalazin Orion may cause a range of adverse reactions, most of which are mild and reversible.

Common Side Effects

  • Rectal irritation or burning sensation
  • Abdominal pain or cramping
  • Nausea or mild vomiting
  • Headache
  • Flatulence or bloating
  • Increased bowel urgency

Serious or Rare Side Effects

  • Severe allergic reaction (rash, swelling, anaphylaxis)
  • Acute severe colitis or bloody diarrhea
  • Hepatotoxicity (elevated liver enzymes)
  • Nephrotoxicity (renal function impairment)
  • Pancolitis flare
  • Blood dyscrasias (e.g., neutropenia)

Precautions & Warnings

Before initiating therapy, consider the following safety measures.

  • Pregnancy: safety not established; use only if benefit outweighs risk.
  • Breastfeeding: caution advised; mesalazine may be excreted in milk.
  • Renal impairment: monitor renal function and adjust therapy as needed.
  • Hepatic impairment: assess liver enzymes regularly.
  • Concurrent infection: evaluate and treat infections before starting.
  • Store at room temperature: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mesalazin Orion can interact with several medicines; awareness of the interaction level helps guide monitoring.

Major Interactions (Avoid)

  • Azathioprine: may increase risk of bone‑marrow suppression.
  • Methotrexate: additive toxicity to hepatic and hematologic systems.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (e.g., warfarin): may enhance bleeding tendency.
  • NSAIDs: can exacerbate gastrointestinal irritation.
  • Live vaccines: immunogenic response may be reduced.

Frequently Asked Questions

Mesalazin Orion is indicated for the treatment of ulcerative colitis and ulcerative proctitis. It is applied rectally to deliver mesalazine directly to the inflamed colonic mucosa, helping to reduce inflammation and control symptoms in these inflammatory bowel disease subtypes.

Mesalazine acts by inhibiting the synthesis of prostaglandins and leukotrienes through cyclooxygenase and lipoxygenase blockade. It also scavenges free radicals and modulates immune cell activity, which collectively reduces inflammatory mediators in the colon and promotes mucosal healing.

The specific dose and frequency of Mesalazin Orion are determined by the prescribing clinician based on disease severity, location, and patient response. Healthcare professionals tailor the regimen to each individual, and patients should follow the prescriber's instructions exactly.

Safety data for mesalazine in pregnancy are limited, and the drug is classified as having an unknown pregnancy category. It should only be used if the potential benefit justifies the potential risk. During breastfeeding, caution is advised because mesalazine can be excreted in breast milk.

To place an order, 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 (including any cold‑chain needs), and required import documentation.

Mesalazin Orion belongs to the aminosalicylate class, which is often used as first‑line therapy for mild to moderate ulcerative colitis. Compared with systemic steroids or biologics, mesalazine offers a topical anti‑inflammatory effect with a lower risk of systemic immunosuppression, making it suitable for maintenance and distal disease.

Mesalazin Orion should be stored at room temperature, below 25 °C, in its original packaging. Protect the product from moisture, direct sunlight, and extreme temperature fluctuations to maintain its stability and efficacy.

Mesalazin Orion is a rectal formulation intended for local application. The prescribed dose is typically inserted into the rectum using the supplied applicator or enema device, allowing direct contact with the inflamed mucosa of the distal colon.

Serious risks, though uncommon, include severe allergic reactions such as anaphylaxis, acute severe colitis with bloody diarrhea, hepatotoxicity, and renal dysfunction. Patients should seek immediate medical attention if they experience symptoms like rash, swelling, persistent abdominal pain, or changes in urine output.

Mesalazin Orion is contraindicated in patients with known hypersensitivity to mesalazine or any component of the formulation. It should also be avoided in individuals with severe renal or hepatic impairment unless closely monitored, and in those with active severe infections without appropriate treatment.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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