Product image of Mazalvix (Mesalazine) supplied by GNH India

Mazalvix

Active Ingredient:
Mesalazine
Origin:
EU

Mazalvix (Mesalazine)

Mesalazine, the active ingredient in Mazalvix, is a 5‑aminosalicylic acid (5‑ASA) presented as a rectal formulation for rectal use. It is employed to treat ulcerative colitis, particularly distal disease, by reducing inflammation of the colonic mucosa and helping maintain remission in affected patients.

GNH India supplies Mazalvix as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with established quality‑assured distribution channels across Europe, Asia and the Americas. Our compliance with EU GMP standards ensures product consistency and safety for clinical use.

Manufacturer / TM Owner

Laboratoires Mayoly Spindler

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Indications & Clinical Uses

  • Mazalvix (mesalazine) acts locally in the colon to control inflammation associated with ulcerative colitis and related inflammatory bowel conditions.
  • Ulcerative colitis (distal disease): reduces mucosal inflammation and supports remission in patients with disease limited to the rectum and sigmoid colon.
  • Inflammatory bowel disease (colonic involvement): helps control colonic inflammation when other therapies are insufficient.
  • Proctitis: alleviates symptoms and promotes healing of rectal inflammation.

How It Works

  • Mesalazine exerts its anti‑inflammatory effect by inhibiting cyclooxygenase and lipoxygenase pathways within the colonic epithelium, leading to decreased prostaglandin and leukotriene synthesis. This reduction in pro‑inflammatory mediators diminishes neutrophil activation and cytokine release, thereby limiting mucosal injury and promoting healing of the intestinal lining. Additionally, mesalazine scavenges free radicals and modulates nuclear factor‑κB activity, further contributing to its protective role in the gastrointestinal tract.

Side Effects

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

Common Side Effects

  • Rectal irritation or burning sensation
  • Abdominal cramping or pain
  • Nausea or mild vomiting
  • Headache or dizziness

Serious or Rare Side Effects

  • Severe allergic reactions such as anaphylaxis
  • Pancreatitis
  • Blood dyscrasias including neutropenia or agranulocytosis
  • Hepatotoxicity or liver enzyme elevation

Precautions & Warnings

  • Before initiating Mazalvix, clinicians should consider several precautionary measures to ensure safe use.
  • Renal function assessment: evaluate baseline kidney function and monitor periodically.
  • Hepatic monitoring: check liver enzymes before treatment and during therapy.
  • Hypersensitivity screening: avoid use in patients with known allergy to mesalazine or other 5‑ASA compounds.
  • Concomitant NSAID use: exercise caution as combined therapy may increase renal toxicity.
  • Pregnancy and lactation: safety data are limited; prescribe only if benefit outweighs potential risk.
  • Store at room temperature: keep in original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Mesalazine can interact with other medicines, affecting efficacy or safety.

Major Interactions (Avoid)

  • Warfarin: may increase anticoagulant effect and INR.
  • Azathioprine or 6‑mercaptopurine: risk of enhanced bone‑marrow suppression.
  • High‑dose oral corticosteroids: may increase risk of nephrotoxicity.

Moderate Interactions (Monitor Closely)

  • NSAIDs: combined use can impair renal function.
  • Oral contraceptives: mesalazine may reduce hormonal efficacy.
  • Allopurinol: may raise mesalazine plasma levels.
  • Sulfasalazine: additive gastrointestinal irritation.

Frequently Asked Questions

Mazalvix contains mesalazine, a 5‑aminosalicylic acid that is prescribed to treat ulcerative colitis limited to the distal colon and to manage inflammatory bowel disease affecting the colon. It works locally to reduce mucosal inflammation and help maintain disease remission.

Mesalazine inhibits the cyclooxygenase and lipoxygenase pathways in the colonic lining, lowering the production of prostaglandins and leukotrienes. This suppression of pro‑inflammatory mediators reduces neutrophil activation, cytokine release, and oxidative stress, thereby limiting tissue injury and promoting healing of the intestinal mucosa.

The dosage of Mazalvix is individualized by the prescribing clinician based on disease severity, extent, and patient response. Healthcare professionals determine the appropriate amount, frequency, and duration of therapy in accordance with local prescribing guidelines and the patient’s clinical condition.

Safety data for mesalazine during pregnancy and lactation are limited. The product should only be used when the potential benefit to the mother outweighs any possible risk to the fetus or infant. Clinicians should discuss the uncertainty with the patient and consider alternative therapies when appropriate.

To request Mazalvix, 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 requirements) and the necessary import documentation.

Mazalvix delivers mesalazine directly to the rectal mucosa, offering a targeted approach for distal ulcerative colitis. Compared with oral 5‑ASA formulations, rectal delivery can achieve higher local concentrations with reduced systemic exposure, which may lower the risk of systemic side effects while providing effective symptom control.

Store Mazalvix at room temperature, preferably below 25 °C. Keep the product in its original packaging, protect it from moisture and direct sunlight, and avoid exposure to extreme temperatures. Follow any additional handling instructions provided on the label to maintain product integrity.

Mazalvix is a rectal formulation intended for local application. The prescribed dose is inserted into the rectum using the supplied applicator or as directed by the healthcare professional. Patients should follow the administration instructions carefully to ensure optimal drug contact with the affected mucosa.

Serious adverse events include severe allergic reactions such as anaphylaxis, pancreatitis, blood dyscrasias (e.g., neutropenia or agranulocytosis), and hepatotoxicity. Patients should be instructed to seek immediate medical attention if they experience symptoms such as rash, difficulty breathing, persistent abdominal pain, jaundice, or unexplained fatigue.

Mazalvix should be avoided in individuals with a known hypersensitivity to mesalazine or any other 5‑ASA compounds. It is also contraindicated in patients with severe renal or hepatic impairment where the risk of toxicity outweighs potential benefit, and in those for whom rectal administration is not feasible.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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