Mesalazina Mylan Generics (Mesalazine)

Mesalazine is used to treat inflammatory bowel disease by delivering local anti‑inflammatory activity in the colon.

• Ulcerative colitis: reduces mucosal inflammation, promotes healing of the colon lining, and helps induce and maintain remission in patients with active disease.
• Crohn's disease (mild to moderate): controls colonic inflammation, alleviates symptoms such as abdominal pain and diarrhea, and assists in achieving clinical remission.
• Maintenance of remission in inflammatory bowel disease: provides ongoing anti‑inflammatory effect to sustain disease control after induction therapy.

• Mesalazine acts locally in the gastrointestinal tract, where it is released as 5‑aminosalicylic acid. It inhibits cyclooxygenase and lipoxygenase pathways, reducing prostaglandin and leukotriene synthesis, and modulates cytokine release from immune cells, thereby decreasing mucosal inflammation in the colon. The drug remains largely unabsorbed, allowing high concentrations at the site of disease, and its anti‑oxidant properties further contribute to mucosal protection.

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

Common Side Effects

• Nausea: mild stomach upset or queasiness.
• Headache: transient headache episodes.
• Abdominal pain: cramping or discomfort in the abdomen.
• Diarrhea: loose stools or increased bowel movements.
• Flatulence: excess gas and bloating.
• Fatigue: feeling unusually tired.
• Vomiting: occasional episodes of emesis.

Serious or Rare Side Effects

• Severe allergic reaction: rash, itching, swelling, or difficulty breathing.
• Hepatotoxicity: signs of liver injury such as jaundice or elevated liver enzymes.
• Blood disorders: anemia, leukopenia, or thrombocytopenia.
• Kidney impairment: reduced renal function or interstitial nephritis.
• Pancreatitis: abdominal pain with elevated pancreatic enzymes.

When prescribing mesalazine, several precautions should be observed to ensure safe use.

• Renal function: monitor kidney parameters before and during therapy.
• Hepatic function: assess liver enzymes periodically.
• Blood counts: perform regular complete blood count to detect hematologic changes.
• Pregnancy: use only if potential benefit justifies potential risk, as safety data are limited.
• Concomitant NSAIDs: avoid or use with caution due to increased risk of renal toxicity.
• Store at ambient temperature: keep below 25 °C, in the original packaging, protected from moisture and light.

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

Major Interactions (Avoid)

• Azathioprine or 6‑mercaptopurine: increased risk of bone marrow suppression.
• Anticoagulants (warfarin): potential enhancement of anticoagulant effect, requiring monitoring.

Moderate Interactions (Monitor Closely)

• NSAIDs: may increase risk of renal impairment.
• Digoxin: possible alteration of serum levels.
• Oral contraceptives: may reduce plasma concentrations of mesalazine.
• Antibiotics (e.g., fluoroquinolones): may affect gut flora and drug absorption.