Europe — EMA
Mesalazina Mylan Generics
GNH USA supplies Mesalazina Mylan Generics (Mesalazine), a 5‑aminosalicylic acid for ulcerative colitis, Crohn's disease and maintenance of remission
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What is Mesalazine?
Mesalazine, the active ingredient in Mesalazina Mylan Generics, is a 5-aminosalicylic acid presented as an oral dosage form for oral use. It exerts a local anti‑inflammatory effect in the colon and is employed to treat ulcerative colitis, mild‑to‑moderate Crohn’s disease, and to maintain remission in inflammatory bowel disease.
GNH USA supplies Mesalazina Mylan Generics as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, and globally, with established quality assurance and regulatory compliance across EU and other markets.
What is Mesalazine used for?
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.
What are the side effects of Mesalazine?
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.
What precautions apply to Mesalazine?
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.
What does Mesalazine interact with?
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.
Frequently asked questions
What is Mesalazina Mylan Generics used for?+
How does mesalazine work?+
What is the usual dose of Mesalazina Mylan Generics?+
Is Mesalazina Mylan Generics safe in pregnancy or breastfeeding?+
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