Asapha (Mesalazine)

Mesalamine or 5-aminosalicylic acid (5-ASA), is an anti-inflammatory drug used to treat inflammation of the digestive tract. The mechanism of action of mesalamine is unknown, but appears to have topical absorption rather than systemic effect. Mucosal production of arachidonic acid (AA) metabolites including prostanoids, leukotrienes (LTs) and hydroxyeicosatetraenoic acids are increased in patients with chronic inflammatory bowel disease, and mesalamine may diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin (PG) production in colon.


General characteristics:

Each Mesalamine tablet (E.C tablet) for oral administration contains 500 mg of mesalamine, which is soluble at pH 7.2 and above, releasing mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon.


Indication

• Treatment of mild to moderate active ulcerative colitis (UC).
• Maintenance of remission of ulcerative colitis (UC).
• Maintenance of remission of Crohn's ileo-colitis.


Contraindications:

• Hypersensitivity to salicylates or to any other components of the Asapha tablet.
• Children with chickenpox or flulike symptoms.
• Last weeks of pregnancy.
• During breast-feeding.


Dosage:

< 5 years: Safety and efficacy not established.

Adult:

• Ulcerative Colitis (active, mild to moderate) --------> 0.5-1 G PO TDS for 8 weeks
• Ulcerative Colitis(Remission maintenance) --------> 500 MG PO TDS for up to 8 weeks
• Crohn Disease (Off-label) --------> 0.5-1 G PO 3 TDS for 8 weeks


Side effects:

abdominal pain, flulike syndrome, headache, gas (flatulence), nausea, fatigue, weakness, fever, dizziness, rash, severe itching, acne, sore throat, sensitivity reaction, cholestatic hepatitis, decreased creatinine clearance, liver failure, kidney impairment, vomiting, abdominal distension, diarrhea, joint pain, hives, hair loss, high blood pressure.


Drug interactions:

• Serious interactions of mesalamine are:
• antiacids (e.g., aluminum hydroxide, calcium carbonate, sodium bicarbonate)
• H2 antagonists (e.g., cimetidine, famotidine, ranitidine)
• actulose
• non-steroidal anti-inflammatory drugs (NSAIDs; e.g., naproxen, ibuprofen)
• warfarin
• Azathioprine or 6-mercaptopurine
• Alcohol (Alcohol can irritate stomach and intestines).

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