Mesalazine 500mg

Mesalazine is an anti-inflammatory agent structurally related to salicylates and non-steroidal anti-inflammatory drugs like acetylsalicylic acid. It is one of the primary treatments for inflammatory bowel disease.

Asapha® enteric-coated tablet contains 500mg of Mesalazine, which is soluble at pH=7.2 and above, for oral administration. Mesalazine (5-aminosalicylic acid) is the active component of sulfasalazine; the specific mechanism of action is unknown; however, it is thought that Mesalazine modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF); action appears topical rather than systemic.

• Asapha® is effective for both remission and maintaining remission in patients with diverticular disease.

• Asapha® is useful for patients with more extensive crohn’s disease, those who are intolerant of sulfasalazine, or those with contraindications or intolerance to budesonide.

Therapeutic Fields​

Treatment of mild to moderate active ulcerative colitis (UC)

Maintenance of remission of ulcerative colitis (UC)

Treatment of mild to moderate Crohn’s disease (off-label)

Based on a modelling study in 2021, we observed an increasing trend in the prevalence of IBD from 2017 to now and from 2020 to 2035 in Iran. Notably, it shifted from 23 thousand cases in 2017 to about 30 thousand cases in 2021, and it will be increased to about 69 thousand cases in 2035.

Pediatric inflammatory bowel disease is becoming increasingly common around the world

Dosing and Administration

Pregnancy and Breastfeeding

• Mesalazine can be continued without interruption.
  1020-mg/kg TDS
  0.51-g TDS
  7.515-mg/kg BD
  500mgTDS
• The decision to breastfeed during therapy should consider the risks and benefits

Contraindications

Hypersensitivity to Mesalazine, Amino salicylates, salicylates or any component of the formulation.

Warnings and Precautions

• Renal Impairment:
  Dose adjustment may be necessary since Mesalazine is renally eliminated. Use with caution.
• Hepatic Impairment:
  Evaluate risks versus benefits in patients with preexisting impairment.
• Hypersensitivity reactions; Intolerance syndrome; Photosensitivity; Patients with pyloric stenosis or
  other organic; functional upper GI obstructive disorders; oligospermia.