Mesalazine

What it is and how it works

Mechanism of Action The mechanism of action of mesalamine is not fully understood, but it appears to have a topical anti-inflammatory effect on the colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase and lipoxygenase pathways, is increased in patients with ulcerative colitis, and it is possible that mesalamine diminishes inflammation by blocking cyclooxygenase and inhibiting prostaglandin production in the colon.

Indications

Mesalamine delayed-release tablets are indicated for the: · induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. · treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg. Mesalamine delayed-release tablet is an aminosalicylate indicated for the: • induction and maintenance of remission in adult patients with mildly to moderately active ulcerative colitis. • treatment of mildly to moderately active ulcerative colitis in pediatric patients weighing at least 24 kg.

Dosage and administration (summary)

Administration Instructions • Evaluate renal function prior to initiation of mesalamine delayed-release tablets and periodically while on therapy. • Swallow mesalamine delayed-release tablets whole; do not split or crush. • Administer mesalamine delayed-release tablets with food . • Drink an adequate amount of fluids . Adults • The recommended dosage for the induction of remission in adult patients with mildly to moderately active ulcerative colitis is 2.4 g to 4.8 g (two to four 1.2 g tablets) taken once daily. • The recommended dosage for the maintenance of remission is 2.4 g (two 1.2 g tablets) taken once daily.

Contraindications

Mesalamine is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, or to any of the ingredients of mesalamine . Known or suspected hypersensitivity to salicylates or aminosalicylates or to any of the ingredients of mesalamine.

Warnings and precautions

• Renal Impairment : Assess renal function at the beginning of treatment and periodically during treatment. Evaluate the risks and benefits of mesalamine in patients with known renal impairment or taking nephrotoxic drugs. Discontinue mesalamine if renal function deteriorates while on therapy. ( 5.1 , 7.1 , 8.6 ) • Mesalamine-Induced Acute Intolerance Syndrome : Symptoms may be difficult to distinguish from an ulcerative colitis exacerbation. Monitor for worsening symptoms while on treatment. Discontinue treatment if acute intolerance syndrome is suspected.

Pregnancy

Pregnancy Risk Summary Published data from meta-analyses, cohort studies, and case series on the use of mesalamine during pregnancy have not reliably informed an association with mesalamine and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see Data).

Storage and supply

Mesalamine delayed-release tablets, USP are available as reddish-brown, oval-shaped, enteric-coated tablets containing 1.2 g mesalamine is imprinted with “M19” in black color on one side and plain on other side supplied in: HDPE Bottle with a child-resistant closure of 120 delayed-release tablets NDC 31722-043-12 HDPE Bottle with a child-resistant …

Source: Mesalamine (Mesalamine) — US FDA prescribing information, 2024-02-15, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.