Mesalamine Delayed-Release Tablets Dosage & Rx Info

Mesalamine Delayed-release Tablets Generic Name & Formulations

Legal Class

General Description

Mesalamine 800mg.

Pharmacological Class

Salicylate.

How Supplied

Contact supplier

Manufacturer

Various generic manufacturers

Mechanism of Action

The mechanism of action of mesalamine is not fully understood, but appears to be a topical anti-inflammatory effect on colonic epithelial cells. Mucosal production of arachidonic acid metabolites, both through the cyclooxygenase pathways, that is, prostanoids, and through the lipoxygenase pathways, that is, leukotrienes and hydroxyeicosatetraenoic acids, 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.

Mesalamine Delayed-release Tablets Indications

Indications

Moderately active ulcerative colitis.

Limitations of Use

Safety and effectiveness of mesalamine delayed-release tabs beyond 6 weeks have not been established.

Mesalamine Delayed-release Tablets Dosage and Administration

Adult

Swallow whole; do not crush or chew. Treatment: 1600mg 3 times daily for 6 weeks.

Children

Not established.

Mesalamine Delayed-release Tablets Contraindications

Not Applicable

Mesalamine Delayed-release Tablets Boxed Warnings

Not Applicable

Mesalamine Delayed-release Tablets Warnings/Precautions

Warnings/Precautions

Sulfasalazine allergy. Discontinue if acute intolerance syndrome is suspected. Discontinue at the 1^st signs/symptoms of severe cutaneous adverse reactions. Conditions predisposing to myocarditis or pericarditis. Atopic dermatitis or eczema: may have more severe photosensitivity reactions. Nephrolithiasis. Ensure adequate hydration. Renal or hepatic impairment. History of renal disease. Assess renal function prior to and periodically during therapy. Discontinue if renal function deteriorates while on therapy. Elderly (monitor CBCs, platelets). Pregnancy. Nursing mothers: monitor infants

Mesalamine Delayed-release Tablets Pharmacokinetics

Metabolism

Hepatic.

Elimination

Renal (primary), fecal.

Mesalamine Delayed-release Tablets Interactions

Interactions

Increased toxicity with nephrotoxic drugs (eg, NSAIDs). Increased risk for blood disorders, bone marrow failure, and associated complications with azathioprine or 6-mercaptopurine and/or other drugs known to cause myelotoxicity. May cause elevated test results when measuring urinary normetanephrine; consider other alternative assay.

Mesalamine Delayed-release Tablets Adverse Reactions

Adverse Reactions

Headache, nausea, abdominal pain, diarrhea, nasopharyngitis, dyspepsia; renal impairment (eg, interstitial nephritis, minimal change disease, renal failure [rare]), hypersensitivity reactions (discontinue if occurs), severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP).

Mesalamine Delayed-release Tablets Clinical Trials

See Literature

Mesalamine Delayed-release Tablets Note

Notes

Formerly known under the brand name Asacol HD.

Mesalamine Delayed-release Tablets Patient Counseling