Mesalamine
Check Drug InteractionsCheck known drug interactions.
Check Drug InteractionsMesalamine Prescribing Information
Warnings and Precautions
Renal Impairment (5.1) 11/2022
Mesalamine extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.
Dosage
The recommended dosage in adults is 1.5 g (four 0.375 g capsules) orally once daily in the morning.
Administration Instructions
• Evaluate renal function before initiating therapy with mesalamine extended-release capsules
[see Warnings and Precautions (5.1)].
• Swallow mesalamine extended-release capsules whole. Do not cut, break, crush or chew the capsules.
• Avoid co-administration of mesalamine extended-release capsules with antacids
[see Drug Interactions (7.1)].
• Drink an adequate amount of fluids
[see Warnings and Precautions (5.7)].
• Take mesalamine extended-release capsules without regard to meals
[see Clinical Pharmacology (12.3)].
Mesalamine extended-release capsules USP, 0.375 g are opaque light blue cap / opaque light blue body, hard gelatin capsules size ‘00’ having imprinting “A” on cap in black ink and “255” on body in black ink on either side of a black band filled with light grey to grey color granules.
Geriatric Patients:
Increased risk of blood dyscrasias; monitor blood cell counts and platelet counts. (8.5)Mesalamine extended-release capsules are contraindicated in patients with hypersensitivity to salicylates or aminosalicylates or to any of the components of mesalamine extended-release capsules
[see Warnings and Precautions (5.3), Adverse Reactions (6.2), Description (11)].
We receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available