Mesalamine
Dosing in kidney impairment
Renal Impairment Mesalamine is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Evaluate renal function in all patients prior to initiation and periodically while on mesalamine delayed-release tablets therapy. Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions.
Discontinue mesalamine if renal function deteriorates while on therapy [ see Warnings and Precautions, Drug Interactions and Adverse Reactions ].
Preparation and administration
Important Administration Instructions Do not substitute one mesalamine delayed-release tablet 800 mg for two mesalamine delayed-release 400 mg oral products [see Clinical Pharmacology]. Evaluate renal function prior to initiation of mesalamine delayed-release tablets. Take mesalamine delayed-release tablets on an empty stomach, at least 1 hour before and 2 hours after a meal [see Clinical Pharmacology] .
Swallow mesalamine delayed-release tablets whole. Do not cut, break or chew the tablets. Drink an adequate amount of fluids [see Warnings and Precautions]. Intact, partially intact, and/or tablet shells have been reported in the stool; Instruct patients to contact their healthcare provider if this occurs repeatedly. Protect mesalamine delayed-release tablets from moisture.