Mesalaminedosage

Important Administration Instructions: Do not substitute two mesalamine delayed-release 400 mg capsules with one mesalamine delayed-release 800 mg tablet. Evaluate renal function prior to initiation of mesalamine delayed-release capsules. Take with or without food. Swallow the capsules whole; do not cut, break, crush or chew. For patients who are unable to swallow the capsules, the capsules can be opened and the inner tablets swallowed. Drink an adequate amount of fluids. Treatment of Mildly to Moderately Active Ulcerative Colitis: Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks. Pediatric Patients 5 years or older: See weight-based dosing table in the full prescribing information; twice daily dosing for 6 weeks. Maintenance of Remission of Ulcerative Colitis: Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided doses.

2.1 Important

Administration Instructions Do not substitute two mesalamine delayed-release 400 mg capsules with one mesalamine delayed-release 800 mg tablet. Evaluate renal function prior to initiation of mesalamine delayed-release capsules. Take mesalamine delayed-release capsules with or without food. Swallow the capsules whole; do not cut, break, crush or chew the capsules. For patients who are unable to swallow the capsules whole, carefully open the capsule(s) and swallow the contents (four 100 mg tablets). Open the number of capsules required to make up a complete dose. There are 4 tablets per capsule. Ensure all tablets per capsule are swallowed and no tablets are retained in the mouth. Swallow the tablets whole; do not cut, break, crush or chew the tablets. Drink an adequate amount of fluids. 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 capsules from moisture. Close the container tightly and leave any desiccant pouches present in the bottle along with the capsules.

2.2 Dosage for

Treatment of Mildly to Moderately Active Ulcerative Colitis Adults For adults, the recommended dosage of mesalamine delayed-release capsules is 800 mg (two 400 mg capsules) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks. Pediatrics For pediatric patients 5 years of age and older, the recommended total daily dosage of mesalamine delayed-release capsules is weight-based (up to maximum of 2.4 grams per day) divided into two daily doses for a duration of 6 weeks (see Table 1). Table 1. Pediatric Dosage by Weight Weight Group (kg) Daily Dosage (mg/kg/day) Maximum Daily Dosage (grams per day) Morning Dosage Afternoon Dosage 17 to 32 36 to 71 1.2 two 400 mg capsules one 400 mg capsules 33 to 53 37 to 61 2 three 400 mg capsules two 400 mg capsules 54 to 90 27 to 44 2.4 three 400 mg capsules three 400 mg capsules

2.3 Dosage for

Maintenance of Remission of Ulcerative Colitis The recommended dosage of mesalamine delayed-release capsules in adults is 1.6 grams (four 400 mg capsules) daily in two to four divided doses.