Generic name: MESALAMINE 400mg
Dosage form: capsule, delayed release
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2.1 Important Administration Instructions
• Two DELZICOL 400 mg capsules have not been shown to be interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet.
• Evaluate renal function prior to initiation of DELZICOL
• Take DELZICOL 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 [see Dosage and Administration (2.2, 2.3)].
° 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.
• Intact, partially intact, and/or tablet shells have been reported in the stool; Instruct patients to contact their physician if this occurs repeatedly. Protect DELZICOL capsules from moisture. Close the container tightly and leave any desiccant pouches present in the bottle along with the tablets.
2.2 Dosage for Treatment of Mildly to Moderately Active Ulcerative Colitis
For adults, the recommended dosage of DELZICOL is 800 mg (two 400 mg capsules) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks [see Clinical Studies (14.1)].
For pediatric patients 5 years of age and older, the recommended total daily dosage of DELZICOL 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).
(grams per day)
|17 to 32||36 to 71||1.2||two 400 mg capsules||one 400 mg
|33 to 53||37 to 61||2||three 400 mg capsules||two 400 mg
|54 to 90||27 to 44||2.4||three 400 mg capsules||three 400 mg