Generic name: MESALAMINE 400mg
Dosage form: tablet, delayed release
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2.1 Important Administration Instructions
- Two Asacol 400 mg tablets are not interchangeable or substitutable with one mesalamine delayed-release 800 mg tablet.
- Evaluate renal function prior to initiation of Asacol
- Take Asacol tablets with or without food.
- Swallow Asacol tablets whole. Do not cut, break 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 Asacol tablets from moisture. Close the container tightly and to 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 Asacol is 800 mg (two 400 mg tablets) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks.
For pediatric patients 5 years of age and older, the recommended total daily dosage of Asacol is weight-based (up to maximum of 2.4 grams/day) divided into two daily doses for a duration of 6 weeks (see Table 1).
|Daily Dosage (mg/kg/day)||Maximum Daily Dosage
|Morning Dosage||Afternoon Dosage|
|17 to <33||36 to 71||1.2||two 400 mg tablets||one 400 mg tablet|
|33 to <54||37 to 61||2||three 400 mg tablets||two 400 mg tablets|
|54 to 90||27 to 44||2.4||three 400 mg tablets||three 400 mg tablets|
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- Drug class: 5-aminosalicylates