Asacol HD Dosage

2.1 Important Administration Instructions

● Do not substitute one Asacol HD 800 tablet for two mesalamine delayed-release 400 mg oral products [see Clinical Pharmacology (12.3)].

● Evaluate renal function prior to initiation of Asacol HD.

● Take Asacol HD tablets on an empty stomach, at least 1 hour before and 2 hours after a meal [see Clinical Pharmacology (12.3)].

● Swallow Asacol HD tablets whole. Do not cut, break or chew the tablets.

​● Drink an adequate amount of fluids [see Warnings and Precautions (5.6)].

● 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 Asacol HD tablets from moisture.

2.2 Dosage Information

For the treatment of moderately active ulcerative colitis, the recommended dosage of Asacol HD in adults is 1600 mg (two 800 mg tablets) three times daily (total daily dosage of 4.8 grams) for a duration of 6 weeks.