Apriso (Mesalamine) - Indications and Dosage

INDICATIONS AND USAGE

APRISO capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.

DOSAGE AND ADMINISTRATION

The recommended dose for maintenance of remission of ulcerative colitis in adult patients is 1.5 g (four APRISO capsules) orally once daily in the morning. APRISO may be taken without regard to meals. APRISO should not be co-administered with antacids. An evaluation of renal function is recommended before initiating therapy with APRISO.

DOSAGE FORMS AND STRENGTHS

Extended-release capsules containing 0.375 g mesalamine.

HOW SUPPLIED/STORAGE AND HANDLING

APRISO is available as light blue opaque hard gelatin capsules containing 0.375 g mesalamine and with the letters “G” and “M” on either side of a black band imprinted on the capsule.

NDC 65649-103-02 Bottles of 120 capsules
NDC 65649-103-01 Bottles of 4 capsules

Storage:
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F). See USP Controlled Room Temperature.