"The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
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Details with Side Effects
APRISO (mesalamine extended-release capsules) 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 (mesalamine extended-release capsules) capsules) orally once daily in the morning. APRISO (mesalamine extended-release capsules) may be taken without regard to meals. APRISO (mesalamine extended-release capsules) should not be co-administered with antacids. An evaluation of renal function is recommended before initiating therapy with APRISO (mesalamine extended-release capsules) .
Dosage Forms And Strengths
Extended-release capsules containing 0.375 g mesalamine.
Storage And Handling
APRISO (mesalamine extended-release capsules) 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
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.
Manufactured by : Catalent Pharma Solutions for Salix Pharmaceuticals, Inc., Morrisville, NC 27560.
Last reviewed on RxList: 9/14/2009
This monograph has been modified to include the generic and brand name in many instances.
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