"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.
Simponi works by blocking tumor necrosis factor (TNF), which plays an important"...
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DOSAGE AND ADMINISTRATION
The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is two to four 1.2 g tablets taken once daily with a meal for a total daily dose of 2.4 g or 4.8 g. The recommended dosage for the maintenance of remission is two 1.2 g tablets taken once daily with a meal for a total daily dose of 2.4 g.
Dosage Forms And Strengths
The red-brown ellipsoidal delayed-release tablet containing 1.2 g mesalamine is debossed on one side and imprinted with S476.
Storage And Handling
LIALDA is available as red-brown ellipsoidal film coated delayed-release tablets containing 1.2 g mesalamine, and debossed on one side imprinted with S476.
NDC 54092-476-12 HDPE Bottle with a child-resistant closure of 120 delayed-release tablets.
Store at room temperature 15 °C to 25 °C (59 °F to 77 °F); excursions permitted to 30 °C (86 °F).
See USP Controlled Room Temperature.
Manufactured for Shire US Inc., 725 Chesterbrook Blvd., Wayne, PA 19087, USA by Cosmo S.p.A., Milan, Italy. By license of Nogra Pharma Limited, Dublin, Ireland. Revised: Sep 2013.
Last reviewed on RxList: 1/27/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Lialda Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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