"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"...
DOSAGE AND ADMINISTRATION
Mild to Moderate Ulcerative Colitis
The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is 9 mg taken orally once daily in the morning with or without food for up to 8 weeks. UCERIS should be swallowed whole and not chewed, crushed or broken.
If concomitant administration with ketoconazole, or any other CYP3A4 inhibitor, is indicated, patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Avoid grapefruit juice, which is known to inhibit CYP3A4, when taking UCERIS. In these cases, discontinuation of UCERIS or the CYP3A4 inhibitor should be considered [See DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].
Dosage Forms And Strengths
White, round, biconvex extended release tablets debossed with “MX9”. Each extended release tablet contains 9 mg budesonide.
Storage And Handling
UCERIS (budesonide) extended release tablets 9 mg, are white, round, biconvex tablets and debossed with “MX9”. They are supplied as follows:
NDC (68012-309-30): Bottles of 30 tablets.
Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F). [See USP Controlled Room Temperature].
Keep container tightly closed. Protect from light and moisture.
Manufactured for Santarus, Inc., San Diego, CA 92130 1-888-778-0887. Manufactured by: Cosmo S.p.A., Milan, Italy. Revised: January 2013
Last reviewed on RxList: 1/28/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Uceris 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.
Find out what women really need.