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Uceris

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Uceris

INDICATIONS

UCERIS (budesonide) extended release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.

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.

CYP3A4 Inhibitors

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].

HOW SUPPLIED

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.

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