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Uceris

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Uses

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

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History

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Other Information

UCERIS (budesonide) extended release tablets, for oral administration, contain budesonide, a synthetic corticosteroid, as the active ingredient. Budesonide is designated chemically as (RS)-11β, 16α, 17,21 tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with butyraldehyde.

Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6  and its molecular weight is 430.5. Its structural formula is:

uceris-chemical-structure

Budesonide is a white to off-white, tasteless, odorless powder that is practically insoluble in water, sparingly soluble in alcohol, and freely soluble in chloroform.

UCERIS, a delayed and extended-release tablet, is coated with a polymer film, which breaks down at or above pH 7.0. The tablet core contains budesonide with polymers that provide for extended release of budesonide.

Each tablet contains the following inactive ingredients: stearic acid, lecithin, microcrystalline cellulose, hydroxypropylcellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethylcitrate, and titanium dioxide.

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Uceris Manufacturers

  • Santarus, Inc.
    Uceris | Santarus, Inc.
    No Recall

    Uceris | Santarus, Inc.

    Uceris | Santarus, Inc.
    2.1 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.

    2.2 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 (7) and Clinical Pharmacology (12.3)].

    2.1 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.

    2.2 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 (7) and Clinical Pharmacology (12.3)].

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