Drug Catalog - Product Detail
UCERIS EXTENDED RELEASE TABS 9MG 30CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68012-0309-30 | BAUSCH HEALTH | 30 | 9MG | TABLET |
PACKAGE FILES
Generic Name
BUDESONIDE
Substance Name
BUDESONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA203634
Description
11 DESCRIPTION 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 C 25 H 34 O 6 and its molecular weight is 430.5. Its structural formula is: Budesonide is a white to off-white, odorless, crystalline 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. 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, hydroxypropyl cellulose, lactose, silicon dioxide, magnesium stearate, methacrylic acid copolymer types A and B, talc, triethyl citrate, and titanium dioxide. uceris-1.jpg
How Supplied
16 HOW SUPPLIED/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°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.
Indications & Usage
1 INDICATIONS AND USAGE UCERIS ® extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. UCERIS (budesonide) is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is one 9 mg tablet to be taken once daily in the morning with or without food for up to 8 weeks. ( 2.1 ) 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 or crushed. 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 )].