Drug Catalog - Product Detail
BUDESONIDE CAPS. CP 3MG 100
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0501-01 | PAR PHARMACEUTICAL | 100 | 3MG | CAPSULE |
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Description
11 DESCRIPTION Budesonide, the active ingredient of budesonide capsules, is a synthetic corticosteroid. 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, tasteless, odorless powder that is practically insoluble in water and heptane, sparingly soluble in ethanol, and freely soluble in chloroform. Its partition coefficient between octanol and water at pH 5 is 1.6 x 10 3 ionic strength 0.01. Each capsule for oral administration contains 3 mg of micronized budesonide with the following inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres. The capsule shells have the following inactive ingredients: gelatin, iron oxide, and titanium dioxide. Chemical Structure Budesonide 22R Chemical Structure Budesonide 22S
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Budesonide 3 mg capsules are hard gelatin capsules with an opaque light grey body and an opaque pink cap, coded with ENTOCORT EC 3 mg on the capsule and are supplied as follows: NDC 49884-501-01 Bottles of 100 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Keep container tightly closed.
Indications & Usage
1 INDICATIONS AND USAGE Budesonide is a glucocorticosteroid indicated for: • Treatment of mild to moderate active Crohn’s disease involving the ileum and/or the ascending colon. ( 1.1 ) • Maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months. ( 1.2 ) 1.1 Mild to Moderate Active Crohn’s Disease Budesonide is indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Budesonide is indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION • Mild to moderate active Crohn’s disease: 9 mg once daily in the morning for up to 8 weeks. Repeated 8 week courses of budesonide can be given for recurring episodes of active disease. ( 2.1 ) • Maintenance of clinical remission of mild to moderate Crohn’s disease: 6 mg once daily for up to 3 months. Continued treatment with budesonide 6 mg for more than 3 months has not been shown to provide substantial clinical benefit. ( 2.2 ) 2.1 Mild to Moderate Active Crohn’s Disease The recommended adult dosage for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon is 9 mg orally taken once daily in the morning for up to 8 weeks. Repeated 8 week courses of budesonide can be given for recurring episodes of active disease. 2.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease Following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), budesonide 6 mg orally is recommended once daily for maintenance of clinical remission up to 3 months. If symptom control is still maintained at 3 months an attempt to taper to complete cessation is recommended. Continued treatment with budesonide 6 mg for more than 3 months has not been shown to provide substantial clinical benefit. Patients with mild to moderate active Crohn’s disease involving the ileum and/or ascending colon have been switched from oral prednisolone to budesonide with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating budesonide treatment. 2.3 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. Grapefruit juice, which is known to inhibit CYP3A4, should also be avoided when taking budesonide. In these cases, reduction in the dose of budesonide capsules should be considered [ see Drug Interactions (7) and Clinical Pharmacology (12.3) ].