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Drug Catalog - Product Detail

BUDESONIDE 3MG CAP 100CT

NDC Mfr Size Str Form
64980-0255-01 RISING PHARMACEUTICALS 100 3MG NA
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Generic Name
BUDESONIDE
Substance Name
BUDESONIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA207367
Description
11 DESCRIPTION Budesonide, the active ingredient of BUDESONIDE Capsules, is a synthetic corticosteroid. Budesonide is designated chemically as 16α, 17-[(1RS)-butylidenebis(oxy)]-11β,21-dihydroxypregna-1,4,diene-3,20-dione. Budesonide is provided as a mixtureof two epimers (22R and 22S). The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5. Its structural formula is: Epimer 22 R or Epimer B Epimer 22 S or Epimer A Budesonide is a white or almost white, odorless crystalline powder that is practically insoluble in water, freely soluble in dichloromethane, sparingly soluble in alcohol. 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, lactose monohydrate, methacrylic acid copolymer dispersion, triethyl citrate, sodium hydroxide, talc and sugar spheres. The capsule shells have the following inactive ingredients, gelatin, iron oxide red, iron oxide black, iron oxide yellow and titanium dioxide. Sugar Spheres contains the following inactive ingredients Sucrose and corn starch. The imprinting ink contains the following nonvolatile components black iron oxide, potassium hydroxide and shellac. Budesonide Structural Formula Budesonide Structural Formula 2
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING BUDESONIDE Capsules, 3 mg are hard gelatin capsules size “0” light grey opaque body and pink opaque cap imprinted with black ink “AC” on Cap and “520” on body filled with white to off white Pellets. BUDESONIDE Capsules, 3 mg are supplied as follows: NDC 64980-255-01 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 Capsules is a corticosteroid 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 in adults. ( 1.2 ) 1.1 Treatment of Mild to Moderate Active Crohn’s Disease BUDESONIDE Capsules is indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Pediatric use information is approved for Perrigo Pharma International DAC’s Entocort EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease BUDESONIDE Capsules 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 in adults.
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Administration Instructions (2.1) : Take once daily in the morning Swallow whole. Do not chew or crush. Avoid consumption of grapefruit juice for the duration of therapy Recommended Dosage: Mild to moderate active Crohn’s disease (2.2) : Adults: 9 mg once daily for up to 8 weeks; repeat 8 week treatment courses for recurring episodes of active disease. Maintenance of clinical remission of mild to moderate Crohn’s disease (2.3). Adults: 6 mg once daily for up to 3 months; taper to complete cessation after 3 months. Continued treatment for more than 3 months has not been shown to provide substantial clinical benefit. When switching from oral prednisolone, begin tapering prednisolone concomitantly with initiating BUDESONIDE Capsules. Hepatic Impairment: Consider reducing the dosage to 3 mg once daily in adult patients with moderate hepatic impairment (Child-Pugh Class B). (2.4, 5.1, 8.6) 2.1 Administration Instructions Take BUDESONIDE Capsules once daily in the morning. Swallow BUDESONIDE Capsules whole. Do not chew or crush. Avoid consumption of grapefruit juice for the duration of BUDESONIDE Capsules therapy [see Drug Interactions (7.1) ]. 2.2 Treatment of Mild to Moderate Active Crohn’s Disease The recommended dosage of BUDESONIDE Capsules is: Adults: 9 mg orally once daily for up to 8 weeks. Repeated 8 week courses of BUDESONIDE Capsules can be given for recurring episodes of active disease. Pediatric use information is approved for Perrigo Pharma International DAC’s Entocort EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 2.3 Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease The recommended dosage in adults, following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), is BUDESONIDE Capsules 6 mg orally 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 Capsules 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 Capsules with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating BUDESONIDE Capsules treatment. 2.4 Dosage Adjustment in Adult Patients with Hepatic Impairment Consider reducing the dosage of BUDESONIDE Capsules to 3 mg once daily for adult patients with moderate hepatic impairment (Child-Pugh Class B). Avoid use in patients with severe hepatic impairment (Child-Pugh Class C) [see Warnings and Precautions (5.1), Use in Specific Populations (8.6) ].