Budesonide
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Questions & Answers
Side Effects & Adverse Reactions
Glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic glucocorticosteroid is recommended. Since budesonide capsules (enteric coated) are a glucocorticosteroid, general warnings concerning glucocorticoids should be followed.
Care is needed in patients who are transferred from glucocorticosteroid treatment with high systemic effects to corticosteroids with lower systemic availability, since symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop. Adrenocortical function monitoring may be required in these patients and the dose of systemic steroid should be reduced cautiously.
Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressant doses of glucocorticosteroids. In patients who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of glucocorticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior glucocorticosteroid treatment to the risk is also not known. If exposed, therapy with varicella zoster immune globulin (VZIG) or pooled intravenous immunoglobulin (IVIG), as appropriate, may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package insert for complete VZIG and IG prescribing information.) If chicken pox develops, treatment with antiviral agents may be considered.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Budesonide capsules (enteric coated) are indicated for:
- the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon and
- 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.
History
There is currently no drug history available for this drug.
Other Information
Budesonide, USP, the active ingredient of budesonide capsules (enteric coated), is a synthetic corticosteroid. It 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 molecular formula of budesonide is C25H34O6 and its molecular weight is 430.5 g/mole. Its structural formula is:
Budesonide is a white or almost white crystalline powder that is freely soluble in methylene chloride, sparingly soluble in alcohol and practically insoluble in water. Its partition coefficient between octanol and water at pH 5 is 1.6 x 103 ionic strength 0.01.
Each capsule contains 3 mg of micronized budesonide with the following inactive ingredients: acetyltributyl citrate, colloidal silicon dioxide, crospovidone, dimethicone, ethylcellulose, FD&C Red No. 40, gelatin, lactose monohydrate, magnesium stearate, methacrylic acid copolymer, polysorbate 80, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide and triethyl citrate.
The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.
Sources
Budesonide Manufacturers
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Udl Laboratories, Inc.
![Budesonide Capsule [Udl Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Budesonide | Chain Drug Consortium, Llc
directions
Adults and Children 12 years of age and over take 1 caplet every 4 hours as needed
children 6 to under 12 years of age consult a doctor
do not exceed 6 doses in a 24 hour period or as directed by a doctor. -
Par Pharmaceutical Inc.
Budesonide | Par Pharmaceutical Inc.
2.1 Mild to Moderate Active Crohn’s DiseaseThe 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 DiseaseFollowing 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 inhibitorsIf 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)].
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Mylan Pharmaceuticals Inc.
Budesonide | Mylan Pharmaceuticals Inc.
2.1 Mild to Moderate Active Crohn’s DiseaseThe 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 capsules (enteric coated) can be given for recurring episodes of active disease.
2.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s DiseaseFollowing an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), budesonide capsules (enteric coated) 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 capsules (enteric coated) 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 (enteric coated) with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating budesonide capsule (enteric coated) treatment.
2.3 CYP3A4 inhibitorsIf 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 capsules (enteric coated). In these cases, reduction in the dose of budesonide capsules (enteric coated) should be considered [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
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Carilion Materials Management
Budesonide | Carilion Materials Management
2.1 Mild to Moderate Active Crohn’s DiseaseThe 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 capsules (enteric coated) can be given for recurring episodes of active disease.
2.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s DiseaseFollowing an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), budesonide capsules (enteric coated) 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 capsules (enteric coated) 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 (enteric coated) with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating budesonide capsule (enteric coated) treatment.
2.3 CYP3A4 inhibitorsIf 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 capsules (enteric coated). In these cases, reduction in the dose of budesonide capsules (enteric coated) should be considered [ ]. see and Drug Interactions (7)Clinical Pharmacology (12.3)
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Golden State Medical Supply, Inc.
Budesonide | Golden State Medical Supply, Inc.
2.1 Mild to Moderate Active Crohn’s DiseaseThe 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 capsules (enteric coated) can be given for recurring episodes of active disease.
2.2 Maintenance of Clinical Remission of Mild to Moderate Crohn’s DiseaseFollowing an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), budesonide capsules (enteric coated) 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 capsules (enteric coated) 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 (enteric coated) with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating budesonide capsule (enteric coated) treatment.
2.3 CYP3A4 inhibitorsIf 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 capsules (enteric coated). In these cases, reduction in the dose of budesonide capsules (enteric coated) should be considered [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
![Budesonide Capsule [Par Pharmaceutical Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=5c73928d-2b96-42f5-1fb9-90965c214c21&name=6f5e0c8c-0697-4975-88a6-0c88b29f0f30-03.jpg)
![Budesonide Capsule [Mylan Pharmaceuticals Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=4a578d93-087e-42f7-a258-a49afef41dea&name=a5c63bee-ad0a-4140-ba53-9d7383b41e36-02.jpg)
![Budesonide Capsule [Carilion Materials Management]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=7633c9b3-dfb5-446f-a260-e44b6e48afa2&name=68151-4374.jpg)
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