|fdaLIADAdult='''Mild to Moderate Active Crohn’s Disease'''
* Dosing Information
* 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.
:* Dosage
'''Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease'''
=====Condition2=====
* Budesonide capsules (enteric coated) are 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.
* Dosing Information
==Dosage==
:* Dosage
'''Mild to Moderate Active Crohn’s Disease'''
=====Condition3=====
* 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 capsules (enteric coated) can be given for recurring episodes of active disease.
* Dosing Information
'''Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease'''
:* Dosage
* Following 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.
=====Condition4=====
* 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.
* Dosing Information
'''CYP3A4 inhibitors'''
:* Dosage
* 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 capsules (enteric coated). In these cases, reduction in the dose of budesonide capsules (enteric coated) should be considered.
<!--Off-Label Use and Dosage (Adult)-->
==DOSAGE FORMS AND STRENGTHS==
<!--Guideline-Supported Use (Adult)-->
* Budesonide capsules (enteric coated) 3 mg have a red opaque cap and red opaque body, hard shell gelatin capsule filled with white to off-white enteric-coated pellets with no markings. The capsules are axially printed with MYLAN over 7155 in black ink on both the cap and body.
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====
Line 111:
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<!--Contraindications-->
<!--Contraindications-->
|contraindications=* Condition1
|contraindications=* Budesonide capsules (enteric coated) are contraindicated in patients with [[hypersensitivity]] to budesonide or any of the ingredients of budesonide capsules (enteric coated). [[Anaphylactic reactions]] have occurred.
|warnings='''Hypercorticism and Adrenal Suppression'''
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
* When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. 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.
'''Transferring Patients from Systemic Glucocorticosteroid Therapy'''
=====Endocrine=====
* Care is needed in patients who are transferred from glucocorticosteroid treatment with high systemic effects to corticosteroids with lower systemic availability, such as budesonide capsules (enteric coated), 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 glucocorticosteroid treatment with high systemic effects should be reduced cautiously.
'''Immunosuppression'''
* 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. If [[chicken pox]] develops, treatment with antiviral agents may be considered.
=====Hematologic and Lymphatic=====
* Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent [[tuberculosis]] infection, untreated fungal, bacterial, systemic viral or parasitic infections.
* Replacement of systemic glucocorticosteroids with budesonide capsules (enteric coated) may unmask allergies (e.g., [[rhinitis]] and [[eczema]]), which were previously controlled by the systemic drug.
* Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver [[cirrhosis]].
=====Metabolic and Nutritional=====
'''Other Glucocorticosteroid Effects'''
* Caution should be taken in patients with [[hypertension]], [[diabetes mellitus]], [[osteoporosis]], [[peptic ulcer]], [[glaucoma]] or [[cataracts]], or with a family history of [[diabetes]] or [[glaucoma]], or with any other condition where glucocorticosteroids may have unwanted effects.
|clinicalTrials='''Systemic glucocorticosteroid use may result in the following''':
* Hypercorticism and Adrenal Suppression.
* Symptoms of steroid withdrawal in those patients transferring from Systemic Glucocorticosteroid Therapy.
* Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
* The safety of budesonide capsules (enteric coated) was evaluated in 651 patients in five short-term, active disease state studies. They ranged in age from 17 to 74 (mean 35), 40% were male and 97% were white, 2.6% were greater than or equal to 65 years of age. Five hundred and twenty patients were treated with budesonide capsules (enteric coated) 9 mg (total daily dose). The most common adverse reactions reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. Clinical studies have shown that the frequency of glucocorticosteroid-associated adverse reactions was substantially reduced with budesonide capsules (enteric coated) compared with prednisolone at therapeutically equivalent doses. Adverse reactions occurring in greater than or equal to 5% of the patients are listed in Table 1:
[[File:XXXXX.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
* The safety of budesonide capsules (enteric coated) was evaluated in 233 patients in four long-term clinical trials (52 weeks). A total of 145 patients were treated with budesonide capsules (enteric coated) 6 mg. A total of 8% of budesonide capsule (enteric coated) patients discontinued treatment due to adverse reactions compared with 10% in the placebo group. The adverse reaction profile in long-term treatment of [[Crohn’s disease]] was similar to that of short-term treatment with budesonide capsules (enteric coated) 9 mg in active [[Crohn’s disease]].
=====Neurologic=====
* In the long-term clinical trials, the following adverse reactions occurred in greater than or equal to 5% of the 6 mg budesonide capsule (enteric coated) patients and are not listed in (Table 1) or by body system below: [[diarrhea]] (10%); [[sinusitis]] (8%); infection viral (6%); and [[arthralgia]] (5%).
* Adverse reactions, occurring in patients treated with budesonide capsules (enteric coated) 9 mg (total daily dose) in short-term active disease state studies and/or budesonide capsules (enteric coated) 6 mg (total daily dose) long-term, with an incidence less than 5% and greater than placebo are listed below by system organ class:
:*'''Blood and lymphatic system disorders''':[[leukocytosis]]
:*Cardiac disorders: palpitation, tachycardia
:*Eye disorders: eye abnormality, vision abnormal
:*General disorders and administration site conditions: asthenia, chest pain, dependent edema, face edema, flu-like disorder, malaise, fever
Table 2 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in short-term clinical trials.
=====Respiratory=====
[[File:XXXXX.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
* Table 3 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in long-term clinical trials.
[[File:XXXXX.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
* The incidence of signs/symptoms of hypercorticism as described above in long-term clinical trials was similar to that seen in the short-term clinical trials.
=====Skin and Hypersensitivy Reactions=====
* A randomized, open, parallel-group multicenter safety study specifically compared the effect of budesonide capsules (enteric coated) (less than 9 mg per day) and prednisolone (less than 40 mg per day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Bone mineral density decreased significantly less with budesonide capsules (enteric coated) than with prednisolone in steroid-naïve patients, whereas no difference could be detected between treatment groups for steroid-dependent patients and previous steroid users. The incidence of symptoms associated with hypercorticism was significantly higher with prednisolone treatment.
'''Clinical Laboratory Test Findings'''
* The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to budesonide capsules (enteric coated), were reported in greater than or equal to 1% of patients: [[hypokalemia]], [[leukocytosis]], [[anemia]], [[hematuria]], [[pyuria]], [[erythrocyte]] sedimentation rate increased, [[alkaline phosphatase]] increased, atypical neutrophils, [[C-reactive protein]] increased, and [[adrenal insufficiency]].
|postmarketing=* The following adverse reactions have been reported during post-approval use of budesonide capsules (enteric coated). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
=====Special Senses=====
:*'''Immune System Disorders''':[[Anaphylactic reactions]]
:*'''Nervous System Disorders''':Benign [[intracranial hypertension]]
:*'''Psychiatric Disorders''':[[Mood swings]]
=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* BUDESONIDE®<ref>{{Cite web | title =budesonide capsule|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a578d93-087e-42f7-a258-a49afef41dea }}</ref>
|brandNames=* BUDESONIDE®<ref>{{Cite web | title =budesonide capsule|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4a578d93-087e-42f7-a258-a49afef41dea }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
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Overview
Budesonide (capsule) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Mild to Moderate Active Crohn’s Disease
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.
Maintenance of Clinical Remission of Mild to Moderate Crohn’s Disease
Budesonide capsules (enteric coated) are 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
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 capsules (enteric coated) can be given for recurring episodes of active disease.
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 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.
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 capsules (enteric coated). In these cases, reduction in the dose of budesonide capsules (enteric coated) should be considered.
DOSAGE FORMS AND STRENGTHS
Budesonide capsules (enteric coated) 3 mg have a red opaque cap and red opaque body, hard shell gelatin capsule filled with white to off-white enteric-coated pellets with no markings. The capsules are axially printed with MYLAN over 7155 in black ink on both the cap and body.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Budesonide (capsule) in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Budesonide (capsule) in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Budesonide (capsule) in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Budesonide (capsule) in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Budesonide (capsule) in pediatric patients.
Contraindications
Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Anaphylactic reactions have occurred.
Warnings
Hypercorticism and Adrenal Suppression
When glucocorticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. 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.
Transferring Patients from Systemic Glucocorticosteroid Therapy
Care is needed in patients who are transferred from glucocorticosteroid treatment with high systemic effects to corticosteroids with lower systemic availability, such as budesonide capsules (enteric coated), 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 glucocorticosteroid treatment with high systemic effects should be reduced cautiously.
Immunosuppression
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. If chicken pox develops, treatment with antiviral agents may be considered.
Glucocorticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infection, untreated fungal, bacterial, systemic viral or parasitic infections.
Replacement of systemic glucocorticosteroids with budesonide capsules (enteric coated) may unmask allergies (e.g., rhinitis and eczema), which were previously controlled by the systemic drug.
Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of budesonide capsules (enteric coated) was evaluated in 651 patients in five short-term, active disease state studies. They ranged in age from 17 to 74 (mean 35), 40% were male and 97% were white, 2.6% were greater than or equal to 65 years of age. Five hundred and twenty patients were treated with budesonide capsules (enteric coated) 9 mg (total daily dose). The most common adverse reactions reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. Clinical studies have shown that the frequency of glucocorticosteroid-associated adverse reactions was substantially reduced with budesonide capsules (enteric coated) compared with prednisolone at therapeutically equivalent doses. Adverse reactions occurring in greater than or equal to 5% of the patients are listed in Table 1:
File:XXXXX.pngThis image is provided by the National Library of Medicine.
The safety of budesonide capsules (enteric coated) was evaluated in 233 patients in four long-term clinical trials (52 weeks). A total of 145 patients were treated with budesonide capsules (enteric coated) 6 mg. A total of 8% of budesonide capsule (enteric coated) patients discontinued treatment due to adverse reactions compared with 10% in the placebo group. The adverse reaction profile in long-term treatment of Crohn’s disease was similar to that of short-term treatment with budesonide capsules (enteric coated) 9 mg in active Crohn’s disease.
In the long-term clinical trials, the following adverse reactions occurred in greater than or equal to 5% of the 6 mg budesonide capsule (enteric coated) patients and are not listed in (Table 1) or by body system below: diarrhea (10%); sinusitis (8%); infection viral (6%); and arthralgia (5%).
Adverse reactions, occurring in patients treated with budesonide capsules (enteric coated) 9 mg (total daily dose) in short-term active disease state studies and/or budesonide capsules (enteric coated) 6 mg (total daily dose) long-term, with an incidence less than 5% and greater than placebo are listed below by system organ class:
Table 2 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in short-term clinical trials.
File:XXXXX.pngThis image is provided by the National Library of Medicine.
Table 3 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in long-term clinical trials.
File:XXXXX.pngThis image is provided by the National Library of Medicine.
The incidence of signs/symptoms of hypercorticism as described above in long-term clinical trials was similar to that seen in the short-term clinical trials.
A randomized, open, parallel-group multicenter safety study specifically compared the effect of budesonide capsules (enteric coated) (less than 9 mg per day) and prednisolone (less than 40 mg per day) on bone mineral density over 2 years when used at doses adjusted to disease severity. Bone mineral density decreased significantly less with budesonide capsules (enteric coated) than with prednisolone in steroid-naïve patients, whereas no difference could be detected between treatment groups for steroid-dependent patients and previous steroid users. The incidence of symptoms associated with hypercorticism was significantly higher with prednisolone treatment.
The following adverse reactions have been reported during post-approval use of budesonide capsules (enteric coated). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:
01.png){kind=link}