Budesonide (capsule)

Budesonide (capsule)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Overview

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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

There is limited information regarding Off-Label Guideline-Supported Use of Budesonide (capsule) in adult patients.

Non–Guideline-Supported Use

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)

There is limited information regarding FDA-Labeled Use of Budesonide (capsule) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Budesonide (capsule) in pediatric patients.

Non–Guideline-Supported Use

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.

Increased Systemic Glucocorticosteroid Susceptibility

• Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis.

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.

Adverse Reactions

Clinical Trials Experience

Systemic glucocorticosteroid use may result in the following:

• Hypercorticism and Adrenal Suppression.
• Symptoms of steroid withdrawal in those patients transferring from Systemic Glucocorticosteroid Therapy.
• Immunosuppression
• Increased Systemic Glucocorticosteroid Susceptibilty
• Other Glucocorticosteroid Effects

Clinical Trials Experience

• 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:

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.

• 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
• Gastrointestinal disorders: anus disorder, Crohn’s disease aggravated, enteritis, epigastric pain, gastrointestinal fistula, glossitis, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder
• Infections and infestations: Ear infection-not otherwise specified, bronchitis, abscess, rhinitis, urinary tract infection, thrush
• Investigations: c-reactive protein increased, weight increased
• Metabolism and nutrition disorders: appetite increased, hypokalemia
• Musculoskeletal and connective tissue disorders: arthritis, cramps, myalgia
• Nervous system disorders: hyperkinesia, parasthesia, tremor, vertigo, dizziness, somnolence, amnesia
• Psychiatric disorders: agitation, confusion, insomnia, nervousness, sleep disorder
• Renal and urinary disorders: dysuria, micturition frequency, nocturia
• Reproductive system and breast disorders: intermenstrual bleeding, menstrual disorder
• Respiratory, thoracic and mediastinal disorders: dyspnea, pharynx disorder
• Skin and subcutaneous tissue disorders: acne, alopecia, dermatitis, eczema, skin disorder, sweating increased, purpura
• Vascular disorders: flushing, hypertension

Table 2 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in short-term clinical trials.

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.

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.

• 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 Experience

• 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:

• Immune System Disorders:Anaphylactic reactions
• Nervous System Disorders:Benign intracranial hypertension
• Psychiatric Disorders:Mood swings

Drug Interactions

There is limited information regarding Budesonide (capsule) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Budesonide (capsule) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Budesonide (capsule) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Budesonide (capsule) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Budesonide (capsule) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Budesonide (capsule) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Budesonide (capsule) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Budesonide (capsule) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Budesonide (capsule) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Budesonide (capsule) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Budesonide (capsule) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Budesonide (capsule) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Budesonide (capsule) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Budesonide (capsule) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Budesonide (capsule) in the drug label.

Pharmacology

There is limited information regarding Budesonide (capsule) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Budesonide (capsule)01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Budesonide (capsule) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Budesonide (capsule) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Budesonide (capsule) in the drug label.

Clinical Studies

The safety and efficacy of budesonide capsules (enteric coated)were evaluated in 994 patients with mild to moderate active Crohn’s disease of the ileum and/or ascending colon in five randomized and double-blind studies. The study patients ranged in age from 17 to 85 (mean 35), 40% were male and 97% were white. Of the 651 patients treated with budesonide capsules (enteric coated), 17 (2.6%) were greater than or equal to 65 years of age and none were greater than 74 years of age. The Crohn’s Disease Activity Index (CDAI) was the main clinical assessment used for determining efficacy in these five studies. The CDAI is a validated index based on subjective aspects rated by the patient (frequency of liquid or very soft stools, abdominal pain rating and general well-being) and objective observations (number of extraintestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight and hematocrit). Clinical improvement, defined as a CDAI score of less than or equal to 150 assessed after 8 weeks of treatment, was the primary efficacy variable in these five comparative efficacy studies of budesonide capsules (enteric coated). Safety assessments in these studies included monitoring of adverse reactions. A checklist of potential symptoms of hypercorticism was used.

One study (Study 1) compared the safety and efficacy of budesonide capsules (enteric coated) 9 mg daily in the morning to a comparator. At baseline, the median CDAI was 272. Budesonide capsules (enteric coated) 9 mg daily resulted in a significantly higher clinical improvement rate at Week 8 than the comparator. See Table 4.

This image is provided by the National Library of Medicine.

• Two placebo-controlled clinical trials (Studies 2 and 3) were conducted. Study 2 involved 258 patients and tested the effects of graded doses of budesonide capsules (enteric coated) (1.5 mg twice daily, 4.5 mg twice daily, or 7.5 mg twice daily) versus placebo. At baseline, the median CDAI was 290. The 3 mg per day dose level (data not shown) could not be differentiated from placebo. The 9 mg per day arm was statistically different from placebo (Table 4), while no additional benefit was seen when the daily budesonide capsule (enteric coated) dose was increased to 15 mg per day (data not shown). In Study 3, the median CDAI at baseline was 263. Neither 9 mg daily nor 4.5 mg twice daily budesonide capsule (enteric coated) dose levels was statistically different from placebo (Table 4).

• Two clinical trials (Studies 4 and 5) compared budesonide capsules (enteric coated) with oral prednisolone (initial dose 40 mg per day). At baseline, the median CDAI was 277. Equal clinical improvement rates (60%) were seen in the budesonide capsules (enteric coated) 9 mg daily and the prednisolone groups in Study 4. In Study 5, 13% fewer patients in the budesonide capsules (enteric coated) group experienced clinical improvement than in the prednisolone group (no statistical difference) (Table 4).

• The proportion of patients with normal plasma cortisol values (greater than 150 nmol/L) was significantly higher in the budesonide capsule (enteric coated) groups in both trials (60% to 66%) than in the prednisolone groups (26% to 28%) at Week 8.

• The efficacy and safety of budesonide capsules (enteric coated) for maintenance of clinical remission were evaluated in four double-blind, placebo-controlled, 12-month trials in which 380 patients were randomized and treated once daily with 3 mg or 6 mg budesonide capsules (enteric coated) or placebo. Patients ranged in age from 18 to 73 (mean 37) years. Sixty percent of the patients were female and 99% were Caucasian. The mean CDAI at entry was 96. Among the four clinical trials, approximately 75% of the patients enrolled had exclusively ileal disease. Colonoscopy was not performed following treatment. Budesonide capsules (enteric coated) 6 mg per day prolonged the time to relapse, defined as an increase in CDAI of at least 60 units to a total score greater than 150 or withdrawal due to disease deterioration. The median time to relapse in the pooled population of the four studies was 154 days for patients taking placebo, and 268 days for patients taking budesonide capsules (enteric coated) 6 mg per day. Budesonide capsules (enteric coated) 6 mg per day reduced the proportion of patients with loss of symptom control relative to placebo in the pooled population for the four studies at 3 months (28% vs. 45% for placebo).

How Supplied

• Budesonide Capsules (enteric coated) are available as 3 mg capsules.

• The 3 mg capsule is a red opaque cap/red opaque body, hard-shell gelatin capsule filled with white to off-white enteric-coated pellets with no markings. The capsule is axially printed with MYLAN over 7155 in black ink on both the cap and body. They are available as follows:

• NDC 0378-7155-01

bottles of 100 capsules

• NDC 0378-7155-05

bottles of 500 capsules

Storage

• Store at 20° to 25°C (68° to 77°F).

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

• Patients being treated with budesonide capsules (enteric coated) should receive the following information and instructions. This information is intended to aid the patient in the safe and effective use of the medication. It is not a disclosure of all possible adverse or intended effects. For proper use of budesonide capsules (enteric coated) and to attain maximum improvement, the patient should read and follow the accompanying FDA-Approved Patient Labeling.

Hypercorticism and Adrenal Suppression

• Patients should be advised that budesonide capsules (enteric coated) may cause systemic glucocorticosteroid effects of hypercorticism and adrenal suppression. Patients should taper slowly from systemic glucocorticosteroids if transferring to budesonide capsules (enteric coated).

Immunosuppression

• Patients who are on immunosuppressant doses of glucocorticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to consult their physician without delay. Patients should be informed of potential worsening of existing tuberculosis, fungal, bacterial, viral or parasitic infections [see WARNINGS AND PRECAUTIONS (5.3)].

How to Take Budesonide Capsules (enteric coated)

• Budesonide capsules (enteric coated) should be swallowed whole and NOT CHEWED OR BROKEN. Patients should be advised to avoid the consumption of grapefruit juice for the duration of their budesonide capsules (enteric coated) therapy.

Precautions with Alcohol

• Alcohol-Budesonide (capsule) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• BUDESONIDE®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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