Budesonide

BUDESONIDE- budesonide capsule
Carilion Materials Management

1 INDICATIONS AND USAGE

1.1 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.

1.2 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.

2 DOSAGE AND ADMINISTRATION

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 capsules (enteric coated) 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 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 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 [ ]. see and Drug Interactions (7)Clinical Pharmacology (12.3)

3 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 over in black ink on both the cap and body. MYLAN 7155

4 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 [ ]. see Adverse Reactions (6.2)

5 WARNINGS AND PRECAUTIONS

5.1 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.

5.2 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.

5.3 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. (See prescribing information for VZIG and IG.) 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.

5.4 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 [ ]. see Use in Specific Populations (8.6)

5.5 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.

6 ADVERSE REACTIONS

Systemic glucocorticosteroid use may result in the following:

Hypercorticism and Adrenal Suppression [ ] see Warnings and Precautions (5.1)
Symptoms of steroid withdrawal in those patients transferring from Systemic Glucocorticosteroid Therapy [ ] see Warnings and Precautions (5.2)
Immunosuppression [ ] see Warnings and Precautions (5.3)
Increased Systemic Glucocorticosteroid Susceptibilty [ ] see Warnings and Precautions (5.4)
Other Glucocorticosteroid Effects [ ] see Warnings and Precautions (5.5)

6.1 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:

Table 1. Adverse Reactions Occurring in Greater Than or Equal to 5% of the Patients in Any Treated Group
*
This drug is not approved for the treatment of Crohn’s disease in the United States.

Budesonide Capsules (Enteric Coated)

9 mg

n = 520

Placebo

n = 107

Prednisolone

40 mg

n = 145

Comparator *

n = 88

Adverse Reaction

Number (%)

Number (%)

Number (%)

Number (%)

Headache

107(21)

19(18)

31(21)

11(13)

Respiratory Infection

55(11)

7(7)

20(14)

5(6)

Nausea

57(11)

10(9)

18(12)

7(8)

Back Pain

36(7)

10(9)

17(12)

5(6)

Dyspepsia

31(6)

4(4)

17(12)

3(3)

Dizziness

38(7)

5(5)

18(12)

5(6)

Abdominal Pain

32(6)

18(17)

6(4)

10(11)

Flatulence

30(6)

6(6)

12(8)

5(6)

Vomiting

29(6)

6(6)

6(4)

6(7)

Fatigue

25(5)

8(7)

11(8)

0(0)

Pain

24(5)

8(7)

17(12)

2(2)

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:

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

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

Table 2. Summary and Incidence of Signs/Symptoms of Hypercorticism in Short-Term Studies
*
Statistically significantly different from budesonide capsules (enteric coated) 9 mg.
Adverse reaction dictionary included term hair growth increased, local and hair growth increased, general.

Budesonide Capsules (Enteric Coated)

9 mg

n = 427

Placebo

n = 107

Prednisolone

Taper 40 mg

n = 145

Signs/Symptom

Number (%)

Number (%)

Number (%)

Acne

63(15)

14(13)

33(23) *

Bruising Easily

63(15)

12(11)

13(9)

Moon Face

46(11)

4(4)

53(37) *

Swollen Ankles

32(7)

6(6)

13(9)

Hirsutism

22(5)

2(2)

5(3)

Buffalo Hump

6(1)

2(2)

5(3)

Skin Striae

4(1)

2(2)

0(0)

Table 3 displays the frequency and incidence of signs/symptoms of hypercorticism by active questioning of patients in long-term clinical trials.

Table 3. Summary and Incidence of Symptoms of Hypercorticism in Long-Term Studies

Budesonide Capsules (Enteric Coated)

3 mg

n = 88

Budesonide Capsules (Enteric Coated)

6 mg

n = 145

Placebo

n = 143

Signs/Symptom

Number (%)

Number (%)

Number (%)

Bruising Easily

4(5)

15(10)

5(4)

Acne

4(5)

14(10)

3(2)

Moon Face

3 (3)

6(4)

0

Hirsutism

2 (2)

5(3)

1(1)

Swollen Ankles

2 (2)

3(2)

3(2)

Buffalo Hump

1 (1)

1 (1)

0

Skin Striae

2 (2)

0

0

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.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.