Budesonide Inhalation (Page 2 of 8)

5.6 Hypercorticism and Adrenal Suppression

Budesonide inhalation suspension, will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing budesonide inhalation suspension. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with budesonide inhalation suspension should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients post-operatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism, and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when budesonide is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of budesonide inhalation suspension should be reduced slowly, consistent with accepted procedures for tapering of systemic corticosteroids and for management of asthma.

5.7 Reduction in Bone Mineral Density

Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term outcomes is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids), should be monitored and treated with established standards of care.

5.8 Effects on Growth

Orally inhaled corticosteroids, including budesonide, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving budesonide inhalation suspension routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including budesonide inhalation suspension, each patient should be titrated to his/her lowest effective dose [see Use in Specific Populations (8.4)].

5.9 Glaucoma and Cataracts

Glaucoma, increased intraocular pressure, and cataracts have been reported following the long-term administration of inhaled corticosteroids, including budesonide. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.

5.10 Paradoxical Bronchospasm and Upper Airway Symptoms

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If acute bronchospasm occurs following dosing with budesonide inhalation suspension, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with budesonide inhalation suspension should be discontinued and alternate therapy instituted.

5.11 Eosinophilic Conditions and Churg-Strauss Syndrome

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions. Some of these patients have clinical features of vasculitis consistent with Churg- Strauss syndrome, a condition that is often treated with systemic corticosteroids therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of inhaled corticosteroids. Healthcare providers should be alert to eosinophilia, vasculitis rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between budesonide and these underlying conditions has not been established.

5.12 Drug Interactions with Strong Cytochrome P450 3A4Inhibitors

Caution should be exercised when considering the coadministration of budesonide inhalation suspension with ketoconazole, and other known strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) because adverse effects related to increased systemic exposure to budesonide may occur [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

6 ADVERSE REACTIONS

Systemic and inhaled corticosteroid use may result in the following:

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 incidence of common adverse reactions is based on three double-blind, placebo-controlled, randomized U.S. clinical trials in which 945 patients, 12 months to 8 years of age, (98 patients ≥12 months and <2 years of age; 225 patients ≥2 and <4 years of age; and 622 patients ≥4 and ≤8 years of age) were treated with budesonide inhalation suspension (0.25 to 1 mg total daily dose for 12 weeks) or vehicle placebo. The incidence and nature of adverse events reported for budesonide inhalation suspension was comparable to that reported for placebo. The following table shows the incidence of adverse events in U.S. controlled clinical trials, regardless of relationship to treatment, in patients previously receiving bronchodilators and/or inhaled corticosteroids. This population included a total of 605 male and 340 female patients and 78.4% were Caucasian, 13.8% African American, 5.5% Hispanic and 2.3% Other.

Table 1: Adverse Reactions occurring at an incidence of ≥3% in at least one active treatment group where the incidence was higher with Budesonide Inhalation Suspension than placebo

Adverse Events

Vehicle Placebo (n=227) %

Budesonide Inhalation Suspension Total Daily Dose

0.25 mg (n=178) %

0.5 mg (n=223) %

1 mg (n=317) %

Respiratory System Disorder

Respiratory Infection

36

34

35

38

Rhinitis

9

7

11

12

Coughing

5

5

9

8

Resistance Mechanism Disorders

Otitis Media

11

12

11

9

Viral Infection

3

4

5

3

Moniliasis

2

4

3

4

Gastrointestinal System Disorders

Gastroenteritis

4

5

5

5

Vomiting

3

2

4

4

Diarrhea

2

4

4

2

Abdominal Pain

2

3

2

3

Hearing and Vestibular Disorders

Ear Infection

4

2

4

5

Platelet, Bleeding and Clotting Disorders

Epistaxis

1

2

4

3

Vision Disorders

Conjunctivitis

2

<1

4

2

Skin and Appendages Disorders

Rash

3

<1

4

2

The information below includes all adverse reactions by system organ class with an incidence of 1 to < 3%, in at least one budesonide inhalation suspension treatment group where the incidence was higher with budesonide inhalation suspension than with placebo, regardless of relationship to treatment.

Blood and Lymphatic System Disorders:
cervical lymphadenopathy

Ear and Labyrinth Disorders:
earache

General Disorders and Administration Site Conditions:
fatigue, flu-like disorder

Immune System Disorders:
allergic reaction

Infections and Infestations:
eye infection, herpes simplex, external ear infection, infection

Injury, Poisoning and Procedural Complication:
fracture

Metabolism and Nutrition Disorders:
anorexia

Musculoskeletal and Connective Tissue Disorders:
myalgia

Nervous System Disorders:
hyperkinesia

Psychiatric Disorders:
emotional lability

Respiratory, Thoracic, and Mediastinal Disorders:
chest pain, dysphonia, stridor

Skin and Subcutaneous Tissue Disorders:
contact dermatitis, eczema, pustular rash, pruritus, purpura

The incidence of reported adverse events was similar between the 447 budesonide inhalation suspension -treated (mean total daily dose 0.5 to 1 mg) and 223 conventional therapy-treated pediatric asthma patients followed for one year in three open- label studies.

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