Budesonide Inhalation

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE Budesonide inhalation suspension is an inhaled corticosteroid indicated for: • Maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. () Limitations of Use: Not indicated for the relief of acute bronchospasm. () 1.1 Maintenance Treatment of Asthma Budesonide inhalation suspension is indicated for the maintenance treatment of asthma and as prophylactic therapy in children 12 months to 8 years of age. Limitations of Use: • Budesonide inhalation suspension is NOT indicated for the relief of acute bronchospasm. Dosage and administration 2 DOSAGE AND ADMINISTRATION The recommended starting dose and highest recommended dose of budesonide inhalation suspension, based on prior asthma therapy, are listed in the following table. Previous Therapy Recommended Starting Dose Highest Recommended Dose Bronchodilators alone 0.5 mg total daily dose administered twice daily in divided doses 0.5 mg total daily dose Inhaled Corticosteroids 0.5 mg total daily dose administered twice daily in divided doses 1 mg total daily dose Oral Corticosteroids 1 mg total daily dose administered as 0.5 mg twice daily 1 mg total daily dose Recommended dosing based on previous therapy (). Start with the lowest recommended dose: • Bronchodilators alone: 0.25 mg twice daily • Inhaled corticosteroids: 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice daily • Once asthma stability is achieved, titrate the dose downwards. • For inhalation use via compressed air driven jet nebulizers only (not for use with ultrasonic devices). Not for injection. () 2.1 Dosing Recommendations Dosing recommendations based on previous therapy are as follows: • Bronchodilators alone: 0.25 mg twice daily • Inhaled corticosteroids: 0.25 mg twice daily up to 0.5 mg twice daily • Oral corticosteroids: 0.5 mg twice daily In all patients, it is desirable to downward-titrate to the lowest effective dose once asthma stability is achieved. 2.2 Directions for Use Budesonide inhalation suspension should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask. Ultrasonic nebulizers are not suitable for the adequate administration of budesonide inhalation suspension and, therefore, are NOT recommended. The effects of mixing budesonide inhalation suspension with other nebulizable medications have not been adequately assessed. Budesonide inhalation suspension should be administered separately in the nebulizer [see ( )] . A Pari-LC-Jet Plus Nebulizer (with face mask or mouthpiece) connected to a Pari Master compressor was used to deliver budesonide inhalation suspension to each patient in 3 U.S. controlled clinical studies. The safety and efficacy of budesonide inhalation suspension delivered by other nebulizers and compressors have not been established. Warnings and cautions 5 WARNINGS AND PRECAUTIONS • Localized Infections : Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation. () • Deterioration of Disease and Acute Asthma Episodes : Do not use for the relief of acute bronchospasm. () • Hypersensitivity Reactions : Anaphylaxis, rash, contact dermatitis, urticaria, angioedema, and bronchospasm have been reported with use of budesonide inhalation suspension. Discontinue budesonide inhalation suspension if such reactions occur. () • Immunosuppression : Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. () • Transferring Patients from Systemic Corticosteroid Therapy : Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to budesonide inhalation suspension. () • Hypercorticism and Aadrenal Suppression : May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, reduce budesonide inhalation suspension slowly. () • Reduction in Bone Mineral Density with Long-term Administration : Monitor patients with major risk factors for decreased bone mineral content. () • Effects on Growth : Monitor growth of pediatric patients. () • Glaucoma and Cataracts : Close monitoring is warranted. () • Paradoxical Bronchospasm : Discontinue budesonide inhalation suspension and institute alternative therapy if paradoxical bronchospasm occurs. () • Eosinophilic Conditions and Churg-Strauss Syndrome : Be alert to eosinophilic conditions. () 5.1 Local Effects In clinical trials with budesonide inhalation suspension, localized infections with Candida albicans occurred in the mouth and pharynx in some p