Budesonide Inhalation
Generic Name: budesonide inhalation
Brand Names:
Budesonide Inhalation
11 DESCRIPTION Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as ( RS )-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20 dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5.
Overview
11 DESCRIPTION Budesonide, the active component of budesonide inhalation suspension, is a corticosteroid designated chemically as ( RS )-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20 dione cyclic 16,17-acetal with butyraldehyde. Budesonide is provided as a mixture of two epimers (22R and 22S). The empirical formula of budesonide is C 25 H 34 O 6 and its molecular weight is 430.5.
Uses
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 ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 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
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 either once daily or twice daily in divided doses 0.5 mg total daily dose Inhaled Corticosteroids 0.5 mg total daily dose administered either once daily or twice daily in divided doses 1 mg total daily dose Oral Corticosteroids 1 mg total daily dose administered either as 0.5 mg twice daily 1 mg total daily dose Recommended dosing based on previous therapy ( 2 ).
Side Effects
6 ADVERSE REACTIONS Systemic and inhaled corticosteroid use may result in the following: Candida albicans Infection [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.3) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ] Growth Effects in Pediatric Patients [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Glaucoma, Increased Intraocular Pressure and Cataracts [see Warnings and Precautions (5.9) ] Eosinophilic Conditions and Churg-Strauss Syndrome [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence of ≥3%) are respi...
Interactions
7 DRUG INTERACTIONS Strong Cytochrome P450 3A4 Inhibitors (e.g., ritonavir): Use with caution. May cause increased systemic corticosteroid effects. ( 5.12 , 7.1 ) 7.1 Inhibitors of Cytochrome P450 3A4 The main route of metabolism of corticosteroids, including budesonide, is via cytochrome P450 (CYP) isoenzyme 3A4 (CYP3A4). After oral administration of ketoconazole, a strong inhibitor of CYP3A4, the mean plasma concentration of orally administered budesonide increased. Concomitant administration of a CYP3A4 inhibitor may inhibit the metabolism of, and increase the systemic exposure to, budesonide.
Warnings
For inhalation only. Do not swallow. Only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor. Do not use with an ultrasonic nebulizer. 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. ( 5.1 ) Deterioration of Disease and Acute Asthma Episodes: Do not use for the relief of acute bronchospasm. ( 5.2 ) 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 ( 5.3 ) Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). 4 CONTRAINDICATIONS The use of budesonide inhalation suspension is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women. However, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Budesonide inhalation suspension is supplied in sealed aluminum foil envelopes containing one single-dose ampule. There are 30 ampules in a carton. Each single-dose ampule contains 2 mL of white to off-white sterile liquid suspension.
Frequently Asked Questions
What is Budesonide Inhalation used for?▼
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 ( 1 ) Limitations of Use: Not indicated for the relief of acute bronchospasm ( 1 ) 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.
What are the side effects of Budesonide Inhalation?▼
6 ADVERSE REACTIONS Systemic and inhaled corticosteroid use may result in the following: Candida albicans Infection [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.3) ] Immunosuppression [see Warnings and Precautions (5.4) ] Hypercorticism and Adrenal Suppression [see Warnings and Precautions (5.6) ] Reduction in Bone Mineral Density [see Warnings and Precautions (5.7) ] Growth Effects in Pediatric Patients [see Warnings and Precautions (5.8) and Use in Specific Populations (8.4) ] Glaucoma, Increased Intraocular Pressure and Cataracts [see Warnings and Precautions (5.9) ] Eosinophilic Conditions and Churg-Strauss Syndrome [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence of ≥3%) are respi...
Can I take Budesonide Inhalation during pregnancy?▼
8.1 Pregnancy Risk Summary There are no adequate well-controlled studies of budesonide inhalation suspension in pregnant women. However, there are published studies on the use of budesonide, the active ingredient in budesonide inhalation suspension, in pregnant women.
What are the important warnings for Budesonide Inhalation?▼
For inhalation only. Do not swallow. Only use budesonide inhalation suspension with a jet nebulizer machine that is connected to an air compressor. Do not use with an ultrasonic nebulizer. 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. ( 5.1 ) Deterioration of Disease and Acute Asthma Episodes: Do not use for the relief of acute bronchospasm. ( 5.2 ) 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 ( 5.3 ) Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; or ocular herpes simplex). 4 CONTRAINDICATIONS The use of budesonide inhalation suspension is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.