Pulmicort Respules Budesonide Suspension for Inhalation

1. Indications and Usage
Bronchial Asthma: Regular treatment of bronchial asthma as a prophylactic therapy.
COPD: Treatment of chronic obstructive pulmonary disease to reduce exacerbations.
Alternative Therapy: Can be used as an alternative or to reduce the dosage of oral corticosteroids.
2. Dosage and Administration
Administration Route: Must be administered via a suitable nebulizer under medical guidance. It is not intended for intravenous or oral administration. The suspension should be shaken well before use.
Adults: The usual starting dose is 1-2 mg twice daily. For maintenance, the dose is typically 0.5-1 mg twice daily.
Children: The usual starting dose is 0.5-1 mg twice daily. For maintenance, the dose is typically 0.25-0.5 mg twice daily.
Clinical Management: In patients transitioning from oral corticosteroids, oral steroids should be tapered gradually over several weeks to allow recovery of hypothalamic-pituitary-adrenal (HPA) function.
Combination Therapy: For patients also using inhaled bronchodilators, the bronchodilator should be administered prior to the corticosteroid to increase drug delivery to the bronchial tree.
3. Mechanism of Action
Anti-inflammatory Effects: Budesonide acts as an agonist for the glucocorticoid receptor, suppressing the release of inflammatory mediators and reducing airway inflammation.
Immune Response: It inhibits the migration and activation of inflammatory cells, thereby reducing airway hyperresponsiveness and mucus secretion.
4. Safety and Warnings
Adrenal Suppression: Long-term use, especially at high doses, may lead to HPA axis suppression and systemic corticosteroid effects.
Oral Candidiasis: Use after inhalation: Rinsing the mouth with water after inhalation is recommended to reduce the risk of oral candidiasis.
Paradoxical Bronchospasm: If paradoxical bronchospasm occurs, the drug must be discontinued immediately.
Ocular Effects: Long-term use may increase the risk of glaucoma and cataracts.
Infection Risk: May increase susceptibility to infections, including tuberculosis.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Oral candidiasis, hoarseness, throat irritation, headache, and nausea.
Rare Adverse Reactions: Hypersensitivity reactions, paradoxical bronchospasm, and HPA axis suppression.
Clinical Research: Clinical trials have demonstrated that inhaled budesonide effectively reduces asthma exacerbations and improves lung function with a favorable systemic safety profile compared to oral corticosteroids.
6. Drug Interactions
Strong CYP3A4 Inhibitors: Concomitant use with ketoconazole, itraconazole, ritonavir, or clarithromycin may increase systemic corticosteroid effects.
Bronchodilators: Pre-treatment with short-acting β2-agonists can enhance the delivery and efficacy of inhaled budesonide.
7. Pharmaceutical Information
Active Ingredient: Budesonide.
Appearance: White or off-white suspension.
Storage: Store at controlled room temperature, protected from light and moisture.