Class: Inhaled Corticosteroid/Bronchodilator Combination
Dosage Forms. Metered Dose Inhaler (MDI): (Budesonide/Formoterol) 80 mcg/4.5 mcg/inhalation, 160 mcg/4.5 mcg/inhalation
Common FDA Label Indication, Dosing, and Titration.
1. Asthma: Children 5-11 y of age, 80 mcg/4.5 mcg, 2 inhalations bid; Children 12 y of age and older and Adults, 80 mcg/4.5 mcg, 2 inhalations bid, may titrate to 160 mcg/4.5 mcg, 2 inhalations bid
2. COPD: 160 mcg/4.5 mcg 2 inhalations bid
Off-Label Uses. None
MOA. Budesonide is an anti-inflammatory with potent glucocorticoid and weak mineralocorticoid activity. It exhibits a broad range of active inhibition against multiple cell types and mediators involving allergic and nonallergic/irritant-mediated inflammation. Formoterol is a long-acting selective β2-adrenergic agonist that produces bronchodilation.
Drug Characteristics: Budesonide/Formoterol
Medication Safety Issues: Budesonide/Formoterol
Drug Interactions: Budesonide/Formoterol
Adverse Reactions: Budesonide/Formoterol
Efficacy Monitoring Parameters. Monitor PFTs. Resolution of asthma symptoms (symptoms, number of exacerbations, nighttime awakenings, need for rescue albuterol).
Toxicity Monitoring Parameters. Growth velocity in pediatric patients during prolonged therapy; use alternative therapy or seek emergency treatment if paradoxical bronchospasms occur.
Key Patient Counseling Points. Advise patient on proper inhalation technique. If more than 1 inhalation is prescribed, wait 1 min after initial inhalation and shake the inhaler again before the next inhalation. After administration, rinse mouth with water and spit, and wash face to minimize risk of developing oral candidiasis. Wash the mouthpiece and air dry thoroughly at least once a week.
Clinical Pearls. Long-acting beta agonists (LABAs) increase the risk of asthma-related deaths. Budesonide/formoterol should only be used for patients not adequately controlled on a long-term asthma control medication. This drug is not indicated for acute asthma exacerbations. LABAs may increase the risk of asthma-related hospitalization in pediatric and adolescent patients.