AEROBID
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AEROBID (AEROBID).
Aerobid (flunisolide) is a corticosteroid that binds to glucocorticoid receptors, leading to inhibition of inflammatory mediators such as prostaglandins and leukotrienes, reduction of eosinophil migration, and decreased airway hyperresponsiveness.
| Metabolism | Primarily metabolized via hepatic cytochrome P450 3A4 (CYP3A4) to inactive metabolites; also undergoes first-pass metabolism. |
| Excretion | Renal elimination of inactive metabolites accounts for ~95% of dose; <10% excreted unchanged. Biliary/fecal elimination is minimal (<5%). |
| Half-life | 2.0–3.5 hours (terminal) after inhalation; rapid clearance supports twice-daily dosing. |
| Protein binding | ~84% bound to albumin; also binds to corticosteroid-binding globulin (CBG). |
| Volume of Distribution | 3.4–4.2 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Inhalation: ~30% systemic bioavailability from the lung; swallowed portion undergoes extensive first-pass metabolism, contributing limited oral bioavailability. |
| Onset of Action | Therapeutic effect develops over 1–2 weeks of regular inhalation; immediate bronchodilator effect is not expected. |
| Duration of Action | Dosing interval is 12 hours; clinical effect persists with regular use for asthma control. |
2 inhalations (250 mcg each) twice daily via oral inhalation; maximum 4 inhalations twice daily.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No specific guidelines; use caution due to potential for systemic accumulation in severe hepatic impairment. |
| Pediatric use | Children 6-15 years: 2 inhalations (250 mcg each) twice daily; maximum 4 inhalations twice daily. Children under 6 years: not recommended. |
| Geriatric use | No specific dose adjustment; use lowest effective dose due to increased risk of systemic effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AEROBID (AEROBID).
| Breastfeeding | Not known whether inhaled flunisolide is excreted in human milk. Systemic corticosteroids appear in breast milk, but inhaled doses produce low systemic levels. M/P ratio not established. Caution is advised; consider risk/benefit. |
| Teratogenic Risk | FDA Pregnancy Category C. Animal studies have shown teratogenic effects (cleft palate, fetal mortality) at systemic exposures comparable to clinical doses. Human data are insufficient. Corticosteroids are generally considered low risk for major malformations when used at low-to-moderate doses, but high systemic exposure during first trimester may increase risk of oral clefts. Use only if benefit outweighs risk. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to flunisolide or any component of the formulation","Status asthmaticus or other acute episodes of asthma requiring intensive measures"]
| Precautions | ["Not indicated for relief of acute bronchospasm","May cause systemic corticosteroid effects, including adrenal suppression, especially at high doses or prolonged use","Increased susceptibility to infections, including oral candidiasis and fungal infections","Hypothalamic-pituitary-adrenal (HPA) axis suppression upon withdrawal or stress","Potential for growth suppression in children"] |
| Food/Dietary | No specific food interactions. Grapefruit/grapefruit juice may increase systemic corticosteroid levels; though clinically insignificant for inhaled forms, consider monitoring. Avoid alcohol with oral corticosteroids, but no data for inhaled. |
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| Fetal Monitoring | Monitor maternal adrenal function if high doses used long-term. Fetal growth and development should be monitored via ultrasound if prolonged use during pregnancy. |
| Fertility Effects | No specific human data on fertility effects. In animals, corticosteroids may impair fertility at high doses. Unlikely at inhaled doses but unknown. |
| Clinical Pearls | AEROBID (flunisolide) is an inhaled corticosteroid for maintenance treatment of asthma, not for acute bronchospasm. Rinse mouth after each use to prevent oral candidiasis and dysphonia. Titrate to lowest effective dose. Monitor for adrenal suppression during stress or prolonged use. Inhaled corticosteroids may reduce growth velocity in children; monitor growth. |
| Patient Advice | Use AEROBID regularly as prescribed, not for acute asthma attacks. · Rinse mouth and throat with water after each use to prevent oral thrush. · Priming: shake well and spray into air until fine mist appears before first use or if not used for >1 week. · Clean inhaler mouthpiece weekly by wiping with dry cloth; do not wash. · Keep track of doses; replace actuator after labeled number of actuations. |