QVAR 80
Clinical safety rating: caution
Comprehensive clinical and safety monograph for QVAR 80 (QVAR 80).
Beclomethasone dipropionate is a corticosteroid that exhibits anti-inflammatory activity. It binds to the glucocorticoid receptor, leading to inhibition of inflammatory mediators such as cytokines, chemokines, and arachidonic acid metabolites. It also reduces edema and mucus production in the airways.
| Metabolism | Beclomethasone dipropionate is rapidly hydrolyzed by esterases in the lungs and liver to its active metabolite, beclomethasone-17-monopropionate (17-BMP). Further metabolism occurs via CYP3A4 to inactive metabolites. |
| Excretion | Primarily hepatic metabolism, with metabolites excreted in feces (60-70%) and urine (30-40%). Less than 1% of unchanged drug is excreted in urine. |
| Half-life | Terminal elimination half-life is approximately 2.9 hours after inhalation. This short half-life supports twice-daily dosing but does not fully reflect pulmonary residence time. |
| Protein binding | 87-90% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 0.7 L/kg, indicating extensive distribution into tissues and lungs. |
| Bioavailability | Inhalation: Approximately 50-60% of delivered dose reaches the lungs; swallowed portion has negligible systemic bioavailability due to extensive first-pass metabolism. |
| Onset of Action | Improvement in asthma control may be observed within 1-2 weeks of regular inhalation therapy; maximal benefit may take 4 weeks. |
| Duration of Action | Duration of effect is 12 hours, supporting twice-daily administration. Clinical trials show sustained bronchodilation over 12 hours. |
80 mcg orally via oral inhalation twice daily (maximum 320 mcg twice daily)
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dose adjustment required for renal impairment |
| Liver impairment | No specific recommendations; use caution in severe hepatic impairment |
| Pediatric use | For children 4-11 years: 40-80 mcg twice daily; for 12 years and older: same as adult |
| Geriatric use | No specific dose adjustment; initiate at lower end of dosing range |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for QVAR 80 (QVAR 80).
| Breastfeeding | Inhaled beclomethasone dipropionate is excreted in breast milk in low amounts; M/P ratio not established. No adverse effects reported in nursing infants at therapeutic doses. Use with caution, especially with high doses. |
| Teratogenic Risk | FDA Pregnancy Category C. In first trimester: no adequate human studies; animal studies show increased incidence of cleft palate and delayed ossification at high systemic doses. Second and third trimesters: may reduce fetal growth and cause neonatal adrenal insufficiency if used chronically at high doses. Avoid unless benefit outweighs risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures","Hypersensitivity to beclomethasone dipropionate or any ingredient in the formulation"]
| Precautions | ["Risk of adrenal insufficiency during and after transfer from systemic corticosteroids","Potential for systemic corticosteroid effects including hypercorticism and hypothalamic-pituitary-adrenal (HPA) axis suppression","Increased susceptibility to infections due to immunosuppression","Oropharyngeal candidiasis and hoarseness","Paradoxical bronchospasm may occur","Reduced bone mineral density with long-term use","Monitor for glaucoma and cataracts"] |
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| Fetal Monitoring |
| Monitor maternal asthma control (peak expiratory flow, symptoms). For chronic high-dose use, assess fetal growth by ultrasound. Monitor neonate for adrenal suppression if used long-term in third trimester. |
| Fertility Effects | No known adverse effects on fertility in humans. Animal studies show no impairment at inhaled doses. |