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. |
| Molecular Weight | 521 |
| Action Class | Inhaled Corticosteroid |
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 | Limited human data; animal studies show no evidence of teratogenicity at inhaled doses. Use only if potential benefit justifies risk. |
| 2nd trimester | Inhaled corticosteroids are generally considered safe; monitor for potential intrauterine growth restriction with prolonged high doses. |
| 3rd trimester | Use with caution; possible risk of neonatal adrenal suppression if high doses used near term. |
Clinical note
Comprehensive clinical and safety monograph for QVAR 80 (QVAR 80).
| Placental transfer | Beclomethasone dipropionate and its active metabolite cross the placenta; plasma levels in cord blood are approximately 20% of maternal levels. |
| Breastfeeding | Beclomethasone dipropionate is excreted in human milk in low amounts; no adverse effects reported in breastfed infants. Use at lowest effective dose. |
■ FDA Black Box Warning
None.
| Common Effects | Headache, Pharyngitis, Sinusitis, Upper respiratory tract infection, Cough, Hoarseness (dysphonia), Throat irritation |
| Serious Effects | Adrenal insufficiency (with prolonged use or high doses), Oropharyngeal candidiasis, Paradoxical bronchospasm, Increased risk of pneumonia in patients with COPD, Growth suppression in children, Osteoporosis with long-term use, Cataracts and glaucoma |
Hypersensitivity to beclomethasone dipropionate or any componentStatus asthmaticusPrimary treatment of acute bronchospasm
| 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 |
Loading safety data…
| Lactation Rating | L2 |
| 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. |
| 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. |
| Food/Dietary | No known food interactions. Grapefruit juice does not affect beclomethasone. |
| Clinical Pearls | QVAR 80 (beclomethasone dipropionate HFA) is a hydrofluoroalkane-propelled inhaled corticosteroid. Prime the inhaler with 2 test sprays before first use or if not used for >7 days. Rinse mouth with water after each use to prevent oral candidiasis. Taper patients off oral steroids slowly when transitioning to inhaled therapy. Monitor for adrenal insufficiency during stress or surgery. Use with caution in patients with active or quiescent tuberculosis, untreated fungal, bacterial, or viral infections. |
| Patient Advice | Use QVAR 80 exactly as prescribed; do not stop without consulting your doctor. · Shake the inhaler well for 5 seconds before each use. · Prime with 2 test sprays if new or not used for 7 days. · Rinse mouth with water after each dose and spit out; do not swallow. · Clean the inhaler mouthpiece weekly with a dry cloth. · Do not use as a rescue inhaler for sudden breathing problems; use your rescue inhaler (e.g., albuterol). · Carry a warning card if you have been on oral steroids or high-dose inhaled steroids. · Notify your doctor if you experience worsening symptoms, signs of infection, or vision changes. |