VANCERIL DOUBLE STRENGTH
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VANCERIL DOUBLE STRENGTH (VANCERIL DOUBLE STRENGTH).
Beclomethasone dipropionate is a corticosteroid with anti-inflammatory activity. It binds to the glucocorticoid receptor, leading to inhibition of phospholipase A2, reduced arachidonic acid release, and decreased synthesis of prostaglandins and leukotrienes. It also suppresses cytokine production, adhesion molecule expression, and eosinophil survival, thereby reducing airway inflammation.
| Metabolism | Metabolized primarily by esterase enzymes in the lung and liver to the active metabolite beclomethasone-17-monopropionate (B-17-MP). Further metabolism via CYP3A4 to inactive metabolites. |
| Excretion | Primarily hepatic metabolism; metabolites excreted renally (~90% as free and conjugated metabolites) and fecally (<10%). |
| Half-life | Terminal elimination half-life: 1.5–2 hours for beclomethasone dipropionate; 2.7 hours for active metabolite beclomethasone-17-monopropionate. Clinical context: supports twice-daily dosing. |
| Protein binding | 87% bound to plasma proteins (mainly albumin and corticosteroid-binding globulin). |
| Volume of Distribution | Vd: 20–30 L for beclomethasone dipropionate; clinical meaning: extensive tissue distribution, high lung uptake. |
| Bioavailability | Absolute bioavailability from inhalation: 10–25% (orally inhaled); systemic absorption from swallowed fraction: negligible (<1% oral bioavailability). |
| Onset of Action | Inhalation: 1–4 weeks for full therapeutic effect; some improvement within 24–72 hours. |
| Duration of Action | Duration: 12 hours; clinical effect persists with regular dosing due to receptor occupancy. |
2 inhalations (168 mcg beclomethasone dipropionate) twice daily via oral inhalation.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No formal studies in hepatic impairment. Caution advised in severe hepatic disease due to potential for increased systemic exposure. |
| Pediatric use | Not recommended for use in pediatric patients. Safety and efficacy in children have not been established. |
| Geriatric use | No specific dose adjustment recommended. Use with caution due to potential for increased sensitivity and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VANCERIL DOUBLE STRENGTH (VANCERIL DOUBLE STRENGTH).
| Breastfeeding | Unknown if beclomethasone dipropionate or metabolites are excreted in human milk. The M/P ratio is not established. Consider risk-benefit; caution advised, especially with high-dose or prolonged use. |
| Teratogenic Risk | Insufficient human data; however, based on animal studies and the drug's mechanism (inhaled corticosteroid), risk is likely low. Avoid first trimester if possible. Use only if benefit outweighs potential risk, as systemic absorption minimal at recommended doses. |
■ FDA Black Box Warning
None
| Serious Effects |
["Primary treatment of status asthmaticus or other acute episodes of asthma requiring intensive measures","Hypersensitivity to any ingredient of the preparation"]
| Precautions | ["Risk of adrenal insufficiency during and after transfer from systemic corticosteroids","Prophylaxis and treatment of oral candidiasis","Paradoxical bronchospasm requiring immediate discontinuation and alternative therapy","Systemic corticosteroid effects such as hypercorticism and adrenal suppression at high doses or prolonged use","Not indicated for acute bronchospasm or status asthmaticus","Use with caution in patients with active or quiescent tuberculosis, untreated fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex"] |
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| Fetal Monitoring |
| Monitor fetal growth (ultrasound) if used long-term or at high doses; assess maternal adrenal function if systemic effects suspected; observe for signs of hypoadrenalism in neonate if high doses used near term. |
| Fertility Effects | No known adverse effects on fertility in humans; animal studies show no impairment at therapeutic doses. Inhaled corticosteroids unlikely to affect reproductive function. |