VANCERIL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VANCERIL (VANCERIL).
Beclomethasone dipropionate is a corticosteroid that exerts anti-inflammatory effects by inhibiting phospholipase A2, reducing prostaglandin and leukotriene synthesis, and suppressing inflammatory cell migration and cytokine production in the airways.
| Metabolism | Primarily metabolized via esterase-mediated hydrolysis to beclomethasone-17-monopropionate (active metabolite) and further to beclomethasone (inactive); CYP3A4 involvement is minor. |
| Excretion | Primarily hepatic metabolism; <10% excreted unchanged in urine, <5% in feces. |
| Half-life | Terminal elimination half-life is approximately 2.8 hours in adults; prolonged in patients with hepatic impairment. |
| Protein binding | 80-85% bound to plasma proteins, including albumin and corticosteroid-binding globulin. |
| Volume of Distribution | Volume of distribution is approximately 0.5-1.0 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral inhalation: 20-30%; oral: 20-25%; IV: 100%. |
| Onset of Action | Oral inhalation: 24 hours for clinical effect; IV or oral: 30 minutes to several hours depending on indication. |
| Duration of Action | Duration of effect following inhalation is 4-6 hours; for oral or IV, duration is variable based on dose and indication. |
2 inhalations (84 mcg) 3-4 times daily via oral inhalation.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No adjustment required for renal impairment. |
| Liver impairment | No adjustment required for hepatic impairment. |
| Pediatric use | Children 6-12 years: 1-2 inhalations (42-84 mcg) 3-4 times daily; children >12 years: same as adult. |
| Geriatric use | No specific adjustment; use lowest effective dose due to potential for increased systemic effects. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VANCERIL (VANCERIL).
| Breastfeeding | It is not known whether beclomethasone dipropionate is excreted in human breast milk. Corticosteroids are excreted in breast milk in small amounts. Because of the potential for adverse effects in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | VANCERIL (beclomethasone dipropionate) is a corticosteroid. In animal studies, corticosteroids have been shown to be teratogenic. However, in humans, inhaled corticosteroids at recommended doses are not associated with a significant increase in congenital malformations. There is a potential risk of intrauterine growth restriction and adrenal suppression in the fetus, particularly with high doses. Use during pregnancy only if clearly needed. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to beclomethasone or any component","Status asthmaticus (primary treatment)","Systemic fungal infections (if systemic absorption is of concern)"]
| Precautions | ["Risk of adrenal suppression with prolonged high-dose use","Increased susceptibility to infections due to immunosuppression","Oropharyngeal candidiasis","Paradoxical bronchospasm","Growth suppression in children","Osteoporosis with long-term use"] |
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| Fetal Monitoring | Monitor maternal adrenal function if high doses are used. Monitor fetal growth and development via ultrasound if prolonged high-dose therapy is used. Monitor for signs of adrenal suppression in the neonate if maternal therapy continued to delivery. |
| Fertility Effects | No specific studies on VANCERIL and human fertility. Animal studies with corticosteroids have shown effects on fertility, but relevance to humans is unknown. |