BECLOVENT
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BECLOVENT (BECLOVENT).
Glucocorticoid receptor agonist; inhibits inflammatory mediators, reduces airway hyperresponsiveness, and suppresses immune cell activity.
| Metabolism | Hepatic via CYP3A4 to inactive metabolites. |
| Excretion | Primarily hepatic metabolism via CYP3A4; metabolites are excreted in feces (60-70%) and urine (10-15%); less than 5% unchanged drug in urine. |
| Half-life | Terminal elimination half-life of beclomethasone dipropionate is 0.5 hours; active metabolite beclomethasone-17-monopropionate has half-life of 2.7 hours; clinically, systemic effects persist for 12-24 hours. |
| Protein binding | Beclomethasone dipropionate is 87% bound to albumin; beclomethasone-17-monopropionate is 94-96% bound to albumin and corticosteroid-binding globulin. |
| Volume of Distribution | Beclomethasone dipropionate Vd is 20 L/kg; beclomethasone-17-monopropionate Vd is 424 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Inhalation: pulmonary bioavailability of active metabolite is 30-40% of delivered dose; oral bioavailability negligible (<1%) due to extensive first-pass metabolism; intranasal: systemic bioavailability approximately 40% of dose. |
| Onset of Action | Inhalation: bronchodilation begins within 1-2 weeks, with maximal effect at 4-6 weeks; intranasal: symptom relief within 12-24 hours; no data for oral or parenteral routes. |
| Duration of Action | Inhalation: duration of anti-inflammatory effect is 12-24 hours, allowing twice-daily dosing; intranasal: effect persists for 24 hours with regular use. |
2 inhalations (84 mcg) twice daily; not to exceed 10 inhalations (420 mcg) per day. Administered via oral inhalation using a metered-dose inhaler.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dosage adjustment required for renal impairment; pharmacokinetics not significantly altered. |
| Liver impairment | No specific guidelines; use caution in severe hepatic impairment due to potential systemic accumulation. |
| Pediatric use | Children 6-12 years: 1-2 inhalations (42-84 mcg) twice daily; maximum 5 inhalations (210 mcg) per day. Children over 12 years: same as adult dosing. |
| Geriatric use | No specific dose adjustment; monitor for systemic effects and instruct on correct inhaler technique. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for BECLOVENT (BECLOVENT).
| Breastfeeding | Beclomethasone is excreted into breast milk in low amounts. The M/P ratio is unknown but expected to be low due to high first-pass metabolism. Use with caution, but generally considered compatible with breastfeeding at recommended doses. |
| Teratogenic Risk | Inhaled corticosteroids like beclomethasone are not associated with a major increase in congenital malformations based on large epidemiological studies. However, high systemic exposure may increase risk of intrauterine growth restriction and adrenal suppression. Use if benefit clearly outweighs risk, especially for severe asthma control. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to beclomethasone or any component","Status asthmaticus (not for acute bronchospasm)"]
| Precautions | ["Risk of adrenal insufficiency upon switching from systemic corticosteroids","Oropharyngeal candidiasis","Increased risk of pneumonia in COPD patients","Potential for growth suppression in children","Osteoporosis with long-term use"] |
| Food/Dietary | No significant food interactions. Avoid grapefruit juice if taking concurrent CYP3A4 substrates, though not specific to beclomethasone. Generally, no dietary restrictions. |
| Clinical Pearls |
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| Fetal Monitoring | Monitor maternal asthma control regularly. Consider fetal growth assessment (ultrasound) and monitoring for signs of maternal adrenal suppression if high doses used long-term. No specific fetal monitoring required beyond routine prenatal care. |
| Fertility Effects | No known adverse effects on fertility from inhaled beclomethasone at therapeutic doses. Systemic corticosteroids may affect ovulation, but inhaled route minimizes systemic exposure. |
| Beclomethasone dipropionate (BECLOVENT) is an inhaled corticosteroid used for maintenance treatment of asthma. It is not indicated for acute bronchospasm. To reduce oropharyngeal candidiasis, advise patients to rinse mouth with water after each use. Monitor for adrenal suppression during prolonged use or high doses. May require dose adjustment when switching from oral corticosteroids. |
| Patient Advice | Use BECLOVENT regularly as prescribed, not for sudden breathing problems. · Rinse mouth with water after each use to prevent thrush. · Do not stop suddenly; taper under medical supervision if discontinuing. · Inform your doctor if you experience worsening symptoms, oral thrush, or signs of adrenal insufficiency (fatigue, weakness, weight loss). · Keep inhaler clean and primed as directed. |