BECONASE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for BECONASE (BECONASE).
Beclomethasone dipropionate is a corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive properties. It binds to glucocorticoid receptors, modulating gene expression to inhibit phospholipase A2, reduce arachidonic acid release, and decrease production of prostaglandins and leukotrienes, thereby suppressing nasal mucosal inflammation.
| Metabolism | Primarily hydrolyzed by esterases in the lung, liver, and plasma to its active metabolite beclomethasone-17-monopropionate (17-BMP). Further metabolism via CYP3A4 to inactive metabolites. |
| Excretion | Primarily hepatic metabolism; <10% excreted renally as unchanged drug; biliary/fecal excretion accounts for minimal elimination. |
| Half-life | 1.5-3 hours (terminal elimination half-life); no accumulation with once-daily dosing. |
| Protein binding | 87% bound to plasma proteins, primarily corticosteroid-binding globulin and albumin. |
| Volume of Distribution | 0.5-1.5 L/kg; indicates extensive distribution into tissues. |
| Bioavailability | Intranasal: <1% systemic absorption due to extensive first-pass metabolism and local administration. |
| Onset of Action | Intranasal: 12-24 hours for symptom relief; maximal effect within 1-2 weeks. |
| Duration of Action | Symptom relief persists for 24 hours after single dose; requires regular use for full therapeutic effect. |
| Molecular Weight | 521.25 |
1-2 sprays (42-84 mcg) per nostril twice daily; intranasal.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No adjustment required. |
| Liver impairment | No adjustment required. |
| Pediatric use | Children 6-11 years: 1 spray (42 mcg) per nostril twice daily; children ≥12 years: same as adult. |
| Geriatric use | No specific adjustment; use lowest effective dose. |
| 1st trimester | No adequate studies in pregnant women. Beclomethasone dipropionate is a corticosteroid; animal studies have shown teratogenicity with high systemic doses. However, intranasal administration results in minimal systemic exposure. Use only if clearly needed. |
| 2nd trimester | Limited data; systemic absorption is low. Use if benefit outweighs risk. |
| 3rd trimester | Avoid unnecessary use near term; rare reports of adrenal suppression in neonates with prolonged maternal corticosteroid use. Minimal risk with intranasal route. |
Clinical note
Comprehensive clinical and safety monograph for BECONASE (BECONASE).
| Placental transfer | Beclomethasone dipropionate and its active metabolite beclomethasone-17-monopropionate cross the placenta in animal studies. In humans, the degree of transfer with intranasal use is minimal due to low systemic absorption. |
| Breastfeeding | Beclomethasone is excreted into human breast milk in low amounts after intranasal administration. Systemic exposure to the infant is expected to be negligible. Caution is advised; use only if clearly needed. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to beclomethasone or any component of the formulationUntreated nasal mucosal infection (e.g., herpes simplex)
| Precautions | Risk of suppression of hypothalamic-pituitary-adrenal (HPA) axis with prolonged use at higher than recommended doses, Possible development of localized Candida albicans infections of the nose and pharynx, Caution in patients with active or quiescent tuberculosis, untreated fungal, bacterial, or viral infections, or ocular herpes simplex, Use with caution in patients with recent nasal ulcers, nasal surgery, or nasal trauma until healing has occurred |
| Food/Dietary | No specific food interactions reported. Beconase is administered intranasally and has negligible systemic absorption, so dietary restrictions are not required. |
Loading safety data…
| Lactation Rating | L2 (probably compatible) |
| Teratogenic Risk | Beclomethasone dipropionate (BECONASE) is an inhaled corticosteroid. In pregnant women, available data from cohort studies and case series do not show an increased risk of major congenital malformations or adverse fetal outcomes. However, the potential for fetal harm cannot be completely ruled out. Trimester-specific risks: First trimester: No evidence of teratogenicity in animal studies at clinically relevant doses, but human data are limited. Second and third trimesters: No increased risk of fetal growth restriction or adrenal suppression reported, but high doses may theoretically affect fetal adrenal function. |
| Fetal Monitoring | No specific fetal monitoring required. Assess maternal asthma control regularly. If used throughout pregnancy, monitor infant for signs of adrenal suppression (rare) such as lethargy, poor feeding, or vomiting. |
| Fertility Effects | No adverse effects on fertility reported in human studies. Animal studies showed no impairment of fertility at recommended doses. |
| Clinical Pearls | Beconase (beclomethasone dipropionate) is an intranasal corticosteroid for allergic rhinitis. Onset of action is not immediate; regular use for several days to weeks is required for full effect. Priming the nasal spray with 6 sprays before first use is essential. Avoid spraying directly onto the nasal septum to prevent irritation and bleeding. For best results, administer after clearing nasal passages. Systemic absorption is minimal at recommended doses, but monitor for growth suppression in children with prolonged high-dose use. |
| Patient Advice | Use Beconase regularly as prescribed, not for immediate symptom relief. · Prime the spray with 6 test sprays before first use or if not used for 7 days. · Blow nose gently before dosing to clear nasal passages. · Tilt head forward, insert nozzle into nostril, and spray away from the septum. · Avoid spraying into eyes or on the nasal septum. · Do not exceed recommended dosage; side effects are rare but include nasal irritation or nosebleeds. · Inform your doctor if symptoms do not improve after 3 weeks. · If also using a decongestant spray, use the decongestant first, then wait 10-15 minutes before Beconase. |