QNASL
Clinical safety rating: caution
Comprehensive clinical and safety monograph for QNASL (QNASL).
Beclomethasone dipropionate is a corticosteroid with anti-inflammatory activity. It binds to glucocorticoid receptors, inhibiting inflammatory mediators such as prostaglandins and leukotrienes, and reducing nasal inflammation.
| Metabolism | Hepatic metabolism via CYP3A4 to active metabolite beclomethasone-17-monopropionate (17-BMP) and other inactive metabolites. |
| Excretion | The majority of a dose (approximately 40-50%) is excreted in feces as unchanged drug and metabolites, with about 10-15% excreted in urine as metabolites. Biliary excretion is the primary route of elimination. |
| Half-life | The terminal elimination half-life is approximately 8-10 hours in healthy adults, supporting twice-daily administration for systemic effects; however, intranasal administration results in minimal systemic absorption, and local half-life in nasal tissues is not well characterized. |
| Protein binding | Beclomethasone dipropionate is 87% bound to plasma proteins, primarily albumin and corticosteroid-binding globulin. |
| Volume of Distribution | The volume of distribution for beclomethasone dipropionate after intravenous administration is approximately 20 L (0.3 L/kg for a 70 kg adult), indicating extensive tissue distribution. |
| Bioavailability | The absolute bioavailability after intranasal administration is less than 1% due to extensive first-pass metabolism in the liver and local degradation; oral bioavailability is also less than 1%. |
| Onset of Action | Improvement in nasal symptoms may be observed within 12 hours after the first intranasal dose, with significant clinical effect typically seen by 24-36 hours. |
| Duration of Action | The therapeutic effect lasts for approximately 24 hours after intranasal administration, allowing once or twice daily dosing; however, consistent use over several days is required for maximal symptom control. |
| Molecular Weight | 521 |
1 to 2 sprays (80 mcg/spray) per nostril once daily; maximum 2 sprays/nostril/day.
| Dosage form | AEROSOL, METERED |
| Renal impairment | No dose adjustment required for renal impairment. |
| Liver impairment | No dose adjustment required for hepatic impairment. |
| Pediatric use | For children 12 years and older: same as adult. For children 4-11 years: 1 spray (80 mcg) per nostril once daily. |
| Geriatric use | No specific dose adjustment; use with caution due to potential increased systemic sensitivity. |
| 1st trimester | Insufficient human data; based on animal studies, potential risk cannot be ruled out. Use only if clearly needed. |
| 2nd trimester | Insufficient human data; based on animal studies, potential risk cannot be ruled out. Use only if clearly needed. |
| 3rd trimester | Insufficient human data; based on animal studies, potential risk cannot be ruled out. Use only if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for QNASL (QNASL).
| Placental transfer | Beclomethasone dipropionate and its metabolites cross the placenta in animals; human data not available. |
| Breastfeeding | It is unknown if beclomethasone dipropionate (active ingredient) is excreted in human milk. However, other corticosteroids are excreted. Caution should be exercised when administered to a nursing woman. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to beclomethasone dipropionate or any component of the formulation
| Precautions | Local nasal effects: epistaxis, nasal ulceration, Candida albicans infection, Hypothalamic-pituitary-adrenal (HPA) axis suppression with higher doses, Slowing of growth in children, Increased susceptibility to infections due to immunosuppression, Ocular effects: glaucoma, cataracts, Hypersensitivity reactions including anaphylaxis, Use caution in patients with tuberculosis, herpes simplex, or other infections |
| Food/Dietary | No specific food interactions known for QNASL. It can be used with or without food. Avoid concomitant use with grapefruit juice if using oral beclomethasone; however, intranasal route has minimal systemic absorption, but caution may be considered. |
Loading safety data…
| Lactation Rating |
| L3 (Moderately Safe) |
| Teratogenic Risk | QNASL (beclomethasone dipropionate) is an intranasal corticosteroid. Based on animal studies, corticosteroids have been associated with an increased risk of cleft palate and other fetal malformations at high systemic exposures. However, intranasal administration results in minimal systemic absorption. Available human data from epidemiological studies do not suggest an increased risk of congenital anomalies from intranasal corticosteroids. Therefore, the fetal risk is considered low, but caution is warranted, especially during the first trimester. |
| Fetal Monitoring | No specific monitoring is routinely required. As with any corticosteroid use during pregnancy, monitor for signs of adrenal suppression or growth retardation in the fetus if used at high doses or systemically, though this is unlikely with intranasal use. |
| Fertility Effects | In animal studies, beclomethasone dipropionate did not impair fertility at clinically relevant doses. Human data are lacking, but intranasal corticosteroids are not expected to affect fertility due to minimal systemic absorption. |
| Clinical Pearls | QNASL (beclomethasone dipropionate) is a intranasal corticosteroid for allergic rhinitis. Priming not required with QNASL; however, if not used for 7+ days, pump requires 2 sprays or until fine mist appears. Dose adjustment not needed in renal or hepatic impairment. Avoid contact with eyes. Monitor for nasal septal perforation, localized Candida infections, and potential growth suppression in children. |
| Patient Advice | Use QNASL regularly for best results; it is not for immediate symptom relief. · Do not share the spray bottle with others to prevent infection spread. · If a dose is missed, take it as soon as remembered unless near next dose; do not double. · Prime the pump after 7 days of non-use by spraying 2 times into the air away from face. · Avoid spraying into eyes; if contact occurs, rinse with water for 10 minutes. · Report persistent nosebleeds, severe nasal irritation, or signs of infection (fever, facial pain). · For children, monitor growth rate if used long-term. |