NASALIDE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for NASALIDE (NASALIDE).
Corticosteroid that reduces inflammation by inhibiting phospholipase A2, decreasing arachidonic acid release, and suppressing prostaglandin and leukotriene synthesis.
| Metabolism | Primarily hepatic via CYP3A4; undergoes extensive first-pass metabolism. |
| Excretion | Primarily hepatic metabolism via CYP3A4; metabolites and unchanged drug excreted in feces (approximately 60%) and urine (approximately 40%, with <1% unchanged). |
| Half-life | Terminal elimination half-life: 1-2 hours; clinically, intranasal dosing achieves prolonged local effects with minimal systemic accumulation. |
| Protein binding | High (approximately 80%), primarily bound to albumin. |
| Volume of Distribution | Approximately 2.8 L/kg; indicates extensive tissue distribution. |
| Bioavailability | Intranasal: Approximately 49% systemic absorption relative to intravenous administration; oral bioavailability <1% due to extensive first-pass metabolism. |
| Onset of Action | Intranasal: Symptomatic improvement may occur within 12 hours; full benefit typically seen after several days to 1 week. |
| Duration of Action | Duration of clinical effect: 24 hours after a single intranasal dose; sustained effect with daily use. |
2 sprays (100 mcg total) per nostril twice daily; maximum 8 sprays (400 mcg) per day in each nostril.
| Dosage form | SPRAY, METERED |
| Renal impairment | No dosage adjustment required for renal impairment. |
| Liver impairment | No specific guidelines; use with caution in severe hepatic impairment due to potential corticosteroid effects. |
| Pediatric use | Children 6-14 years: 1 spray (50 mcg) per nostril twice daily; maximum 4 sprays (200 mcg) per day in each nostril. Children ≥14 years: same as adult. |
| Geriatric use | No specific adjustment; use lowest effective dose due to potential increased osteoporosis risk. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for NASALIDE (NASALIDE).
| Breastfeeding | It is not known whether flunisolide is excreted in human breast milk. Because many corticosteroids are excreted in human milk, caution should be exercised when intranasal flunisolide is administered to a nursing woman. M/P ratio: not available. |
| Teratogenic Risk | FDA Pregnancy Category C. In animal studies, corticosteroids have been shown to be teratogenic at high systemic doses. However, intranasal flunisolide has minimal systemic absorption; therefore, fetal exposure is low. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if potential benefit justifies potential risk to the fetus. First trimester: insufficient data; avoid unless necessary. Second and third trimesters: no specific risks identified; limited data suggest safety. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to flunisolide or any component","Untreated localized nasal mucosal infections (e.g., herpes simplex)"]
| Precautions | ["May cause growth suppression in children with prolonged use","Potential for adrenal insufficiency with systemic absorption","Nasal septum perforation and local irritation reported","Monitor for immunosuppression or infections (e.g., Candida)"] |
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| Fetal Monitoring | Monitor maternal nasal symptoms for efficacy. No specific fetal monitoring required due to low systemic absorption. However, if used chronically, monitor maternal adrenal function if high doses are used; consider growth monitoring in newborns if prolonged high-dose exposure. |
| Fertility Effects | No specific studies on human fertility. In animal studies, systemic corticosteroids may impair fertility at high doses. Intranasal flunisolide with low systemic bioavailability is unlikely to affect fertility. |