OMNARIS
Clinical safety rating: caution
Comprehensive clinical and safety monograph for OMNARIS (OMNARIS).
Ciclesonide is a prodrug that is converted to its active metabolite, des-ciclesonide, which binds to the glucocorticoid receptor with high affinity, leading to anti-inflammatory effects via inhibition of inflammatory mediators.
| Metabolism | Ciclesonide is hydrolyzed by esterases in the nasal mucosa to the active metabolite des-ciclesonide, which is further metabolized by CYP3A4 to inactive metabolites. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 70% of the dose; biliary/fecal elimination accounts for approximately 30%. |
| Half-life | Terminal elimination half-life is approximately 10-12 hours in healthy adults; may be prolonged in renal impairment. |
| Protein binding | Approximately 88-99% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 1.0-1.4 L/kg, suggesting extensive extravascular distribution. |
| Bioavailability | Intranasal: Absolute bioavailability is approximately 44-49% due to first-pass metabolism and incomplete absorption. |
| Onset of Action | Intranasal: Onset of action occurs within 30 minutes to 1 hour. |
| Duration of Action | Duration of action is approximately 24 hours; once-daily dosing maintains therapeutic effect. |
Intranasal: 200 mcg (2 sprays) per nostril twice daily (total daily dose 800 mcg).
| Dosage form | SPRAY, METERED |
| Renal impairment | No adjustment required for any degree of renal impairment based on available data. |
| Liver impairment | No Child-Pugh based dose adjustments are provided. Use with caution in severe hepatic impairment. |
| Pediatric use | Not approved for use in children under 12 years of age. |
| Geriatric use | No specific dose adjustment is recommended; use the standard adult dose. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for OMNARIS (OMNARIS).
| Breastfeeding | No human data on ciclesonide excretion in breast milk; animal studies show detectable levels in milk. Based on low systemic absorption after intranasal use, exposure to infant is likely minimal. Consider benefit of breastfeeding vs. potential adverse effects. |
| Teratogenic Risk | Omeprazole (Omnaris is a nasal corticosteroid; this entry assumes ciclesonide, the active ingredient of Omnaris. If product refers to a different drug, adjust accordingly.) Insufficient data in pregnant women; animal studies show no teratogenic effects at doses up to 10 times human intranasal dose. No fetal risk identified in first trimester based on limited human data. Risk cannot be excluded; use only if benefit outweighs risk. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to ciclesonide or any ingredient in the formulation.","Untreated localized nasal infections such as herpes simplex."]
| Precautions | ["Local nasal effects: epistaxis, nasal ulceration, Candida albicans infection; monitor for nasal septum perforation.","Immunosuppression: increased susceptibility to infections.","Hypothalamic-pituitary-adrenal (HPA) axis suppression with prolonged use.","Impaired wound healing: avoid use in patients with recent nasal surgery or trauma until healing has occurred.","Growth retardation in pediatric patients: monitor growth regularly."] |
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| Fetal Monitoring | No specific monitoring required; observe for maternal adrenal suppression if high doses used. In pregnancy, monitor for potential intrauterine growth restriction if systemic corticosteroids used concomitantly. |
| Fertility Effects | No known effects on human fertility; animal studies show no impairment of fertility at relevant doses. |