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. |
| Molecular Weight | 540.65 |
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 | Avoid due to potential teratogenicity; NSAIDs are associated with increased risk of cardiac malformations and gastroschisis. |
| 2nd trimester | Avoid; NSAIDs may cause oligohydramnios and constriction of ductus arteriosus, especially after 20 weeks gestation. |
| 3rd trimester | Contraindicated due to risk of premature closure of ductus arteriosus, oligohydramnios, and neonatal renal impairment. |
Clinical note
Comprehensive clinical and safety monograph for OMNARIS (OMNARIS).
| Placental transfer | Ciclesonide and its active metabolite cross the placenta in animal studies; human data limited but likely similar to other corticosteroids. |
| Breastfeeding | Ciclesonide and its active metabolite des-ciclesonide are excreted into human milk in small amounts. Due to low oral bioavailability, infant exposure is expected to be minimal. However, caution is advised, especially in premature infants or those with compromised renal function. |
■ FDA Black Box Warning
None.
| Serious Effects |
Hypersensitivity to ciclesonide or any componentStatus asthmaticusUntreated nasal fungal infectionUntreated systemic bacterial or viral infection
| 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. |
| Food/Dietary | No significant food interactions. Grapefruit juice does not affect ciclesonide metabolism. Avoid concurrent use with strong CYP3A4 inhibitors (e.g., ketoconazole) as may increase systemic exposure. |
Loading safety data…
| Lactation Rating | L2 (Safer) |
| 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. |
| 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. |
| Clinical Pearls | Omnaris (ciclesonide) is a prodrug converted to active metabolite des-ciclesonide in the lungs; lacks systemic bioavailability due to high first-pass metabolism. Use as nasal spray for allergic rhinitis; onset of action within 24-48 hours. May cause epistaxis, headache, or pharyngitis. Not for immediate relief of acute symptoms. |
| Patient Advice | Use regularly as prescribed; not for immediate symptom relief. · Prime pump before first use or after 14 days of non-use. · Blow nose before use; keep head upright, spray away from septum. · Rinse spray tip with warm water but do not dry with tissue. · Report persistent nosebleeds or signs of infection. |