Dosing and uses of Omnaris, Zetonna (ciclesonide intranasal)
Adult dosage forms and strengths
intranasal spray
- 50mcg/actuation (Omnaris)
- 37mcg/actuation (Zetonna)
Seasonal/Perennial Allergic Rhinitis
Omnaris: 2 sprays/nostril qDay (ie, 200 mcg/day)
Zetonna: 1 spray/nostril qDay (ie, 74 mcg/day)
Dosing Considerations
Must be used on a daily basis as effectiveness depends on regular use
Onset of effect is usually seen 36 hr after 1st dose
Administration
Gently shake and prime nasal spray by actuating 3 times before using for the first time or when not in use for 4 consecutive days
Pediatric dosage forms and strengths
intranasal spray
- 37mcg/actuation (Zetonna)
- 50mcg/actuation (Omnaris)
Seasonal Allergic Rhinitis
Omnaris
- <6 years: Safety and efficacy not established
- >6 years: 2 sprays/nostril qDay (ie, 200 mcg/day)
Zetonna
- <12 years: Safety and efficacy not established
- >12 years: 1 spray/nostril qDay (ie, 74 mcg/day)
Perennial Allergic Rhinitis
Omnaris
- <12 years: Safety and efficacy not established
- >12 years: 2 sprays/nostril qDay (ie, 200 mcg/day)
Zetonna
- <12 years: Safety and efficacy not established
- >12 years: 1 spray/nostril qDay (ie, 74 mcg/day)
Administration
Gently shake and prime nasal spray by actuating 3 times before using for the first time or when not in use for 4 consecutive days
Omnaris, Zetonna (ciclesonide intranasal) adverse (side) effects
1-10%
Headache (3.1-6.6%)
Epistaxis (2.9-6%)
Nasopharyngitis (3.7%)
Nasal discomfort (3.2%)
Ear pain (2.2%)
Postmarketing Reports
Nasal congestion
Nasal ulcer
Dizziness
Localized infections of nose/mouth with Candida albicans
Warnings
Contraindications
Hypersensitivity
Cautions
Epistaxis, Candida albicans infection, nasal septal perforation, and impaired wound healing reported; monitor patients periodically for signs of adverse effects on nasal mucosa
Avoid spraying directly onto nasal septum
Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma
Monitor for change in vision or with history of increased IOP, glaucoma, and/or cataracts
Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex
Corticosteroids are known to cause immunosuppression; more serious or even fatal infections (eg, chickenpox or measles) may occur in susceptible patients
Hypercorticism and adrenal suppression with very high dosages or at the regular dosage in susceptible individuals; discontinue gradually if these changes occur
Potential reduction in growth velocity in children
Nasal/inhaled corticosteroids may increase risk for glaucoma and cataracts
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown whether distributed in breast milk; however, other corticosteroids are excreted in human milk; exercise caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Omnaris, Zetonna (ciclesonide intranasal)
Mechanism of action
Glucocorticoid
Ciclesonide is a prodrug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application; desciclesonide has anti-inflammatory activity with 120 times the affinity for the glucocorticoid receptor than the parent compound
Absorption
Bioavailability: Negligible
Distribution
Protein Bound: >99%
Vd: 2.9 L/kg (parent compound); 12.1 L/kg (active metabolite)
Metabolism
Metabolites: Prodrug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1)
Metabolized by: Desciclesonide metabolized in liver by CYP3A4 and to a lesser extent by CYP2D6
Elimination
Excretion: Feces (66%); urine (~20%)
