Trade Names:Omnaris- Spray, suspension 50 mcg
Anti-inflammatory activity with a high affinity for the glucocorticoid receptor.
Prodrug converted to active metabolite, des-ciclesonide, after topical administration. Negligible serum concentrations following intranasal administration. Des-ciclesonide C max below 30 pg/mL.
Following IV administration, Vd of ciclesonide and des-ciclesonide are approximately 2.9 and 12.1 L/kg, respectively, and protein binding averages at least 99% for ciclesonide and its metabolite.
Des-ciclesonide is metabolized in the liver by the CYP3A4 isozyme and, to a lesser degree, CYP2D6.
After IV administration, predominantly excreted in the feces (66%) and approximately 20% or less in the urine.
When administered by oral inhalation, dosage adjustments are not needed in patients with hepatic function impairment.
Treatment of nasal symptoms associated with seasonal or perennial allergic rhinitis.
Nasal inhalation 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril once daily (max, 200 mcg/day).Seasonal Allergic RhinitisAdults and Children 6 yr of age and older
Nasal inhalation 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril once daily (max, 200 mcg/day).
Store at 59° to 86°F. Do not freeze.
May increase des-ciclesonide exposure by about 3.6-fold. Coadminister with caution.
None well documented.
Nasopharyngitis (7%); epistaxis (5%); pharyngolaryngeal pain (3%); ear pain (2%).
Closely monitor patients with a change in vision and with a history of glaucoma or cataracts.
Category C .
Safety and efficacy not established in children younger 6 yr of age.Perennial allergic rhinitis
Safety and efficacy not established in children younger than 12 yr of age. May cause a reduction in growth velocity when administered to children.
Use with caution, usually starting at the low end of the dosage range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapy.
Replacement of systemic corticosteroids with topical corticosteroids can be accompanied by signs of adrenal insufficiency. Some patients may experience symptoms of corticosteroid withdrawal (eg, depression, joint or muscular pain, lassitude). In patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause severe exacerbation of symptoms.
Patients on drugs that suppress the immune system are more susceptible to infections (eg, chickenpox, measles).
Because of the inhibitory effect of corticosteroids on wound healing, patients experiencing recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
There are no data available.
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