Ciclesonide
Pronouncation: (sye-KLES-oh-nide)Class: Corticosteroid
Trade Names:
Omnaris
- Spray, suspension 50 mcg
Pharmacology
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Anti-inflammatory activity with a high affinity for the glucocorticoid receptor.
Pharmacokinetics
Absorption
Prodrug converted to active metabolite, des-ciclesonide, after topical administration. Negligible serum concentrations following intranasal administration. Des-ciclesonide C max below 30 pg/mL.
Distribution
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.
Metabolism
Des-ciclesonide is metabolized in the liver by the CYP3A4 isozyme and, to a lesser degree, CYP2D6.
Elimination
After IV administration, predominantly excreted in the feces (66%) and approximately 20% or less in the urine.
Special Populations
Hepatic Function ImpairmentWhen administered by oral inhalation, dosage adjustments are not needed in patients with hepatic function impairment.
Indications and Usage
Treatment of nasal symptoms associated with seasonal or perennial allergic rhinitis.
Contraindications
Standard considerations.
Dosage and Administration
Perennial Allergic RhinitisAdults and Children 12 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).
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).
General Advice
- Before use, gently shake the nasal spray, then prime the pump by actuating 8 times.
- If product is not used for 4 or more consecutive days, it should be gently shaken and primed with 1 spray or until a fine mist appears.
Storage/Stability
Store at 59° to 86°F. Do not freeze.
Drug Interactions
KetoconazoleMay increase des-ciclesonide exposure by about 3.6-fold. Coadminister with caution.
Laboratory Test Interactions
None well documented.
Adverse Reactions
CNS
Headache (7%).
EENT
Nasopharyngitis (7%); epistaxis (5%); pharyngolaryngeal pain (3%); ear pain (2%).
Precautions
MonitorClosely monitor patients with a change in vision and with a history of glaucoma or cataracts. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Seasonal allergic rhinitisSafety and efficacy not established in children younger 6 yr of age.
Perennial allergic rhinitisSafety and efficacy not established in children younger than 12 yr of age. May cause a reduction in growth velocity when administered to children.
Elderly
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.
Adrenal insufficiency
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.
Infection
Patients on drugs that suppress the immune system are more susceptible to infections (eg, chickenpox, measles).
Wound healing
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.
Overdosage
Symptoms
There are no data available.
Patient Information
- Instruct patient on the correct administration technique.
- Warn patients taking immunosuppressant doses or corticosteroids to avoid exposure to measles and chickenpox, and, if exposed, to seek medical advise.
- Caution patient not to spray into the eyes or onto the nasal septum.
- Instruct patient to contact health care provider if symptoms do not improve within a reasonable time or if conditions worsen.
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