Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aerosol Solution, Nasal:
Zetonna: 37 mcg/actuation (6.1 g)
Suspension, Nasal:
Omnaris: 50 mcg/actuation (12.5 g) [contains edetate sodium (tetrasodium)]
Pharmacokinetics/Pharmacodynamics
Absorption
Minimal systemic absorption
Metabolism
Ciclesonide hydrolyzed to active metabolite, des-ciclesonide via esterases in nasal mucosa; further metabolism via hepatic CYP3A4 and 2D6
Onset of Action
24-48 hours; further improvement observed over 1-2 weeks in seasonal allergic rhinitis or 5 weeks in perennial allergic rhinitis
Use: Labeled Indications
Seasonal and perennial allergic rhinitis: Management of seasonal and perennial allergic rhinitis.
Use: Off Label
Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment):yes
Based on the Infectious Diseases Society of America (IDSA) guidelines for acute bacterial rhinosinusitis (ABRS) in children and adults and the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, ciclesonide (nasal), among other intranasal corticosteroids, is effective and recommended as an adjunctive treatment to antibiotic therapy for the management of ABRS, primarily when a history of allergic rhinitis exists (according to IDSA guidelines).
Chronic rhinosinusitis:yes
Based on the American Academy of Otolaryngology-Head and Neck Surgery Foundation (AAO-HNS) guidelines for adult sinusitis, ciclesonide (nasal), among other intranasal corticosteroids, is effective and recommended (with or without nasal saline irrigation) for the symptomatic relief of chronic rhinosinusitis.
Contraindications
Hypersensitivity to ciclesonide or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Active or quiescent tuberculosis infections of the respiratory tract.
Dosage and Administration
Dosing: Adult
Perennial allergic rhinitis, seasonal allergic rhinitis:
Omnaris: Two sprays (50 mcg/spray) per nostril once daily; maximum: 200 mcg/day
Zetonna: One spray (37 mcg/spray) per nostril once daily; maximum: 74 mcg/day
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Product formulations are not interchangeable: Omnaris: One spray delivers 50 mcg; Zetonna: One spray delivers 37 mcg
Perennial allergic rhinitis: Intranasal:
Omnaris (50 mcg/spray):
Children 2 to 11 years: Limited data available: 1 or 2 sprays (50 mcg or 100 mcg) per nostril once daily; maximum daily dose: 200 mcg/day (Berger 2008; Kim 2007)
Children ≥12 years and Adolescents: 2 sprays (100 mcg) per nostril once daily; maximum daily dose: 200 mcg/day
Zetonna (37 mcg/spray): Children ≥12 years and Adolescents: 1 spray (37 mcg) per nostril once daily; maximum daily dose: 74 mcg/day
Seasonal allergic rhinitis: Intranasal:
Omnaris (50 mcg/spray): Children ≥6 years and Adolescents: 2 sprays (100 mcg) per nostril once daily; maximum daily dose: 200 mcg/day
Zetonna (37 mcg/spray): Children ≥12 years and Adolescents: 1 spray (37 mcg) per nostril once daily; maximum daily dose: 74 mcg/day
Administration
Intranasal Blow nose to clear nostrils. Insert applicator into nostril, keeping bottle upright, and close off the other nostril. Breathe in through nose. While inhaling, press pump to release spray. Avoid spraying directly onto the nasal septum or into eyes. Discard after the "discard by" date or after labeled number of doses has been used, even if bottle is not completely empty.
Omnaris: Shake bottle gently before using. Prime pump prior to first use (press 8 times until fine mist appears) or if spray has not been used in 4 consecutive days (press 1 time or until a fine mist appears). Nasal applicator may be removed and rinsed with warm water to clean.
Zetonna: Use nasal canister with supplied nasal actuator only. Prime pump prior to first use (press 3 times until fine mist appears) or if spray has not been used in 10 consecutive days (press 3 times or until a fine mist appears). If canister and actuator become separated, spray 1 test spray in air before using. Clean outside of nose piece with a clean, dry tissue or cloth weekly; do not wash or put in water.
Storage
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Omnaris: Do not freeze. Use within 4 months after opening aluminum pouch.
Zetonna: Protect from heat or open flame (>49°C [120°F]). Do not puncture.
Drug Interactions
Desmopressin: Corticosteroids (Nasal) may enhance the hyponatremic effect of Desmopressin. Avoid combination
Esketamine: Corticosteroids (Nasal) may diminish the therapeutic effect of Esketamine. Management: Patients who require a nasal corticosteroid on an esketamine dosing day should administer the nasal corticosteroid at least 1 hour before esketamine. Consider therapy modification
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
>10%:
Respiratory: Epistaxis (≤11%)
1% to 10%:
Central nervous system: Headache (3% to 7%)
Gastrointestinal: Nausea (≥2%)
Genitourinary: Urinary tract infection (≥2%)
Infection: Influenza (≥2%)
Neuromuscular & skeletal: Back pain (≥2%), strain (≥2%)
Otic: Otalgia (2%)
Respiratory: Nasopharyngitis (2% to 7%), nasal discomfort (3% to 6%), pharyngolaryngeal pain (≥3%), bronchitis (≥2%), cough (≥2%; may be dose-responsive), nasal septum disorder (≥2%; may be dose-responsive), oropharyngeal pain (≥2%), sinusitis (≥2%), streptococcal pharyngitis (≥2%), viral upper respiratory tract infection (≥2%), upper respiratory infection (≤2%)
<1%, postmarketing, and/or case reports: Angioedema (with angioedema of the lips, angioedema of the oropharynx, and angioedema of the tongue), dizziness, dysgeusia, dyspepsia, leukocytosis, nasal candidiasis, nasal congestion, nasal mucosa ulcer, pharyngeal candidiasis, rhinorrhea, throat irritation, xerostomia
Warnings/Precautions
Concerns related to adverse effects:
- Adrenal suppression: When used at excessive doses, may cause hypercortisolism or suppression of hypothalamic-pituitary-adrenal (HPA) axis, particularly in younger children or in patients receiving high doses for prolonged periods. HPA axis suppression may lead to adrenal crisis. Withdrawal and discontinuation of a corticosteroid should be done slowly and carefully. Particular care is required when patients are transferred from systemic corticosteroids to inhaled products due to possible adrenal insufficiency or withdrawal from steroids, including an increase in allergic symptoms.
- Delayed wound healing: Avoid nasal corticosteroid use in patients with recent nasal septal ulcers, nasal surgery or nasal trauma until healing has occurred.
- Immunosuppression: Prolonged use of corticosteroids may increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Exposure to chickenpox should be avoided; corticosteroids should be used with caution, if at all, in patients with ocular herpes simplex, latent tuberculosis, and/or TB reactivity, or in patients with untreated fungal, viral, or bacterial infections.
- Local nasal effects: Nasal septal perforation, nasal ulceration, epistaxis, and localized Candida albicans infections of the nose and/or pharynx may occur. Monitor patients periodically for adverse nasal effects.
- Ocular disease: Increased intraocular pressure, open-angle glaucoma, and cataracts have occurred with intranasal corticosteroid use; use with caution in patients with a history of increased intraocular pressure, cataracts and/or glaucoma. Consider routine eye exams in chronic users or in patients who report visual changes.
Special populations:
- Pediatric: Avoid using higher than recommended dosages; suppression of linear growth (ie, reduction of growth velocity), reduced bone mineral density, or hypercortisolism (Cushing syndrome) may occur; titrate to lowest effective dose. Reduction in growth velocity may occur when corticosteroids are administered to pediatric patients, even at recommended doses via intranasal route (monitor growth).
Pregnancy
Pregnancy Considerations
Information related to the use of ciclesonide in pregnancy has not been located (Alhussien 2018).
Intranasal corticosteroids, including ciclesonide, may be acceptable for the treatment of rhinitis during pregnancy when used at recommended doses (Lal 2016; Wallace 2008). Pregnant females adequately controlled on ciclesonide may continue therapy; if initiating treatment during pregnancy, use of an agent with more data in pregnant females may be preferred (Namazy 2016; Wallace 2008).
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience stuffy nose, nosebleed, headache, dizziness, sore throat, or ear pain. Have patient report immediately to prescriber signs of infection, signs of adrenal gland problems (severe nausea, vomiting, severe dizziness, passing out, muscle weakness, severe fatigue, mood changes, lack of appetite, or weight loss), nasal sores, runny nose, wheezing, thrush, or vision changes (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
