Version May 2024
Note: For patients with mucous crusting, rinsing with saline nasal spray before administration can remove mucous crusting and improve nasal coating (Ref). If nasal obstruction is so severe that sprays cannot penetrate, consider concomitant use of an intranasal decongestant for up to 5 days (Ref).
Allergic rhinitis, perennial or seasonal:
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
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
No dosage adjustment necessary.
Refer to adult dosing.
(For additional information see "Ciclesonide (nasal): Pediatric drug information")
Note: Product formulations are not interchangeable: Omnaris: One spray delivers 50 mcg; Zetonna: One spray delivers 37 mcg
Allergic rhinitis, p erennial: 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 (Ref).
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
Allergic rhinitis, s easonal: 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
There are no dosage adjustments provided in the manufacturer's labeling; has not been studied.
Children and Adolescents: No dosage adjustment necessary.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>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
Hypersensitivity to ciclesonide or any component of the formulation
Canadian labeling: Additional contraindications (not in US labeling): Tuberculosis (TB) infection (latent TB) or disease (active TB) of the respiratory tract.
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, tuberculosis (TB) infection (latent TB), 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).
Omnaris 12.5 g bottles contain 120 actuations.
Zetonna 6.1 g canisters contain 60 actuations.
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 (edta) sodium (tetrasodium)]
No
Aerosol solution (Zetonna Nasal)
37 mcg/ACT (per gram): $43.02
Suspension (Omnaris Nasal)
50 mcg/ACT (per gram): $28.27
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, Nasal:
Omnaris: 50 mcg/actuation (7.1 g, 12.5 g) [contains edetate (edta) disodium]
Generic: 50 mcg/actuation ([DSC])
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.
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.
Seasonal and perennial allergic rhinitis: Management of seasonal and perennial allergic rhinitis.
Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment):; Chronic rhinosinusitis:; Nonallergic rhinitis
Substrate of CYP3A4 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
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. Risk D: Consider therapy modification
Outcome data related to the use of ciclesonide in pregnancy have not been located (Alhussien 2018).
Systemic absorption is minimal following nasal inhalation at recommended doses.
Maternal use of intranasal corticosteroids in usual doses is not associated with an increased risk of fetal malformations or preterm birth (ERS/TSANZ [Middleton 2020]). Although use of intranasal ciclesonide is likely acceptable, other agents may be preferred for the treatment of allergic rhinitis during pregnancy (Alhussien 2018; BSACI [Scadding 2017]; ERS/TSANZ [Middleton 2020]).
It is not known if sufficient quantities of ciclesonide are absorbed following nasal inhalation to produce detectable amounts in breast milk; however, systemic absorption is minimal at recommended doses.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. However, maternal use of intranasal ciclesonide is considered compatible with breastfeeding (ERS/TSANZ [Middleton 2020]).
Monitor growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular changes; signs/symptoms of Candida infection (long-term therapy).
Onset of action: 24-48 hours; further improvement observed over 1-2 weeks in seasonal allergic rhinitis or 5 weeks in perennial allergic rhinitis
Absorption: Minimal systemic absorption
Metabolism: Ciclesonide hydrolyzed to active metabolite, des-ciclesonide via esterases in nasal mucosa and lungs; further metabolism via hepatic CYP3A4 and 2D6
Bioavailability: <1%
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