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Ciclesonide (Nasal)

Pronunciation

(sye KLES oh nide)

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)]

Brand Names: U.S.

  • Omnaris
  • Zetonna

Pharmacologic Category

  • Corticosteroid, Nasal

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

Management of seasonal and perennial allergic rhinitis

Use: Unlabeled

Adjunct to antibiotics in empiric treatment of acute bacterial rhinosinusitis (ABRS) (Chow, 2012)

Contraindications

Hypersensitivity to ciclesonide or any component of the formulation

Dosing: Adult

Perennial allergic rhinitis, seasonal allergic rhinitis:

Omnaris®: 2 sprays (50 mcg/spray) per nostril once daily; maximum: 200 mcg/day

Zetonna™: 1 spray (37 mcg/spray) per nostril once daily; maximum: 74 mcg/day

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Perennial allergic rhinitis: Children ≥12 years: Refer to adult dosing:

Seasonal allergic rhinitis:

U.S. labeling: Children ≥6 year: Refer to adult dosing.

Canadian labeling: Children ≥12 years: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

No dosage adjustment necessary.

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

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. 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% (Limited to important or life-threatening): 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 hypercorticism 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 hypercorticism (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 Risk Factor

C

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Hypoadrenalism may occur in newborns following maternal use of corticosteroids in pregnancy; monitor. Intranasal corticosteroids may be used in the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP, 2005; 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 headache, pharyngitis, or ear pain. Have patient report immediately to prescriber signs of infection, severe dizziness, passing out, severe rhinitis, severe nosebleed, nasal sores, wheezing, thrush, severe nausea, severe vomiting, severe loss of strength and energy, 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 healthcare 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.

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