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Ciclesonide (Nasal)

Medically reviewed by Drugs.com. Last updated on Sep 7, 2020.

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 (edta) 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

Seasonal and perennial allergic rhinitis: Management of seasonal and perennial allergic rhinitis.

Off Label Uses

Acute bacterial rhinosinusitis, adjunct to antibiotics (empiric treatment):

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:

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.

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

Adverse Reactions

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

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).

Monitoring Parameters

Monitor growth in pediatric patients; signs/symptoms of HPA axis suppression/adrenal insufficiency; ocular changes; signs/symptoms of Candida infection (long-term therapy).

Pregnancy Considerations

Information related to the use of ciclesonide in pregnancy has not been located (Alhussien 2018).

Maternal use of intranasal corticosteroids in usual doses are 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]).

Patient Education

What is this drug used for?

• It is used to ease allergy signs.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stuffy nose

• Nosebleed

• Headache

• Dizziness

• Sore throat

• Ear pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Infection

• Adrenal gland problems like 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

• Vision changes

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.