Ciclesonide

What is Ciclesonide?

• Ciclesonide (Zetonna) Nasal Aerosol is a corticosteroid used to seasonal and year-round allergy symptoms in adults and children 12 years of age and older.

What are the uses of this medicine?

This medicine is used:

• for treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

How does this medicine work?

• Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application.
• Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120 times higher than the parent compound.
• The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known.
• Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic inflammation.

Who Should Not Use this medicine ?

This medicine cannot be used:

• with a known hypersensitivity to ciclesonide or any of the ingredients of Zetonna.

What drug interactions can this medicine cause?

• In vitro studies and clinical pharmacology studies suggested that des-ciclesonide has no potential for metabolic drug interactions or protein binding-based drug interactions.

Is this medicine FDA approved?

• Initial U.S. Approval: 2006

How should this medicine be used?

Recommended dosage: Adults and Adolescents (12 Years of Age and Older):

• The recommended dose of Zetonna is 1 actuation per nostril once daily (37 mcg per actuation). The maximum total daily dosage should not exceed 1 actuation in each nostril (74 mcg per day).

Administration:

• Read the Instructions for Use at the end of this leaflet for specific information about the right way to use Zetonna Nasal Aerosol.
• Use Zetonna Nasal Aerosol exactly as your healthcare provider tells you to use it. Do not take more of your medicine or take it more often than your healthcare provider tells you.
• Zetonna Nasal Aerosol is used 1 time each day, 1 spray in each nostril. Do not use more than a total of 1 spray in each nostril per day.
• Zetonna Nasal Aerosol may begin to work within 36 hours after you take your first dose. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.
• If your symptoms do not improve or get worse, call your healthcare provider.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Nasal Aerosol: 37 mcg of ciclesonide per actuation.

Supplied in a 6.1 g canister containing 60 actuations.

This medicine is available in fallowing brand namesː

• Zetonna

What side effects can this medication cause?

The most common side effects of this medicine include:

• Nasal discomfort
• Headache
• Nose bleeds

Zetonna Nasal Aerosol may cause serious side effects, including:

• nose bleeds and nasal ulcers
• hole in the cartilage in the nose (nasal septal perforation)
• thrush (Candida), a fungal infection in your nose, mouth, or throat
• slow wound healing
• eye problems such as glaucoma and cataracts
• immune system problems that may increase your risk of infections
• adrenal insufficiency
• slowed or delayed growth in children
• allergic reactions

What special precautions should I follow?

• Local Nasal Effects, including epistaxis, ulceration, nasal septal perforations, Candida albicans infection, impaired wound healing were observed more frequently in patients treated with Zetonna. Prior to initiating therapy, examine patients for evidence of septal perforation, erosions, ulceration, nasal surgery, and trauma. Avoid spraying Zetonna directly onto the nasal septum. Avoid use in patients with recent septal perforation, nasal erosion, nasal ulcers, nasal surgery, or nasal trauma. Monitor patients periodically for signs of adverse effects on the nasal mucosa. Discontinue Zetonna if erosions, ulcerations or perforations occur.
• Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.
• Hypersensitivity reactions have been reported following administration of ciclesonide with manifestations such as angioedema, with swelling of the lips, tongue and pharynx.
• Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. More serious or even fatal course of chicken pox or measles in susceptible individuals. Use caution in patients with the above because of the potential for worsening of these infections.
• Hypercorticism and adrenal suppression may occur when intranasal corticosteroids, such as Zetonna, are used at higher than recommended dosages or in susceptible individuals at recommended dosages. If such changes occur, discontinue Zetonna slowly.
• Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving Zetonna.

What to do in case of emergency/overdose?

Symptoms of overdosage:

• Chronic overdosage may result in signs or symptoms of hypercorticism.

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled trials in pregnant women. Zetonna should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness for seasonal and perennial allergic rhinitis in children 12 years of age and older have been established.
• The safety and efficacy of Zetonna for treatment of the symptoms of seasonal and perennial allergic rhinitis in patients 11 years of age and younger have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: ciclesonide
• Inactive ingredients: HFA propellant and ethanol

Who manufactures and distributes this medicine?

Manufactured for: Covis Pharma Zug, 6300 Switzerland

• Made in the United Kingdom

What should I know about storage and disposal of this medication?

• Store Zetonna Nasal Aerosol at room temperature between 59°F and 86°F (15°C to 30°C).
• Do not puncture the Zetonna Nasal Aerosol canister.
• Do not store the Zetonna Nasal Aerosol canister near heat or a flame. Temperatures above 120°F (49°C) may cause the canister to burst.
• Do not throw the Zetonna Nasal Aerosol canister into a fire or an incinerator.
• Safely throw away medicine that is out of date or no longer needed.
• Keep Zetonna Nasal Aerosol clean and dry at all times.
• Keep Zetonna Nasal Aerosol and all medicines out of the reach of children.

• Dailymed label info on Ciclesonide
• FDA Ciclesonide

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