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ciclesonide

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Overview

What is Zetonna?

The active component of ZETONNA is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11ß,16α)-. Ciclesonide is delivered as the R-epimer. The empirical formula is CHO and its molecular weight is 540.7. Its structural formula is as follows:

Ciclesonide is a white to yellow-white powder. It is soluble in dehydrated alcohol, acetone, dichloromethane, and chloroform. ZETONNA is comprised of a pressurized, metered-dose aerosol canister and actuator, which is fitted with a dose indicator. ZETONNA is intended for intranasal use only. Each canister contains a solution of ciclesonide in propellant HFA-134a (1,1,1,2 tetrafluoroethane) and ethanol. After priming, ZETONNA delivers 50 mcg of ciclesonide from the valve and 37 mcg of ciclesonide from the actuator. This product delivers 50 microliters (59.3 milligrams) of solution as fine particle mist from the valve with each actuation.



What does Zetonna look like?



What are the available doses of Zetonna?

ZETONNA Nasal Aerosol is provided at strength of 37 mcg per actuation strength containing 60 actuations per canister.

What should I talk to my health care provider before I take Zetonna?

How should I use Zetonna?

ZETONNA Nasal Aerosol is a corticosteroid indicated for treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older. ()

Administer ZETONNA by the intranasal route only. Prior to initial use, ZETONNA must be primed by actuating three times. If ZETONNA is not used for ten consecutive days, it must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, reassemble ZETONNA and test spray once into the air before using. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.


What interacts with Zetonna?

Sorry No Records found


What are the warnings of Zetonna?

Sorry No Records found


What are the precautions of Zetonna?

Sorry No Records found


What are the side effects of Zetonna?

Sorry No records found


What should I look out for while using Zetonna?

ZETONNA is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA [].


What might happen if I take too much Zetonna?

Chronic overdosage may result in signs or symptoms of hypercorticism []. There are no data on the effects of acute or chronic overdosage with ZETONNA.


How should I store and handle Zetonna?

Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing.ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60ZETONNA is supplied as a pressurized aluminum canister with a purple and white plastic actuator integrated with a dose indicator and a cap. The contents of one 6.1 gram canister provide 60 actuations, after initial priming. Each actuation delivers 37 mcg of ciclesonide from the nasal actuator. Prior to initial use, or when not used for ten consecutive days, ZETONNA must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, ZETONNA should be reassembled and actuated once into the air to test before using. The actuator and canister should be discarded after reaching zero in the indicator window since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose. The ZETONNA canister should only be used with the ZETONNA actuator. The actuator is fitted with a dose indicator and should not be used with other inhalation aerosol medications. The correct amount of medication in each inhalation cannot be ensured after the labeled number of actuations from the canister has been used, even though the inhaler may not feel completely empty and may continue to operate. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. For optimal results, canister should be at room temperature when used.Contents under PressureDo not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.Keep out of reach of children. Avoid spraying in eyes or directly onto the nasal septum.ZETONNA 37 mcg, 60 metered actuations; net fill weight 6.1 g.NDC Number 70515-737-60


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

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.

Non-Clinical Toxicology
ZETONNA is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA [].

No specific drug interactions have been demonstrated.

Epistaxis and Nasal Ulceration

see Adverse Reactions ()

The occurrence of local nasal adverse events was further evaluated in a separate, postmarketing 26-week randomized, open-label, active-controlled nasal and ocular safety trial conducted in patients with perennial allergic rhinitis. In this study epistaxis was observed in 6% of patients treated with ZETONNA and nasal ulceration was identified in 3 of 367 patients administered ZETONNA. []

Nasal Septal Perforation

see Adverse Reactions ()

Before starting ZETONNA conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Periodically monitor patients with nasal examinations during treatment for adverse effects in the nasal cavity. If an adverse reaction (e.g. erosion, ulceration, perforation) is noted, discontinue ZETONNA. Avoid spraying ZETONNA directly onto the nasal septum.

Candida albicans

Impaired Wound Healing

Systemic and local corticosteroid use may result in the following:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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