Generic Name: ciclesonide
Date of Approval: January 20, 2011
Company: Sunovion Pharmaceuticals Inc.

Treatment for: Allergic Rhinitis

FDA Approves Zetonna

The U.S. Food and Drug Administration has approved Zetonna (ciclesonide) nasal aerosol to treat the symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

Zetonna Nasal Aerosol Patient Information

Note: For Use in the Nose Only.

  • Do not spray Zetonna Nasal Aerosol in your eyes or directly onto your nasal septum (the wall between the 2 nostrils).
  • Do not use your near heat or an open flame.

Read this Patient Information leaflet before you start using this medication and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions, ask your healthcare provider or pharmacist.

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

What is Zetonna Nasal Aerosol?

Zetonna Nasal Aerosol is a prescription medicine that treats seasonal and year-round allergy symptoms in adults and children 12 years of age and older.

Zetonna Nasal Aerosol contains ciclesonide, which is a man-made (synthetic) corticosteroid. Corticosteroids are natural substances found in the body and reduce inflammation. When you spray the aerosol into your nose, it may help reduce nasal symptoms of allergic rhinitis (inflammation of the lining of the nose) such as stuffy nose, runny nose, itching and sneezing. Zetonna Nasal Aerosol may also help you if you have red, itchy, and watery eyes.

It is not known if Zetonna Nasal Aerosol is safe and effective in children 11 years of age and younger.

Who should not use Zetonna Nasal Aerosol?

Do not use Zetonna Nasal Aerosol if you are allergic to ciclesonide or any of the ingredients. See the end of this Patient Information leaflet for a complete list of ingredients contained in this medication.

Before using Zetonna Nasal Aerosol

Before you use Zetonna Nasal Aerosol tell your healthcare provider if you:

  • have had recent nose problems such as a hole in the cartilage of your nose, nasal ulcers, nasal surgery, or nasal injury.
  • have or have had eye problems such as increased intraocular pressure, glaucoma, or cataracts.
  • have any infections including tuberculosis or ocular herpes simplex. have not had or been vaccinated for chicken pox or measles.
  • are pregnant or plan to become pregnant. It is not known if ciclesonide nasal spray will harm your unborn baby. Talk to your healthcare provider about the best way to feed your baby.
  • are breastfeeding or plan to breastfeed. It is not known if ciclesonide nasal spray passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you are using Zetonna Nasal Aerosol.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctors and pharmacist when you get a new medicine.

How should I use Zetonna Nasal Aerosol?

  • Read the Instructions for Use supplied with the product for specific information about the right way to use Zetonna Nasal Aerosol.
  • Use 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.
  • It 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.

Zetonna side effects

Zetonna Nasal Aerosol may cause serious side effects, including:

  • nose bleeds and nasal ulcers. Call your healthcare provider right away if you start to have more nose bleeds or nasal ulcers.
  • hole in the cartilage in the nose (nasal septal perforation). Stop using and call your doctor right away if you have symptoms of a nasal perforation. Symptoms of nasal perforation may include:
    • crusting in the nose
    • nosebleeds
    • runny nose
    • whistling sound when you breathe
  • thrush (Candida), a fungal infection in your nose, mouth, or throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat.
  • slow wound healing. You should not use Zetonna Nasal Aerosol until your nose has healed, if you have a sore in your nose, if you have had surgery in your nose, or if your nose has been injured.
  • eye problems such as glaucoma and cataracts. If you have a history of glaucoma or cataracts or have a family history of eye problems, you should have regular eye exams while using this medication.
  • immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that may weaken your body’s ability to fight infections. Avoid contact with people who have contagious diseases such as chicken pox or measles while you use Zetonna Nasal Aerosol. Symptoms of an infection may include:
    • fever
    • pain
    • aches
    • chills
    • feeling tired
    • nausea
    • vomiting
  • adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Call your healthcare provider right away if you experience the following symptoms of adrenal insufficiency:
    • tiredness
    • weakness
    • dizziness
    • nausea
    • vomiting
  • slowed or delayed growth in children. A child’s growth should be checked regularly while using Zetonna Nasal Aerosol. allergic reactions. Call your healthcare provider right away if you experience swelling of the lips, tongue, or throat.

The most common side effects include:

  • Nasal discomfort
  • Headache
  • Nose bleeds

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Zetonna Nasal Aerosol.

For more information, ask your doctor or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Zetonna Nasal Aerosol?

Store at room temperature between 59°F and 86°F (15°C to 30°C).

Do not puncture the canister.

Do not store the canister near heat or a flame.

Temperatures above 120°F (49°C) may cause the canister to burst.

Do not throw the canister into a fire or an incinerator. Safely throw away medicine that is out of date or no longer needed.

Keep clean and dry at all times.

Keep all medicines out of the reach of children.

General Information About the Safe and Effective Use of Zetonna Nasal Aerosol

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Zetonna Nasal Aerosol for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information. If you would like more information, talk with your healthcare provider.

You can ask your pharmacist or healthcare provider for information that is written for health professionals. You may want to read this leaflet again. Please DO NOT THROW IT AWAY until you have finished your medicine.

For more information, go to www.zetonna.com or call 1-888-394-7377.

What are the ingredients in Zetonna Nasal Aerosol?

Active ingredient: ciclesonide

Inactive ingredients: HFA propellant and ethanol

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