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Zetonna

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Zetonna

PATIENT INFORMATION

ZETONNA™
(Ze toe' nah)
(ciclesonide) Nasal Aerosol

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 ZETONNA Nasal Aerosol near heat or an open flame.

Read this Patient Information leaflet before you start using ZETONNA Nasal Aerosol 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 about ZETONNA Nasal Aerosol, ask your healthcare provider or pharmacist.

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 ZETONNA Nasal 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 in ZETONNA Nasal Aerosol. See the end of this Patient Information leaflet for a complete list of ingredients in ZETONNA Nasal Aerosol.

What should I tell my healthcare provider 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 ZETONNA Nasal Aerosol will harm your unborn baby. Talk to your healthcare provider about the best way to feed your baby if you are using ZETONNA Nasal Aerosol.
  • are breastfeeding or plan to breastfeed. It is not known if ZETONNA Nasal Aerosol 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 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 possible side effects of ZETONNA Nasal Aerosol?

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 ZETONNA Nasal Aerosol 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 you use ZETONNA Nasal Aerosol.
  • 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 with ZETONNA Nasal Aerosol 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.

How should I store ZETONNA Nasal Aerosol?

  • 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.

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 ZETONNA Nasal Aerosol 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 about ZETONNA Nasal Aerosol. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ZETONNA Nasal Aerosol 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

Instructions for Use

ZETONNA™
[Ze toe' nah]
(ciclesonide) Nasal Aerosol

Read these Instructions for Use for ZETONNA Nasal Aerosol before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

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 your 2 nostrils).
  • Do not use your ZETONNA Nasal Aerosol near heat or an open flame.

The Parts of Your ZETONNA Nasal Aerosol

ZETONNA Nasal Aerosol comes as a canister fitted into a nasal actuator with a dose indicator. Do not use the actuator with a canister of medicine from any other inhaler. Do not use the ZETONNA Nasal Aerosol canister with an actuator from any other inhaler. (See Figure A)

Figure A

ZETONNA Nasal Aerosol - Illustration

Priming Your ZETONNA Nasal Aerosol For Use

  • Remove ZETONNA Nasal Aerosol from its package.
  • Before you use ZETONNA Nasal Aerosol for the first time or if you have not used your medicine for 10 days in a row, you will need to prime your ZETONNA Nasal Aerosol.
  • Open the purple plastic dust cap by gently squeezing both sides and pulling the cap away from the nasal actuator. Hold the nasal actuator upright. (See Figure B)

Figure B

Opening the purple plastic dust cap -  Illustration

  • Spray 3 times into the air away from the face, by pressing down fully on the top of the canister three times (See Figure C). Make sure the canister returns to its original position after each spray.

Figure C

Spray 3 times into the air - Illustration

Using Your ZETONNA Nasal Aerosol

Step 1. Open the purple plastic dust cap.

Step 2. Hold the nasal actuator upright, with the nose piece pointing upwards, between your thumb and forefinger (and middle finger) (See Figure D).

Figure D

Hold the nasal actuator upright - Illustration

Step 3. Tilt your head back slightly and insert the end of the nose piece into 1 nostril, pointing it slightly toward the outside nostril wall away from the nasal septum (the wall between the 2 nostrils), while holding your other nostril closed with 1 finger (See Figure E). Do not get any spray in your eyes or directly on your nasal septum.

Figure E

Hold your other nostril closed - Illustration

Step 4. Press down on the canister to release 1 spray and at the same time breathe in gently through the nostril. Hold your breath for a few seconds then breathe out slowly through your mouth.

Step 5. Remove the nose piece from your nostril. Make sure the canister has returned to its original position and repeat steps 2-4 for the second spray in your other nostril.

Step 6. Replace the protective purple dust cap on the nasal actuator.

Step 7. Avoid blowing your nose for the next 15 minutes.

Cleaning Your Nasal Actuator

The outside of the nose piece should be cleaned weekly, by wiping with a clean, dry tissue or cloth (see Figure F).

Do not wash or put any part of the ZETONNA Nasal Aerosol canister or actuator in water.

Figure F

Cleaning Your Nasal Actuator - Illustration

How to Tell if Your ZETONNA Nasal Aerosol Is Empty

  • Each canister of ZETONNA Nasal Aerosol contains enough medicine for you to spray medicine 60 times (or 30 times for sample size product). This does not count the first 3 priming sprays.
  • The actuator of your ZETONNA Nasal Aerosol is fitted with a dose indicator which shows you how much medicine is left after each use. The dose indicator will display the number of sprays remaining in groups of 5 or 10 actuations.
  • The display window will begin showing a green color. As you continue to use the medicine, the window will show a yellow color. A yellow color in the window means that you need to replace your medicine soon. When the medicine is almost empty, the window will show a red color.
  • When the window shows red and you see the dose indicator read zero, “0” (see Figure G), you should throw away the canister and nasal actuator.

Figure G

The dose indicator - Illustration

  • Do not throw your ZETONNA Nasal Aerosol canister in the fire or an incinerator.
  • Do not use your ZETONNA Nasal Aerosol after zero is shown in the window of the dose indicator even though it may look like there is medicine left in the canister. You may not get the right amount of medicine.
  • Talk with your healthcare provider before your supply of ZETONNA Nasal Aerosol runs out to see if you should get a refill of your medicine.

What to Do if You Drop Your ZETONNA Nasal Aerosol

  • If you drop your ZETONNA Nasal Aerosol, the canister may become separated from the actuator. If this happens, insert the canister into the actuator as shown in Figure H, test spray once into the air away from your face, then use as described above.

Figure H

Inserting the canister into the actuator - Illustration

  • If the ZETONNA Nasal Aerosol is dropped, the dose counter may not work. It is recommended to keep track of the number of sprays taken from your ZETONNA Nasal Aerosol based on your records.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 2/6/2012
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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