What is Zetonna?

Ciclesonide nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by perennial (year-round) or seasonal hay fever (allergic rhinitis). It is a steroid (cortisone-like medicine) that works by preventing the inflammation that occurs with allergic reactions.

This medicine is available only with your doctor's prescription.

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it in your eyes, on the nasal septum (the wall between the two nostrils), or on your skin. If it does get on these areas, rinse it off right away and call your doctor.

In order for this medicine to help you, it must be used on a regular basis as ordered by your doctor. This medicine usually begins to work in about 2 days, but up to 2 weeks may pass before you feel the full effects.

Do not use this medicine for any other nose problem without checking with your doctor first.

To use the spray:

• Shake the canister gently before each use.
• When you use the Zetonna™ nasal spray for the first time or if you have not used this medicine for 10 days in a row, you must prime the spray. Press down fully on the top of the canister 3 times or until a fine spray comes out.
• Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
• Close the opposite nostril with a finger. 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.
• Spray the opposite nostril using the same steps.
• Do not blow your nose for 15 minutes after using the spray.
• Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on. Do not wash or put any part of Zetonna™ nasal spray in water.
• After you prime the Zetonna™ nasal spray, there will only be 60 doses or sprays. At first, the display window will show a green color. A yellow color indicates that your medicine needs to be replaced soon. When the medicine is almost empty, the window will show a red color.
• If the Zetonna™ nasal spray is dropped, the dose counter may not work. Keep track of the number of sprays taken based on your records.
• Throw this medicine away after you use 60 sprays or when the window shows red and the dose indicator read zero "0".

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For treatment of perennial allergic rhinitis:
    • Adults and teenagers—
      • Omnaris™: 2 sprays in each nostril once a day.
      • Zetonna™: 1 spray in each nostril once a day. Each spray contains 37 micrograms (mcg). However, the total dose is usually not more than 74 mcg in each nostril per day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.
  • For seasonal allergic rhinitis:
    • Adults and teenagers—
      • Omnaris™: 2 sprays in each nostril once a day.
      • Zetonna™: 1 spray in each nostril once a day. Each spray contains 37 micrograms (mcg). However, the total dose is usually not more than 74 mcg in each nostril per day.
    • Children—
      • Omnaris™:
        • Children 6 years of age and older—2 sprays in each nostril once a day.
        • Children younger than 6 years of age—Use and dose must be determined by your doctor.
      • Zetonna™:
        • Children younger than 12 years of age—Use and dose must be determined by your doctor.

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zetonna™ in children 12 years of age and older with seasonal and perennial allergic rhinitis. However, safety and efficacy have not been established in children younger than 12 years of age.

Appropriate studies have not been performed on the relationship of age to the effects of Omnaris™ in children younger than 6 years of age with seasonal allergic rhinitis, and in children younger than 12 years of age with perennial allergic rhinitis. Safety and efficacy have not been established in these age groups.

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ciclesonide nasal spray in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving ciclesonide nasal spray.

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bemiparin
• Macimorelin
• Nadroparin
• Sargramostim

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts, history of or
• Glaucoma, history of—Use with caution. May make these conditions worse.

• Chicken pox (includes recent exposure) or
• Herpes simplex infection of the eye or
• Infections (bacteria, fungus, virus, or parasite), active or untreated or
• Measles (includes recent exposure) or
• Tuberculosis, active or history of—Can reduce the body's ability to fight infections.

• Injury to the nose or
• Nose surgery, recent or
• Sores or ulcers in the nose, recent—May prevent proper healing of these conditions.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine may increase your risk of having some unwanted effects in the nose. Check with your doctor right away if you or your child have bloody mucus, sores inside the nose, unexplained nosebleeds, or a whistling sound when you breathe while you are using this medicine.

You may get infections more easily while you are using this medicine. Avoid being around people who are sick or have infections such as chickenpox or measles or if you have never had these infections. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.

This medicine may cause thrush (a type of fungus infection) in the nose or throat. Tell your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.

This medicine can cause a serious allergic reaction called angioedema. Call your doctor right away if you start to have swelling of your face, lips, tongue, throat, arms, or legs, or if you are having trouble swallowing or breathing while you are using this medicine.

This medicine may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think your child is not growing properly or if you have any questions about this.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have any of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, menstrual cycle changes, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while taking this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).