Frequently Asked Questions About OMNARIS (ciclesonide) Nasal Spray

 

General questions about OMNARIS Nasal Spray

What is OMNARIS Nasal Spray?
How does OMNARIS Nasal Spray work?

Questions about nasal allergies

What are nasal allergies?
What is the difference between seasonal (outdoor) and year-round (indoor) allergies?

Questions about how OMNARIS Nasal Spray works

What is the active ingredient in OMNARIS Nasal Spray?
Is OMNARIS a steroid?
Does OMNARIS have a taste or smell?
How effective is OMNARIS Nasal Spray?
How quickly does OMNARIS Nasal Spray start to work?
How long does OMNARIS Nasal Spray work?
Can OMNARIS Nasal Spray be used in children younger than 12 years of age?
What are the most common side effects of OMNARIS Nasal Spray?

Questions about using OMNARIS Nasal Spray

How much does OMNARIS Nasal Spray cost?
Can I get a sample of OMNARIS Nasal Spray?
How much OMNARIS Nasal Spray do I use each day?
How long does OMNARIS Nasal Spray last?
How do I use OMNARIS Nasal Spray?
Why does OMNARIS Nasal Spray contain a foil pouch?
How long can OMNARIS Nasal Spray be used after opening/removing the foil pouch?
What happens if my OMNARIS Nasal Spray freezes?

What is OMNARIS Nasal Spray?
OMNARIS is a nasal steroid spray for people with seasonal or year-round allergies. It contains a medication called ciclesonide, which works to relieve the inflammation that causes nasal allergy symptoms, such as sneezing, itchy nose, runny nose, and congestion.

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How does OMNARIS Nasal Spray work?
OMNARIS Nasal Spray works by reducing allergic inflammation, a major cause of nasal allergy symptoms like sneezing, runny, itchy nose, and congestion.

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What are nasal allergies?
Nasal allergies (also called simply "allergies" or "hay fever", or by its medical term, "allergic rhinitis"), is a condition where your nasal passages become swollen and irritated due to allergic inflammation. Nasal allergies may be seasonal or year-round.

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What is the difference between seasonal (outdoor) and year-round (indoor) allergies?
Seasonal allergic rhinitis — or seasonal allergies — occurs only at certain times of the year, when you are exposed to certain seasonal allergens such as tree, grass, or ragweed pollen. Perennial allergic rhinitis — also called "year-round" or "indoor" allergies — may occur throughout the year, when you are exposed to certain allergens such as pet dander or dust.

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What is the active ingredient in OMNARIS Nasal Spray?
The ingredient in OMNARIS Nasal Spray is ciclesonide (sye-KLES-oh-nide), a drug that is converted in the nasal passages to an active form, des-ciclesonide — an effective anti-inflammatory agent that treats nasal allergy symptoms like sneezing, runny, itchy nose, and congestion.

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Is OMNARIS a steroid?
OMNARIS is an intranasal steroid. It is NOT the same as an anabolic steroid — the kind of steroid you may hear about some athletes misusing. Intranasal steroids are very effective for relieving nasal allergy symptoms because they reduce the inflammation inside the nasal passages that causes symptoms. They are considered well tolerated and generally safe when taken as directed.

Like all steroid nasal sprays, OMNARIS may cause slowed growth in children. The growth of children using OMNARIS should be monitored routinely by a healthcare professional.

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Does OMNARIS have a taste or smell?
OMNARIS Nasal Spray is a unique formulation that is scent-free, taste-free, and alcohol-free.

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How effective is OMNARIS Nasal Spray?
In clinical trials, OMNARIS Nasal Spray was shown to significantly improve nasal allergy symptoms including sneezing, runny, itchy nose, and congestion in people with seasonal or year-round nasal allergy symptoms.

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How quickly does OMNARIS Nasal Spray start to work?
OMNARIS Nasal Spray may begin to improve nasal allergy symptoms (runny, itchy nose, sneezing, and congestion) within 24-48 hours after the first dose. When using OMNARIS Nasal Spray daily as prescribed, your symptoms will continue to improve over the next 1 to 2 weeks for seasonal allergy symptoms, and over the next 5 weeks for year-round allergy symptoms. If your symptoms do not improve within 2 weeks after taking OMNARIS Nasal Spray or if your condition worsens, you should contact your healthcare professional.

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How long does OMNARIS Nasal Spray work?
In clinical trials, OMNARIS Nasal Spray resulted in significant improvements in nasal allergy symptoms such as sneezing, runny, itchy nose, and congestion for a full 24-hour period. OMNARIS does not lose its effectiveness over time.

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Can OMNARIS Nasal Spray be used in children younger than 12 years of age?
For treating seasonal (outdoor) nasal allergy symptoms, OMNARIS Nasal Spray is approved for adults and children 6 years of age and older. For treating year-round (indoor) nasal allergy symptoms, OMNARIS Nasal Spray is approved for adults and adolescents 12 years of age and older.

If you have any questions about who should use OMNARIS Nasal Spray, please contact a healthcare professional.

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What are the most common side effects of OMNARIS Nasal Spray?
The most common side effects that may occur with use of OMNARIS Nasal Spray are headache, nose bleed, sore throat, and ear pain.

Please contact your healthcare professional to discuss any side effects or other concerns while taking OMNARIS Nasal Spray. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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How much does OMNARIS Nasal Spray cost?
The cost of OMNARIS Nasal Spray varies depending on your insurance plan and how you pay for your medicines. You may be eligible for the OMNARIS Relief Is Here Program. If you qualify, you may be able to reduce your copay to $11.00 on each of your next 12 prescriptions or refills of OMNARIS Nasal Spray. Learn more about how to get OMNARIS for $11.*

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Can I get a sample of OMNARIS Nasal Spray?
Samples of OMNARIS Nasal Spray are available from certain healthcare professionals. Please check with your doctor or other healthcare professional to find out if a product sample is available.

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How much OMNARIS Nasal Spray do I use each day?
The recommended dose of OMNARIS Nasal Spray is 200 micrograms per day, which is two 50-microgram sprays in each nostril, once a day. You should never use more than 2 sprays in each nostril each day unless told to do so by your healthcare professional.

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How long does OMNARIS Nasal Spray last?
Each bottle of OMNARIS Nasal Spray contains 120 metered sprays after initial priming. This is typically a 30-day supply for most patients.

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How do I use OMNARIS Nasal Spray?
Before you use OMNARIS Nasal Spray for the first time, each bottle must be gently shaken and then the pump must be primed by pressing eight times. You should receive complete instructions along with your prescription. For more information, see the OMNARIS Patient's Instructions for Use.

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Why does OMNARIS Nasal Spray contain a foil pouch?
Each bottle of OMNARIS Nasal Spray is packaged in an outer foil pouch, which maintains the stability and integrity of the product.

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How long can OMNARIS Nasal Spray be used after opening/removing the foil pouch?
After you take the OMNARIS bottle out of the foil pouch, it can be used for 120 sprays (after initial priming) or for 4 months, whichever comes first. After 120 sprays or 4 months, you should discard the OMNARIS bottle.

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What happens if my OMNARIS Nasal Spray freezes?
If frozen, the proper amount of drug may not be administered with each spray, and the bottle should be discarded.

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OMNARIS (ciclesonide) Nasal Spray is for the treatment of nasal allergy symptoms associated with seasonal allergic rhinitis (seasonal allergies) in adults and children 6 years of age and older, and with perennial allergic rhinitis (year-round allergies) in adults and adolescents 12 and older.

Important Safety Information

Patients using corticosteroid drugs that weaken the immune system are more susceptible to infection and should avoid exposure to chickenpox or measles. If you have tuberculosis, eye herpes, or untreated infections of any kind, speak to your doctor before using OMNARIS. Yeast infections of the nose and throat may occur.

Patients who have recently had an ulcer in the nose, trauma to the nose or nasal surgery should not use OMNARIS until healing has occurred. Rare instances of nasal irritation and eye problems have been reported following the use of nasal steroids. Talk with your doctor if you have a history of eye problems or experience a change in vision.

Patients taking higher doses of a nasal steroid than recommended, or certain other at-risk individuals, may experience symptoms of a hormonal imbalance, including very rarely changes in menstruation, acne, and weight gain. Like all steroid nasal sprays, OMNARIS may cause slowed growth in children. The growth of children using OMNARIS should be monitored routinely by a healthcare professional.

The most common side effects that may occur with OMNARIS are headache, nosebleed, sore throat and ear pain.

The health information contained on this website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. The product discussed on this site may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

For more information, please see the OMNARIS Full Prescribing Information and the OMNARIS Patient's Instructions for Use.

OMNARIS is available by prescription. Ask your healthcare professional if OMNARIS is right for you. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The health information contained on this website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. This site is intended for U.S. residents only. The product discussed on this site may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

©2010 Sepracor Inc.and SEPRACOR are registered trademarks of Sepracor Inc.

OMNARIS is a registered trademark of Nycomed GmbH, used with permission.

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