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How OMNARIS (ciclesonide) Nasal Spray Works

 

How OMNARIS® (ciclesonide) Nasal Spray Works

OMNARIS fights nasal allergy symptoms — such as sneezing, runny, itchy nose, and congestion caused by allergic inflammation — in a unique taste-free, scent-free, alcohol-free nasal spray

  • OMNARIS Nasal Spray delivers the medicine ciclesonide (sye-KLES-oh-nide) directly to the inflamed tissue inside your nasal passages.
  • The medicine in OMNARIS works to reduce the allergic inflammation that plays a large role in causing nasal allergy symptoms such as sneezing, runny, itchy nose, and congestion.
  • OMNARIS is a unique formulation that stays inside your nasal passages to do its job.

Relief that keeps working — when taken as directed
OMNARIS (ciclesonide) Nasal Spray is a medicine that works best when used regularly, as directed — not just when you have symptoms. So even if you start to feel better after you begin taking it, be sure to keep using it as you’ve been directed — so you keep on feeling better.

After spraying into your nose, OMNARIS Nasal Spray may begin to work within 24-48 hours after the first dose. Use OMNARIS daily and 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.

How OMNARIS Works: The Details
OMNARIS® (ciclesonide) Nasal Spray has a unique water-based formulation called a "hypotonic suspension". Once it is sprayed into your nose, water in the formula is quickly absorbed into your nasal tissue, leaving the medicine behind to work where it’s needed.

Once inside your nasal passages, the medicine in OMNARIS, ciclesonide, is quickly converted to an active form, des-ciclesonide — an effective anti-inflammatory agent. It helps reduce the swelling and irritation inside your nasal passages, which in turn helps to relieve nasal allergy symptoms such as sneezing, runny, itchy nose, and congestion.

OMNARIS is a type of medicine known as an intranasal steroid (INS).

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. 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.

As with other steroids, there may be side effects. The most common side effects that may occur with OMNARIS Nasal Spray are headache, nosebleed, sore throat and ear pain. To learn more, please see Patient Information and Important Safety Information.

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Indication and Dosing

OMNARIS® (ciclesonide) Nasal Spray is for the treatment of nasal allergy symptoms associated with seasonal allergies in adults and children 6 years of age and older, and with year-round allergies in adults and adolescents 12 and older. It is for use in the nose only. OMNARIS is used 1 time each day, 2 sprays per nostril.

Important Safety Information

Do not spray OMNARIS Nasal Spray in your eyes or directly onto your nasal septum (the wall inside your nose between your two nostrils).

OMNARIS Nasal Spray 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 OMNARIS Nasal Spray 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, and a 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 OMNARIS Nasal Spray 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 OMNARIS Nasal Spray.
  • 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 OMNARIS Nasal Spray. Symptoms of an infection may include: fever, pain, aches, chills, feeling tired, nausea, and 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, and vomiting.
  • slowed or delayed growth in children. A child's growth should be checked regularly while using OMNARIS Nasal Spray.
  • allergic reactions. Call your healthcare provider right away if you experience swelling of the lips, tongue, or throat.

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

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 OMNARIS Nasal Spray.

For more information, please see the OMNARIS Full Prescribing Information and the OMNARIS Patient Information. You may also call 1-888-394-7377.

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.

OMNARIS® (ciclesonide) Nasal Spray is available by prescription. Ask your healthcare professional if OMNARIS Nasal Spray is right for you.

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 18 years of age and older. 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.

OMNARIS is the registered trademark of Takeda GmbH, used under license. Sunovion Pharmaceuticals Inc. is a U.S. subsidiary of Dainippon Sumitomo Pharma Co. Ltd., is a registered trademark of Dainippon Sumitomo Pharma Co. Ltd.

© 2013 Sunovion Pharmaceuticals Inc. All rights reserved. 01/13 OMNV070-12.

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