Omnaris (ciclesonide nasal spray) belongs to a class of medications called corticosteroids. Ciclesonide works by preventing and decreasing the release of substances in the body that cause inflammation (swelling that can cause other symptoms) in the nose.

Omnaris nasal spray is used to treat nasal symptoms (congestion, sneezing, stuffy. itchy, runny nose) caused by seasonal allergies in adults and children 6 years of age and older.

Omnaris is also used to treat nasal symptoms caused by perennial allergies (occurs all year round) in adults and children who are at least 12 years old.

Before using Omnaris, tell your doctor if you have asthma, glaucoma, tuberculosis or other infection of the lungs, an open sore inside your nose, or a recent nose injury or surgery. Tell your doctor if you are or have been using any other steroid medications: oral, inhaled, or injected.

Omnaris comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

It may take 1 to 2 days before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 2 to 5 weeks of treatment.

If you stopped using another steroid medication when you started using Omnaris, you may have steroid withdrawal symptoms. These symptoms include joint or muscle pain, depression, and weakness. Do not stop using any steroid medication without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Although it is not likely that your body will absorb enough ciclesonide, when receiving doses of Omnaris nasal spray, to cause serious side effects, tell your doctor if you have any steroid-related symptoms such as irregular menstrual periods, acne, increased hair growth, swelling, rapid weight gain, roundness of the face, increased sweating, depression, anxiety, or unusual thoughts or behavior.

Call your doctor at once if you have sores or white patches inside or around your nostrils, or if you have any vision problems, such as tunnel vision.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

USe Omnaris exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Never use Omnaris in larger amounts, or for longer than prescribed.

If you take another steroid medicine, do not stop it suddenly. Ask your doctor about tapering your dose.

The usual dose of Omnaris is 2 sprays in each nostril once daily. Follow your doctor's dosing instructions very carefully.

Before your first use, gently shake Omnaris and prime it with 8 sprays into the air, away from your face. Prime again whenever the nasal spray has not been used in longer than 4 days, or if it has been dropped. You should shake Omnaris gently before each use.

To use the Omnaris nasal spray:

• With your head upright insert the tip of bottle into the nostril and press your other nostril closed. Breathe in and spray the medicine into your nose. Use in your other nostril if directed.

• If the spray gets in your eyes or mouth or on your skin, rinse with water.

• Do not blow your nose for a few minutes. Do not use the nasal spray more than 1 time in 24 hours.

Your symptoms may not improve for up to 1 to 5 weeks. Call your doctor if your symptoms do not improve, or if they get worse.

If you use Omnaris long-term, you may need frequent eye exams.

Store this medicine in an upright position at room temperature, away from moisture and heat. Do not freeze. Keep the spray bottle clean and dry.

Throw away the Omnaris nasal spray after you have used 120 sprays or 4 months after removing the bottle from the foil pouch, even if there is still medicine left in the bottle.

Usual Adult Dose of Omnaris for Allergic Rhinitis:

Nasal spray (50 mcg/spray): 2 sprays in each nostril once a day (200 mcg)
Maximum dose: 200 mcg (2 sprays in each nostril once a day).

Usual Pediatric Dose of Omnaris for Allergic Rhinitis:

Seasonal allergic rhinitis:
6 years and older:
-Nasal spray (50 mcg/spray): 2 sprays in each nostril once a day (200 mcg)
Maximum dose: 200 mcg (2 sprays in each nostril once a day)

Seasonal and perennial allergic rhinitis:
12 years and older:
-Nasal spray (50 mcg/spray): 2 sprays in each nostril once a day (200 mcg)
Maximum dose: 200 mcg (2 sprays in each nostril once a day)

Use: Treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis

You should not use Omnaris if you are allergic to ciclesonide.

To make sure Omnaris is safe for you, tell your doctor if you have:

• asthma, tuberculosis, or other lung problems;

• any type of infection caused by bacteria, virus, fungus, or parasites;

• glaucoma, cataracts, or herpes infection of the eyes;

• a sore inside your nose that has not yet healed;

• a recent nose injury or surgery; or

• not been vaccinated for or not had chickenpox or measles.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any illness or infection you had within the past several weeks.

It is not known if ciclesonide nasal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using Omnaris.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using Omnaris.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting this medicine in your eyes. If this does happen, rinse with water. Also, do not spray this medicine directly on the tissue that separates your nostrils (nasal septum).

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Omnaris nasal spray.

Get emergency medical help if you have signs of an allergic reaction to Omnaris: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• pale skin, easy bruising, unusual bleeding; or

• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Side effects may occur if nasal steroid medicine is absorbed into your bloodstream. To make sure Omnaris is safe for you, tell your doctor if you have:

• swelling, weight gain (especially in your face or your upper back and torso);

• thinning skin, stretch marks, acne, increased facial hair;

• irregular menstrual periods, changes in sexual function; or

• memory problems, feeling irritable.

Omnaris may cause serious side effects. Call your doctor at once if you have:

• runny or bloody nose, crusting inside the nose, whistling sound when you breathe, nasal ulcers;

• blurred vision, eye pain or redness, seeing halos around lights;

• signs of thrush (a fungal infection)--sores or white patches in your mouth or throat, trouble swallowing; or

• decreased adrenal gland hormones--nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods.

Common Omnaris side effects may include:

• headache, dizziness;

• nosebleed, nasal irritation;

• stuffy nose, sore throat; or

• ear pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with ciclesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.