Omnaris

Generic Name: Ciclesonide
Brand Names: Omnaris

What is Omnaris?

Omnaris (ciclesonide) is a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Omnaris is used to treat nasal symptoms (congestion, sneezing, runny nose) caused by seasonal allergies in adults and children as young as 6 years old. Omnaris is also used to treat nasal symptoms caused by year-round allergies in adults and children who are at least 12 years old.

Omnaris may also be used for purposes not listed in this medication guide.

Important information about Omnaris

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

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.

What should I discuss with my health care provider before using Omnaris?

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

To make sure you can safely use Omnaris, tell your doctor if you have any of these other conditions:

  • asthma;
  • glaucoma or cataracts;
  • tuberculosis or other infection of the lungs;
  • a sore inside your nose that has not yet healed;
  • a recent nose injury or surgery; or
  • if you are or have been using an oral, inhaled, or injected steroid such as cortisone, methylprednisolone, prednisone, beclomethasone (Beclovent), flunisolide (AeroBid), fluticasone (Advair, Flovent), triamcinolone (Azmacort), and others.

FDA pregnancy category C. It is not known whether Omnaris will harm an unborn baby . Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether ciclesonide passes into breast milk or if it could harm a nursing baby. Do not use Omnaris nasal spray without telling your doctor if you are breast-feeding a baby.

Long-term use of steroid medication can slow a child's growth. Tell your doctor if the child using this medication is not growing or gaining weight properly.

How should I use Omnaris?

Use Omnaris exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

The usual dose of Omnaris nasal spray is 2 sprays into each nostril once per day. Follow your doctor's instructions.

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

If needed, blow your nose to clear your nostrils just before using Omnaris.

Shake the Omnaris bottle well just before each use.

Before using the spray for the first time, you must prime the spray pump. Shake the medicine well and spray 8 test sprays into the air and away from your face. Prime the spray pump any time you have not used your nasal spray for longer than 4 days. Spray until a fine mist appears.

It may take 1 to 2 days before your symptoms improve. Keep using Omnaris nasal spray 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.

Store Omnaris in an upright position at room temperature, away from moisture and heat. Do not allow the medicine to 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.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

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

An overdose of Omnaris nasal spray is not expected to produce life threatening symptoms. However, long term use of high steroid doses can lead to symptoms such as thinning skin , easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using Omnaris?

Avoid getting this medication in your eyes. If this does happen, rinse with water and call your doctor. Omnaris can lower the blood cells that help your body fight infections. 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.

Omnaris side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Omnaris: hives; difficult breathing; swelling of your face, lips, tongue , or throat. Nasal steroid medicine can be absorbed into your bloodstream, which may cause steroid side effects throughout the body. Although it is not likely that your body will absorb enough of this medication to cause serious side effects, tell your doctor if you have any of these steroid-related symptoms:

  • irregular menstrual periods;
  • acne or increased hair growth;
  • swelling, rapid weight gain, roundness of the face;
  • increased sweating; or
  • depression, anxiety, 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.

Less serious Omnaris side effects may include:

  • headache;
  • nosebleed;
  • 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.

What other drugs will affect Omnaris?

Tell your doctor about all other medicines you use, especially ketoconazole (Nizoral).

There may be other drugs that can interact with Omnaris. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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