Omnaris

What is Omnaris used for?

Omnaris is a prescription medicine that is used to ease allergy signs.

Description

The active component of OMNARIS Nasal Spray is ciclesonide, a non-halogenated glucocorticoid having the chemical name pregna -1,4-diene-3,20-dione, 16,17-[[R-cyclohexylmethylene]bis(oxy)]-11-hydroxy-21-(2-methyl-1-oxopropoxy)-,(11β,16α)-. Ciclesonide is delivered as the R-epimer. The empirical formula is C32H44O7 and its molecular weight is 540.7. Its structural formula is as follows:

Ciclesonide is a white to yellow-white powder, practically insoluble in water and freely soluble in ethanol and acetone. OMNARIS Nasal Spray is a metered-dose, manual-pump spray formulation containing a hypotonic aqueous suspension of ciclesonide. OMNARIS Nasal Spray also contains microcrystalline cellulose, carboxymethylcellulose sodium, hypromellose, potassium sorbate and edetate sodium; and hydrochloric acid to adjust the pH to 4.5.

 Mechanism of Action

Ciclesonide is a pro-drug that is enzymatically hydrolyzed to a pharmacologically active metabolite, C21-desisobutyryl-ciclesonide (des-ciclesonide or RM1) following intranasal application. Des-ciclesonide has anti-inflammatory activity with affinity for the glucocorticoid receptor that is 120-times higher than the parent compound.

The precise mechanism through which ciclesonide affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in allergic inflammation.

Before taking Omnaris, tell your doctor:

• If you are allergic to this medicine (Omnaris); any part of this medicine (Omnaris); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Omnaris) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Omnaris?

• Tell all of your health care providers that you take this medicine (Omnaris). This includes your doctors, nurses, pharmacists, and dentists.
• It may take a few weeks to see the full effect.
• This medicine may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Talk with your doctor if you come into contact with anyone who has chickenpox or measles and you have not had chickenpox, measles, or the vaccines for them.
• If you have had any recent nose surgery, injury, ulcers, or sores, talk with your doctor.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Omnaris best taken?

Use this medicine (Omnaris) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take this medicine (Omnaris) by mouth. Use in your nose only. Keep out of your mouth and eyes (may burn).
• Blow your nose before use.
• Prime by spraying 8 sprays before first using. If this medicine (Omnaris) has not been used for 4 days, spray 1 time or until you see a fine mist.
• Shake well before use.
• When using, tilt your head forward a little.
• Close 1 nostril.
• Put nose spray tube into other nostril.
• Spray up the nose only. Do not spray onto the wall joining the two nostrils.
• Put the cap back on after you are done using your dose.
• Do not blow your nose for 15 minutes after you use this medicine (Omnaris).
• Follow how to clean carefully.
• Keep using this medicine (Omnaris) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

What are the side effects of Omnaris that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Nose sores.
• Runny nose that is new or worse.
• Whistling sound when you breathe.
• Redness or white patches in mouth or throat.
• Change in eyesight.

What are some other side effects of Omnaris?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Nose or throat irritation.
• Nosebleed.
• Ear pain.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Omnaris?

• Store at room temperature. Do not freeze.
• Throw away any part not used after 120 sprays or 4 months after opening pouch.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 50 MCG CARTON LABEL