Omnaris

DRUG 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)-,(11?,16?)-. 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:

OMNARIS® (ciclesonide) Structural Formula Illustration

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

What are the possible side effects of ciclesonide nasal (Omnaris)?

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

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
  • ...

Read All Potential Side Effects and See Pictures of Omnaris »

What are the precautions when taking ciclesonide nasal spray (Omnaris)?

Before using ciclesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent nasal ulcers/trauma/surgery, tuberculosis (untreated or active infections), herpes infection of the eye, decreased adrenal gland function, a certain eye disease (glaucoma).

Avoid exposure to chickenpox or measles infection while using this medication. If you are exposed to these infections, seek immediate medical attention.

Rarely, using corticosteroid medications for a long time can make it more...

Read All Potential Precautions of Omnaris »


Omnaris Consumer (continued)

SIDE EFFECTS: Nosebleeds, irritation of the nose, or ear pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Using corticosteroids in the nose for a long time may infrequently cause fungal infections of the nose or throat. Tell your doctor immediately if you develop any of the following: fever, pain in the nose, severe sore throat, pain when swallowing, white patches on the back of the throat.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe nosebleeds, severe pain in the nose, whistling sound while breathing.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ciclesonide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: recent nasal ulcers/trauma/surgery, tuberculosis (untreated or active infections), herpes infection of the eye, decreased adrenal gland function, a certain eye disease (glaucoma).

Avoid exposure to chickenpox or measles infection while using this medication. If you are exposed to these infections, seek immediate medical attention.

Rarely, using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past few months.

Though it is unlikely, this medication may slow down a child's growth if used for a long time. The effect on final adult height is unknown. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Omnaris Patient Information Including Side Effects

Brand Names: Omnaris

Generic Name: ciclesonide (nasal) (Pronunciation: sik le SON ide)

  • What is ciclesonide (Omnaris)?
  • What are the possible side effects of ciclesonide nasal (Omnaris)?
  • What is the most important information I should know about ciclesonide (Omnaris)?
  • What should I discuss with my health care provider before using ciclesonide (Omnaris)?
  • How should I use ciclesonide nasal (Omnaris)?
  • What happens if I miss a dose (Omnaris)?
  • What happens if I overdose (Omnaris)?
  • What should I avoid while using ciclesonide nasal (Omnaris)?
  • What other drugs will affect ciclesonide nasal (Omnaris)?
  • Where can I get more information?

What is ciclesonide (Omnaris)?

Ciclesonide is a corticosteroid. It prevents the release of substances in the body that cause inflammation.

Ciclesonide is used to treat nasal symptoms of seasonal allergies and hay fever, such as sneezing, itching, and runny or stuffy nose.

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

What are the possible side effects of ciclesonide nasal (Omnaris)?

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

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 as soon as possible 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 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. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ciclesonide (Omnaris)?

You should not use this medication if you are allergic to ciclesonide.

Before using ciclesonide, tell your doctor if you are allergic to any drugs, or 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.

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

Call your doctor if your nasal allergy symptoms get worse, or if they do not improve after using this medication for 2 weeks. It may take up to 5 weeks for your symptoms to improve if you use this medicine only during certain times of the year.

If you stopped using another steroid medication when you started using ciclesonide, 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 of this medication 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, or unusual thoughts or behavior.

Call your doctor as soon as possible 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 side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome.

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

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