Omnaris Hfa

For adults and adolescents 12 years of age and older, the usual recommended dose is 1 spray in each nostril once daily. The maximum total daily dosage should not exceed 1 spray in each nostril (100 µg per day). For the best results, ciclesonide nasal spray should be used regularly each day.

Shake the medication gently before using it and gently blow your nose to clear your nostrils before each use.

If you are using Omnaris HFA (Ciclesonide-nasal) for the first time, you will need to prime the pump by spraying the pump in the air, away from you, about 3 times. If you have not used the nasal spray for 7 or more days in a row you will need to prime the pump again with 1 spray or until a fine mist appears.

Clean the applicator tip with a clean, dry tissue once a week. Do not wash or put any part of the canister or actuator in water.

You should dispose of the bottle of medication once the dose indicator window reads zero. Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to take Omnaris HFA (Ciclesonide-nasal) exactly as prescribed by your doctor. If you miss a dose of Omnaris HFA (Ciclesonide-nasal) by several hours, skip the missed dose and continue with your regular dosing schedule. Do not double a dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Omnaris HFA (Ciclesonide-nasal) at room temperature in an upright position, keep it from freezing, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Each spray delivers 50 µg ciclesonide. Nonmedicinal ingredients: propellant HFA-134a (norflurane) and ethanol.

Ciclesonide nasal spray should not be used by anyone who:

• is allergic to ciclesonide or to any of the ingredients of the medication
• has an active (or history of) Tuberculosis lung infection

There may be an interaction between ciclesonide nasal spray and any of the following:

• Ceritinib
• Desmopressin
• itraconazole
• ketoconazole
• nelfinavir
• ritonavir

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Omnaris HFA (Ciclesonide-nasal). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Omnaris HFA (Ciclesonide-nasal).

Growth in adolescents: Corticosteroids such as ciclesonide nasal spray may impair the growth of adolescents. Your doctor will monitor for this. Talk to your doctor if you have any concerns.

Infections: Corticosteroids such as ciclesonide nasal spray may worsen existing infections, mask the signs of infection, and cause new infections. If you use Omnaris HFA (Ciclesonide-nasal) for several months or longer, your doctor will monitor you periodically for signs of infection. People using Omnaris HFA (Ciclesonide-nasal) who have not had Chickenpox or Measles or have not been vaccinated against these infections should take special care to avoid exposure to them. People with herpes simplex infection of the eye should talk to their doctor before using Omnaris HFA (Ciclesonide-nasal).

Other steroid medications: People who have been taking steroid medications by mouth or by inhalation should discuss with their doctor how Omnaris HFA (Ciclesonide-nasal) may affect their medical condition, how their medical condition may affect the dosing and effectiveness of Omnaris HFA (Ciclesonide-nasal), and whether any special monitoring is needed.

Vision problems: Rarely, corticosteroids such as ciclesonide nasal spray causes Glaucoma or Cataracts. Report any vision changes to your doctor immediately.

Wound healing: Corticosteroids such as ciclesonide nasal spray can impair the ability of wounds to heal. Omnaris HFA (Ciclesonide-nasal) should not be used if you have ulcers in your nose, have had nasal surgery, or have had nasal trauma, until wounds have completely healed.

Pregnancy: Omnaris HFA (Ciclesonide-nasal) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while using Omnaris HFA (Ciclesonide-nasal), contact your doctor immediately.

Breast-feeding: It is not known if ciclesonide nasal spray passes into breast milk. If you are a breast-feeding mother and are using Omnaris HFA (Ciclesonide-nasal), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Omnaris HFA (Ciclesonide-nasal) have not been established for children under 12 years of age.