Omnaris

Omnaris is a prescription medication used to treat nasal symptoms from seasonal and year-round allergies. Omnaris belongs to a group of drugs called synthetic corticosteroids, which reduce inflammation. Inflammation is a common factor in allergies.

This medication comes in the form of a nasal spray and is usually taken once a day.

Common side effects of Omnaris include headache, nose bleeds, and stuffy nose.

Omnaris is a prescription medication used to treat nasal symptoms from seasonal and year-round allergies. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sunovion Pharmaceuticals Inc.

Common side effects with Omnaris nasal spray include:

• headache
• nose bleeds
• stuffy nose
• ear pain
• sore throat
• dizziness

See "Drug Precautions" section for other risks of using Omnaris.

These are not all the possible side effects of Omnaris. Tell your healthcare provider about any side effects that bother you or do not go away.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take ketoconazole (Nizoral).

Some serious side effects have occurred with Omnaris nasal spray include:

• Nasal fungal infection.
• Slow healing of wounds. Do not use Omnaris nasal spray until your nose has healed, if you have a sore in your nose, you have had surgery on your nose, or your nose has been injured.
• Eye problems, including glaucoma and cataracts. You should have regular eye exams. Tell your doctor if you notice a change in vision while using Omnaris nasal spray.
• Immune system effects may increase your risk of infection. You should avoid being around people with Chicken Pox or Measles.
• Slow growth in children. A child using Omnaris should have his/her growth checked regularly.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Omnaris there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving Omnaris, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Omnaris, or any other medication
• have or have ever had:
  • tuberculosis
  • cataracts
  • glaucoma
  • untreated infection
  • herpes infection
• are pregnant or plan to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C.  No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Omnaris is excreted in human breast milk or if it will harm your nursing baby. 

Use your nasal spray exactly as prescribed by your healthcare provider.

Seasonal allergy symptoms may improve over 1 to 2 weeks; year-round allergy symptoms may improve over 5 weeks. If your symptoms do not improve or get worse, call your healthcare provider.

Patient's Instructions for Use

Omnaris nasal spray is supplied in an amber glass bottle in a protective plastic sleeve and should be handled with care.

Preparing For Use

1. Remove Omnaris nasal spray from its foil pouch. Count 4 months from today and write this new date on the sticker on the carton (the date that is 4 months after removing the bottle from the foil pouch). Peel off the sticker and place it in the space on your nasal spray bottle. It is important that you throw away the nasal spray bottle after this date.
2. Priming Omnaris nasal spray. Before you use Omnaris nasal spray for the first time, you will need to prime the bottle. Hold the bottle upright and shake the bottle gently. To prime Omnaris nasal spray, fully press down on the finger rests of the applicator eight times. If you do not use the nasal spray for 4 days, you will need to shake the bottle gently, and prime the pump again by spraying one time, or until you see a fine mist.

Using the Spray

1. Blow your nose to clear your nostrils, if needed.
2. Shake the bottle gently and remove the dust cap.
3. Hold the bottle firmly with your index and middle finger on either side of the applicator (on finger rests) while supporting the base of the bottle with your thumb.
4. Insert applicator tip into one nostril, and close the other nostril with your finger.
5. Tilt your head forward slightly. Keep the bottle upright, and press the finger rests quickly and firmly to activate the pump. Breathe in (inhale) through your nose as you spray. Try not to get any spray in your eyes or directly on your nasal septum (the wall between the two nostrils).
6. Repeat steps 3-5 for the second spray in the same nostril and for each spray in the other nostril.

Each bottle of Omnaris nasal spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use a bottle of Omnaris nasal spray after 120 sprays (not counting the priming sprays) have been used or after the “discard by date” you wrote on the sticker when you opened the foil pouch. You may still see some medicine in the bottle. Talk with your healthcare provider before your supply of Omnaris nasal spray runs out to see if you should get a refill of your medicine.

Applicator Cleaning Instructions

Wipe the applicator tip with a clean tissue and replace the dust cap, after you use your nasal spray each day.

If the applicator is clogged or needs more thorough cleaning, use the following cleaning instructions (Do not try to unblock the tiny spray hole on the applicator with a pin or other sharp object. Do not twist or try to remove the white plastic pump attached to the medicine bottle.):

1. Remove the dust cap, hold the white plastic pump firmly with one hand and then carefully pull upwards to free the applicator.
2. Wash the dust cap and applicator with warm water.
3. Dry the applicator, and put it back on the bottle. The applicator will snap into place when properly positioned.
4. Prime the unit with one spray or until you see a fine mist.
5. Put the dust cap back on the applicator.

Omnaris nasal spray:

• Use 1 time each day, 2 sprays in each nostril.
• Do not use more than a total of 2 sprays in each nostril each day.

If you use too much ciclesonide call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Omnaris nasal spray:

• Keep clean and dry at all times.
• Store between 59° F and 86° F.
• Do not freeze.
• Keep this medication and all medicines out of the reach of children.