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Omnaris® nasal spray

This product is manufactured by Takeda Canada using the ingredient ciclesonide.

This product is taken via nasal inhalation.

Why is it prescribed?

Ciclesonide is used to control the signs and symptoms of asthma that are responsive to orally inhaled corticosteroids in patients over 6 years of age. Ciclesonide is not presently recommended for those less than 6 years of age. It is also used as a nasal spray to relieve the symptoms that may occur with hay fever [seasonal allergic rhinitis (SAR)] or other year-round allergies [perennial allergic rhinitis (PAR)], including stuffiness/congestion in the nose, runny nose, itching and sneezing.

Omnaris® nasal spray is intended for nasal inhalation only.
Your doctor or pharmacist should have instructed you on the proper use and care of your Omnaris® nasal spray.

Preparing For Use:
1. Remove Omnaris® from its tamper proof foil pouch and write the date of opening on the sticker provided. Peel off this sticker and place it on your nasal spray bottle. It’s important to throw away the nasal spray bottle 4 months after this date.
2. Shake the bottle gently and prime the pump by pressing downward on the shoulders of the applicator eight times. Read the complete instructions carefully and use only as directed. If unused within 4 or more consecutive days, reprime by spraying one time or until a fine mist appears. There is enough medication in this bottle to allow for the required priming and repriming, in addition to the 120 doses.
Using the Spray:
1. Blow your nose to clear your nostrils if needed.
2. Shake the bottle gently and remove the cap.
3. Hold the bottle firmly with your index and middle finger on either side of the spray tip while supporting the base of the bottle with your thumb.
4. Insert spray tip into one nostril, and close the other nostril with your finger.
5. Tilt your head forward slightly and keeping the bottle upright, press the pump quickly and firmly and inhale through your nose as you spray.
Avoid spraying in eyes or directly onto the nasal septum.
6. If a second spray is required in this nostril, repeat steps 3-5. Repeat steps 3-6 for the other nostril.

This medication is not meant to give you instant relief of your nasal congestion but is to correct the underlying problem responsible for your symptoms.
You probably won't notice much improvement until after 2-3 days of regular use.
Check with the doctor if you notice signs of infection in your nose, throat or sinuses, if repeated unusual bleeding occurs or if your nose was recently operated on or injured.
Your Omnaris® should be stored between 15 and 30 degrees centigrade.


Alternatives

Other products that have the same ingredient as Omnaris® nasal spray are •Alvesco® MDI •

See other products used in the treatment of •allergic rhinitis •allergies •asthma •seasonal allergies •seasonal rhinitis •

The usual dose in children over 12 years of age and adults is 2 sprays into each nostril once a day. The maximum daily dose should not exceed 2 sprays in each nostril (200 micrograms/day).
Omnaris® is not presently approved for use in patients younger than 12 years of age.


Ciclesonide is a corticosteroid that possesses anti-inflammatory activity. It helps to control symptoms and prevent asthma attacks by decreasing inflammation in the lungs, thereby opening the airways and improving breathing. It is also used as a nasal spray for the treatment of seasonal allergic rhinitis, including hayfever, and perennial allergic rhinitis  Whether inhaled through the nose or into the lungs, the effect of the drug is local (acting directly on the tissue it comes in contact with). The amount absorbed by the body is minimal and therefore the incidence of unwanted effects is low.


Along with its needed effects, ciclesonide may cause some unwanted or undesirable effects. Often, ciclesonide users who use their medication properly, never experience any unwanted effects. The severity and duration of these effects are dependant on many factors including duration of therapy, dose, route of administration and individual response. Possible unwanted effects include:

  • hoarseness
  • difficulty speaking


Less Common:

 

  • nausea
  • fungal infection in the mouth
  • headache
  • bad taste in the mouth
  • throat pain
  • throat irritation
  • dry throat


Rare:

 

 

  • sudden wheeziness and chest pain or tightness
  • swelling of eyelids, face, lips, tongue or throat
  • lumpy skin rash or “hives” anywhere on the body


When used as a nasal spray, headache, nose-bleeds, and burning or irritation inside the nose can occur.

 


Use as directed. Never use a higher dose than what you have been prescribed. Using higher than recommended doses will cause greater absorption by the body and possibly lead to greater occurrence of unwanted effects. Optimal relief of symptoms may require a few days of continuous therapy. If symptoms do not improve or the condition worsens, the doctor should be contacted. Treatment with ciclesonide should never be stopped without first consulting your doctor. Discontinuation of ciclesonide may require gradual tapering or you may experience a flare-up of your condition. 
Inadequate response can often be a result of improper use of the delivery device. Your doctor or pharmacist should instruct you on the correct use of these preparations. Each product comes with a package insert that should be read and then kept as a reference.
It is important that your doctors and pharmacists know that you are using or have used ciclesonide or any other corticosteroids as this may change the treatment plan. When you have been treated with oral corticosteroids (e.g. prednisone) for prolonged periods and are being transferred to orally inhaled ciclesonide, you may experience withdrawal symptoms (e.g. joint and/or muscular pain and depression). These symptoms should be reported to your doctor, especially if you have associated asthma or another condition in which too rapid a decrease in systemic steroids may cause a severe flare-up of symptoms.
Ciclesonide may mask some signs of infection and new infections may appear. The body tends to have a decreased resistance to infections while on this therapy so anything of this nature should be reported to the doctor.


Drug Interactions:

Due to very low absorption at therapeutic doses, it is unlikely that there would be any important interactions. However, it is important to tell your doctor and pharmacist of any prescription or over-the-counter medications you are taking. In people with hypoprothrombinemia (deficiency of a clotting factor in the blood resulting in an increased tendency to bleed) ASA (e.g. Aspirin®) should be cautiously used in combination with corticosteroids. Drugs containing itraconazole (an azole antifungal), ritonavir or nelfinivir (drugs used in the treatment of HIV or AIDS) may interact with ciclesonide.

Use is not recommended in the following situations:

  • Allergy to ciclesonide or any component of the preparation
  • Untreated fungal, bacterial or tuberculosis infection of the respiratory tract
  • Primary treatment of acute episodes of asthma

Caution is recommended in the following situations:

  • hypothyroidism
  • eosinophilia (an increased level of certain blood cells in the blood)
  • hypoprothrombinemia (difficiency of a clotting factor increasing tendancy to bleed)
  • cirrhosis of the liver
  • severe liver impairment
  • suppressed immune system
  • previous treatment for prolonged periods with oral corticosteroids (eg. prednisone)
  • glaucoma

Use in pregnancy and breastfeeding:  Consult your doctor if you suspect you are pregnant or if you are breastfeeding. Ciclesonide should only be used in pregnancy or while breast feeding if the benefit to the mother outweighs the risk to the fetus or baby.