OMNARIS (ciclesonide) Instructions for Use

As a mother, it was hard to send Blake to school because I new other mothers would think that he was contagious and had a cold... I knew he was just suffering from allergies, but I knew that other people didn't always know that. - Melissa Z, Mother

How to Use OMNARIS (ciclesonide) Nasal Spray

Dosage

For adults and children (6 years of age and older) with seasonal allergy symptoms: The recommended dose is 2 sprays in each nostril once a day.

For adults and adolescents (12 years of age and older) with year-round allergy symptoms: the recommended dose is 2 sprays in each nostril once a day.

You should not use more than a total of 2 sprays in each nostril daily.

Preparing for Use

  1. Remove OMNARIS Nasal Spray from its foil pouch. Count 4 months from this date and write this date (that is 4 months from removing the bottle from the foil pouch) on the sticker provided on the carton. Peel off this sticker and place it in the space provided on your nasal spray bottle. It's important to throw away the nasal spray bottle after this date.
  2. Before the first use, 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 you have not used the nasal spray for 4 days, shake the bottle gently and prime the pump again by spraying one time or until a fine mist appears.

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 while supporting the base of the bottle with your thumb (Figure 1).

4. Insert applicator tip into one nostril, and close the other nostril with your finger
(Figure 2).

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 (Figure 3). Avoid spraying in eyes or directly onto the 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.

Storage

Keep your nasal spray clean and dry at all times. Store medication between 59° F and 86° F. Do not freeze. Keep out of the reach of young children.

Applicator Cleaning

After daily use of your nasal spray, wipe the applicator tip with a clean tissue and replace the dust cap.

If the applicator is clogged or requires 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 attempt to remove the white plastic pump attached to the medication bottle.)

Remove the dust cap, grasp the white plastic pump firmly with one hand, and then carefully pull upwards on the applicator finger rests with the other hand to free the applicator.

Wash the dust cap and applicator with warm water.

Dry and replace the applicator. The applicator will snap into place when properly positioned.

Prime the unit with one spray or until a fine mist appears.

Replace the dust cap.

When Should I Discard My Nasal Spray Bottle?

You should discard your nasal spray bottle upon the soonest of:

  • After you have used the labeled number of sprays;
  • The "discard by" date you wrote on the sticker when you opened the foil pouch; or
  • When the expiration date on the product is reached.

You may want to obtain a refill before your supply runs out if recommended by your healthcare provider.

Print the Patient’s Instructions for Use

Follow the link below for a printable version of the OMNARIS Nasal Spray bottle Patient’s Instructions for Use.

Download the OMNARIS Patient's Instructions for Use.

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For more information about OMNARIS Nasal Spray, please see Frequently Asked Questions.

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OMNARIS (ciclesonide) Nasal Spray is for the treatment of nasal allergy symptoms associated with seasonal allergic rhinitis (seasonal allergies) in adults and children 6 years of age and older, and with perennial allergic rhinitis (year-round allergies) in adults and adolescents 12 and older.

Important Safety Information

Patients using corticosteroid drugs that weaken the immune system are more susceptible to infection and should avoid exposure to chickenpox or measles. If you have tuberculosis, eye herpes, or untreated infections of any kind, speak to your doctor before using OMNARIS. Yeast infections of the nose and throat may occur.

Patients who have recently had an ulcer in the nose, trauma to the nose or nasal surgery should not use OMNARIS until healing has occurred. Rare instances of nasal irritation and eye problems have been reported following the use of nasal steroids. Talk with your doctor if you have a history of eye problems or experience a change in vision.

Patients taking higher doses of a nasal steroid than recommended, or certain other at-risk individuals, may experience symptoms of a hormonal imbalance, including very rarely changes in menstruation, acne, and weight gain. Like all steroid nasal sprays, OMNARIS may cause slowed growth in children. The growth of children using OMNARIS should be monitored routinely by a healthcare professional.

The most common side effects that may occur with OMNARIS are headache, nosebleed, sore throat and ear pain.

The health information contained on this website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. The product discussed on this site may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

For more information, please see the OMNARIS Full Prescribing Information and the OMNARIS Patient's Instructions for Use.

OMNARIS is available by prescription. Ask your healthcare professional if OMNARIS is right for you. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The health information contained on this website is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. This site is intended for U.S. residents only. The product discussed on this site may have different product labeling in different countries. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

©2010 Sepracor Inc.and SEPRACOR are registered trademarks of Sepracor Inc.

OMNARIS is a registered trademark of Nycomed GmbH, used with permission.

Sepracor

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