Omnaris (Ciclesonide Nasal) - Indications and Dosage

INDICATIONS AND USAGE

Seasonal Allergic Rhinitis

OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.

Perennial Allergic Rhinitis

OMNARIS Nasal Spray is indicated for the treatment of nasal symptoms associated with perennial allergic rhinitis in adults and adolescents 12 years of age and older.

DOSAGE AND ADMINISTRATION

Seasonal Allergic Rhinitis

Adults and Children (6 Years of Age and Older): The recommended dose of OMNARIS Nasal Spray is 200 mcg per day administered as 2 sprays (50 mcg/spray) in each nostril once daily.

Perennial Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older): The recommended dose of OMNARIS Nasal Spray is 200 mcg per day administered as 2 sprays (50 mcg/spray) in each nostril once daily.

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. If the product is not used for four consecutive days, it should be gently shaken and reprimed with one spray or until a fine mist appears.

Directions for Use

Illustrated patient's instructions for proper use accompany each package of OMNARIS Nasal Spray.

HOW SUPPLIED

OMNARIS is supplied in an amber glass bottle and provides for nasal delivery with a manual metered pump. OMNARIS Nasal Spray is supplied with an oxygen absorber sachet and enclosed in a foil pouch. OMNARIS Nasal Spray provides 120 metered sprays after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. The OMNARIS Nasal Spray bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after removal from the foil pouch either after 120 sprays following initial priming (since the amount of ciclesonide delivered per spray thereafter may be substantially less than the labeled dose) or after 4 months. Patient instructions are also provided.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temp]. Do not freeze. Shake gently before use. Do not spray in eyes. Keep out of reach of children.

OMNARIS Nasal Spray 50 mcg, 120 metered sprays; net fill weight 12.5 g. (NDC 63402-701-01)

Manufactured for:

Sepracor Inc.
Marlborough, MA 01752 USA

Made in Germany

For customer service, call 1-888-394-7377
To report adverse events, call 1-877-737-7226
For medical information, call 1-800-739-0565

November 2007

USA F.1/1207/3.5472.73