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Omnaris

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Omnaris

Indications
Dosage
How Supplied

INDICATIONS

Treatment of 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.

Treatment of 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

Administer OMNARIS Nasal Spray by the intranasal route only. 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. Illustrated patient's instructions for proper use accompany each package of OMNARIS Nasal Spray.

Seasonal Allergic Rhinitis

Adults and Children (6 Years of Age and Older)

The recommended dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

Perennial Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older)

The recommended dose of OMNARIS Nasal Spray is 2 sprays per nostril once daily (200 mcg). The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day).

HOW SUPPLIED

Dosage Forms And Strengths

OMNARIS Nasal Spray is a metered-dose, manual-pump spray formulation containing a hypotonic aqueous suspension of ciclesonide. Once primed, each actuation of the pump delivers 50 mcg ciclesonide in a volume of 70 microliters from the nasal actuator.

Storage And Handling

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. The contents of one 12.5 gram bottle provide 120 actuations, after initial priming. Each spray delivers 50 mcg of ciclesonide from the nasal actuator. Prior to initial use, OMNARIS Nasal Spray must be gently shaken and then the pump must be primed by actuating eight times. 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 Temperature]. Do not freeze. Shake gently before use. 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 Sunovion Pharmaceuticals Inc., Marlborough MA 01752 USA. Made in Germany. Revised: March 2013

Last reviewed on RxList: 4/4/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Omnaris - User Reviews

Omnaris User Reviews

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