OMNARIS Nasal spray Ref.[10887] Active ingredients: Ciclesonide

Source: FDA, National Drug Code (US)  Revision Year: 2019 

1. Indications and Usage

1.1 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.

1.2 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.

2. 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.

2.1 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).

2.2 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).

10. Overdosage

Chronic overdosage may result in signs or symptoms of hypercorticism [see Warnings and Precautions (5.4)].

There are no data available on the effects of acute or chronic overdosage with OMNARIS Nasal Spray.

16.2. Storage and Handling

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.

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