INDICATIONS

Fluticasone propionate nasal spray is indicated for the management of the nasal symptoms of seasonal and perennial allergic and nonallergic rhinitis in adults and pediatric patients 4 years of age and older.

Safety and effectiveness of fluticasone propionate nasal spray in children below 4 years of age have not been adequately established.

DOSAGE AND ADMINISTRATION

Patients should use fluticasone propionate nasal spray at regular intervals as directed since its effectiveness depends on its regular use.

Adults: The recommended starting dosage in adults is two sprays (50 mcg of fluticasone propionate each) in each nostril once-a-day (total daily dose, 200 mcg). The same dosage divided into 100 mcg given twice-a-day (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dosage to 100 mcg (one spray in each nostril) once daily for maintenance therapy.

Adolescents and Children (4 Years of Age and Older): Patients should be started with 100 mcg (one spray in each nostril once-a-day). Patients not adequately responding to 100 mcg may use 200 mcg (two sprays in each nostril). Once adequate control is achieved, the dosage should be decreased to 100 mcg (one spray in each nostril) daily.

The maximum total daily dosage should not exceed two sprays in each nostril (200 mcg per day). (See CLINICAL PHARMACOLOGY: Individualization Of Dosage and CLINICAL PHARMACOLOGY: CLINICAL STUDIES.)

Fluticasone propionate nasal spray is not recommended for children under 4 years of age.

Directions for Use: Illustrated patient's instructions for proper use accompany each package of Flonase nasal spray.

HOW SUPPLIED

Flonase nasal spray 50 mcg provides 120 acutations. Each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. The bottle should be discarded when the labeled number of actuations has been reached even though the bottle is not completely empty.

Storage: Store between 4¾30°C (39¾86°F).