Rx Item-Fluticasone Propionate 50Mcg Spray 16Gm By Apotex Pharma

FLUTICASONE- fluticasone propionate spray, metered
Morton Grove Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

? Fluticasone Propionate Nasal Spray, USP 50 mcg per spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older.

2 DOSAGE AND ADMINISTRATION

Administer Fluticasone Propionate Nasal Spray by the intranasal route only. Prime Fluticasone Propionate Nasal Spray before using for the first time or after a period of non-use (1 week or more) by shaking the contents well and releasing 6 sprays into the air away from the face. Shake Fluticasone Propionate Nasal Spray gently before each use.



Patients should use Fluticasone Propionate Nasal Spray at regular intervals since its effectiveness depends on its regular use. Maximum effect may take several days and individual patients will experience a variable time to onset and different degree of symptom relief.

2.1 Adults
The recommended starting dosage in adults is 2 sprays (50 mcg of fluticasone propionate each) in each nostril once daily (total daily dose, 200 mcg). The same total daily dose, 1 spray in each nostril administered twice daily (e.g., 8 a.m. and 8 p.m.) is also effective. After the first few days, patients may be able to reduce their dose to 1 spray in each nostril once daily for maintenance therapy.

Maximum total daily doses should not exceed 2 sprays in each nostril (total dose, 200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.

2.2 Adolescents and Children (Aged 4 Years and Older)
The recommended starting dosage in adolescents and children, aged 4 years and older is 1 spray in each nostril once daily (total daily dose, 100 mcg). Patients not adequately responding to 1 spray in each nostril may use 2 sprays in each nostril once daily (total daily dose, 200 mcg). Once adequate control is achieved, the dosage should be decreased to 1 spray in each nostril once daily.

The maximum total daily dosage should not exceed 2 sprays in each nostril (200 mcg/day). There is no evidence that exceeding the recommended dose is more effective.

3 DOSAGE FORMS AND STRENGTHS

Fluticasone Propionate Nasal Spray is a nasal spray suspension. Each 100-mg spray delivers 50 mcg of fluticasone propionate.

Fluticasone Propionate 50mcg S
60505-0829-01 Fluticasone Propionate 50mcg Spray 16gm by Apotex pharma

Fluticasone Propionate 50Mcg Spray 16Gm
BRAND: FLUTICASONE NDC: 60505-0829-01,60505082901 UPC: 3-60505-08291-9 ,360505082919 Roxane Labs

FLUTICASONE PROPIONATE NA
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Fluticasone Propionate 50mcg S
60505-0829-01 Fluticasone Propionate 50mcg Spray 16gm by Apotex pharma