September 5, 2015
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Flonase

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Flonase




Indications
Dosage
How Supplied

INDICATIONS

FLONASE® Nasal Spray is indicated for the management of the nasal symptoms of perennial nonallergic rhinitis in adult and pediatric patients aged 4 years and older.

DOSAGE AND ADMINISTRATION

Administer FLONASE Nasal Spray by the intranasal route only. Prime FLONASE 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 FLONASE Nasal Spray gently before each use.

Patients should use FLONASE 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.

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.

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.

HOW SUPPLIED

Dosage Forms And Strengths

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

Storage And Handling

FLONASE Nasal Spray, 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter, and green dust cover in a box of 1 (NDC 0173-0453-01) with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of fluticasone propionate in 100 mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used.

Store between 4° and 30°C (39° and 86°F).

GlaxoSmithKline Research Triangle Park, NC 27709. Revised: Jan 2015

Last reviewed on RxList: 2/24/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

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