Flonase

Flonase Information

Generic Name: Fluticasone Propionate

Flonase (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 Flonase (fluticasone propionate) nasal spray in children below 4 years of age have not been adequately established.

Flonase Ingredients and Composition

How Does Flonase Work?

Flonase (fluticasone propionate) is a synthetic, trifluorinated corticosteroid with anti-inflammatory activity. In vitro dose response studies on a cloned human glucocorticoid receptor system involving binding and gene expression afforded 50% responses at 1.25 and 0.17 nM concentrations, respectively. Fluticasone propionate was threefold to fivefold more potent than dexamethasone in these assays. Data from the McKenzie vasoconstrictor assay in man also support its potent glucocorticoid activity.

In preclinical studies, Flonase revealed progesterone-like activity similar to the natural hormone. However, the clinical significance of these findings in relation to the low plasma levels is not known.

The precise mechanism through which Flonase (fluticasone propionate) affects allergic rhinitis symptoms is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation. In seven trials in adults, fluticasone propionate nasal spray has decreased nasal mucosal eosinophils in 66% (35% for placebo) of patients and basophils in 39% (28% for placebo) of patients. The direct relationship of these findings to long-term symptom relief is not known.

Fluticasone propionate nasal spray, Flonase, like other corticosteroids, is an agent that does not have an immediate effect on allergic symptoms. A decrease in nasal symptoms has been noted in some patients 12 hours after initial treatment with fluticasone propionate nasal spray. Maximum benefit may not be reached for several days. Similarly, when corticosteroids are discontinued, symptoms may not return for several days.

How To Take Flonase and Flonase Dosage and Administration

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

Adults:

The recommended starting Flonase 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 of Flonase (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 Flonase sprays in each nostril (200 mcg per day).

Flonase (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.

If you suspect a Flonase Overdose

Chronic overdosage with Flonase (fluticasone propionate) nasal spray may result in signs/symptoms of hypercorticism. Intranasal administration of 2 mg (10 times the recommended dose) of fluticasone propionate twice daily for 7 days to healthy human volunteers was well tolerated. Single oral doses of Flonase of up to 16 mg have been studied in human volunteers with no acute toxic effects reported. Repeat oral doses up to 80 mg daily for 10 days in volunteers and repeat oral doses up to 10 mg daily for 14 days in patients were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups. Acute overdosage with this dosage form is unlikely since one bottle of fluticasone propionate nasal spray contains approximately 8 mg of fluticasone propionate.

The oral and subcutaneous median lethal Flonase doses in mice and rats were >1000 mg/kg (>20,000 and >41,000 times, respectively, the maximum recommended daily intranasal dose in adults and >10,000 and >20,000 times, respectively, the maximum recommended daily intranasal dose in children on a mg/m2 basis).

Flonase Side Effects

Flonase Precautions and Contraindications

General:

Rarely, immediate hypersensitivity reactions or contact dermatitis may occur after the administration of Flonase (fluticasone propionate) nasal spray. Rare instances of wheezing, nasal septum perforation, cataracts, glaucoma and increased intraocular pressure have been reported following the intranasal application of corticosteroids, including fluticasone propionate.

Use of excessive doses of corticosteroids such as Flonase may lead to signs or symptoms of hypercorticism, suppression of HPA function, and/or reduction of growth velocity in children or teenagers. Physicians should closely follow the growth of children and adolescents taking corticosteroids, by any route, and weigh the benefits of corticosteroid therapy against the possibility of growth suppression if growth appears slowed.

Although systemic effects have been minimal with recommended doses of fluticasone propionate nasal spray, potential risk increases with larger doses. Therefore, larger than recommended doses of Flonase (fluticasone propionate) nasal spray should be avoided.

When used at higher than recommended doses, or in rare individuals at recommended doses, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of Flonase (fluticasone propionate) nasal spray should be discontinued slowly consistent with accepted procedures for discontinuing oral corticosteroid therapy.

In clinical studies with Flonase (fluticasone propionate) administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of treatment with Flonase (fluticasone propionate) nasal spray. Patients using Flonase (fluticasone propionate) nasal spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Flonase (fluticasone propionate) nasal spray should be used with caution, if at all, in patients with active or quiescent tuberculous infection; untreated local or systemic fungal or bacterial, or systemic viral infections or parasitic infection; or ocular herpes simplex.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid such as Flonase until healing has occurred.

Flonase Drug Interactions

In a placebo-controlled, crossover study in eight healthy volunteers, coadministration of a single dose of orally inhaled Flonase (fluticasone propionate) (1000 mcg, 5 times the maximum daily intranasal dose) with multiple doses of ketoconazole (200 mg) to steady state resulted in increased mean fluticasone propionate concentrations, a reduction in plasma cortisol AUC, and no effect on urinary excretion of cortisol. This interaction may be due to an inhibition of the cytochrome P450 3A4 isoenzyme system by ketoconazole, which is also the route of metabolism of fluticasone propionate. No drug interaction studies have been conducted with Flonase (fluticasone propionate) nasal spray; however, care should be exercised when fluticasone propionate is coadministered with long-term ketoconazole and other known cytochrome P450 3A4 inhibitors.

Flonase Clinical Trials and Studies

Storing Flonase

Storage: Store between 4-30°C (39-86°F).