Flonase (Fluticasone propionate)

Flonase Review

Fluticasone propionate, the active component of FLONASE Nasal Spray.FLONASE Nasal Spray, 50 mcg is an aqueous suspension of microfine fluticasone propionate for topical administration to the nasal mucosa by means of a metering, atomizing spray pump. FLONASE Nasal Spray also contains microcrystalline cellulose and carboxymethylcellulose sodium, dextrose, 0.02% w/w benzalkonium chloride, polysorbate 80, and 0.25% w/w phenylethyl alcohol, and has a pH between 5 and 7.

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Flonase Drug Class and Mechanism

Inflammation is recognized as an important component in the pathogenesis of asthma. Glucocorticoids have been shown to inhibit multiple cell types (e.g., mast cells, eosinophils, basophils, lymphocytes, macrophages, and neutrophils) and mediate production or secretion (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in the asthmatic response. These anti-inflammatory actions of glucocorticoids may contribute to their efficacy in asthma. Typically, however, the action on the cells affected requires several days. Therefore, inhaled steroids are not used for immediate relief of asthma, but instead as preventive and maintenance therapy.

Flonase Uses

Fluticasone is a potent synthetic corticosteroid often prescribed as treatment for asthma and allergic rhinitis. The related fluticasone propionate is marketed with the brand names Flixotide (UK) for asthma and Flixonase (UK) for allergic rhinitis by Allen & Hanburys. In the US, it is marketed for asthma as Flovent, and allergic rhinitis as Flonase, by GlaxoSmithKline. GlaxoSmithKline also markets a combination of fluticasone and salmeterol as Advair (US) or Seretide (UK).

Flonase Side Effects

In controlled US studies, more than 3,300 patients with seasonal allergic, perennial allergic, or perennial nonallergic rhinitis received treatment with intranasal fluticasone propionate. In general, adverse reactions in clinical studies have been primarily associated with irritation of the nasal mucous membranes, and the adverse reactions were reported with approximately the same frequency by patients treated with the vehicle itself. The complaints did not usually interfere with treatment. Less than 2% of patients in clinical trials discontinued because of adverse events; this rate was similar for vehicle placebo and active comparators.

Systemic corticosteroid side effects were not reported during controlled clinical studies up to 6 months' duration with FLONASE Nasal Spray. If recommended doses are exceeded, however, or if individuals are particularly sensitive or taking FLONASE Nasal Spray in conjunction with administration of other corticosteroids, symptoms of hypercorticism, e.g., Cushing syndrome, could occur.

The following incidence of common adverse reactions (>3%, where incidence in fluticasone propionate-treated subjects exceeded placebo) is based upon 7 controlled clinical trials in which 536 patients (57 girls and 108 boys aged 4 to11 years, 137 female and 234 male adolescents and adults) were treated with FLONASE Nasal Spray 200 mcg once daily over 2 to 4 weeks and 2 controlled clinical trials in which 246 patients (119 female and 127 male adolescents and adults) were treated with FLONASE Nasal Spray 200 mcg once daily over 6 months. Also included in the table are adverse events from 2 studies in which 167 children (45 girls and 122 boys aged 4 to11 years) were treated with FLONASE Nasal Spray 100 mcg once daily for 2 to 4 weeks.

Flonase Pregnancy

Teratogenic Effects: Pregnancy Category C. Subcutaneous studies in the mouse and rat at 45 and 100 mcg/kg, respectively (approximately equivalent to and 4 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis, respectively) revealed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. In the rabbit, fetal weight reduction and cleft palate were observed at a subcutaneous dose of 4 mcg/kg (less than the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). However, no teratogenic effects were reported at oral doses up to 300 mcg/kg (approximately 25 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis) of fluticasone propionate to the rabbit. No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration (see CLINICAL PHARMACOLOGY). Fluticasone propionate crossed the placenta following oral administration of 100 mcg/kg to rats or 300 mcg/kg to rabbits (approximately 4 and 25 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis). There are no adequate and well-controlled studies in pregnant women. Fluticasone propionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Flonase Overdose

An overdose of this medication is not likely to occur. If you do think that an overdose has occurred, call an emergency room or poison control center.

Flonase More Information

Avoid items or activities that you know are allergens for you if they make your symptoms worse. Clean areas where dust or pet fur may aggravate your condition. Avoid exposing yourself to known sources of infection. Stay away from people with chicken pox, measles, or any other type of infection. Your immune system may not be strong enough to fight off an infection while you are using Flonase Nasal Spray nasal.