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Flonase - Side Effects & Drug Interactions

[Fluticasone]



Regular-use patients who have responded may be able to be maintained (after 4 to 7 days) on 100 mcg/ day (1 spray in each nostril once daily). Some patients (12 years of age and older) with seasonal allergic rhinitis may find as-needed use of FLONASE Nasal Spray (not to exceed 200 mcg daily) effective for symptom control (see Clinical Trials). Greater symptom control may be achieved with scheduled regular use. Efficacy of as-needed use of FLONASE Nasal Spray has not been studied in pediatric patients under 12 years of age with seasonal allergic rhinitis, or patients with perennial allergic or nonallergic rhinitis.

Pediatric patients (4 years of age and older) should be started with 100 mcg (1 spray in each nostril once daily). Treatment with 200 mcg (2 sprays in each nostril once daily or 1 spray in each nostril twice daily) should be reserved for pediatric patients not adequately responding to 100 mcg daily. Once adequate control is achieved, the dosage should be decreased to 100 mcg (1 spray in each nostril) daily. 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.

Drug Interactions

Fluticasone propionate is a substrate of cytochrome P450 3A4. A drug interaction study with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a highly potent cytochrome P450 3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations
(see CLINICAL PHARMACOLOGY: Drug Interactions).

During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing syndrome and adrenal suppression. Therefore, coadministration of fluticasone propionate and ritonavir is not recommended unless the potential benefit to the patient outweighs the risk of systemic corticosteroid side effects.
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