Flonase - Side Effects & Drug Interactions

diarrhea,

fever,

flu-like symptoms,

aches and pains,

dizziness,

bronchitis.

Observed During Clinical Practice

In addition to adverse events reported from clinical trials, the following events have been identified during postapproval use of intranasal fluticasone propionate in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to fluticasone propionate or a combination of these factors.

General:

Hypersensitivity reactions, including angioedema, skin rash, edema of the face and tongue, pruritus, urticaria, bronchospasm, wheezing, dyspnea, and anaphylaxis/ anaphylactoid reactions, which in rare instances were severe.

Ear, Nose, and Throat:

Alteration or loss of sense of taste and/ or smell and, rarely, nasal septal perforation, nasal ulcer, sore throat, throat irritation and dryness, cough, hoarseness, and voice changes.

Eye:

Dryness and irritation, conjunctivitis, blurred vision, glaucoma, increased intraocular pressure, and cataracts. Cases of growth suppression have been reported for intranasal corticosteroids, including FLONASE (see PRECAUTIONS: Pediatric Use).

Drug Interactions

Fluticasone propionate is a substrate of cytochrome P450 3A4. Coadministration of fluticasone propionate and the highly potent cytochrome P450 3A4 inhibitor ritonavir is not recommended based upon a multiple-dose, crossover drug interaction study in 18 healthy subjects. Fluticasone propionate aqueous nasal spray (200 mcg once daily) was coadministered for 7 days with three P450 3A4 inhibitors: ritonavir (100 mg twice daily), ketoconazole (200 mg once daily), and erythromycin (500 mg twice daily).

Coadministration with ritonavir resulted in a significant increase in plasma fluticasone propionate exposure and a significant decrease (86%) in plasma cortisol area under the plasma concentration versus time curve (AUC). Coadministration with ketoconazole resulted in a slight increase in fluticasone propionate exposure and a 7% reduction in the area under the plasma cortisol AUC. Coadministration with erythromycin did not affect fluticasone propionate pharmacokinetics; there was a 2% reduction in the plasma cortisol AUC.