Intranasal steroid potency

There are no data with intranasal fluticasone furoate in patients with hepatic impairment. Data are available following inhaled administration of fluticasone furoate (as fluticasone furoate or fluticasone furoate/vilanterol) to subjects with hepatic impairment that are also applicable for intranasal dosing. A study of a single 400 microgram dose of orally inhaled fluticasone furoate in patients with moderate hepatic impairment (Child-Pugh B) resulted in increased C max (42 %) and AUC(0-∞) (172 %) and a modest (on average 23 %) decrease in cortisol levels in patients compared to healthy subjects. Following repeat dosing of orally inhaled fluticasone furoate/vilanterol for 7 days, there was an increase in fluticasone furoate systemic exposure (on average two-fold as measured by AUC (0–24) ) in subjects with moderate or severe hepatic impairment (Child-Pugh B or C) compared with healthy subjects. The increase in fluticasone furoate systemic exposure in subjects with moderate hepatic impairment (fluticasone furoate/vilanterol 200/25 micrograms) was associated with an average 34% reduction in serum cortisol compared with healthy subjects. There was no effect on serum cortisol in subjects with severe hepatic impairment (fluticasone furoate/vilanterol 100/ micrograms). Based on these findings the average predicted exposure of 110 micrograms of intranasal fluticasone furoate in this patient population would not be expected to result in suppression of cortisol.

Patients should take the medication as directed and should not exceed the prescribed dosage. The patient should contact the physician if symptoms do not improve after two weeks, or if the condition worsens. Patients who experience recurrent episodes of epistaxis (nosebleeds) or nasal septum discomfort while taking this medication should contact their physician. For proper use of RHINOCORT AQUA (budesonide) Nasal Spray and to attain maximum improvement, the patient should read and follow the accompanying patient information carefully. Do not use RHINOCORT AQUA (budesonide) Nasal Spray after the labeled number of sprays have been used (does not include priming) or after the expiration date shown on the carton or bottle label.

Persons who are using drugs that suppress the immune system (., corticosteroids) are more susceptible to infections than healthy individuals. Chickenpox and measles , for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin ( IG ) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chickenpox or measles develops, treatment with antiviral agents may be considered.

The PROPEL sinus implants are intended for use after sinus surgery to maintain patency and to locally deliver steroid to the sinus mucosa: PROPEL for use in the ethmoid sinus, PROPEL Mini for use in the ethmoid sinus and frontal sinus opening, and PROPEL Contour for use in the frontal and maxillary sinus ostia. The implants are intended for use in patients ≥18 years of age. Contraindications include patients with intolerance to mometasone furoate (MF) or a hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implants in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For complete prescribing information see IFU at . Rx only.

Intranasal steroid potency

intranasal steroid potency

The PROPEL sinus implants are intended for use after sinus surgery to maintain patency and to locally deliver steroid to the sinus mucosa: PROPEL for use in the ethmoid sinus, PROPEL Mini for use in the ethmoid sinus and frontal sinus opening, and PROPEL Contour for use in the frontal and maxillary sinus ostia. The implants are intended for use in patients ≥18 years of age. Contraindications include patients with intolerance to mometasone furoate (MF) or a hypersensitivity to bioabsorbable polymers. Safety and effectiveness of the implants in pregnant or nursing females have not been studied. Risks may include, but are not limited to, pain/pressure, displacement of implant, possible side effects of intranasal MF, sinusitis, epistaxis, and infection. For complete prescribing information see IFU at . Rx only.

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