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.
Information from the National Library of Medicine
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Ages Eligible for Study: 18 Years to 85 Years (Adult, Senior) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion criteria included the following:
Steroids are the most effective anti-inflammatory drugs available, and are derivatives of natural hormones which the body creates to help the body cope with injury or stress. However, prolonged use of oral or systemic steroids can result in suppression of normal steroid levels in the body. Therefore, these medications should be taken exactly as prescribed, usually in a gradually decreasing dose, to avoid sudden withdrawal. Withdrawal symptoms are uncommon in patients who have used steroids for less than two weeks at a time. Continued or repeated use of steroids can reduce your ability to fight infection and can result in weight gain, fluid retention, acne, increased body hair, purple marks on the abdomen, collection of fatty deposits under the skin, and easy bruising. High doses of steroids will frequently cause nervousness, sleeplessness, excitation, and sometimes depression or confusion. Steroids can also cause elevation of blood sugar or blood pressure or change in salt balance. Prolonged steroids can cause thinning of the bones, muscle weakness, glaucoma, and cataracts. They can aggravate ulcers. Patients who are pregnant, have a history of stomach ulcers, glaucoma, diabetes, high blood pressure, tuberculosis, osteoporosis, or recent vaccination, should not take steroids unless absolutely necessary. A very rare complication of steroids is interruption of the blood supply to the hip bone which can result in a fracture that requires a hip replacement.