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Based on data with another glucocorticoid metabolised by CYP3A4, co-administration with ritonavir is not recommended because of the potential risk of increased systemic exposure to fluticasone furoate (see Interactions and Pharmacology: Pharmacokinetics under Actions).
Systemic effects with nasal corticosteroids have been reported, particularly at high doses prescribed for prolonged periods. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroid preparations. A reduction in growth velocity has been observed in children treated with fluticasone furoate 110 micrograms daily for one year (see Adverse Reactions and Pharmacology: Pharmacodynamics: Clinical Studies under Actions). Therefore, children should be maintained on the lowest dose which delivers adequate symptom control (see Dosage & Administration). As with other intranasal corticosteroids, physicians should be alert to potential systemic steroid effects including ocular changes (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Nasal: Nasal side effects: in clinical trial data, the common side effects reported were epistaxis and nasal ulceration. Post-marketing cases of nasal septal perforation have been reported in patients following the intranasal application of fluticasone furoate nasal spray (see Adverse Reactions).
Glaucoma and Cataracts: Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure (IOP), glaucoma, and/or cataracts.
Glaucoma and cataract formation was evaluated with intraocular pressure measurements and slit lamp examinations in 1 controlled 12-month trial in 806 adolescent and adult patients aged 12 years and older and in 1 controlled 12-week trial in 558 children aged 2 to 11 years. The patients had perennial allergic rhinitis and were treated with either fluticasone furoate nasal spray (110 mcg once daily in adult and adolescent patients and 55 or 110 mcg once daily in pediatric patients) or placebo. Intraocular pressure remained within the normal range (less than 21 mmHg) in greater than or equal to 98% of the patients in any treatment group in both trials. However, in the 12-month trial in adolescents and adults, 12 patients, all treated with fluticasone furoate nasal spray 110 mcg once daily, had intraocular pressure measurements that increased above normal levels (greater than or equal to 21 mmHg). In the same trial, 7 patients (6 treated with fluticasone furoate nasal spray 110 mcg once daily and 1 patient treated with placebo) had cataracts identified during the trial that were not present at baseline.
Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, angioedema, rash, and urticaria, may occur after administration of fluticasone furoate nasal spray. Discontinue fluticasone furoate nasal spray if such reactions occur (see Contraindications).
Hypothalamic-Pituitary-Adrenal Axis Effects: Hypercorticism and Adrenal Suppression: When intranasal steroids are used at higher-than-recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of fluticasone furoate nasal spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.
Effects on Ability to Drive and Use Machines: Based on the pharmacology of fluticasone furoate and other intranasally administered steroids, there is no reason to expect an effect on ability to drive or to operate machinery with AVAMYS Nasal Spray.
