Treatment of symptoms of allergic rhinitis in adults, adolescents and children aged ≥6 years.
Composition:
1 dose of nasal spray contains 27.5 micrograms of fluticasone furoate.
Action:
Synthetic corticosteroid with a strong anti-inflammatory effect for topical application to the nasal mucosa. Relieves nasal symptoms (leakage of watery discharge, a feeling of nasal congestion, sneezing, itching in the nose) and the eyes (pruritus, burning, tearing, redness of the eyes). The onset of action occurs after 8 hours after administration, further improvement is observed over the Next few days of therapy. The effectiveness of the preparation is maintained within 24 hours between consecutive doses administered once a day. The drug undergoes incomplete absorption and is largely metabolised in the liver and intestine in the first-pass mechanism, so the systemic effect is negligible. The absolute bioavailability after intranasal administration is 0.5%. It is more than 99% bound to plasma proteins. It is metabolised by CYP3A4 to the inactive 17β-carboxylic acid metabolite. After oral or intravenous administration, the drug is mainly excreted in the faeces, 1-2% of the dose is excreted in the urine. In patients with severe hepatic impairment, exposure may be increased.
Contraindications:
Hypersensitivity to the components of the preparation.
Precautions:
Use with caution in patients with severe hepatic impairment (increased fluticasone exposure). The use of nasal corticosteroids, especially at high doses and (or) over a long period, may cause systemic symptoms. Therefore, the dose should be reduced to the lowest dose, ensuring effective control of the symptoms of rhinitis. Treatment with doses higher than recommended may cause clinically significant suppression of adrenal function. In patients using doses greater than those recommended during periods of stress or surgery, consideration should be given to the addition of systemic corticosteroids. If the adrenal function is suspected, caution should be exercised in patients whose steroidal therapies are converted into a nasal formulation. Nasal and inhaled corticosteroids may cause the development of glaucoma and / or cataracts. Patients with impaired vision or with increased intraocular pressure, glaucoma and / or a history of cataract should be closely monitored. In children receiving nasal corticosteroids at the recommended doses, cases of growth retardation have been reported. It is recommended to regularly measure the growth in children who have been treated for a long time with nasal corticosteroids; if growth slows down, treatment should be reviewed and, if possible, the nasal corticosteroid dose should be reduced to the lowest effective dose. There are no data on safety and efficacy in children <6 years.
Pregnancy and lactation:
During pregnancy and breastfeeding, use if the expected benefit to the mother outweighs the potential risk to the fetus or child.
Side effects:
Very common: nosebleeds (usually mild or moderate). Common: headache, ulceration of the nasal mucosa. Uncommon: nasal pain, nasal discomfort (including burning, irritation and tenderness of the nose), dryness of the nasal mucosa. Rare: hypersensitivity reactions (including anaphylaxis, angioedema, rash and urticaria). Frequency unknown: transient ocular changes, slowing the growth rate of children. Systemic effects of corticosteroids may occur during intranasal use, especially if high doses are recommended for a long time.
Dosage:
Intranasally. Adults and children ≥12 years: initially 2 doses to each nostril once a day. After getting adequate control of symptoms in maintenance therapy, 1 dose is applied to each nostril once a day. Children 6-11 years: initially 1 dose to each nostril once a day.In patients who are unmanageable, 2 doses can be given in each nostril once a day; as maintenance treatment: 1 dose to each nostril once a day. The duration of treatment should be adjusted to the time of exposure to the allergen.Special groups of patients. No dose adjustment is necessary in the elderly, in patients with impaired renal function, or in patients with mild or moderate hepatic impairment. There are no data on the use of the drug in patients with severe hepatic impairment.
(C)
