Description
Latin name
AVAMYS
Packaging
In a bottle with a dispenser of 120 doses.
In a cardboard box 1 bottle.
Indications
Adults and teenagers (12 years of age and older)
treatment of nasal and ocular symptoms of seasonal allergic rhinitis
treatment of nasal symptoms of perennial allergic rhinitis.
Children (ages 2 to 11)
– treatment of nasal symptoms of seasonal and perennial allergic rhinitis.
Use during pregnancy and lactation
Fluticasone furoate can be used during pregnancy and lactation (breastfeeding) only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or infant.
Clinical data on the use of fluticasone furoate during pregnancy and lactation (breastfeeding) are insufficient.
It is not known whether fluticasone furoate with breast milk is excreted in humans.
Composition
1 dose of nasal spray contains:
Active ingredient:
Fluticasone furoate (micronized) – 27.5 mcg.
Excipients:
Dextrose * – 2750 mcg
Dispersible cellulose – 825 mcg
Polysorbate 80 – 13. 75 μg
Benzalkonium chloride solution ** – 16.5 μg ***
Disodium edetate – 8.25 μg
Purified water – up to 50 μl.
Dosage and administration
The drug is administered intranasally.
To achieve the maximum therapeutic effect, you must adhere to a regular regimen. The onset of action can be observed within 8 hours after the first injection. It may take several days to achieve maximum effect. The patient should be carefully explained the reason for the lack of immediate effect.
For the symptomatic treatment of seasonal and perennial allergic rhinitis.
Adults and teenagers 12 years of age and older: the recommended starting dose is 55 mcg (2 sprays) in each nostril 1 time / day (110 mcg / day). When adequate symptom control is achieved, reducing the dose to 27.5 mcg (1 spray) in each nostril 1 time / day (55 mcg / day) may be effective for maintenance treatment.
For children aged 2 to 11 years: the recommended starting dose is 27.5 mcg (1 spray) in each nostril 1 time / day (55 mcg / day).
In the absence of the desired effect at a dose of 27.5 μg (1 spray) in each nostril 1 time / day, it is possible to increase the dose to 55 μg (2 spray) in each nostril 1 time / day (110 μg / day). When adequate symptom control is achieved, it is recommended that the dose be reduced to 27.5 mcg (1 spray) in each nostril 1 time / day (55 mcg / day).
Insufficient data to recommend the use of fluticasone furoate intranasally for the treatment of seasonal and perennial allergic rhinitis in children under 2 years of age.
Elderly patients: dose adjustment not required.
Patients with impaired renal function: dose adjustment not required.
In patients with mild to moderate hepatic impairment: dose adjustment is not required. There is no data on the use in patients with severely impaired liver function.
Terms of use and handling of the drug
The indicator window in plastic packaging allows you to control the level of the drug in the bottle. In vials of 30 or 60 doses, the level of the drug will be immediately visible, and in vials of 120 doses, the initial level of the drug is above the upper border of the viewing window. To check the level of the drug in the bottle, you need to look at it in the light. The level will be visible in the viewing window.
Preparation for use should be carried out when using the spray for the first time, as well as if the bottle was left open. Proper preparation for use will ensure the injection of the required dose of the drug.
Without removing the cap, shake the bottle well for 10 seconds. The drug is a fairly thick suspension and becomes more liquid with shaking. Spraying is possible only after shaking.
Remove the cap by gently pulling it with the thumb and forefinger.
Hold the bottle upright and point the tip away from you.
Press the button with force, press a few times (minimum 6) until a small cloud appears from the tip (if you cannot press the button with one thumb, you should press it with the thumbs of both hands).
Spray is ready to use.
Apply nasal spray
Shake the vial thoroughly.
Remove the cap.
Clean your nose and tilt your head slightly forward.
Insert the tip into one nostril while continuing to hold the vial upright.
Point the spray tip at the outside of the nose, not on the nasal septum. This will ensure the correct injection of the drug.
Start breathing through the nose and pressing once with your fingers to spray the drug.
Remove the nebulizer from the nostril and exhale through the mouth.
If it is necessary to make two injections into each nostril (as prescribed by the doctor), repeat steps 4-6.
Repeat the procedure for the other nostril.
Close the bottle cap.
Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with water.
Side effects
Determination of the frequency of adverse reactions:
Very often ( 1/10).
Often ( 1/100, <1/10). Sometimes ( 1/1000, <1/100). Rarely ( 1/10 000, <1/1000). Very rare (<1/10 000, including isolated cases). From the respiratory system: very often – nosebleeds. In adults and adolescents, cases of epistaxis were noted more often with prolonged use (more than 6 weeks) than with a short course (up to 6 weeks). In studies in children with a duration of therapy up to 12 weeks, the incidence of nosebleeds was similar in the fluticasone furoate and placebo groups. Often – ulceration of the mucous membrane of the nasal cavity. Allergic reactions: rash, urticaria, Quincke’s edema, anaphylaxis. Drug Interaction Fluticasone furoate is rapidly metabolized in the liver with the participation of the CYP3A4 isoenzyme. In the study of the drug interaction of fluticasone furoate and the CYP3A4 inhibitor ketoconazole, there were more cases of determination of plasma concentrations of fluticasone furoate, which were higher than the threshold, in the group of patients receiving ketoconazole (6 out of 20 patients) compared to 20 placebo patients. This small increase did not lead to a statistically significant difference in plasma cortisol content for 24 h between the two groups. Based on theoretical data, no drug interaction of fluticasone furoate with intranasal administration with other drugs that are metabolized with the participation of cytochrome P450 isoenzymes is anticipated. Therefore, no clinical studies were conducted to study the interaction of fluticasone furoate and other drugs. Based on data obtained in a study with other ACS that is also exposed to CYP3A4-mediated metabolism, as well as literature on other ACSs that undergo CYP3A4-mediated metabolism, co-administration of a potentiometric drug is not recommended. risk of increased systemic exposure of fluticasone furoate. overdose Symptoms: In a bioavailability study, doses were administered intranasally 24 times the recommended dose for adults for more than 3 days, with no adverse systemic reactions observed. Treatment: It is unlikely that an acute overdose will require treatment other than medical observation. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C. Do not cool , do not freeze. Expiration 3 years. Deystvuyuschee substances fluticasone furoate Pharmacy pharmacy dosage form dosage form nasal spray Glakso SmithKlyan, United Kingdom
