Instructions Avamis nasal spray dosed 27.5 mcg/dose bottle 120 doses
Composition
active ingredient: fluticasone furoate;
1 dose of the drug contains fluticasone furoate 27.5 mcg;
excipients: anhydrous glucose, dispersed cellulose, polysorbate 80, benzalkonium chloride solution, disodium edetate, purified water.
Dosage form
Nasal spray, suspension, metered.
Main physicochemical properties: white, homogeneous suspension of fluticasone furoate.
Pharmacotherapeutic group
Anti-edematous and other drugs for local use in diseases of the nasal cavity. Corticosteroids. ATX code R01A D12.
Pharmacological properties
Fluticasone furoate undergoes extensive first-pass metabolism and incomplete absorption in the liver and intestines, resulting in very low systemic exposure. Typically, intranasal administration of 110 mcg once daily results in undetectable plasma concentrations (< 10 pg/ml). The absolute bioavailability of fluticasone furoate when administered 880 mcg 3 times daily (total daily dose 2640 mcg) is 0.5%.
The level of binding of fluticasone furoate to plasma proteins is more than 99%. The drug is widely distributed, the volume of distribution is on average 608 liters.
Fluticasone furoate is rapidly eliminated (total plasma clearance 58 l/h) from the systemic circulation, mainly by hepatic metabolism involving the cytochrome P450 enzyme CYP3A4 to an inactive 17β-carboxylic metabolite (GW694301X). The main mechanism of metabolism is hydrolysis of S-fluoromethyl carbothioate to the 17β-carboxylic acid metabolite. It is excreted after oral and intravenous administration mainly in the feces with evidence of excretion of fluticasone furoate and its metabolites in the bile. After intravenous administration, the half-life is 15.1 hours. The level of excretion in urine is approximately 1% and 2% after oral and intravenous administration, respectively.
Indication
Symptomatic treatment of allergic rhinitis.
Contraindication
Hypersensitivity to any component of the drug.
Interaction with other medicinal products and other types of interactions
Fluticasone furoate is rapidly eliminated by extensive first-pass metabolism in the liver by cytochrome P450 3A4.
Based on the results of the use of another glucocorticoid, fluticasone propionate, which is also metabolized by CYP3A4, co-administration with ritonavir is not recommended due to increased systemic exposure to fluticasone furoate.
Fluticasone furoate should be used with caution in combination with strong CYP3A4 inhibitors, including those containing cobicistat, due to the increased risk of systemic adverse reactions. Such combinations should be avoided unless the expected benefit outweighs the potential increased risk of systemic corticosteroid adverse reactions. In such cases, patients should be monitored for the development of systemic adverse reactions.
In a clinical drug interaction study of fluticasone furoate with the strong CYP3A4 inhibitor ketoconazole, the number of subjects with measurable plasma fluticasone furoate concentrations was higher in the ketoconazole group (6 of 20) compared to the placebo group (1 of 20). This slight increase in systemic exposure did not result in a statistically significant difference in 24-hour serum cortisol levels between the two groups.
Data from enzyme induction and inhibition studies suggest that there is no reason to expect metabolic interactions between fluticasone furoate and other cytochrome P450 metabolic mediators at the intranasal doses appropriate for clinical use. Therefore, clinical drug interaction studies with fluticasone furoate have not been conducted.
Application features
The use of higher than recommended doses of intranasal corticosteroids may cause clinically significant adrenal suppression. During periods of stress or elective surgery, the need for additional systemic steroids should be considered if there is evidence of use of higher than recommended doses of intranasal corticosteroids. Fluticasone furoate at a dose of 110 mcg per day has not been associated with suppression of the hypothalamic-pituitary-adrenal axis in adults and children. However, the dose of intranasal fluticasone furoate should be reduced to the lowest effective dose that controls the symptoms of allergic rhinitis. As with other intranasal corticosteroids, the overall systemic exposure of any other form of steroid therapy should be considered when co-administering other forms of steroid therapy.
If there is any evidence of adrenal suppression, switching a patient from systemic steroid treatment to intranasal fluticasone furoate should be done with caution.
Vision impairment
Visual impairment may occur with systemic and topical corticosteroids. If a patient presents with symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist for evaluation of possible causes, which may include cataracts, glaucoma, or rare conditions such as central serous chorioretinopathy, which have been reported with systemic and topical corticosteroids.
Growth retardation has been observed in children treated with intranasal corticosteroids at recommended doses. Growth retardation has been observed in children treated with fluticasone furoate at a dose of 110 mcg per day for one year (see section 4.8). Therefore, children should be treated with the lowest effective dose to maintain adequate control of symptoms (see section 4.2). It is recommended that the growth of children receiving long-term treatment with intranasal corticosteroids be monitored regularly. If the child's growth is slowed, the therapy should be reviewed with the aim of reducing the dose, if possible to the minimum effective dose to control symptoms. Referral to a paediatrician should also be considered.
It is not recommended to use the drug together with ritonavir due to the increased risk of systemic exposure to fluticasone furoate.
Use during pregnancy or breastfeeding
Pregnancy
There is insufficient data on the use of the drug during pregnancy. In animal studies, glucocorticoids have caused deformities, including cleft palate and intrauterine growth retardation. This is unlikely to be relevant to humans at recommended doses, which result in minimal systemic exposure. Fluticasone furoate should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus or child.
Breast-feeding
It is not known whether fluticasone furoate is excreted in human milk after intranasal administration. Fluticasone furoate should be used during breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus/infant.
Fertility
There are no data on the effect on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
Avamys has no or negligible influence on the ability to drive and use machines.
Method of administration and doses
Avamys should be prescribed for intranasal use only.
Adults and children aged 12 years and over: the recommended initial dose is 2 sprays (27.5 mcg per spray) in each nostril once daily (total daily dose – 110 mcg).
After achieving control of rhinitis symptoms, the maintenance dose of the drug can be reduced to 1 spray in each nostril once a day (total daily dose - 55 mcg).
Children aged 6 to 11 years: the recommended initial dose is 1 spray in each nostril once a day (total daily dose is 55 mcg).
In case of insufficient control of rhinitis symptoms with 1 spray in each nostril once a day (total daily dose – 55 mcg), the dose can be increased to 2 sprays in each nostril once a day (total daily dose – 110 mcg).
After achieving control of rhinitis symptoms, it is recommended to reduce the dose to 1 spray in each nostril once a day (total daily dose - 55 mcg).
Elderly patients: use the same doses as for adults.
Renal insufficiency: no dose adjustment is required.
Hepatic insufficiency: no dose adjustment is required.
To obtain the full therapeutic effect, the drug must be used regularly. The onset of action is observed 8 hours after the first application, however, the maximum therapeutic effect occurs several days after the start of treatment, and therefore patients should be informed that the effect of the treatment will be observed with regular use of the drug. The duration of treatment should be limited to the period of exposure to the allergen.
Application
The nasal spray (see picture below) consists of a glass bottle placed in a plastic housing with a protective cap covering the spray tip (a special device at the top of the spray). There are small holes in the lower parts of the housing through which you can see the presence of the drug in the glass bottle. You will be able to see the liquid level in a full 30-dose bottle, but not in a full 120-dose bottle, because the liquid level in it is above the hole.
On one side of the plastic case there is a large dosing button, when pressed, the drug is released through the sprayer.
Six important facts about spray you need to know
Avamys comes in a dark glass bottle. To check the amount of spray remaining in the bottle, hold the bottle upright against a bright light. This will allow you to see the level of the liquid through the opening.
If you are using the bottle for the first time, shake the bottle well for 10 seconds without removing the cap. This is important because Avamys is a thick suspension that becomes more liquid when shaken. Use is only possible after the suspension becomes liquid.
To inject, you must press the dosing button firmly.
If you have difficulty pressing the button with your thumb, you can do it with the thumbs of both hands.
;Always keep the nasal spray bottle closed when not in use. This helps to keep dust out, maintain pressure and prevent the spray from clogging. When the cap is on the bottle, the spray button cannot be accidentally pressed.
Do not try to clean the tip hole with a needle or other sharp objects. This will damage the device.
Preparation for use
You should prepare a bottle of nasal spray:
before using it for the first time;
if the cap has been removed for 5 days or the intranasal device has not been used for 30 days or more.
Proper preparation of the spray will ensure that the correct dose of the drug is injected. Follow these steps:
1. Without removing the cap, shake the bottle well for 10 seconds.
2. Remove the cap by squeezing it firmly on the sides with your thumb and forefinger.
3. Hold the nasal spray bottle upright, then tilt and turn the sprayer away from you.
4. Press the button firmly. Press at least 6 times until the sprayer releases fine droplets of spray into the air.
The nasal spray is now ready for use.
Using a nasal spray
1. Shake the nasal spray bottle vigorously.
2. Remove the cap.
Clear your nasal cavity, then tilt your head forward slightly.
Insert the spray into your nostril. Aim the tip of the spray at the outer wall of your nose, not the nasal septum. This will ensure proper injection of the medication.
Press the button firmly all the way down while breathing in through your nose.
6. Remove the spray from your nostril and exhale through your mouth.
7. If, according to the doctor's recommendation, it is necessary to perform 2 injections into each nostril, it is necessary to repeat points 4 - 6.
8. Repeat steps 4 – 7 for the second nostril.
9. Close the bottle with the cap.
Sprayer care
After each use:
1. Wipe the inside of the sprayer and cap with a clean, dry cloth.
2. Do not use water to clean it.
3. Never try to clean the tip hole with a needle or other sharp objects.
4. Always close the bottle with the cap immediately after completing the procedure.
If your sprayer is not working:
Check the level of the medicine in the bottle by looking through the opening. If the level is very low, there may not be enough medicine for the nebulizer to work.
Check the device for damage.
If you think the sprayer is clogged, do not use a needle or other sharp object to clean it.
You should try to get the device working by repeating the steps in the “Preparation for use” section.
If the sprayer still does not work or releases a jet of liquid, contact the pharmacy or a representative of GlaxoSmithKline Pharmaceuticals Ukraine LLC by phone at (044) 585-51-85 or +38 (050) 381-43-49, or by e-mail at ua.complaints@gsk.com for advice.
Avoid contact with eyes. If this happens, rinse eyes with water.
Children: Avamys is not recommended for use in children under 6 years of age, as the efficacy and safety of this medicine in patients in this age group have not been established.
Overdose
In clinical studies, no adverse effects were observed with intranasal administration of up to 2640 mcg per day for more than 3 days. It is unlikely that any treatment other than medical observation will be necessary in the event of acute overdose.
Side effects
Adverse reactions are classified according to frequency into the following categories: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and < 1/1,000), very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data).
Respiratory system.
Very common: nosebleeds.
Epistaxis was usually mild to moderate. In adults and adolescents, epistaxis occurred more frequently with prolonged use (more than 6 weeks) than with use for up to 6 weeks. In pediatric clinical trials of up to 12 weeks duration, the incidence of epistaxis was similar in the fluticasone furoate and placebo groups.
Uncommon: nasal pain, discomfort (including burning, irritation, nasal soreness), nasal dryness.
Very rare: perforation of the nasal septum.
Immune system.
Rare: hypersensitivity reactions including anaphylaxis, angioedema, rash and urticaria.
Nervous system.
Common: headache.
Organs of vision.
Frequency unknown: transient visual disturbances, visual acuity reduced.
Children.
Musculoskeletal system and connective tissues.
Frequency unknown: growth retardation.
In a one-year clinical study evaluating the growth of prepubertal children treated with 110 mcg of fluticasone furoate once daily, there was a difference in growth velocity of -0.27 cm per year compared to the placebo group.
Systemic action.
Systemic effects may occur, especially when high doses are used for long periods of time (see section 4.4). Growth retardation has been reported in children treated with nasal corticosteroids.
Expiration date
3 years. After first opening – 2 months.
Storage conditions
Store at a temperature not exceeding 30 ° C. Do not refrigerate. Do not freeze. Keep out of the reach of children.
Packaging
Dark glass bottles with a dosing device, sprayer and cap. The bottle contains 120 doses.
Vacation category
According to the recipe.
Producer
Glaxo Wellcome SA, Spain
Address
Avenida de Extremadura 3, Pol. Ind. Allendeduero, 09400 Aranda de Duero, Burgos, Spain/ Avda. de Extremadura, 3, Pol. Ind. Allendeduero, 09400 Aranda dе Duero, Burgos, Spain.
