Avamis nasal spray - instructions, use, contraindications, dosage, analogues

Compound

Active ingredient: Fluticasone furoate, 27.5 mcg (0.0275 mg) per dose. Belongs to the class of new generation corticosteroids for topical use.

Excipients: dextrose - 2750 mcg, dispersible cellulose - 825 mcg, polysorbate 80 - 13.75 mcg, benzalkonium chloride solution - 16.5 mcg, disodium edetate - 8.12 mcg, purified water - up to 50 mcg.

Avamys antibiotic or not? No, this drug is not an antibacterial agent, although it has pronounced anti-inflammatory activity. This effect is achieved due to the combination of properties inherent in all steroid hormones.

Avamys nasal spray dosed 27.5 µg/dose, 120 doses

Registration Certificate Holder

GlaxoSmithKline Trading (Russia)

Dosage form

Medicine - Avamys

Description

Dosed nasal spray

in the form of a homogeneous white suspension.

1 dose

fluticasone furoate (micronized) 27.5 mcg

Excipients

: dextrose* - 2750 mcg, dispersible cellulose - 825 mcg, polysorbate 80 - 13.75 mcg, benzalkonium chloride solution** - 16.5 mcg***, disodium edetate - 8.25 mcg, purified water - up to 50 mcg.

30 doses - dark glass bottles equipped with a dosing (50 µl) spray device (1) - outer plastic cases (1) with an indicator window, a push valve and a cap with an elastomer limiter - cardboard packs. 60 doses - dark glass bottles equipped with a dosing (50 µl) spray device (1) - outer plastic cases (1) with an indicator window, a push valve and a cap with an elastomer limiter - cardboard packs. 120 doses - dark glass bottles equipped with a dosing (50 µl) spray device (1) - plastic outer cases (1) with an indicator window, a push valve and a cap with an elastomer limiter - cardboard packs.

* anhydrous dextrose is used. ** contains 50% benzalkonium chloride. *** the content of benzalkonium chloride is 8.25 mcg/dose or 0.015% (w/m) in suspension. When packaging the drug in vials, an excess amount of suspension is provided, equal to approximately 2.2 g, 2.3 g and 2 g for packages of 30, 60 and 120 doses, respectively. Excess application is necessary to ensure that at least 30, 60 and 120 doses are sprayed from the package.

Indications

Adults and teenagers (ages 12 and older)

treatment of nasal and ocular symptoms of seasonal allergic rhinitis;
Treatment of nasal symptoms of year-round allergic rhinitis.

Children (ages 2 to 11)

treatment of nasal symptoms of seasonal and perennial allergic rhinitis.

Contraindications for use

hypersensitivity to fluticasone furoate and other components of the drug.

Carefully

the drug should be used in patients with severe liver dysfunction, because The pharmacokinetics of fluticasone furoate may vary.

pharmachologic effect

Fluticasone furoate is a synthetic trifluorinated corticosteroid with high affinity for glucocorticoid receptors and has a pronounced anti-inflammatory effect.

Drug interactions

Fluticasone furoate is rapidly eliminated, undergoing primary metabolism in the liver with the participation of the CYP3A4 isoenzyme of the cytochrome P450 system. In a drug interaction study between fluticasone furoate and the highly active CYP3A4 inhibitor ketoconazole, more cases of fluticasone furoate plasma concentrations above the threshold were observed in the group of patients receiving ketoconazole (6 out of 20 patients) compared with placebo (1 out of 20 patients). ). This small increase did not result in a statistically significant difference in 24-hour plasma cortisol between the two groups.

Based on theoretical data, no drug interaction is expected between fluticasone furoate administered intranasally, according to the instructions for use, with other drugs that are metabolized with the participation of isoenzymes of the cytochrome P450 system. Therefore, clinical studies have not been conducted to study the interaction of fluticasone furoate and other drugs.

Dosage regimen

Avamis is intended for intranasal use only.

To achieve maximum therapeutic effect, it is necessary to adhere to a regular regimen of use. The onset of action can be observed within 8 hours after the first administration. It may take several days to achieve maximum effect. The reason for the lack of immediate effect should be carefully explained to the patient.

Treatment of nasal and ocular symptoms of seasonal allergic rhinitis, nasal symptoms of perennial allergic rhinitis in adults and adolescents (ages 12 years and older)

The recommended initial dose is 2 sprays (27.5 mcg of fluticasone furoate per spray) into each nostril 1 time/day (110 mcg/day).

Once adequate symptom control is achieved, dose reduction to 1 spray in each nostril once a day (55 mcg/day) may be effective for maintenance treatment.

Treatment of nasal symptoms of seasonal and perennial allergic rhinitis in children aged 2 to 11 years

The recommended initial dose is 27.5 mcg (1 spray) in each nostril 1 time/day (55 mcg/day).

If there is no desired effect at a dose of 27.5 mcg (1 spray) in each nostril 1 time/day, the dose can be increased to 55 mcg (2 sprays) in each nostril 1 time/day (110 mcg/day). When adequate control of symptoms is achieved, it is recommended to reduce the dose to 27.5 mcg (1 spray) in each nostril 1 time / day (55 mcg / day).

There are no data to recommend the use of intranasal fluticasone furoate as a treatment for seasonal and perennial allergic rhinitis in children under 2 years of age.

Dose adjustments in elderly patients

not required.

Dose adjustment in patients with impaired renal function

not required.

Dose adjustments in patients with mild to moderate hepatic impairment (Child-Pugh class A and B)

no dose adjustment is required.
There are no data available in patients with severe hepatic impairment (Child-Pugh class C)
. Caution should be exercised when determining the dose for patients with severe liver dysfunction, because such patients may be more at risk of systemic adverse reactions associated with the use of GCS.

Rules for use and handling of the drug

The indicator window in the plastic package allows you to control the level of the drug in the bottle. In 30- or 60-dose vials, the drug level will be visible immediately, and in 120-dose vials, the initial drug level is above the upper limit of the viewing window. The nasal spray is available in orange glass bottles, which are in plastic cases. To check the level of the drug in the bottle, you need to hold it up to the light. The level will be visible through 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 that the required dose of the drug is injected.

1. Without removing the cap, shake the bottle well for 10 seconds. The drug is a rather thick suspension and becomes more liquid when shaken. Spraying is only possible after shaking.

2. Remove the cap by gently pulling it with your thumb and forefinger.

3. Hold the bottle vertically and point the tip away from you.

4. Press the button firmly and make several presses (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).

5. The spray is ready for use.

Using a nasal spray

1. Shake the bottle thoroughly.

2. Remove the cap.

3. Clear your nose and tilt your head slightly forward.

4. Insert the tip into one nostril, continuing to hold the bottle vertically.

5. Point the tip of the sprayer at the outer wall of the nose, not at the nasal septum. This will ensure proper injection of the drug.

6. Start inhaling through your nose and press once with your fingers to spray the drug.

7. Remove the atomizer from your nostril and exhale through your mouth.

8. If it is necessary to make two injections into each nostril (as prescribed by a doctor), you should repeat steps 4-6.

9. Repeat the procedure for the other nostril.

10. Close the bottle with a cap.

11. Avoid getting the spray in your eyes. If the drug gets into your eyes, rinse them thoroughly with water.

Sprayer care

After each use:

1. Blot the tip and the inner surface of the cap with a dry, clean cloth. Avoid contact with water.

2. Do not try to clean the tip hole with a pin or other sharp objects.

3. Always cap the bottle and keep it closed. The cap protects the sprayer from dust and clogging, seals the bottle, and prevents accidental pressing of the button.

If the sprayer does not work:

1. Check the level of the remaining drug in the bottle through the viewing window. If there is only a small amount of liquid left, it may not be enough to operate the sprayer.

2. Check the bottle for damage.

3. Check if the tip hole is clogged. Do not attempt to clean the tip hole with a pin or other sharp object.

4. Try to activate the device by repeating the procedure for preparing the nasal spray for use.

Overdose

Symptoms:

In a bioavailability study, doses 24 times higher than the recommended adult dose were used intranasally for more than 3 days, and no adverse systemic reactions were observed.

Treatment:

It is unlikely that acute overdose will require treatment other than medical supervision.

Side effect

The adverse events presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥1/10); often (≥1/100, <1/10); uncommon (≥1/1000, <1/100); rare (≥1/10,000, <1/1000); very rare (<1/10,000, including isolated cases).

Adverse events observed in clinical studies

From the respiratory system:

very often - nosebleeds. In adults and adolescents, cases of nosebleeds were observed more often with long-term use (more than 6 weeks) than with a short course (up to 6 weeks). In studies in children with treatment durations of up to 12 weeks, the incidence of epistaxis was similar in the fluticasone furoate and placebo groups. Often - ulceration of the nasal mucosa.

From the musculoskeletal system:

frequency unknown - growth retardation in children.

The results of a study conducted over a year in prepubertal children who received fluticasone furoate at a dose of 110 mcg 1 time / day do not allow us to determine the statistical frequency of this adverse event, since it is impossible to calculate the effect of the drug on final growth indicators in children who took part in the study. research.

Skeletal growth retardation in children is a systemic adverse event characteristic of GCS with long-term oral or parenteral administration.

Adverse events observed during post-registration surveillance

From the immune system

rarely - hypersensitivity reactions, including anaphylaxis, Quincke's edema, rash, urticaria.

From the nervous system:

often - headache.
From the respiratory system:
uncommon - rhinalgia, nasal discomfort (including burning, nasal irritation and soreness), dry nose; very rarely - perforation of the nasal septum.

From the side of the organ of vision:

frequency unknown - transient visual impairment. Systemic side effects characteristic of GCS may occur.

special instructions

Avamis is intended for intranasal use only.

Fluticasone furoate undergoes first-pass metabolism through the liver with the participation of the CYP3A4 isoenzyme of the cytochrome P450 system. Therefore, in patients with severe hepatic impairment, the pharmacokinetics of fluticasone furoate may be altered. No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh class A and B). There are no data in patients with severe liver dysfunction (Child-Pugh class C). Caution should be exercised when determining the dose for patients with severe liver dysfunction, because such patients may be more at risk of systemic adverse reactions associated with the use of GCS.

Based on data from the use of another corticosteroid, which is metabolized by the CYP3A4 isoenzyme of the cytochrome P450 system, with ritonavir, the combined use of ritonavir with fluticasone furoate is not recommended due to the possible risk of increased systemic exposure to fluticasone furoate.

Systemic effects characteristic of GCS (such as Cushing's syndrome, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma), as well as a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbance, anxiety, depression or aggression (especially in children) may be observed when using intranasal corticosteroids. The likelihood of such effects occurring is much lower than when using oral forms of GCS and a combination of oral and intranasal GCS. Effects may vary between individual patients and between different corticosteroids. If there is any reason to suspect possible adrenal dysfunction, caution should be exercised when switching patients from systemic steroid therapy to fluticasone furoate.

Children receiving 110 mcg of fluticasone furoate daily for one year experienced a decrease in growth rate. However, the results of this study do not allow us to determine the statistical frequency of this adverse event, since it is not possible to calculate the effect of the drug on final growth in children. The maintenance dose in children should be the lowest dose that provides adequate control of symptoms.

It is recommended to regularly monitor the growth of children receiving long-term therapy with intranasal corticosteroids. If growth slows, therapy should be reconsidered, if possible, to reduce the intranasal dose of corticosteroids to the lowest dose that maintains effective control of symptoms. In addition, attention should be paid to the issue of referring the patient to a pediatrician.

As with the use of other intranasal corticosteroids, physicians must be vigilant regarding the possible systemic effects of corticosteroids, incl.
changes in the organ of vision. Therefore, careful monitoring is warranted in patients with impaired vision or a history of elevated intraocular pressure, glaucoma and/or cataracts. Effect on the ability to drive vehicles and operate machinery
Based on the pharmacological properties of fluticasone furoate and other corticosteroids for topical use, an effect on the ability to drive vehicles or operate other mechanisms is not expected.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C; do not refrigerate, do not freeze.

Best before date

Shelf life: 3 years. Do not use after the expiration date.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions when breastfeeding - With caution.

There is insufficient data on the use of fluticasone furoate during pregnancy and breastfeeding.

Fertility

There is no data on the effect of the drug on human fertility.

Pregnancy

There are no data on the use of fluticasone furoate in pregnant women. GCS have been shown in animal studies to cause malformations, including cleft palate and intrauterine growth retardation.

It is unlikely that these data are relevant for people receiving intranasal corticosteroids at recommended therapeutic doses.

Fluticasone furoate can be used during pregnancy only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus.

Breastfeeding period

The excretion of fluticasone furoate into breast milk has not been studied. Fluticasone furoate can be used in nursing women only if the expected benefit to the mother outweighs the potential risk to the baby.

Use for renal impairment

Restrictions for impaired renal function - No restrictions.

In patients with impaired renal function, no dose adjustment is required.

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

In patients with mild to moderate liver dysfunction, no dose adjustment is required. There are no data on use in patients with severe liver dysfunction.

Use in elderly patients

Restrictions for elderly patients - No restrictions.

Elderly patients do not require dose adjustment.

Use in children

Restrictions for children - With caution. There is insufficient data to recommend the use of intranasal fluticasone furoate for the treatment of seasonal and perennial allergic rhinitis in children under 2 years of age

Terms of sale

The drug is available with a prescription.

Contacts for inquiries

GlaxoSmithKline Trading JSC (Russia)

125167 Moscow Leningradsky Prospekt, 37a, bldg. 4 BC "Arcus III" Tel. Fax

Pharmacological properties

Fluticasone furoate is a synthetic glucocorticosteroid, code ATX (ATC) R01A D12. In combination with salmeterol, the drug belongs to the group of drugs included in the list of essential drugs. Developed for the symptomatic treatment of allergic and vasomotor rhinitis, relieving edema and other inflammatory diseases.

The principle of action of Avamis is based on the versatile effects of glucocorticoids on the human body. Fluticasone furoate is characterized by powerful anti-inflammatory and antiallergic activity. By inhibiting the synthesis of potent inflammatory mediators, the drug effectively relieves the symptoms of allergic rhinitis.

The mechanism of action of Avamis is distinguished by its clear affinity for GC receptors. The high pharmacodynamic activity of fluticasone furoate provides excellent therapeutic results in the lowest possible dose compared to other glucocorticoids.

Being a trifluorinated derivative, honey has low absorption when applied topically. Only 0.5% of the daily dose (from 2640 mcg) administered intranasally enters the systemic circulation. This low bioavailability rarely causes structural complications.

The low load of nasal spray on the body is due to its significant binding ability. Fluticasone furoate can bind to proteins contained in blood plasma by 99% or more. The volume of distribution of the drug is 608 l.

Avamys is metabolized primarily in the liver, through the formation of inactive metabolites of 17-carboxylic acid. Accordingly, excretion occurs through the intestines with feces. The half-life is 10-11 hours.

How long does it take for Avamys to start working? It takes several days to achieve results and relieve congestion. The appearance of the therapeutic effect depends on the chosen dose.

The drug acts most quickly 8 hours after the first use of the nasal aerosol, when using a concentration of 110 mcg. At a dosage of 55 mcg, improvement is observed after 24 hours.

Avamis 27.5 mcg/dose 120 doses nasal spray.

Trade name AVAMIS International nonproprietary name Fluticasone Dosage form Dosage nasal spray, 27.5 mcg/dose, 120 doses Composition 1 dose contains the active substance - fluticasone furoate (micronized) 27.5 mcg, excipients: anhydrous glucose, dispersed cellulose, polysorbate 80, benzalkonium chloride 50 % solution, disodium edetate, purified water Description Homogeneous white suspension Pharmacotherapeutic group Anticongestants and other nasal preparations for topical use. Glucocorticosteroids. Fluticasone furoate. ATC code R01AD12 Pharmacological properties Pharmacokinetics Absorption After intranasal administration of fluticasone furoate (110 mcg per day), the maximum concentration (Cmax) in the blood plasma is not detected in most patients (i.e., it is less than 10 pg/ml), the systemic effect of the drug is insignificant . Quantifiable levels were observed in only 31% of patients aged 12 years and older. The absolute bioavailability of intranasal fluticasone furoate administered 880 mcg three times daily (total daily dosage 2640 mcg) is 0.50%. Distribution Upon reaching equilibrium concentration in blood plasma, fluticasone furoate has a large volume of distribution (about 608 l). It has a fairly high ability to bind to blood plasma proteins (more than 99%). Metabolism Fluticasone furoate is rapidly eliminated from blood plasma (total plasma clearance 58.7 l/h), mainly as a result of metabolism in the liver to an inactive 17β-carboxyl metabolite (GW694301X) under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system. The main route of metabolism is the hydrolysis of S-fluoromethyl carbothioate to the 17β-carboxyl acid metabolite. Elimination The main route of elimination is the excretion of fluticasone propionate and its metabolites in the bile. About 1% of the drug is excreted in the urine. Elderly Data obtained from a limited number of patients showed that there are no significant differences in pharmacokinetics between elderly and younger patients. Children After intranasal administration of fluticasone furoate (110 mcg per day), the maximum concentration (Cmax) in the blood plasma is not detected in most patients (i.e., it is less than 10 pg/ml), the systemic effect of the drug is insignificant. Quantifiable levels were observed in 15.1% of children receiving 110 mcg once daily and only 6.8% of children receiving 55 mcg once daily. Renal Impairment Less than 1% of fluticasone is excreted in the urine, so no effect on the pharmacokinetics of the drug is expected in the case of renal impairment. Hepatic Impairment There are no data related to intranasal fluticasone use in patients with hepatic impairment. No effect on the pharmacokinetics of the drug is expected in cases of mild to moderate hepatic impairment. There are no data on the use of the drug in patients with severe liver failure; in such patients, increased fluticasone exposure may occur. Gender, race No effect. Pharmacodynamics Avamys is a synthetic trifluorinate corticosteroid for topical use. It has high activity at glucocorticoid receptors and a powerful anti-inflammatory effect. A single dose of 110 mcg provides a significant improvement in the patient's well-being (reduction of rhinorrhea, nasal congestion, sneezing, itching in the nose, relief of eye symptoms such as itching, burning, tearing and redness of the eyes). Improvement in nasal and ocular symptoms is observed 8 hours after the first administration and persists for a full 24 hours after a single daily administration of the drug. Avamis improves the quality of life of patients, including physical and social activity. Indications for use - treatment of symptoms of allergic rhinitis in adults and children over 6 years of age. Method of administration and dosage Avamis is intended for intranasal administration only. To obtain complete therapy, it is recommended to use the drug according to the schedule described below. The onset of action of the drug is observed within 8 hours after the first administration, however, it may take several days before the maximum effect is achieved, about which the patient should be warned. The duration of therapy should be limited to the period of allergic exposure. Adults and adolescents over 12 years of age The initial recommended dose is two sprays into each nasal passage once a day (total daily dose 110 mcg). As the symptoms of the disease are controlled, the dose is reduced to 1 injection into each nostril once a day (55 mcg per day). The dose should be titrated to the lowest dose that achieves symptom control. Children from 6 to 11 years old One injection (27.5 mcg) into each nasal passage 1 time per day (55 mcg per day). If there is no effect with this dosing regimen, the daily dose of the drug can be increased to 110 mcg per day, but the daily dose should not exceed 2 injections into each nasal passage. As the symptoms of the disease are controlled, the dose is reduced to 1 injection into each nostril once a day (55 mcg per day). Children under 6 years of age There is limited experience with this category of people. There are no data on efficacy and safety in this cohort of individuals. Elderly No dose adjustment is required. Use for renal failure No dose adjustment is required. Use for liver failure No dose adjustment is required for mild to moderate liver failure. There are no data on the use of the drug in severe liver failure, but caution should be exercised when using it, since this cohort of individuals has a greater risk of developing systemic adverse reactions associated with the use of corticosteroids. Instructions for use of Avamys are in a glass bottle placed in a plastic case. The case has a window that allows you to see the remainder of the drug in the bottle. When the button is pressed firmly, the suspension is sprayed through the tip. The tip is protected by a cap. Check during use Before use, you should carefully shake the bottle, take it by placing your index and middle fingers on either side of the tip, and your thumb under the bottom. When using the drug for the first time, you should check the serviceability of the nebulizer. Point the tip away from you and press at least 6 times until a small cloud appears from the tip. The device should be retested only if the bottle has been stored without a cap for 5 days and if the drug has not been used for 30 days. How to use the spray You need to clear your nose (blow your nose lightly). Close one nasal passage and insert the tip into the other nasal passage. Tilt your head slightly forward while continuing to hold the bottle vertically. Then you should begin to inhale through your nose and, continuing to inhale, press the button once with your finger to spray the drug. Exhale through your mouth. Repeat the procedure for a second spray into the same nasal passage, if necessary. Next, repeat the described procedure completely, inserting the tip into the other nasal passage. After use, blot the tip and button with a dry, clean cloth. Put on the protective cap. Do not wash in water. Side effects The adverse reactions listed below are grouped by frequency of occurrence: very common (>1/10), common (>1/100, <1/10), uncommon (>1/1000, <1/100), rare ( ≥1/10,000 and <1/1000), very rare (<1/10,000). Very common - nosebleeds In adults and adolescents, nosebleeds are more common with long-term use of the drug (more than 6 weeks) than with short-term use. In children, no relationship was observed between bleeding and duration of therapy. Common - headache - ulceration of the nasal mucosa Uncommon - pain, increased sensitivity, dryness, burning, irritation in the nasal passages, discomfort, including nosebleeds Rare - hypersensitivity reactions, including anaphylactic reactions, vascular edema, rash and urticaria Not known - growth retardation in children (in a one-year clinical study in prepubertal children receiving Avamis at a dose of 110 mcg per day, the average growth retardation was -0.27 cm compared to the placebo group) Contraindications - hypersensitivity to any of the components of the drug - combined use with ritonavir - children under 6 years of age Drug interactions Caution should be exercised when using Avamys simultaneously with strong inhibitors of the CYP3A4 enzyme. Co-administration with a CYP3A4 inhibitor such as ritonavir is not recommended due to the potential risk of increased systemic elimination of fluticasone furoate. The CYP3A4 inhibitor ketoconazole may increase plasma concentrations of fluticasone (in clinical studies, when compared, the ketoconazole group observed more frequent increases in plasma fluticasone levels (6 of 20 patients) than placebo (1 of 20 patients), which generally did not affect difference in fluticasone concentration during 24-hour monitoring of the two groups). There is no reason to assume any metabolic interactions or inhibitory effects between Avamys and the metabolism of other drugs mediated by cytochrome P450, but clinical studies have not been conducted to study this interaction. Special instructions The drug is indicated for intranasal use only. For full therapeutic effect, a regular treatment regimen is recommended. It may take several days to achieve maximum effect. Systemic effects of the drug are possible, mainly when using doses higher than recommended, as well as with long-term use of the drug. Systemic effects are much lower than with oral corticosteroids and may vary between patients. Potential systemic effects may include Cushing's syndrome, development of Cushingoid symptoms, adrenal suppression, growth retardation in children and adolescents, cataracts, glaucoma and, in rarer cases, psychological and behavioral effects (psychomotor hyperreactivity, sleep disturbance, anxiety, depression, aggression - mainly in children). Use of the drug in doses higher than recommended may lead to clinically significant suppression of adrenal function. If symptoms consistent with adrenal suppression develop, the use of systemic corticosteroids during periods of stress or surgery should be considered. The use of Avamys at a dose of 110 mcg per day did not cause disorders of the hypothalamic-pituitary-adrenal axis in adults, children and adolescents; however, once control of rhinitis symptoms is achieved, the dose should be reduced to the minimum effective dose. As with other intranasal corticosteroids, the total systemic load should be assessed during concomitant use of other forms of corticosteroids. If there is suspicion of adrenal dysfunction, caution must be exercised when transferring patients from treatment with systemic corticosteroids to Avamys. Intranasal and inhaled corticosteroids may cause the development of glaucoma and/or cataracts. Careful monitoring of patients with complaints of changes in visual function or with increased intraocular pressure, glaucoma and/or cataracts in the anamnesis is necessary. Cases of growth retardation have been identified in children receiving the drug in recommended doses (110 mcg per day), and therefore it is recommended to regularly monitor the growth of children on long-term therapy with intranasal corticosteroids. If growth retardation is detected, therapy should be reconsidered in order to reduce the dose received to the minimum effective dose. Consultation with a pediatrician is also necessary. Avamys contains benzalkonium chloride, which may cause irritation to the nasal mucosa. Co-administration with ritonavir is not recommended due to the increased risk of systemic effects of fluticasone furoate. Renal impairment Fluticasone furoate is not detected in the urine of healthy people after intranasal administration. Less than 1% is excreted in the urine and, therefore, renal impairment does not affect the pharmacokinetics of fluticasone furoate. Hepatic Impairment An average dose of 110 mcg in patients with moderate hepatic impairment does not suppress cortisol production. In patients with severe liver failure, caution should be exercised when prescribing Avamys due to the possibility of a more frequent development of systemic adverse reactions. Pregnancy and lactation When using the drug at a dose of 110 mcg per day, the concentration of fluticasone furoate in plasma could not be determined, and therefore the potential risk of toxic effects on the fetus is very low. However, the use of Avamis during pregnancy is only possible if the expected benefit to the mother outweighs the potential risk to the fetus. It is unknown whether fluticasone is excreted in breast milk; therefore, the use of Avamis is possible only when the expected benefit to the mother outweighs the potential risk to the child. Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms No special studies have been conducted; the drug’s effect on the ability to drive a vehicle or potentially dangerous mechanisms is not expected. Overdose Symptoms: When using doses exceeding the recommended dose for adults by 24 times for 3 days, no systemic adverse reactions were observed. Treatment: In acute overdose, it is unlikely that any therapy other than observation will be necessary. Release form and packaging Dosed nasal spray 27.5 mcg/dose, 120 doses in a bottle. The bottle with the dispensing device is placed in a whitish plastic case. One bottle along with instructions for use in the state and Russian languages is placed in a cardboard box. Storage conditions Store at a temperature not exceeding 30 °C. Do not freeze. After first opening, store for no more than 2 months. Keep out of the reach of children! Shelf life: 3 years Do not take the drug after the expiration date. Conditions for dispensing from pharmacies By prescription

Indications for use

Officially, Avamis does not treat the disease, but eliminates the symptoms of exclusively seasonal and year-round allergic rhinitis in adults and children over 2 years of age. Relatively recently, studies began on the feasibility of using the drug to relieve acute symptoms of bronchial asthma.

As an additional short-term therapy, hormonal nasal drops are sometimes used to treat other conditions. Due to its ability to relieve swelling, the drug is popular among ENT doctors.

Any inflammation of the nasal mucosa is accompanied by mucus secretion. Prolonged colds, left unattended, often lead to the addition of a secondary infection and the development of drug-allergic rhinitis. In this case, the prescription of corticosteroids is justified.

Is it possible to have Avamis for green snot? Green, yellow, or brown colored nasal mucus is often caused by a bacterial infection. The use of hormonal sprays in the treatment of runny nose in adults and children is acceptable in complex therapy. The drug helps against green snot, as it prevents the accumulation of pus in the nasal cavity.

Why is Avamis prescribed:

eliminating the symptoms of allergic rhinitis;
improvement in vasomotor rhinitis;
relieving nasal congestion during bacterial and viral runny nose;
facilitating secretion in the treatment of sinusitis, sphenoiditis, frontal sinusitis, ethmoiditis, severe runny nose;
reducing swelling, ear congestion due to otitis, eustachitis;
relieving inflammation, hypertrophy, tissue hyperplasia with adenoiditis, tonsillitis, enlarged tonsils, accompanied by thick snot.

Indications for taking corticosteroids are also chronic runny nose, prolonged rhinitis, aggravated by loss of smell. But it is prohibited to use sprays or nasal drops based on hormones on your own for a viral infection, colds or even flu.

The benzalkonium chloride contained in the composition, if the dose is incorrectly selected or the duration of use of the spray, can damage tissues. In order not to look for a means to restore the nasal mucosa later, the spray is prescribed by a doctor.

Can Avamys be dripped into the ear? No, the drug must be sprayed only into the nose. The use of an ear product is aimed at reducing swelling in the Eustachian tube and reducing pressure in the inner ear.

One of the proven advantages of fluticasone furoate is the ability to relieve conjunctival lesions in allergic rhinitis: burning, redness, tearing in the eyes. However, Avamys is not an eye drop.

Is it possible to spray Avamys in the throat? No, the drug is designed for intranasal use. That is, its area of action is the nasal mucosa. By removing swelling, the drug improves the discharge of secretions, mucus does not flow into the throat, and as a result, the cough disappears. But you can’t use it for cough either.

Avamis nasal spray 27.5 mcg/dose 120 doses bottle 1 pc. in Moscow

Intranasally.

To achieve maximum therapeutic effect, it is necessary to adhere to a regular regimen of use. The onset of action can be observed within 8 hours after the first administration. It may take several days to achieve maximum effect. The lack of immediate effect should be carefully explained to the patient.

For the symptomatic treatment of seasonal and perennial allergic rhinitis

Adults and teenagers (12 years and older):

The recommended initial dose is 2 sprays (27.5 mcg of fluticasone furoate in 1 spray) into each nostril once a day (110 mcg/day). Once adequate symptom control is achieved, reducing the dose to 1 spray in each nostril once daily (55 mcg/day) may be effective for maintenance treatment.

Children from 2 to 11 years old:

The recommended initial dose is 1 injection (27.5 mcg of fluticasone furoate per injection) into each nostril once a day (55 mcg/day). If there is no desired effect with 1 spray into each nostril once a day, the dose can be increased to 2 sprays into each nostril once a day (110 mcg/day). Once adequate control of symptoms is achieved, it is recommended to reduce the dose to 1 spray in each nostril once a day (55 mcg/day).

Children under 2 years old:

There is insufficient data to recommend the use of intranasal fluticasone furoate as a treatment for seasonal and perennial allergic rhinitis in children under 2 years of age.

Elderly patients:

no dose adjustment is required.

Patients with impaired renal function:

no dose adjustment is required.

Patients with impaired liver function:

No dose adjustment is required in patients with mild to moderate liver dysfunction. There are no data on use in patients with severe liver dysfunction.

Instructions for use of nasal spray

To spray, press the spray button firmly. The removable cap protects the sprayer from dust and clogging.

Six important facts about the drug

The nasal spray is available in orange glass bottles. In order to check the level of the drug in the bottle, you need to look through it into the light. The level will be visible through the viewing window.
If the nasal spray is used for the first time, shake the bottle well for 10 seconds without removing the cap. The drug is a rather thick suspension and becomes more liquid when shaken. Injection is only possible after shaking.
To inject, you must press the button firmly.
If you cannot press the button with one thumb, you must use the fingers of both hands.
Always keep the nasal spray bottle closed. The cap protects the atomizer from dust and clogging and seals the bottle. In addition, the cap prevents accidental pressing of the button.
Do not attempt to clean the tip hole with a pin or other sharp object. They can damage the spray bottle.

Preparation for use should be carried out if:

the spray is used for the first time;
or the bottle was left open.

Proper preparation for using the spray will ensure that the required dose of the drug is injected.

Before use:

Without removing the cap, shake the bottle well for 10 s;
remove the cap by gently pulling it with your thumb and forefinger;
it is necessary to hold the bottle vertically and point the tip away from you;
Press the button firmly and press several times (minimum 6) until a small cloud appears from the tip.

Using a nasal spray

It is necessary to shake the bottle thoroughly.
Remove the cap.
Clear your nose and tilt your head slightly forward.
Insert the tip into one nostril, continuing to hold the bottle vertically (Figure 7).
Point the tip of the sprayer at the outer wall of the nose, not at the nasal septum. This will ensure proper injection of the drug.
Start inhaling through your nose and press once with your finger to inject the drug (Figure 8).
Avoid getting the spray in your eyes! If the drug gets into your eyes, rinse them thoroughly with water.
Remove the atomizer from your nostril and exhale through your mouth.
If, according to the doctor’s recommendation, it is necessary to make 2 injections into each nostril, you must repeat steps 4–6.
Repeat the procedure for the other nostril.
Close the bottle with a cap.

Sprayer care

After each use:

blot the tip and the inner surface of the cap with a dry, clean cloth (Figure 9 and 10), avoid contact with water;
Never try to clean the tip hole with a pin or other sharp objects;
You must always close the bottle; the cap protects the sprayer from dust and clogging and seals the bottle.

If the sprayer does not work:

it is necessary to check the level of the remaining drug in the bottle through the viewing window; if there is only a small amount of liquid left, it may not be enough for the sprayer to work;
check the bottle for damage;
check whether the tip hole is clogged; Do not try to clean the tip hole with a pin or other sharp objects;
you must try to activate the device by repeating the procedure for preparing the nasal spray for use.

Contraindications

In case of hypersensitivity or individual intolerance to fluticasone furoate or any other component of the composition indicated in the annotation to the instructions, Avamis should not be used. Do not prescribe hormonal sprays and drops for a runny nose in children under 2 years of age.

Among the general contraindications to the use of hormonal drugs are:

herpes viruses, especially type 4, which causes mononucleosis;
respiratory tuberculosis;
recent therapy with Ritonavir (in patients with HIV infection);
surgical interventions on the nasopharynx.

These conditions severely suppress the immune system. Corticosteroids have immunosuppressive properties, which are the key to treating true allergies. But increasing this load on the body has a negative impact on health.

Is it possible to have Avamis at a fever? There is no reliable data on the effect of the drug in hyperthermia. In order to reduce fever, hormonal intranasal sprays are not used.

Use during pregnancy and lactation

There is no exact data on the effect of fluticasone furoate on the body of pregnant and breastfeeding women. There are no data on the effects of Avamys on human fertility.

Available information comes from animal studies. In experimental subjects carrying offspring, drugs from the group of corticosteroids caused intrauterine malformations. The release of the active substance into breast milk has not been studied.

The use of Avamis for the treatment of women during pregnancy and lactation is permissible only if the possible benefit to the mother is higher than the risk to the child.

Directions for use and doses

A drug based on fluticasone furoate is prescribed for the treatment of runny nose caused by a reaction to an allergen in adults and children. The suspension is administered exclusively intranasally, injecting it into each nasal passage. One spray corresponds to 1 dosage and contains 27.5 mcg of active substance.

At what age can Avamis be used? The drug is prescribed to children from two years of age. Before this period, there is no supporting information on the advisability of using fluticasone furoate. In patients under 2 years of age, intranasal glucocorticosteroids are not administered for the treatment of allergic rhinitis.

For children over 12 years of age and adults, the recommended daily dose of Avamis is 110 mcg. That is, 2 injections into each nasal passage once a day (27.5 * 2 injections * 2 nostrils). For elderly patients, patients with moderate and moderate liver dysfunction, kidney dysfunction, the drug is prescribed in the same amount.

To prevent exacerbations and maintain the achieved therapeutic effect, the daily dose can be halved, to 55 mcg once. That is, 1 injection into each nasal passage once a day.

When is it better to take Avamys in the morning or at night? The time of administration of the drug has no fundamental influence on the result. It is important that each subsequent spraying is carried out at the same time of day. An individually possible regimen is 2 doses 2 times a day - 1 spray, each of which corresponds to a dose of 27.5 mcg, morning and evening.

For children over 2 years of age, the recommended daily dose of Avamis is 55 mcg - 1 injection into each nostril once a day. In the absence of a positive effect, a temporary increase in the drug received is allowed up to 2 sprays into each nasal passage daily (110 mcg). After the elimination of acute symptoms, you must return to the initial dose.

How many days is the course of treatment with Avamys? The treatment and administration regimen is determined individually. Like all hormonal agents, fluticasone furoate has a cumulative effect. To relieve nasal and ocular symptoms of seasonal and year-round rhinitis, the minimum duration of treatment is usually 2 weeks to a month.

The duration of use of Avamis often coincides with the time of action of the irritant. For example, for seasonal allergies in the spring, it is used throughout the entire period of ragweed flowering.

Is it possible to blow your nose after Avamis? According to studies, most of the drug administered intranasally is removed during the natural process of clearing the airways (mucociliary clearance) and is ultimately swallowed. This does not affect the effectiveness of Avamis. Therefore, blowing your nose after spraying should not reduce the effect. But if you clean your nose before administering the spray, then the desire to blow your nose will be minimal.

The method of using the intranasal spray is simple. Before use, you must prepare a bottle of suspension. It is better to inject after preliminary toileting of the nasal passages.

How to use Avamis correctly if your nose can’t breathe:

15-30 minutes before using the spray, if there is severe congestion, drip a vasoconstrictor that pierces the nose;
clear the passages of mucus, rinse them if necessary;
tilt your head slightly forward and insert the tip of the bottle into the nostril;
simultaneously inhale and spray Avamis by pressing the special button;
when injecting, try to direct the jet not at the partition, but at the opposite wall of the passage;
repeat the procedure from the second nostril.

For patients with impaired renal function, moderate and moderate impairment of liver function, no dose adjustment of the spray is necessary. Elderly people take the drug in the usual adult concentration.

After what time can the course of treatment with Avamys be repeated? The frequency of use of intranasal glucocorticoid is determined by the doctor, individually based on the stage of the disease. Long-term, year-long use of the spray with constant monitoring of the condition and breaks for 1-2-4 months is allowed.

Avamys itself does not relieve nasal congestion within half an hour, unlike vasoconstrictor drops. But when used correctly, it provides free breathing for a long time, without the need for frequent injections.

What to do if Avamis doesn’t help? The remedy does not begin to act immediately; it takes time to relieve nasal congestion, usually 1-2 days. According to the experience of patients who have been helped by Avamis, complete control of allergy symptoms is achieved only after using it as a course.

Cases of lack of effect occur when the drug is irrationally prescribed. Additional research is required and the treatment regimen needs to be changed. If the spray no longer helps, it is worth checking the expiration date and storage conditions.

How many times a year can Avamys be used? The frequency and duration of each course of the drug is determined by the doctor. There are known cases of 18 months of continuous use. Typically, a spray is prescribed for each exacerbation of allergic rhinitis.

Instructions for use AVAMYS™

The drug is used only intranasally.

To achieve the full therapeutic effect, it is recommended to adhere to a regular regimen of use. The onset of action can be observed within 8 hours after the first administration. It may take several days to achieve maximum effect. The patient should be explained that the symptoms of the disease will improve with continued regular use. The duration of treatment should be limited to the period of exposure to the allergen.

Adults and teenagers (ages 12 and older)

The recommended initial dose is 2 sprays (27.5 mcg of fluticasone furoate per spray) into each nostril 1 time per day (110 mcg/day).

Once adequate symptom control is achieved, reducing the dose to 1 spray in each nostril once a day (55 mcg/day) may be sufficient to maintain the effect.

The dose should be titrated to the lowest dose that provides effective symptom control.

Children aged 6 to 11 years

The recommended initial dose is 1 spray (27.5 mcg of fluticasone furoate in one spray) in each nostril 1 time / day (55 mcg / day).

If there is no desired effect when using 1 spray in each nostril 1 time/day, the dose can be increased to 2 sprays in each nostril 1 time/day (110 mcg/day). Once adequate control of symptoms is achieved, it is recommended to reduce the dose to 1 spray in each nostril once a day (55 mcg/day).

Children under 6 years of age

The safety and effectiveness of fluticasone furoate in this category of patients have not been established. It is not possible to give dosage recommendations.

In elderly patients

no dose adjustment is required.

In patients with impaired renal function

no dose adjustment is required.

In patients with impaired liver function

no dose adjustment is required (see section “Pharmacokinetics”).

Instructions for using nasal spray

Description of nasal spray

The drug is available in orange glass bottles, which are in plastic cases. The drug is available in bottles of 30, 60 and 120 doses (Fig. a).

The indicator window in the plastic package allows you to control the level of the drug in the bottle. In bottles of 30 or 60 doses, the drug level will be visible immediately (Fig. a), and in bottles of 120 doses, the initial level of the drug is above the upper limit of the viewing window.

To inject, you must press the spray button firmly.

The removable cap protects the sprayer from dust and clogging.

Six important facts about the drug

1. Nasal spray is available in orange glass bottles. In order to check the level of the drug in the bottle, you need to hold it up to the light. The level will be visible through the viewing window.

2. When using the nasal spray for the first time, shake the bottle well for 10 seconds without removing the cap. The drug is a rather thick suspension and becomes more liquid when shaken (Fig. b). Spraying is only possible after shaking.

3. To inject, you must press the button firmly (Fig. c).

4. If you cannot press the button with one thumb, you should use the fingers of both hands (Fig. d).

5. Always keep the nasal spray bottle closed. The cap protects the atomizer from dust and clogging and seals the bottle. In addition, the cap prevents accidental pressing of the button.

6. Never attempt to clean the tip hole with a pin or other sharp object. They can damage the spray bottle.

Preparing the spray for use

Preparation for use should be carried out if:

the spray is used for the first time;
the bottle remained open for 5 days;
the bottle has not been used for 30 days or more.

Proper preparation for using the spray will ensure that the required dose of the drug is injected.

Before use:

Without removing the cap, shake the bottle well for 10 seconds;
remove the cap by gently pulling it with your thumb and forefinger (Fig. e).

hold the bottle vertically and point the tip away from you;
press the button firmly. Press several times (minimum 6) until a small cloud appears from the tip (Fig. f).

- Now the spray is ready for use.

Using a nasal spray

1. Shake the bottle thoroughly.

2. Remove the cap.

3. Clear your nose and tilt your head slightly forward.

4. Insert the tip into one nostril, continuing to hold the bottle vertically (Fig. g).

5. Point the tip of the sprayer at the outer wall of the nose, not at the nasal septum. This will ensure proper injection of the drug.

6. Start inhaling through your nose and press once with your fingers to spray the drug (Fig. h).

7. Avoid getting the spray in your eyes. If the drug gets into your eyes, rinse them thoroughly with water.

8. Remove the atomizer from your nostril and exhale through your mouth.

9. If, according to the doctor’s recommendation, it is necessary to make 2 injections into each nostril, you should repeat steps 4-6.

10. Repeat the procedure for the other nostril.

11. Close the bottle with a cap.

Sprayer care

After each use:

Blot the tip and the inside of the cap with a dry, clean cloth (Fig. i and j). Avoid contact with water;

Never try to clean the tip hole with a pin or other sharp objects;
The bottle should always be closed. The cap protects the atomizer from dust and clogging, and seals the bottle.

If the sprayer does not work:

Check the level of the remaining drug in the bottle through the viewing window. If there is only a small amount of liquid left, it may not be enough to operate the sprayer;
check the bottle for damage;
Check to see if the tip hole is clogged. Do not attempt to clean the tip hole with a pin or other sharp object.

— try to activate the device by repeating the procedure for preparing the nasal spray for use.

Side effect

One of the main problems of all hormonal drugs is withdrawal syndrome. That is, if you abruptly stop using the drug, the symptoms of the disease return again. According to statistics, snot is rare after Avamis. To exclude them, it is better to adhere to the end of treatment regimen chosen by the doctor.

How to cancel Avamis:

upon completion of the prescribed course, take a break of 1 day;
from the second day, give every other day, 10 times;
then give 10 more times, but with a break of 2-3 days;
Thus, gradually increasing the break, discontinue the spray.

Second option: after the course of treatment, continue to use the drug for another 2 weeks, but alternating nostrils daily. That is: 1 day – 1 injection into 1 nasal passage. Then change nostrils with a daily break for another week.

When snot starts flowing after several uses of Avamis, this indicates an individual allergic reaction to the drug. If the discharge occurs after stopping treatment, then in addition to withdrawal syndrome, there is a possibility of symptoms of ARVI. It is possible to catch a cold at the very beginning of taking the medicine. The cause of nasal discharge can be determined by the general condition. If you have a fever after Avamis, then most likely your body has caught an infection.

Is Avamys harmful? How harmful glucocorticoids are and how they are tolerated is determined by the extent of their absorption into the systemic circulation. The low bioavailability of Avamis (no more than 0.5%) indicates a low risk of side effects on the body. However, some adverse events are present in clinical studies and post-marketing surveillance. Their list will help determine the pros and cons of using Avamis.

The most common side effect is nosebleeds, 1 in 10. It is more common when using the spray for longer than 6 weeks. In one case out of a hundred, ulceration of the nasal mucosa, headache and dizziness may occur. Dry mouth and nostrils, discomfort, burning occur once in 1000. Even less often, no more than 1 in 10,000, there are hypersensitive reactions: rash, urticaria, Quincke's edema, anaphylactic shock.

The incidence of severe systemic side effects has not been determined. Taking glucocorticoids can provoke transient visual impairment, glaucoma, cataracts, and growth retardation in children. A decrease in prothrombin after Avamis, taken as directed and in accordance with the instructions, and an associated deterioration in blood clotting, were not encountered.

The connection between Avamys and weight gain, attributed to the effect of steroid hormones on the hypothalamic-pituitary-adrenal axis (HPA), is questionable. The development of Cushing-Cushing syndrome, characterized by obesity, arterial hypertension and other numerous disorders in the functioning of the whole organism, is unlikely. Therefore, to say that Avamis increases blood pressure and promotes weight gain is justified only when taking other hormonal drugs at the same time.

Severe side effects of glucocorticoid therapy occur with severe depression of the body, usually administered orally or parenterally (more details in the “special instructions” section). In the case of Avamys, the load on the body with a synthetic hormone is minimal, and therefore the likelihood of developing unwanted reactions is low.

Avamys 27.5mcg/dose 120doses nasal spray glaxo operations uk limited

pharmachologic effect

Anti-inflammatory local.

Description of the dosage form

Spray: homogeneous white suspension.

Directions for use and doses

Intranasally.

To achieve maximum therapeutic effect, it is necessary to adhere to a regular regimen of use. The onset of action can be observed within 8 hours after the first administration. It may take several days to achieve maximum effect. The lack of immediate effect should be carefully explained to the patient.

For the symptomatic treatment of seasonal and perennial allergic rhinitis

Adults and adolescents (12 years and older): The recommended initial dose is 2 sprays (27.5 mcg of fluticasone furoate per spray) into each nostril once a day (110 mcg/day). Once adequate symptom control is achieved, reducing the dose to 1 spray in each nostril once daily (55 mcg/day) may be effective for maintenance treatment.

Children from 2 to 11 years: the recommended initial dose is 1 spray (27.5 mcg of fluticasone furoate in 1 spray) into each nostril 1 time per day (55 mcg/day). If there is no desired effect with 1 spray into each nostril once a day, the dose can be increased to 2 sprays into each nostril once a day (110 mcg/day). Once adequate control of symptoms is achieved, it is recommended to reduce the dose to 1 spray in each nostril once a day (55 mcg/day).

Children <2 years of age: There are insufficient data to recommend the use of intranasal fluticasone furoate as a treatment for seasonal and perennial allergic rhinitis in children <2 years of age.

Elderly patients: no dose adjustment is required.

Patients with impaired renal function: no dose adjustment is required.

Patients with hepatic impairment: No dose adjustment is required in patients with mild to moderate hepatic impairment. There are no data on use in patients with severe liver dysfunction.

Instructions for use of nasal spray

Description of the nasal spray: the drug is available in orange glass bottles of 30, 60 and 120 doses, which are in plastic cases.

To spray, press the spray button firmly. The removable cap protects the sprayer from dust and clogging.

Six important facts about the drug

1. Nasal spray is available in orange glass bottles. In order to check the level of the drug in the bottle, you need to look through it into the light. The level will be visible through the viewing window.

2. If the nasal spray is used for the first time, shake the bottle well for 10 seconds without removing the cap. The drug is a rather thick suspension and becomes more liquid when shaken. Injection is only possible after shaking.

3. To inject, you must press the button firmly

4. If you cannot press the button with one thumb, you must use the fingers of both hands.

5. Always keep the nasal spray bottle closed. The cap protects the atomizer from dust and clogging and seals the bottle. In addition, the cap prevents accidental pressing of the button.

6. Do not attempt to clean the tip hole with a pin or other sharp object. They can damage the spray bottle.

Preparation for use should be carried out if:

— the spray is used for the first time;

- or the bottle was left open.

Proper preparation for using the spray will ensure that the required dose of the drug is injected.

Before use:

— without removing the cap, shake the bottle well for 10 s;

- remove the cap by smoothly pulling it with your thumb and forefinger;

— it is necessary to hold the bottle vertically and point the tip away from you;

— press the button forcefully, make several presses (minimum 6) until a small cloud appears from the tip.

Using a nasal spray

1. Shake the bottle thoroughly.

2. Remove the cap.

3. Clear your nose and tilt your head slightly forward.

4. Insert the tip into one nostril, continuing to hold the bottle vertically.

5. Point the tip of the sprayer at the outer wall of the nose, not at the nasal septum. This will ensure proper injection of the drug.

6. Start inhaling through your nose and press once with your finger to inject the drug.

7. Avoid getting the spray in your eyes! If the drug gets into your eyes, rinse them thoroughly with water.

8. Remove the atomizer from your nostril and exhale through your mouth.

9. If, according to the doctor’s recommendation, it is necessary to make 2 injections into each nostril, you must repeat steps 4–6.

10. Repeat the procedure for the other nostril.

11. Close the bottle with a cap.

Sprayer care

After each use:

— blot the tip and the inner surface of the cap with a dry, clean cloth; avoid contact with water;

— you should never try to clean the tip hole with a pin or other sharp objects;

— you must always close the bottle; the cap protects the sprayer from dust and clogging and seals the bottle.

If the sprayer does not work:

— it is necessary to check the level of the remaining drug in the bottle through the viewing window; if there is only a small amount of liquid left, it may not be enough for the sprayer to work;

— check the bottle for damage;

— check whether the tip hole is clogged; Do not try to clean the tip hole with a pin or other sharp objects;

— you must try to activate the device by repeating the procedure for preparing the nasal spray for use.

Pharmacodynamics

Fluticasone furoate, a synthetic trifluorinated corticosteroid with high affinity for corticosteroid receptors, has a pronounced anti-inflammatory effect.

Pharmacokinetics

Suction. Fluticasone furoate is not completely absorbed, undergoing first-pass metabolism in the liver, resulting in negligible systemic exposure. Intranasal administration of 110 mcg once daily usually results in unmeasurable plasma concentrations (

Distribution. Fluticasone furoate is more than 99% bound to plasma proteins. When the Css Vd of fluticasone furoate is reached, it averages 608 l.

Metabolism. Fluticasone furoate is rapidly eliminated from the systemic circulation (total plasma clearance 58.7 l), mainly through metabolism in the liver with the formation of an inactive 17β-carboxyl metabolite (GW694301X) with the participation of the CYP3A4 enzyme of the cytochrome P450 system. The main route of metabolism is hydrolysis of the S-fluoromethylcarbothioate group with the formation of a 17β-carboxylic acid metabolite. In vivo studies have shown that fluticasone furoate is not degraded to fluticasone.

Excretion. Excretion of fluticasone furoate and its metabolites when administered orally and intravenously is carried out primarily through the intestines, which reflects their excretion in the bile. About 1 and 2% are excreted by the kidneys after oral administration and intravenous administration, respectively.

Special patient groups

Elderly patients: Pharmacokinetic data are presented only for a small number of elderly patients (n=23/872; 2.6%). There is no evidence that quantifiable concentrations of fluticasone furoate are higher in elderly patients than in younger patients.

Children: Fluticasone furoate is usually found in concentrations that are not quantifiable (

Patients with impaired renal function: Fluticasone furoate was not detected in the urine of healthy volunteers after intranasal administration. Less than 1% of metabolites are excreted via the kidneys, so renal impairment theoretically cannot affect the pharmacokinetics of fluticasone furoate.

Patients with hepatic impairment: A study in patients with moderate hepatic impairment receiving 400 mcg of fluticasone furoate as a single inhalation showed a 42% increase in Cmax and a 172% increase in AUC0-∞ compared to healthy volunteers. Based on the study results, on average, the estimated exposure to intranasal fluticasone furoate 110 mcg in this patient population would not result in cortisol suppression. Therefore, mild hepatic impairment is not likely to result in clinically significant effects at the standard adult dose.

Other pharmacokinetic parameters: Concentrations of fluticasone furoate are not routinely determined (

No dependence on gender, age (including childhood), or race was noted in cases where concentrations were above or below the detection threshold.

Indications for use Avamys 27.5 mcg/dose 120 doses nasal spray glaxo operations uk limited

Symptomatic treatment of seasonal and year-round allergic rhinitis in adults and children over 2 years of age.

Contraindications

Hypersensitivity to fluticasone furoate or any other components of the drug.

With caution: severe liver dysfunction (the pharmacokinetics of fluticasone furoate may vary).

Use of Avamys 27.5 mcg/dose 120 doses nasal spray glaxo operations uk limited during pregnancy and lactation

There is insufficient data on the use of fluticasone furoate during pregnancy and lactation in women. Fluticasone furoate can be used in pregnant women only if the expected benefit to the mother outweighs the potential risk to the fetus.

The excretion of fluticasone furoate in human breast milk has not been studied. Fluticasone furoate can be used in nursing women only if the expected benefit to the mother outweighs the potential risk to the baby.

special instructions

Fluticasone furoate undergoes primary metabolism in the liver via the cytochrome CYP3A4 isoenzyme. Therefore, the pharmacokinetics of fluticasone furoate may be altered in patients with severe hepatic impairment.

Overdose

Symptoms: In a study of the bioavailability of the drug when administered intranasally, doses 24 times higher than the recommended dose for adults were used for more than 3 days, and no adverse systemic reactions were observed.

Treatment: It is unlikely that acute overdose will require measures other than medical supervision.

Side effects Avamys 27.5mcg/dose 120dose nasal spray glaxo operations uk limited

The adverse events presented below are listed depending on body systems and frequency of occurrence. The frequency of occurrence is defined as follows: very often (≥1/10), often (≥1/100 and

From the respiratory system, chest and mediastinal organs: very often - nosebleeds; In adults and adolescents, cases of nosebleeds were observed more often with long-term use (more than 6 weeks) than with a short course (up to 6 weeks). In studies in children with treatment durations of up to 12 weeks, the incidence of epistaxis was similar in the fluticasone furoate and placebo groups; often - ulceration of the nasal mucosa.

Immune system disorders: hypersensitivity reactions, including anaphylaxis, angioedema, rash, urticaria.

Drug interactions

Fluticasone furoate is rapidly metabolized in the liver via the cytochrome P450 isoenzyme CYP3A4. In a drug interaction study between fluticasone furoate and the CYP3A4 inhibitor ketoconazole, more cases of fluticasone furoate plasma concentrations above threshold were observed in the ketoconazole group (6 of 20 patients) compared with placebo (1 of 20 patients). This small increase did not result in a statistically significant difference in 24-hour plasma cortisol between the two groups.

Based on theoretical data, there is no suggestion of any drug interactions between fluticasone furoate, administered intranasally, and other drugs that are metabolized with the participation of the cytochrome P450 system. Thus, clinical studies have not been conducted to study the interaction of fluticasone furoate and other drugs.

Based on data obtained in a study with another medicinal product containing corticosteroids, which is also metabolized by isoenzymes of the cytochrome CYP3A4 system, co-administration with ritonavir is not recommended due to the potential risk of increased systemic exposure to fluticasone furoate.

special instructions

Children receiving 110 mcg of fluticasone furoate every day for a year were diagnosed with growth retardation. But the information does not describe the exact statistics of the development of the pathology, since there is no data on the final indicators. If long-term use of Avamis is necessary, it is important to regularly monitor the child’s health and whether the growth rate meets the norms.

Fluticasone furoate spray should be used with caution in patients with significant adrenal dysfunction. Combined treatment with ritonavir and Avamys is not recommended due to the high risk of increasing systemic concentrations of the hormone. Both warnings are based on studies of the effects of other glucocorticosteroids, but broken down similarly to fluticasone furoate.

Avamys nasal spray 27.5 µg/dose 120 doses fl

Pharmacological group:

Glucocorticosteroid for local use.
Pharmacological properties:
Fluticasone furoate is a synthetic trifluorinated glucocorticosteroid with high affinity for glucocorticosteroid receptors and has a pronounced anti-inflammatory effect.

Pharmacokinetics:

Suction.

Fluticasone furoate is not completely absorbed, undergoing first-pass metabolism in the liver, resulting in negligible systemic exposure. Intranasal administration of 110 mcg once daily does not usually result in measurable plasma concentrations (

Distribution.

Fluticasone furoate is more than 99% bound to plasma proteins. When equilibrium concentration is reached, the volume of distribution of fluticasone furoate averages 608 liters.

Metabolism.

Fluticasone furoate is rapidly eliminated from the systemic circulation (total plasma clearance 58.7 l), mainly through metabolism in the liver with the formation of an inactive 17p-carboxyl metabolite (GW694301X) with the participation of the CYP3A4 enzyme of the cytochrome P450 system. The main route of metabolism is the hydrolysis of the S-fluoromethylcabrothioate group with the formation of a 17P-carboxylic acid metabolite.

In vivo studies have shown that fluticasone furoate is not degraded to fluticasone.

Excretion.

Excretion of fluticasone furoate and its metabolites when administered orally and intravenously is primarily through the intestines, which reflects their excretion in bile. About 1% and 2% are excreted by the kidneys after oral administration and intravenous administration, respectively.

Special groups of patients.

Elderly patients.

Pharmacokinetic data are presented only for a small number of elderly patients (n=23/872; 2.6%). There is no evidence that quantifiable concentrations of fluticasone furoate are higher in elderly patients than in younger patients.

Children.

Fluticasone furoate is not usually found in quantifiable concentrations (

Patients with impaired renal function.

Fluticasone furoate was not detected in the urine of healthy volunteers after intranasal administration. Less than 1% of metabolites are excreted via the kidneys, so renal dysfunction theoretically cannot affect the pharmacokinetics of fluticasone furoate.

Patients with impaired liver function.

A study in patients with moderate hepatic impairment who took 400 mcg of fluticasone furoate as a single inhalation dose showed an increase in maximum concentration (Cmax 42%) and an increase in the area under the concentration-time pharmacokinetic curve compared with healthy volunteers. Based on the study results, on average, the estimated exposure to intranasal fluticasone furoate 110 mcg in this patient population would not result in cortisol suppression. Therefore, mild hepatic impairment is not likely to result in clinically significant effects at the standard adult dose.

Other pharmacokinetic parameters.

Concentrations of fluticasone furoate are usually undetectable (

Overdose

Clinical observations were based on the development and severity of systemic side effects. A dose for adults exceeded 24 times the recommended dose, daily for three days or longer, did not affect the development of unwanted reactions in the body.

How many days in a row can I use Avamys? The course of therapy is determined by the doctor. The purpose of glucocorticoid treatment is important. In complex therapy of ENT diseases, sometimes 2-3 days of using the drug are enough. To eliminate the symptoms of allergic rhinitis, you need to use Avamis for at least 14-30 days without interruption.

There are no known cases of acute overdose. If you suspect that the recommended concentrations of intranasal corticosteroids are exceeded, their administration should be discontinued. Treatment in this case is symptomatic.

Can Avamys be used frequently? Yes, the drug is designed for regular use over a long period of time. Clinical studies have proven its tolerability and safety. But if acute symptoms of rhinitis appear for too long, more than 3-4 months, you need to consult your doctor again.

Interaction with other drugs

Available theoretical data exclude the possibility of Avamis interacting with other drugs that are broken down similarly to fluticasone furoate. The drugs are based on rapid elimination after metabolization by the liver of the ingested part as a result of intranasal use. Thus, no real studies have been conducted examining the interaction of Avamys and other drugs.

Intranasal glucocorticoids can be combined with non-hormonal nasal drops, both in the treatment of allergic rhinitis and in the complex treatment of ENT infections. For example, sea water Quix and Avamis are used alternately. First, the nose is toileted, the nostrils are washed, and then the main product is sprayed.

Avamis and Suprastin are prescribed together as mandatory medications in the treatment of acute manifestations of allergies or adenoiditis. For children, it is better to use antihistamines not in tablets, but in syrup or drops.

For severe nasal congestion, Avamis and Otrivin are used. To relieve edema, a vasoconstrictor is administered, then a glucocorticoid. But, having a cumulative effect, the hormone is able to completely eliminate dependence on regular drops.

Is it possible to have Avamis and IRS 19 together? Yes, it is allowed, if necessary, to relieve swelling with hormonal drugs and boost the immunity of the nasal mucosa with beneficial bacteria. It is optimal to use IRS 19 15-20 minutes after the fluticasone furoate spray.

Avamys and antibiotics are used in the complex treatment of paranasal sinus infections. The hormone will reduce inflammation, relieve swelling, and the antibacterial drug will destroy the cause of the disease. Moreover, for sinusitis and ethmoiditis, Avamis will only be effective with antibiotics.

There is no need to use local glucocorticoids on your own for every runny nose. Hormone therapy has pros and cons; its peculiarity is to suppress the immune system. In case of viral or bacterial infection, reduced natural defense will only increase the proliferation of the pathogen. Sometimes, if you take Avamis irrationally for a long time, you have to treat fungi in both the nose and mouth.

There is no data on the negative effects of Avamis and birth control pills on the body. The types of hormones contained in the composition act differently and do not reduce each other’s effectiveness.

Release form

Avamys is produced in the form of a dosed nasal spray. The modern release form makes it possible to conveniently deliver the medicine to its destination. One spray corresponds to a single dose of the active substance - 27.5 mcg of fluticasone furoate.

What does Avamis look like? The medicine is presented as a white homogeneous suspension, placed in a special package - a bottle and a case. The vial is made of a specific orange glass and is placed inside a plastic case. It is equipped with a valve, a spray mechanism, an indicator window and a cap-shaped limiter. 1 package can contain a volume of 30, 60 or 120 doses.

Avamys, 1 piece, 27.5 mcg/dose, metered nasal spray

Intranasally.

To achieve maximum therapeutic effect, it is necessary to adhere to a regular regimen of use. The onset of action can be observed within 8 hours after the first administration. It may take several days to achieve maximum effect. The lack of immediate effect should be carefully explained to the patient.

For the symptomatic treatment of seasonal and perennial allergic rhinitis

Adults and teenagers (12 years and older):

Children from 2 to 11 years old:

Children under 2 years old:

There is insufficient data to recommend the use of intranasal fluticasone furoate as a treatment for seasonal and perennial allergic rhinitis in children under 2 years of age.

Elderly patients:

no dose adjustment is required.

Patients with impaired renal function:

no dose adjustment is required.

Patients with impaired liver function:

No dose adjustment is required in patients with mild to moderate liver dysfunction. There are no data on use in patients with severe liver dysfunction.

Instructions for use of nasal spray

Description of nasal spray:

the drug is available in orange glass bottles of 30, 60 and 120 doses (Figure 1), which are in plastic cases.

To spray, press the spray button firmly. The removable cap protects the sprayer from dust and clogging.

Six important facts about the drug

3. To inject, you must press the button firmly (Figure 3).

4. If you cannot press the button with one thumb, you must use the fingers of both hands (Figure 4).

5. Always keep the nasal spray bottle closed. The cap protects the atomizer from dust and clogging and seals the bottle. In addition, the cap prevents accidental pressing of the button.

6. Do not attempt to clean the tip hole with a pin or other sharp object. They can damage the spray bottle.

Preparation for use should be carried out if:

— the spray is used for the first time;

- or the bottle was left open.

Proper preparation for using the spray will ensure that the required dose of the drug is injected.

Before use:

— without removing the cap, shake the bottle well for 10 s;

— remove the cap by smoothly pulling it with your thumb and forefinger (Figure 5);

— it is necessary to hold the bottle vertically and point the tip away from you;

— press the button forcefully and make several presses (minimum 6) until a small cloud appears from the tip (Figure 6).

Using a nasal spray

1. Shake the bottle thoroughly.

2. Remove the cap.

3. Clear your nose and tilt your head slightly forward.

4. Insert the tip into one nostril, continuing to hold the bottle vertically (Figure 7).

5. Point the tip of the sprayer at the outer wall of the nose, not at the nasal septum. This will ensure proper injection of the drug.

6. Start inhaling through your nose and press once with your finger to inject the drug (Figure 8).

7. Avoid getting the spray in your eyes! If the drug gets into your eyes, rinse them thoroughly with water.

8. Remove the atomizer from your nostril and exhale through your mouth.

9. If, according to the doctor’s recommendation, it is necessary to make 2 injections into each nostril, you must repeat steps 4–6.

10. Repeat the procedure for the other nostril.

11. Close the bottle with a cap.

Sprayer care

After each use:

— blot the tip and the inner surface of the cap with a dry, clean cloth (Figure 9 and 10), avoid contact with water;

— you should never try to clean the tip hole with a pin or other sharp objects;

— you must always close the bottle; the cap protects the sprayer from dust and clogging and seals the bottle.

If the sprayer does not work:

— it is necessary to check the level of the remaining drug in the bottle through the viewing window; if there is only a small amount of liquid left, it may not be enough for the sprayer to work;

— check the bottle for damage;

— check whether the tip hole is clogged; Do not try to clean the tip hole with a pin or other sharp objects;

— you must try to activate the device by repeating the procedure for preparing the nasal spray for use.

Storage conditions and shelf life

The drug is valid for 3 years from the production date indicated on the packaging. Keep the spray out of the reach of children at a temperature not exceeding 25-30 C. Avoid freezing.

Can Avamis be used if the expiration date has expired? No, it must be disposed of. Storage conditions after opening remain the same. Actions for mandatory care of the bottle and sprayer are added.

How long can Avamys be kept open? The shelf life after opening does not decrease from the total. There is no urgent need to keep the medicine in the refrigerator.

Instructions for using nasal spray

Avamis is produced in orange bottles, which are placed in plastic cases during production. There is no replacement bottle provided. If the spray is used for the first time or has been left open (stored without a protective cap), it must be prepared first.

Shake the case vigorously for 10-15 seconds without removing the lid. Then you should remove the cap and spray the drug at least 6-7 times away from you. You need to spray until a light cloud appears.

How to open Avamis:

take the case in one hand;
place the thumb and index finger of the other hand on the lid;
pull up smoothly.

Pressing the button requires some force. If this does not work, it is permissible to press with the fingers of both hands. Through a special indicator window on the case you can see the amount of the drug. It is important to always try to put the cap on, this ensures a tight seal and prevents dust from entering the sprayer.

Instructions for use of the drug Avamys.

If clogged, do not try to clean the tip with a needle or pin. You need to shake the bottle and press the button firmly several times. If there is little medicine left in the bottle, the nebulizer will stop working.

After each use, carefully blot the tip and the inside of the cap with a dry cloth. Do not allow water or other liquid to get inside the bottle. Restoring a damaged case, tip, or installing a replacement unit is not provided. Therefore, if you try to disassemble Avamis, there is a high probability that you will need to buy a new inhaler.

Avamys

The drug is used intranasally.

For the symptomatic treatment of seasonal and year-round allergic rhinitis
in adults and adolescents aged 12 years and older,
the recommended initial dose is 55 mcg (2 sprays) in each nostril 1 time / day (110 mcg / day).

Once adequate symptom control is achieved, dose reduction to 27.5 mcg (1 spray) in each nostril once a day (55 mcg/day) may be effective for maintenance treatment.

Children aged 2 to 11 years

The recommended initial dose is 27.5 mcg (1 spray) in each nostril 1 time/day (55 mcg/day).

There is insufficient evidence to recommend the use of intranasal fluticasone furoate for the treatment of seasonal and perennial allergic rhinitis in children under 2 years of age.

Elderly patients

no dose adjustment is required.

Patients with impaired renal function

no dose adjustment is required.

In patients with mild to moderate liver dysfunction

no dose adjustment is required.
There are no data on use in patients with severe liver dysfunction
.

Rules for use and handling of the drug

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 that the required dose of the drug is injected.

1. Without removing the cap, shake the bottle well for 10 seconds. The drug is a rather thick suspension and becomes more liquid when shaken. Spraying is only possible after shaking.

2. Remove the cap by gently pulling it with your thumb and forefinger.

3. Hold the bottle vertically and point the tip away from you.

5. The spray is ready for use.

Using a nasal spray

1. Shake the bottle thoroughly.

2. Remove the cap.

3. Clear your nose and tilt your head slightly forward.

4. Insert the tip into one nostril, continuing to hold the bottle vertically.

5. Point the tip of the sprayer at the outer wall of the nose, not at the nasal septum. This will ensure proper injection of the drug.

6. Start inhaling through your nose and press once with your fingers to spray the drug.

7. Remove the atomizer from your nostril and exhale through your mouth.

8. If it is necessary to make two injections into each nostril (as prescribed by a doctor), you should repeat steps 4-6.

9. Repeat the procedure for the other nostril.

10. Close the bottle with a cap.

11. Avoid getting the spray in your eyes. If the drug gets into your eyes, rinse them thoroughly with water.

Sprayer care

After each use:

1. Blot the tip and the inner surface of the cap with a dry, clean cloth. Avoid contact with water.

2. Do not try to clean the tip hole with a pin or other sharp objects.

3. Always cap the bottle and keep it closed. The cap protects the sprayer from dust and clogging, seals the bottle, and prevents accidental pressing of the button.

If the sprayer does not work:

1. Check the level of the remaining drug in the bottle through the viewing window. If there is only a small amount of liquid left, it may not be enough to operate the sprayer.

2. Check the bottle for damage.

3. Check if the tip hole is clogged. Do not attempt to clean the tip hole with a pin or other sharp object.

4. Try to activate the device by repeating the procedure for preparing the nasal spray for use.