Avamys nasal spray 27.5 mcg/dose, 120 doses — Made in Poland — Free Delivery

Pharmacological properties

Pharmacodynamics. Fluticasone furoate is a synthetic fluorinated corticosteroid with a very high level of affinity for glucocorticoid receptors and a strong anti-inflammatory effect.

Pharmacokinetics. Fluticasone furoate undergoes extensive first pass metabolism and incomplete absorption in the liver and intestines, which causes very little systemic effect of the preparation. Usually, with intranasal administration of 110 μg 1 time per day, such a concentration of the preparation in the blood plasma is achieved, which cannot be measured (10 pg / ml). The absolute bioavailability of fluticasone furoate when using 880 mcg 3 times a day (total daily dose of 2640 mcg) is 0.5%.

The level of binding of fluticasone furoate to blood plasma proteins is 99%. The preparation is widely distributed, the volume of distribution averages 608 liters.

Fluticasone furoate is rapidly excreted (total plasma clearance 58 l / h) from the systemic circulation, mainly by hepatic metabolism with the participation of the cytochrome P450 CYP 3A4 enzyme to an inactive carboxylic metabolite (GW694301X). The main metabolic mechanism is the hydrolysis of S-fluoromethylcarbionate to the 17β-carboxylic acid metabolite. It is excreted after oral and intravenous administration, mainly with feces with signs of excretion of fluticasone furoate and its metabolites in bile. After intravenous administration, T1 / 2 - 15.1 hours. The level of excretion in urine is about 1 and 2% after oral and intravenous administration, respectively.

Indications

Symptomatic treatment of allergic rhinitis.

Application

Avamis is used only intranasally.

Adults and children over the age of 12 years: the recommended initial dose is 2 injections (27.5 mcg per 1 injection) in each nasal passage once a day (total daily dose - 110 mcg).

After achieving control over the symptoms of rhinitis, the maintenance dose of the preparation can be reduced to 1 injection into each nasal passage once a day (total daily dose - 55 mcg).

Children aged 6–11 years: the recommended initial dose is 1 injection into each nasal passage once a day (total daily dose - 55 mcg). In case of insufficient control over the symptoms of rhinitis when injected into each nasal passage once a day (total daily dose - 55 mcg), the dose can be increased to 2 injections into each nasal passage once a day (total daily dose - 110 mcg). After achieving control over the symptoms of rhinitis, the dose is reduced to 1 injection into each nasal passage once a day (total daily dose - 55 mcg).

In elderly patients, the same doses are used as in adults.

In renal failure, dose adjustment is not required.

Hepatic impairment does not require dose adjustment.

To achieve the full therapeutic effect, the preparation must be used regularly, which should be communicated to the patient. The onset of action is observed 8 hours after the first application, the maximum therapeutic effect occurs a few days after the start of treatment. The duration of treatment should be limited to the period of exposure to the allergen.

Rules for the use of nasal spray. A nasal metered spray consists of a glass bottle placed in a plastic housing with a protective cap that covers the spray tip (a special device at the upper end of the spray). In the lower part of the body there are small holes through which you can see the presence of the preparation in a glass bottle. On one of the sides of the plastic body there is a large dispensing button, when pressed, the spray is delivered through the sprayer.

Before the first use (and if the preparation has not been used within 1 month), the device should be checked:

• shake the closed bottle thoroughly for about 10 seconds (without removing the protective cap);
• remove the cap by pulling it up, lightly pressing with your fingers on both sides;
• Press the dosing button firmly (at least 6 times) to release a sufficient amount of spray into the air.

Before each use, it is necessary to clean the nasal passages, shake the spray slightly and follow these steps:

• tilt your head slightly forward;
• holding the spray vertically, carefully place the spray in one nasal passage;
• direct the tip of the nebulizer in the opposite direction from the bridge of the nose so that the preparation is evenly distributed in the nasal cavity;
• inhale through the nose and at the same time press the dispensing button on the plastic body to spray the spray into the nasal cavity;
• contact with the spray in the eyes should be avoided; if this happens, rinse eyes with water;
• remove the spray tip from the nose and exhale through the mouth.

To inject the spray into the other nasal passage, the procedure is repeated in the same sequence.

Always close the device with a protective cap after use.

After each use, wipe the spray tip and protective cap with a clean dry cloth.

Contraindications

Hypersensitivity to the components of the preparation.

Side effects

Adverse reactions are distributed in frequency into the following categories: very often (≥1 / 10), often (≥1 / 100 and 1/10), infrequently (≥1 / 1000 and 1/100), rarely (≥1 / 10,000 and 1/1000), very rarely (1/10 000).

From the respiratory system: very often - nosebleeds; often - ulcers on the nasal mucosa. Nosebleeds were usually mild to moderate. In adults and adolescents, nosebleeds occurred more often with prolonged use (6 weeks) than with use up to 6 weeks. In pediatric clinical trials up to 12 weeks, the incidence of epistaxis was similar in the fluticasone furoate group and in the placebo group. Uncommon - pain in the nose, discomfort (including burning, irritation, soreness in the nose), dry nose. Very rarely - perforation of the nasal septum.

From the immune system: rarely - hypersensitivity reactions, including anaphylaxis, angioedema, rash and urticaria.

From the nervous system: often - headache.

From the side of the organs of vision: the frequency is unknown - transient visual impairment.

Children

From the musculoskeletal system and connective tissues: frequency unknown - growth retardation.

Special instructions

It is not recommended to use the preparation together with ritonavir due to the increased risk of systemic effects of fluticasone furoate.

Exceeding the recommended dose of intranasal corticosteroids can cause clinically significant adrenal suppression. During a period of stress or planned surgical intervention, the need for additional use of systemic corticosteroids is taken into account if there are signs that the recommended dose of corticosteroids is exceeded. The use of 110 μg / day of fluticasone furoate is not associated with inhibition of the hypothalamic-pituitary-adrenal system in adults and children. However, the dose of intranasal fluticasone furoate is reduced to the minimum effective dose. As with the use of other intranasal corticosteroids, in the case of the concomitant use of any other types of therapy with corticosteroids, their overall systemic effect is taken into account.

When using nasal corticosteroids, a systemic effect may occur, especially when using preparations in high doses for a long time. The likelihood of such an effect is less than with the use of oral corticosteroids and varies depending on different corticosteroids and the individual response of the patient. Potential systemic effects may include Cushing's syndrome, cushingoid symptoms, adrenal suppression, stunted growth in children and adolescents, cataracts, glaucoma, and, much less commonly, a range of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggression (especially in children ).

The use of nasal and inhaled GCS can cause the development of glaucoma and / or cataracts. Therefore, patients with visual impairment or increased intraocular pressure, glaucoma and / or cataracts should be closely monitored.

In the treatment of children with intranasal corticosteroids in recommended doses, cases of growth retardation were observed. According to a clinical study evaluating the growth rate of prepubertal children who took 110 μg of fluticasone furoate 1 time per day for 1 year, there was a difference in the growth rate of −0.27 cm per year compared with the placebo group. It is recommended to regularly measure the growth of children with long-term therapy with intranasal corticosteroids. If the child is stunted, therapy should be reviewed to reduce the dose, if possible, to the minimum effective to control the symptoms of the disease.

During pregnancy and breastfeeding. There is insufficient data on the use of the preparation during pregnancy or lactation. Fluticasone furoate is used during this period only if the expected benefit to the mother outweighs the possible risk to the fetus / child.

With intranasal use of fluticasone furoate at the maximum recommended doses (110 μg / day), a concentration is achieved that is generally not measurable, therefore the expected potential for reproductive toxicity is very low. The penetration of fluticasone furoate into human breast milk has not been studied.

There is no data on the effect on human fertility.

In children under the age of 6 years, it is not recommended to use Avamis, since the efficacy and safety of using the preparation by patients of this age category has not been established ..

The ability to influence the reaction rate when driving or operating machinery is unlikely.

Interactions

Fluticasone furoate is rapidly excreted by extensive first-pass metabolism in the liver via cytochrome p450 3a4.

According to the results of the use of another GCS - fluticasone propionate, which is also metabolized by CYP 3A4, its combined use with ritonavir is not recommended due to the increased systemic effect of fluticasone furoate.

The use of fluticasone furoate in combination with strong inhibitors of CYP 3A4 should be used with caution due to the increased systemic effect of fluticasone furoate. In a clinical study of the preparation interaction of fluticasone furoate with the potent CYP 3A4 inhibitor ketoconazole, the number of people in whom the plasma concentration of fluticasone furoate is measurable was greater in the ketoconazole group (6 to 20) compared with the placebo group (1 to twenty). This slight increase in systemic influence did not cause a statistically significant difference in 24-hour serum cortisol levels in the 2 groups.

Data on the study of enzymatic induction and inhibition suggest that there is no reason to expect metabolic interactions between fluticasone furoate and other mediators of cytochrome P450 metabolism in appropriate intranasal doses for clinical use. Therefore, clinical studies to study the interaction of fluticasone furoate and other preparations have not been carried out.

Overdose

According to clinical studies, with intranasal administration of up to 2640 μg of the preparation per day for 3 days, no side effects were noted. it is unlikely that in the event of an acute overdose, treatment other than medical supervision will be necessary.

Storage conditions

At a temperature of ≤30 ° c. do not refrigerate. do not freeze. after the first opening, the shelf life is 2 months.