Avamis, nasal spray dosed 27.5mcg/dose, 120 doses

Composition

1 dose of nasal spray contains:  

Active ingredient:  

Fluticasone furoate (micronized) – 27.5 mcg.

Auxiliary substances:  

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 mcl.

Pharmacological action

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

Indications

Adults and adolescents (aged 12 years and older)

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

Children (ages 2-11)

– treatment of nasal symptoms of seasonal and year-round allergic rhinitis.

Contraindications

• Hypersensitivity to the components of the drug.

With caution:  The drug should be used in patients with severe hepatic impairment, as the pharmacokinetics of fluticasone furoate may vary.

Side effects

Determination of the frequency of adverse reactions:

• Very often (≥ 1/10).
• Often (≥ 1/100,
• Sometimes (≥1/1000,
• Rare (≥ 1/10 000,
• Very rare (

Respiratory system disorders:  very often – nosebleeds.

In adults and adolescents, cases of nosebleeds were observed more often with prolonged use (more than 6 weeks) than with a short course (up to 6 weeks). In studies in children with a treatment duration of up to 12 weeks, the number of cases of nosebleeds was similar in the group of fluticasone furoate and placebo. Often – ulceration of the nasal mucosa.

Allergic reactions:  rash, urticaria, angioedema, anaphylaxis.

Interaction

Fluticasone furoate is rapidly metabolized in the liver with the participation of the CYP3A4 isoenzyme.

In the drug interaction study of fluticasone furoate and the CYP3A4 inhibitor ketoconazole, there were more cases of determining the plasma concentration of fluticasone furoate, whose values were higher than the threshold, 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 plasma cortisol levels over 24 hours between the two groups.

Based on theoretical data, no drug interaction of fluticasone furoate during intranasal use with other drugs that are metabolized with the participation of cytochrome P450 isoenzymes is assumed. Therefore, clinical studies to study the interaction of fluticasone furoate and other drugs have not been conducted.

Based on the data obtained in a study with another corticosteroid that also undergoes CYP3A4-mediated metabolism, as well as on the literature data regarding other CORTICOSTEROIDS that undergo CYP3A4-mediated metabolism, co-use of Avamis with ritonavir is not recommended due to the potential risk of increased systemic exposure to fluticasone furoate.

How to take, course of use and dosage

The drug is used intranasally.

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

For symptomatic treatment of seasonal and year-round allergic rhinitis.

Adults and adolescents aged 12 years and older:  the recommended starting dose is 55 mcg (2 sprays) in each nostril 1 time/day (110 mcg/day). When adequate symptom control is achieved, reducing the dose to 27.5 mcg (1 spray) in each nostril 1 time/day (55 mcg/day) may be effective for maintenance treatment.

Children aged 2-11 years:  The recommended starting dose is 27.5 mcg (1 spray) in each nostril 1 time/day (55 mcg/day).

In the absence of the desired effect at a dose of 27.5 mcg (1 spray) in each nostril 1 time/day, it is possible to increase the dose 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 is insufficient evidence to recommend the use of fluticasone furoate intranasally for the treatment of seasonal and year-round 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 hepatic impairment:  no dose adjustment is required. There are no data on its use in patients with severe hepatic impairment.

Rules for using and handling the drug

An indicator window in a plastic package allows you to monitor the level of the drug in the bottle. In 30-or 60-dose bottles, the drug level will be immediately visible, while in 120-dose bottles, the initial drug level is above the upper limit of the viewing window. To check the level of the drug in the bottle, you need to look at it in the light. The level will be visible in the viewing window.

Preparation for use should be carried out when using the spray for the first time, as well as if the bottle was left open. Proper preparation for use will ensure that the required dose of the drug is injected.

Application of nasal spray

Overdose

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

Treatment:  it is unlikely that an acute overdose will require treatment other than medical supervision.

Special instructions

Fluticasone furoate is metabolized during the” first pass ” through the liver with the participation of the CYP3A4 isoenzyme. Therefore, the pharmacokinetics of fluticasone furoate may vary in patients with severe hepatic impairment.

Use in patients with liver function disorders:  In patients with mild to moderate hepatic impairment, no dose adjustment is required. There are no data on its use in patients with severe hepatic impairment.

Use in patients with impaired renal function:  no dose adjustment is required.

Influence on the ability to drive motor vehicles and manage mechanisms

Based on the pharmacological properties of fluticasone furoate and other topical corticosteroids, no effect on the ability to drive vehicles or other mechanisms is expected.

Storage conditions

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

Shelf life

3 years

Active ingredient

of Fluticasone furoate

Conditions of release from pharmacies

By prescription

Dosage form

nasal spray

Purpose

Adults as prescribed by a doctor, Children as prescribed by a doctor, Children over 2 years of age, Anti-allergic

Indications

Allergy, Runny Nose, Hay Fever