Avamis, spray 27.5 mcg/dose 120 doses

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

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 year-round allergic rhinitis.

Pharmacological effect

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

Special instructions

Fluticasone furoate undergoes first-pass metabolism through the liver with the participation of the CYP3A4 isoenzyme. Therefore, in patients with severe hepatic impairment, the pharmacokinetics of fluticasone furoate may be altered.

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

Use for impaired renal function: no dose adjustment is required.

Impact 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 use other mechanisms is not expected.

Active ingredient

Fluticasone furoate

Composition

1 dose of nasal spray contains:

Active substance:

Fluticasone furoate (micronized) – 27.5 mcg.

Excipients:

Dextrose* – 2750 mcg;
Cellulose dispersible – 825 mcg;
Polysorbate 80 – 13.75 mcg;
Benzalkonium chloride solution** – 16.5 mcg***;
Disodium edetate – 8.25 mcg;
Purified water – up to 50 µl.

Contraindications

Hypersensitivity to the components of the drug.

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

Side Effects

Determination of the frequency of adverse reactions:

Very common (≥ 1/10).
Often (≥ 1/100, < 1/10). Sometimes (≥1/1000, <1/100). Rare (≥ 1/10,000, < 1/1000). Very rare (<1/10,000, including isolated cases).

From the respiratory system: very often – nosebleeds.

In adults and adolescents, cases of 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 between fluticasone furoate and placebo. Often – ulceration of the nasal mucosa.

Allergic reactions: rash, urticaria, Quincke’s edema, anaphylaxis.

Interaction

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

In a drug interaction study between fluticasone furoate and the CYP3A4 inhibitor ketoconazole, there were more cases of fluticasone furoate plasma concentrations above the threshold in patients receiving ketoconazole (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, no drug interaction of fluticasone furoate when administered intranasally with other drugs that are metabolized with the participation of isoenzymes of the cytochrome P450 system is not expected. Therefore, 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 GCS that is also subject to CYP3A4-mediated metabolism, as well as based on literature data regarding other GCS that are subject to CYP3A4-mediated metabolism, co-administration of Avamys with ritonavir is not recommended due to the potential risk of increased systemic exposure to fluticasone furoate.

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: Acute overdose is unlikely to require treatment other than medical supervision.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 30°C;

Shelf life

3 years

Manufacturer

Glaxo Wellcome S.A., Spain