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 adolescents (ages 12 years and older)

Children (ages 2 to 11 years)

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

Active ingredient

Composition

1 dose of nasal spray contains:

Active substance:

Fluticasone furoate (micronized) – 27.5 µg.

Auxiliary substances:

Dextrose* – 2750 µg;
Dispersible cellulose – 825 µg;
Polysorbate 80 – 13.75 µg;
Benzalkonium chloride solution** – 16.5 µg***;
Dinatrium edetate – 8.25 µg;
Purified water – up to 50 µl.

How to take, the dosage

The drug is used intranasally.

In order to achieve maximum therapeutic effect, it is necessary to follow a regular regimen of administration. Onset of action may 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.

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

Adults and adolescents 12 years of age 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 once daily (55 mcg/day) may be effective for maintenance treatment.

Children aged 2 to 11 years: Recommended starting dose is 27.5 mcg (1 spray) in each nostril once daily (55 mcg/day).

If 27.5 mcg (1 spray) in each nostril once daily has no desired effect, the dose may be increased to 55 mcg (2 sprays) in each nostril once daily (110 mcg/day). When symptoms are adequately controlled, it is recommended that the dose be reduced to 27.5 mcg (1 spray) in each nostril once daily (55 mcg/day).

There is insufficient data to recommend the use of fluticasone furoate intranasally for the treatment of seasonal and year-round allergic rhinitis in children younger than 2 years of age.

Patients of advanced age: No dose adjustment is required.

Patients with impaired renal function: dose adjustment is not required.

In patients with mild to moderate hepatic impairment: Dose adjustment is not required. There are no data on use in patients with severe hepatic impairment.

Principles of Use and Handling

The indicator window in the plastic package allows control of the level of the drug in the vial. The 30- or 60-dose bottles will show the product level immediately, and the 120-dose bottles will have the initial product level above the top of the viewing window. To check the level in the vial, look at the vial in the light. The level will be visible in the viewing window.

Preparation should be made when using the spray for the first time and also if the bottle has been left open. Proper application preparation will ensure that the correct dose of product is being injected.

Applying the nasal spray

Interaction

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

In a study of drug interactions between fluticasone furoate and the CYP3A4 inhibitor ketoconazole, there were more cases in which plasma concentrations of fluticasone furoate were determined to be above threshold values in the group of patients receiving ketoconazole (6 of 20 patients) compared to placebo (1 of 20 patients). This slight 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 when administered intranasally with other drugs that are metabolized with the participation of cytochrome P450 isoenzymes is expected. Therefore, clinical studies to study the interaction of fluticasone furoate and other medicinal products have not been conducted.

Based on data from a study with another GKS that also undergoes CYP3A4-mediated metabolism and on literature data regarding other GKS that undergo CYP3A4-mediated metabolism, co-administration of Avamis with ritonavir is not recommended because of the potential risk of increased systemic exposure of fluticasone furoate.

Special Instructions

Fluticasone furoate is metabolized by “first pass” through the liver with the participation of the CYP3A4 isoenzyme. Therefore, the pharmacokinetics of fluticasone furoate may be altered in patients with severe liver dysfunction.

Application in hepatic impairment: Patients with mild to moderate hepatic impairment do not require dose adjustment. There are no data on use in patients with severe hepatic impairment.

Application in impaired renal function:Dose adjustment is not required.

Influence on driving and operating ability

Based on the pharmacological properties of fluticasone furoate and other topical GKS, no effect on driving or operating ability is expected.

Contraindications

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

Side effects

Frequency of adverse reactions:

Involved respiratory system:very often – nosebleed.

In adults and adolescents, cases of nasal bleeding have been reported more often with long-term use (more than 6 weeks) than with a short course (up to 6 weeks). In studies in children with the duration of therapy up to 12 weeks, the number of cases of nasal bleeding was similar in the fluticasone furoate and placebo groups. Nasal mucosal ulceration was common.

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

Overdose

Symptoms:In a study of drug bioavailability, intranasal doses of 24 times the recommended adult dose were used 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 monitoring.