Avamys - Nasal Spray 120 Doses

Adults and teenagers (ages 12 and over) :

- treatment of nasal and ocular symptoms of seasonal allergic rhinitis

- treatment of nasal symptoms of perennial allergic rhinitis

Children (ages 2 to 11)

- treatment of nasal symptoms of seasonal and perennial allergic rhinitis

Tradename:

Avamys

Avamys

Compound :

fluticasone furoate (micronized) 27.5 mcg

Auxiliary components :
dextrose, dispersible cellulose, polysorbate 80, benzalkonium chloride solution, disodium edetate, purified water.

Properties :
Fluticasone furoate is a synthetic trifluorinated corticosteroid with high affinity for glucocorticoid receptors and 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 perennial allergic rhinitis.

Children (aged 2 to 11 years) — treatment of nasal symptoms of seasonal and perennial allergic rhinitis.

Dosage and administration :
Avamys is for intranasal use only.

To achieve the maximum therapeutic effect, it is necessary to adhere to a regular regimen of application. 

The onset of action can be observed within 8 hours after the first injection. 

It may take several days to achieve maximum effect. 

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

The recommended initial dose is 2 sprays (27.5 micrograms of fluticasone furoate in one spray) in each nostril 1 time / day (110 micrograms / day).

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

Children aged 2 to 11 :
The recommended initial 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).

Contraindications:

— hypersensitivity to fluticasone furoate and other components of the drug.

The drug should be used with caution in patients with severely impaired liver function, tk. the pharmacokinetics of fluticasone furoate may vary.

Precautionary measures :
Fluticasone furoate is metabolized during the «first pass» through the liver with the participation of the CYP3A4 isoenzyme of the cytochrome P450 system. Therefore, in patients with severely impaired liver function, the pharmacokinetics of fluticasone furoate may change. Dose adjustment in patients with mild to moderate hepatic impairment (Child-Pugh class A and B) is not 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 severely impaired liver function, tk. such patients may be more at risk of systemic adverse reactions associated with the use of corticosteroids.

As with other intranasal corticosteroids, physicians should be vigilant about possible systemic effects of corticosteroids, incl. changes in the organ of vision. Therefore, careful monitoring is warranted in patients with impaired vision or with elevated intraocular pressure, glaucoma and/or cataracts in history.

Side effects :
From the respiratory system: very often — nosebleeds. 

In adults and adolescents, cases of epistaxis 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 a duration of therapy up to 12 weeks, the incidence of epistaxis was similar in the fluticasone furoate and placebo groups. Often — ulceration of the mucous membrane of the nasal cavity.

On the part of the immune system, rarely — hypersensitivity reactions, including anaphylaxis, Quincke’s edema, rash, urticaria.

From the nervous system: often — headache.

From the respiratory system: infrequently — rinalgia, nasal discomfort (including burning, irritation in the nose and soreness), dryness in the nose; very rarely — perforation of the nasal septum.

On the part of the organ of vision: the frequency is unknown — transient visual impairment. There may be systemic side effects characteristic of GCS.

Storage method :
at a temperature not exceeding 30 degrees.

Package :
The cardboard box contains: 120 doses — dark glass bottles equipped with a dosing spray device — plastic outer cases