Avamys is indicated for adults, teenagers and children (from 6 years). Avamys is indicated in the treatment of symptoms of allergic rhinitis.

Dosage

Adults and adolescents (from 12 years old)

The recommended initial dosage is two sprays (27.5 micrograms of fluticasone furoate, by spraying) in each nostril, once daily (total daily dose = 110 micrograms). Br>

As soon as an adequate control of the symptoms is obtained, a reduction of the dosage to one spray in each nostril (daily dose, total = 55 micrograms) can be effective in treatment.

The dose should be adjusted to the minimum dose effective to maintain control of symptoms.
Children (6 to 11 years)

The recommended initial dosage is one spray (27.5 micrograms of fluticasone furoate, by spraying) in each nostril, once daily (total daily dose = 55 micrograms).

Children who do not fully respond to spraying in each nostril once per day (total daily dose = 55 micrograms) may increase the dosage with two sprays in each nostril to one dose per day (total daily dose ; = 110 micrograms). As soon as adequate control of the symptoms is obtained it is recommended to reduce the dosage to one spray in each nostril once daily (total daily dose = 55 micrograms).
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To achieve optimal therapeutic effect, regular use is recommended. An effect appears as early as 8 hours after the first administration. However, several days of treatment may be required to achieve maximum efficacy, and the patient should be advised that his symptoms will improve through regular, continuous intake of the treatment (see section 5.1 Pharmacodynamic properties). The duration of treatment should be limited to the period of exposure, allergenic.

Children under 6 years of age: The safety and efficacy of Avamys in children under 6 years of age have not been established. The data available to date are described under the headings Pharmacodynamic Properties and Pharmacokinetic Properties but no dosage recommendations can be made

Elderly patients: No dosage adjustment is necessary in this population (see section Properties, Pharmacokinetics).
Renal impairment: No dose adjustment is required in this population (see section Pharmacokinetics).
Hepatic impairment: None, dose adjustment is required for patients with mild to moderate hepatic impairment. There are no data for patients with severe hepatic impairment. In patients with severe hepatic impairment, fluticasone furoate should be administered with caution due to an increased risk of systemic adverse effects associated with corticosteroids in these patients (see section 4.4). And pharmacokinetic properties.

Mode of administration

Avamys in suspension for nasal spraying is intended for nasal administration only

The nasal spray should be shaken before use. When first used, it is initiated by pressing the side knob at least six times (until the appearance of a fine mist), keeping the device straight.Removing (about 6 sprays, To the appearance of a fine mist) is required if the cap has been removed for 5 days or if the sprayer has not been used for at least 30 days
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After each use, the sprayer must be cleaned and the cap replaced.

Suspension, white.

Mechanism of action

Class: pharmacotherapeutic: nasal preparations, corticosteroids. ATC code: R01AD12.

The fluticasone furoate is a synthetic, trifluorinated corticoid having a very high affinity for the glucocorticoid receptor and exerting a potent anti-inflammatory activity.


Rhinitis, seasonal allergic in adults and adolescents

Compared to placebo, fluticasone furoate as a nasal spray at a dose of 110 micrograms in one dose per day significantly improved nasal symptoms (including rhinorrhea, nasal obstruction, sneezing and nasal pruritus) and ocular symptoms ( Including pruritus / burning, lacrimation / discharge and redness of the eyes) in each of the four studies performed. The efficacy was maintained for the next 24 hours, administering the product in one dose per day.
95%) at weeks 52 and 104. Increases in posterior subcapsular opacities of the lens Or IOP have not been accompanied by any undesirable effects of the cataract or glaucoma type.

Pediatric population

Rhinitis, seasonal and perennial allergic in children

The pediatric dosage is based on evaluation of efficacy data in children with allergic rhinitis

In seasonal allergic rhinitis, fluticasone furoate, as a 110-microgram nasal spray, was effective in one dose per day. At a dose of 55 micrograms in one dose per day, no significant difference was observed between fluticasone furoate and placebo over all of the outcome measures.

In perennial allergic rhinitis, fluticasone furoate in a nasal spray at a dose of 55 micrograms in one dose per day was more effective than furoate, fluticasone at a dose of 110 micrograms in one dose, Day on the 4 weeks of treatment. A post-hoc analysis of the data collected at 6 and 12 weeks in this study, as well as a 6-week tolerance study on the hypothalamic-pituitary-adrenal axis, showed the efficacy of the furoate Of fluticasone in nasal spray at a dose of 110 micrograms in one dose per day. In a 6-week study evaluating the effect of fluticasone furoate in nasal sprays at a dose of 110 micrograms in one dose per day on adrenal function in children aged 2 to 11 years no effect; Significant effect on 24-hour cortisol levels has not been demonstrated in comparison to placebo.
A multicentre, randomized, double-blind, placebo-controlled, parallel-group study evaluated the effects of treatment with fluticasone furoate as a nasal spray at a dose of 110 micrograms once daily for one year on the , Growth rate with stadiometry in 474 children, prepubescent (5-7.5 years, girls and 5-8.5 years for boys), and, over a 52-week treatment period, Of patients with fluticasone furoate (5.19 cm / year) compared to those receiving placebo (5.46 cm / year). The mean difference observed in the treatment group was -0.27 cm per year [95% CI, -0.48, -0.06]. Br>
Seasonal and perennial allergic rhinitis in children

Growth retardation

Growth retardation has been reported in children receiving nasal corticosteroids at the recommended dosage. Growth retardation was observed in children treated with fluticasone furoate at a dose of 110 micrograms per day for one year (see section 4.8, Adverse Drug Reactions and Pharmacodynamic Properties). The minimum effective dose for the control of symptoms in children should therefore be sought (see Dosage and Administration).

Regular monitoring of child growth and long-term nasal corticosteroid therapy is therefore recommended. If a slowing in growth is observed, treatment should be re-evaluated in order to reduce, if possible, the dose of corticosteroids by the nasal route at the minimum dose to maintain control of the symptoms of rhinitis. In addition, consideration should be given to the orientation of the patient to a pediatrician (see section "Properties, Pharmacodynamics").
Patients under treatment with ritonavir

Concomitant administration of ritonavir is not recommended because of the risk of increased systemic exposure to furoate, fluticasone (see section Interactions with other medicines and other forms of interactions) Code>
Patients with hepatic impairment

Fluticasone furoate undergoes a significant first-pass effect. Therefore, systemic exposure to fluticasone furoate will be greater, in patients with severe hepatic insufficiency, which may increase the frequency of systemic adverse effects (see sections Dosage and Mode of Administration And pharmacokinetic properties). Special attention is advised during treatment in these patients.

Interaction with cytochrome CYP3A4 inhibitors

Fluticasone furoate is rapidly eliminated by an important cytochrome P450 3A4-mediated first-pass effect.


Caution is advised when concomitant administration of fluticasone furoate with potent inhibitors of CYP3A4 as an increase in systemic exposure to fluticasone furoate can not be ruled out. An interaction study of fluticasone furoate, administered nasally with ketoconazole (potent inhibitor of CYP3A4), showed that the number of subjects with measurable concentrations of fluticasone furoate was higher in the group of subjects; Treated with ketoconazole (6 out of 20 subjects) than in the placebo group (1 in 20 subjects). This slight increase in systemic exposure did not result in a statistically significant difference in the 24-hour cortisol concentration between the two groups (see Warnings and Precautions). Br>

Data on the inducer or inhibitor effect of fluticasone furoate suggest theoretically no risk of potential interaction at the doses recommended by the nasal route with other compounds metabolized by cytochrome P450. As a result, it has not been conducted, specific clinical studies, interactions.

Without object.

During a bioavailability study, no systemic adverse reaction was observed after administration for 3 days of intranasal doses up to 2640 micrograms per day (see Pharmacokinetic Properties).

Acute overdose does not generally require any special measure other than patient monitoring.


There are no reliable data on the use of fluticasone furoate in pregnant women. Studies in animals have shown the occurrence of malformations with cleft palate and growth retardation, intrauterine. The clinical significance of these findings for humans is not established in view of the low plasma levels with the nasally administered product (see Pharmacokinetic Properties). Fluticasone furoate will only be used during pregnancy if the expected benefits to the mother are greater than the potential risks to the fetus or newborn.

Breastfeeding

The passage of fluticasone furoate into breast milk, after administration by the nasal route is not known.


Fertility: No data on the effect of fluticasone furoate on fertility in the human species

Security Profile Summary

Epistaxis, nasal ulceration and headache are the most frequent adverse effects reported during fluticasone furoate therapy. The most severe adverse reactions reported are rare, hypersensitivity reactions including anaphylactic reactions (