AVAMYS NASAL SPRAY 27.5 UG/DOSE 120DOSE VIAL

Dosage form

Spray nasal dosed in the form of a homogeneous suspension of white.

Composition

In 1 dose of nasal spray dosed contains:
Active substance
Fluticasone furoate (micronized) 27.5 mcg.
Excipients
Dextrose, dispersible cellulose (contains 11% carmellose sodium), polysorbate 80, benzalkonium chloride (50% solution), disodium edetate, purified water.

Packaging

In a dispenser bottle 120 doses. In a carton one bottle.

Mechanism of action

AVAMIS - GKS for local use. Fluticasone furoate is a synthetic trifluorinated glucocorticosteroid with high affinity for glucocorticoid receptors, has a pronounced anti-inflammatory effect.

Indications and usage

Symptomatic treatment of seasonal and year-round allergic rhinitis in adults and children over 2 years.

Contraindications

Hypersensitivity to the drug.
Carefully:
The drug should be used in patients with severely impaired liver function, since The pharmacokinetics of fluticasone furoate may vary.

Pregnancy and Breastfeeding

Fluticasone furoate can be used during pregnancy and lactation (breastfeeding) only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or infant.
Clinical data on the use of fluticasone furoate during pregnancy and lactation (breastfeeding) is not enough.
It is not known whether fluticasone furoate is excreted in human breast milk.

Dosage and administration

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

• For adults and adolescents aged 12 years and older, the recommended initial dose is 55 mcg (2 sprays) in each nostril 1 time / day (110 mcg / day).
  If adequate symptom control is achieved, reducing the dose to 27.5 mcg (1 spray) in each nostril 1 time / day (55 mcg / day) can be effective for maintenance treatment.

• For children aged 2 to 11 years, 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, with a dose of 27.5 mcg (1 spray) in each nostril 1 time / day, the dose can be increased to 55 mcg (2 sprays) in each nostril 1 time / day (110 mg / day). When an adequate symptom control is achieved, it is recommended to reduce the dose to 27.5 μg (1 spray) in each nostril 1 time / day (55 μg / day).

  Not enough data to recommend the use of fluticasone furoate intranasally for the treatment of seasonal and perennial allergic rhinitis in children under 2 years of age.
  Elderly patients dose adjustment is not required.
  Patients with impaired renal function dose adjustment is not required.
  In patients with mild and moderate hepatic impairment, dose adjustment is not required. There is no evidence of use in patients with severely impaired liver function.

The indicator window in plastic packaging allows you to control the level of the drug in the vial. In bottles of 30 or 60 doses, the level of the drug will be visible immediately, and in bottles of 120 doses, the initial level of the drug is above the upper border of the viewing window. To check the level of the drug in the vial, you need to see 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 vial has been left open. Proper preparation for use will ensure the injection of the required dose of the drug.

1. Without removing the cap, shake the bottle well for 10 seconds. The drug is a rather thick suspension and becomes thinner when shaken. Spraying is possible only after shaking.
2. Remove the cap by gently pulling it with your thumb and forefinger.
3. Hold the bottle vertically and direct the tip away from you.
4. Press the button with force, make several presses (minimum 6) until a small cloud appears from the tip (if you cannot press the button with one thumb, you should press it with the thumbs of both hands).
5. Spray ready for use.

one.Shake the vial thoroughly.
2. Remove the cap.
3. Clean your nose and tilt your head slightly forward.
4. Insert the tip into one nostril, continuing to hold the bottle vertically.
5. Aim the tip of the nebulizer on the outer wall of the nose, not on the nasal septum. This will ensure the correct injection of the drug.
6. Start breathing in through the nose and press once with your fingers to spray the preparation.
7. Take the nebulizer out of the nostrils and exhale through the mouth.
8. If it is necessary to make two injections into each nostril (as prescribed by a physician), repeat points 4-6.
9. Repeat the procedure for the other nostril.
10. Close the bottle cap.
11. Avoid spraying the eyes. In case of contact with eyes, rinse thoroughly with water.

After each use
1. Blot the tip and the inside of the cap with a dry, clean cloth. Avoid water.
2. Do not attempt to clean the tip opening with a pin or other sharp objects.
3. Always close the vial and keep it closed. The cap protects the sprayer from dust and clogging, seals the bottle, prevents accidental pressing of the button.

In case the sprayer does not work
1. Check the level of the remaining drug in the vial through the viewing window. If only a small amount of liquid remains, it may not be enough to operate the sprayer.
2. Check the bottle for damage.
3. Check if the tip hole is clogged. Do not attempt to clean the tip opening with a pin or other sharp objects.
4. Try to power the device by repeating the procedure for preparing the nasal spray for use.

Adverse reactions

On the part of the respiratory system: very often - nosebleeds; often - ulceration of the nasal mucosa. In adults and adolescents, cases of nasal bleeding were noted more often with prolonged use (more than 6 weeks) than with a short course (up to 6 weeks). In studies in children with a duration of treatment up to 12 weeks, the incidence of nose bleeding was similar in the group of fluticasone furoate and placebo.
Allergic reactions: rash, urticaria, angioedema, anaphylaxis.

Drug interactions

Fluticasone furoate is rapidly metabolized in the liver with the participation of the CYP3A4 isoenzyme. In the study of drug interaction of fluticasone furoate and CYP3A4 inhibitor Ketoconazole, there were more cases of determining plasma concentrations of fluticasone furoate, which values ​​were higher than the threshold, in the group of patients treated with ketoconazole (6 out of 20 patients) compared to placebo (1 out of 20 patients). This small increase does not lead to a statistically significant difference in plasma cortisol content within 24 hours between the two groups.

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

Based on the data obtained in the study with another corticosteroids, which is also exposed to CYP3A4-mediated metabolism, and also on the basis of literature data concerning other corticosteroids, which undergo CYP3A4-mediated metabolism, the joint appointment of Avamis with ritonavir is not recommended due to the potential risk increase the systemic exposure of fluticasone furoate.

Symptoms: In the study of the bioavailability of the drug, intranasal doses were used 24 times higher than the recommended dose for adults for more than 3 days, while unwanted systemic reactions were not observed.
Treatment: It is unlikely that an acute overdose will require other treatment than medical supervision.

Store at a temperature not exceeding 30 ° C; do not freeze.

3 years.

Avamys nasal