Description
Release form
Coated tablets white coated non-transparent, uncoated, non-transparent, non-transparent, uncoated white powder
Release form
60 doses – yellow glass bottles (1) with a metering device, adapter and protective cap – plastic cases with a booklet label.
Pharmacological action of
GCS for intranasal use. It has a pronounced anti-inflammatory effect. With intranasal administration, there is no systemic effect, practically does not inhibit the hypothalamic-pituitary-adrenal system.
No significant change in the daily AUC of serum cortisol was detected after administration of fluticasone propionate at a dose of 200 μg / day compared with placebo (ratio: 1.01, 90% CI – confidence interval from 0.9 to 1.14).
The anti-inflammatory effect of fluticasone propionate is realized as a result of its interaction with glucocorticoid receptors. Suppresses the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils. Fluticasone propionate reduces the production of inflammatory mediators and a number of biologically active substances (including histamine, prostaglandins, leukotrienes, cytokines) during the early and late phases of an allergic reaction.
Has a rapid anti-inflammatory effect on the nasal mucosa. The antiallergic effect is manifested already 2-4 hours after the first application. Reduces sneezing, itching in the nose, rhinorrhea, nasal congestion, discomfort in the paranasal sinuses and a feeling of pressure around the nose and eyes.
Also alleviates eye symptoms associated with allergic rhinitis. The decrease in the severity of symptoms (especially nasal congestion) persists for 24 hours after a single application of the spray at a dose of 200 mcg.
Fluticasone propionate improves the quality of life of patients, including physical and social activity.
Indications
Treatment of perennial and seasonal allergic rhinitis, including hay fever (hay fever) in adults and children from 4 years of age: pain, sensation of pressure in the paranasal sinuses, nasal congestion, sneezing, tearing in the nose.
Use during pregnancy and lactation
Before using the drug Flixonase ® during pregnancy and lactation, consult a doctor.
Pregnant and lactating women, Flixonase ® can only be prescribed if the expected benefit to the patient outweighs any possible risk to the fetus or child.
Special instructions
The drug is indicated for intranasal use only.
For adults and children over 12 years of age: Do not use Flixonase ® Nasal Spray for more than 3 months. If it is necessary to use the drug for more than 3 months, a doctor’s consultation is necessary.
For children from 4 to 12 years: do not use Flixonase ® nasal spray for more than 2 months. If it is necessary to use the drug for more than 2 months, a doctor’s consultation is necessary. With prolonged use, regular monitoring of the function of the adrenal cortex is necessary.
There are reports of systemic effects when using nasal GCS, especially in high doses for a long time. These effects are much less likely than when taken orally. Systemic effects when using nasal corticosteroids can occur, in particular, when used in high doses for a long time. The likelihood of these effects is much lower than when taking corticosteroids inside, and they may vary in individual patients and between different corticosteroid drugs.
Possible systemic effects may include Itsenko-Cushing’s syndrome, characteristic signs of cushingoid, adrenal gland suppression, growth retardation in children and adolescents, cataracts, glaucoma, and less commonly a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disturbances, anxiety, depression, or aggressiveness ( especially in children).
In children receiving therapy with certain intranasal corticosteroids in permitted doses, growth retardation was observed. It is recommended to regularly monitor the growth of children receiving long-term treatment with intranasal GCS. When growth is slowed down, treatment should be reviewed to reduce the dose of intranasal GCS, if possible, to the minimum dose, maintaining effective control over symptoms and consult a pediatrician.
The concomitant use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient outweighs the possible risk of developing systemic side effects of corticosteroids.
It is recommended that you stop taking the drug and consult your doctor if there is no improvement within 4 days. Consultation with a doctor is also necessary if the patient has new symptoms, such as severe facial pain, thick discharge from the nose, which may indicate infection and are not associated with allergies.
Infections of the nasal cavity or paranasal sinuses require appropriate treatment, but are not a contraindication to the use of Flixonase ® nasal spray.
In most patients, the fluticasone propionate nasal spray eliminates the symptoms of seasonal allergic rhinitis, but in some cases, with very high concentrations of allergens in the air, additional therapy may be necessary.
Additional therapy may be needed to relieve eye symptoms associated with successful treatment of seasonal allergic rhinitis.
To achieve the maximum therapeutic effect, you must adhere to a regular regimen.
Caution must be exercised when transferring patients with systemic corticosteroids to treatment with fluticasone propionate in the form of a nasal spray, especially if adrenal dysfunction is observed against the background of regular monitoring.
Flixonase ®, a nasal aqueous spray contains benzalkonium chloride, which can cause bronchospasm.
In case of contact with patients with chickenpox, measles and in case of changes in vision, it is recommended to stop treatment and consult a doctor.
Influence on the ability to drive vehicles and mechanisms
In clinical trials, no data were obtained on the effect of the drug on the ability to drive vehicles and other mechanisms, however, side effects that the drug may cause should be considered.
Composition
1 dose:
fluticasone propionate (micronized) 50 mcg
Excipients:
dextrose – 5 mg,
avicel RC591 (microcrystalline cellulose, sodium carmellose) – 1.5 mg,
phenylethanol – 0.25 mg, srdlplklorb.02 mg,
hydrochloric acid – up to pH 6.3-6.5,
purified water – up to 100 mg.
Dosage and administration
Flixonase ® is intended for intranasal use only. To achieve the full therapeutic effect, the drug should be used regularly. The maximum therapeutic effect is manifested after 3-4 days of therapy.
Adults and children over 12 years old
1st week: 2 injections in each nostril 1 time / day (200 mcg / day)
from the 2nd week to 3 months: 1 or 2 injections in each nostril 1 time / day (100-200 mcg / day).
The maximum daily dose is 200 mcg / day (no more than 2 injections in each nostril).
Elderly patients are prescribed in the usual dose intended for adults.
Children 4 to 12 years old
1 injection into each nostril 1 time / day (100 mcg / day). Do not exceed the recommended dose (100 mcg / day). In children aged 4 to 12 years, the drug should be used for the shortest possible period of time necessary to achieve control over the symptoms of the disease. You must consult your doctor if the child needs to use the drug for a period of time exceeding 2 months in a year.
The maximum daily dose is 100 mcg (not more than 1 injection and each nostril).
If there is no effect from the use of the drug in all age groups of patients, consult a doctor.
Terms of use of the drug
Before use, gently shake the bottle, take it, placing the index and middle fingers on both sides of the tip, and the thumb under the bottom.
At the first use of the drug or a break in its use for more than 1 week, you should check the working condition of the nebulizer: point the tip away from you, press a few times until a small cloud appears from the tip. Next, you need to clean your nose (blow your nose). Close one nostril and insert the tip into the other nostril. Tilt your head forward a little while continuing to hold the bottle upright. Then you should start breathing in through your nose and, while continuing to inhale, press once to spray the drug. Breathe out through the mouth. Repeat the procedure for a second spray in the same nostril, if necessary. Next, completely repeat the described procedure by inserting the tip into another nostril. After use, dab the tip with a clean cloth or handkerchief and close it with a cap.
Spray should be flushed at least 1 time per week. To do this, carefully remove the tip and rinse it in warm water. Shake off excess water and leave to dry in a warm place. Avoid overheating. Then carefully set the tip back to the top of the vial. To put on a protective cap.
If the tip hole is clogged, remove the tip as described above and leave it in warm water for a while. Then rinse under running cold water, dry and put on the bottle again. Do not clean the tip opening with a pin or other sharp objects.
Side effects
Determination of the frequency of side effects: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1000 and <1/100), rarely (? 1 / 10,000 and <1/1000), very rarely (<1/10 000, including isolated cases). Very often, often and infrequently occurring adverse reactions are mainly established on the basis of clinical trials. Reactions that occur rarely and very rarely are mainly determined from spontaneous messages. When forming the frequency of occurrence of adverse reactions, background indicators in the placebo group were not taken but attention, since they were generally comparable with the active treatment group. On the part of the immune system: very rarely – hypersensitivity reactions, incl. bronchospasm, rash, swelling of the face and tongue, anaphylactic reactions, anaphylactoid reactions. From the side of the nervous system: often – headache, sensation of unpleasant taste and smell. The appearance of a headache, a sensation of unpleasant taste and smell was also reported when using other nasal sprays. From the side of the organ of vision: very rarely – glaucoma, increased intraocular pressure, cataracts. A small number of spontaneous reports were associated with long-term drug therapy. From the respiratory system: very often – nosebleeds often – dry mucous membranes in the nasal cavity and pharynx, irritation of the mucous membrane in the nasal cavity and pharynx (these adverse reactions, and also nosebleeds were observed when using other intranasal preparations) very rarely – perforation of the nasal septum (reported when taking intranasal GCS). With the use of certain intranasal corticosteroids, systemic effects may develop, especially when given in high doses for a long time. Drug interaction With the simultaneous use of fluticasone propionate with ritonavir, which is a strong inhibitor of the isoenzyme CYP3A4, a significant increase in the concentration of fluticasone propionate in the blood plasma is possible. As a result of this, a sharp decrease in the concentration of cortisol in serum occurs. The use of fluticasone propionate inhaled or intranasally and ritonavir leads to the development of side effects due to the systemic effect of GCS, including Cushing’s syndrome and inhibition of adrenal cortex function. Therefore, the simultaneous use of fluticasone propionate and ritonavir should be avoided, unless the possible benefit outweighs the risk of systemic effects. With the simultaneous use of fluticasone propionate with other, less powerful inhibitors of the CYP3A4 isoenzyme, such as ketoconazole and itraconazole, it increases the exposure of fluticasone propionate and increases the risk of systemic side effects. It is recommended to be careful and, if possible, to avoid long-term combined use of these drugs. Inhibitors of the CYP3A4 isoenzyme cause a negligible (erythromycin) or insignificant (ketoconazole) increase in plasma fluticasone propionate concentrations, which do not entail any noticeable decrease in the concentration of serum cortisol. Nevertheless, caution should be exercised in the combined use of inhibitors of the CYP3A4 isoenzyme (e.g., ketoconazole) and fluticasone propionate due to a possible increase in the plasma concentration of the latter. Overdose There is no data on acute and chronic overdose. Intranasal administration to healthy volunteers of 2 mg of fluticasone propionate 2 times / day for 7 days had no effect on the function of the hypothalamic-pituitary-adrenal system (doses 20 times higher than therapeutic). The use of the drug at doses above recommended for a long time can lead to temporary suppression of adrenal function. In case of overdose, the patient should consult a doctor. Storage conditions The product should be stored out of the reach of children at a temperature not exceeding 30 ° C. Shelf life 3 years Deystvuyushtee substance fluticasone furoate Conditions of dispatch from pharmacies Prescription by dosage form nasal spray Possible product names Flixonase spray 50 mcg / dose, 60 doses
