Flixonase, spray 50 mcg/dose 120 doses

GCS for intranasal use. It has a pronounced anti-inflammatory effect. When administered intranasally there is no systemic action, practically does not inhibit hypothalamic-pituitary-adrenal system.

No significant changes in the daily AUC of serum cortisol were found after administration of fluticasone propionate at a dose of 200 mcg/day compared to 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. It suppresses proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils. Fluticasone propionate decreases production of inflammatory mediators and a number of biologically active substances (including histamine, prostaglandins, leukotrienes, cytokines) during the early and late phase of allergic reaction.

It has rapid anti-inflammatory effect on nasal mucosa. Anti-allergic effect appears 2-4 hours after the first use. It reduces sneezing, nasal itching, rhinorrhea, nasal congestion, nasal sinus discomfort and pressure sensation around nose and eyes.

It also reduces eye symptoms associated with allergic rhinitis. Reduction of symptoms (especially nasal congestion) persists for 24 hours after a single application of 200 mcg spray.

Fluticasone propionate improves patients’ quality of life, including physical and social activity.

Indications

Sneezing, Pollinosis, Increased nasal lacrimation, stuffy nose, allergies, allergic rhinitis, nasal polyposis, sinusitisThe treatment of year-round and seasonal allergic rhinitis, including pollinosis (hay fever) in adults and children from 4 years: pain, pressure in the paranasal sinuses; stuffy nose, sneezing, itching in the nose; lacrimation.

Active ingredient

Fluticasone

Composition

Active ingredient:

Fluticasone propionate (micronized) 50 mcg;

Ancillary substances:

anhydrous dextrose,

microcrystalline cellulose,

microcrystalline carboxymethylcellulose,

phenylethyl alcohol,

benzalkonium chloride solution,

polysorbate 80,

Hydrochloric acid diluted,

purified water.

How to take, the dosage

Flixonase® is intended for intranasal use only. The drug should be used regularly to achieve the full therapeutic effect. The maximum therapeutic effect occurs after 3-4 days of therapy.

Adults and children over 12 years
1st week: 2 injections into each nostril once daily (200 mcg/day);
2nd week to 3 months: 1 or 2 injections into each nostril once daily (100-200 mcg/day).
Maximal daily dose is 200 mcg/day (not more than 2 injections into each nostril).

Elderly patients are prescribed in usual dose intended for adults.

Children aged 4 to 12 years

1 injection in each nostril 1 time/day (100 mcg/day). The recommended dose (100 mcg/day) should not be exceeded. In children aged 4 to 12 years, the drug should be used for the shortest time necessary to achieve symptom control. The attending physician should be consulted 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 (no more than 1 injection and each nostril).

In case of lack of effect of the drug in all age groups of patients you should consult a physician.

Instructions for use

Shake the bottle gently before use by placing the index and middle fingers on either side of the tip and the thumb under the bottom of the bottle.

If you use the drug for the first time or if you do not use it for more than 1 week you should check the performance of the atomizer: direct the tip away from you, make a few pressures until a small cloud appears from the tip. Then you need to clean your nose (blow your nose). Close one nostril and insert the tip in the other nostril. Tilt your head slightly forward, continuing to hold the bottle vertically. Then breathe in through your nose and while continuing to breathe in, press down once with your fingers to atomize the medicine. Exhale through the mouth. Repeat the procedure for a second spray in the same nostril, if necessary. Then repeat the entire procedure, inserting the tip in the other nostril. After use, wipe the tip with a clean cloth or handkerchief and cover it with the cap.

The nebulizer should be flushed at least once a 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 reinstall the tip in its original position at the top of the bottle. Put on the protective cap.

If the tip hole is clogged, the tip should be removed as described above and leave for a while in warm water. Then rinse under cold water, dry and put back on the bottle. Do not clean the tip opening with a pin or other sharp object.

Interaction

Concomitant use of fluticasone propionate with ritonavir, which is a strong inhibitor of CYP3A4 isoenzyme, may cause a significant increase in plasma concentrations of fluticasone propionate.

As a result, there is a sharp decrease in the concentration of cortisol in the serum. Fluticasone propionate use by inhalation or intranasally and ritonavir leads to the development of side effects caused by the systemic action of GCS, including Cushing’s syndrome and suppression of adrenal cortex function. Therefore, concomitant use of fluticasone propionate and ritonavir should be avoided unless the possible benefits exceed the risk of systemic effects.

Concomitant use of fluticasone propionate with other, less potent CYP3A4 isoenzyme inhibitors, such as ketoconazole and itraconazole, leads to increased exposure of fluticasone propionate and increased risk of systemic side effects.

CYP3A4 inhibitors cause negligible (erythromycin) or minor (ketoconazole) increases in plasma concentrations of fluticasone propionate that do not result in any significant decrease in serum cortisol concentrations. However, caution should be exercised when combining CYP3A4 isoenzyme inhibitors (e.g., ketoconazole) and fluticasone propionate due to possible increase in plasma concentrations of the latter.

Special Instructions

The drug is indicated only for intranasal use.

For adults and children from 12 years old: Flixonase® nasal spray should not be used for more than 3 months. If it is necessary to use the drug more than 3 months, it is necessary to consult a physician.

For children from 4 to 12 years old: Flixonase® nasal spray should not be used more than 2 months. If it is necessary to use the drug for more than 2 months, it is necessary to consult a physician. In case of long-term use, regular monitoring of adrenal cortex function is necessary.

There are reports about manifestation of systemic effects when using nasal GCS, especially in high doses for a long time. These effects are much less likely than with oral administration. Systemic effects when using nasal corticosteroids may occur in particular when using them in high doses for a long time. These effects are much less likely to occur than with oral corticosteroids and may vary in individual patients and between different corticosteroids.
Possible systemic effects may include Icenko-Cushing’s syndrome, characteristic signs of cushingoid, suppression of adrenal function, 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 aggression (particularly in children).

Growth retardation has been observed in children treated with some intranasal GCS at approved doses. It is recommended to regularly monitor the growth of children receiving long-term treatment with intranasal GCS. In case of growth retardation, treatment should be reconsidered in order to reduce the dose of intranasal GCS, if possible, to the minimum dose that ensures effective control of symptoms and contact the pediatrician.

Simultaneous use of ritonavir and fluticasone propionate should be avoided unless the potential benefit to the patient exceeds the possible risk of systemic corticosteroid side effects.

It is recommended that the drug be stopped and a physician consulted if there is no improvement within 4 days. Consultation with a physician is also necessary if the patient develops new symptoms such as pronounced facial pain, thick nasal discharge that may indicate an infection and are not related to allergies.

Infections of the nasal cavity or sinuses require appropriate treatment but are not contraindications to the use of Flixonase® nasal spray.

In most patients, Fluticasone Propionate Nasal Spray eliminates the symptoms of seasonal allergic rhinitis, but in some cases, if the concentration of allergens in the air is very high, additional therapy may be necessary.

Additional therapy may be required to relieve eye symptoms against the background of successful therapy of seasonal allergic rhinitis.

To achieve maximum therapeutic effect it is necessary to adhere to a regular pattern of use.

Caution should be exercised when transferring patients from systemic GCS therapy to treatment with fluticasone propionate in nasal spray form, especially if there is impaired adrenal function with regular monitoring.

Flixonase®, nasal aqueous spray contains benzalkonium chloride, which may 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.

Effect on the ability to drive vehicles and mechanisms

No data on the effect of the drug on the ability to drive vehicles and other mechanisms have been obtained in clinical trials, but side effects that the drug may cause should be considered.

Synopsis

Dosed nasal spray in the form of an opaque white suspension, free from foreign particles.

Contraindications

Hypersensitivity to fluticasone propionate and other components of the drug; children under 4 years of age; recent nasal trauma or surgery and nasal cavity.

Before using the drug, the patient should consult a physician in the following cases: taking medications to treat HIV infection, such as ritonavir; taking GCS to treat bronchial asthma, allergies, skin rashes; taking medications to treat fungal infections, such as ketoconazole; taking other potent CYP3A isoenzyme inhibitors, such as itraconazole; if glaucoma or cataracts.

Take with caution in the presence of infections of the nasal cavity or sinuses. Note that nasal infections require appropriate treatment, but are not a contraindication to the use of Flixonase nasal spray.

Side effects

Definition of the frequency of adverse effects: very frequently (≥1/10), frequently (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10 000 and <1/1000), very rarely (<1/10 000, including individual cases).

Very common, frequent and infrequent adverse reactions are mainly established on the basis of data from clinical studies. Rare and very rare reactions were mostly determined from spontaneous reports.

In forming the incidence of adverse reactions, baseline rates in the placebo group were not taken into account, because they were generally comparable to the active treatment group.

Immune system disorders: very rarely – hypersensitivity reactions, including bronchospasm, rash, swelling of the face and tongue, anaphylactic reactions, anaphylactoid reactions.

Nervous system disorders: often – headache, unpleasant taste and odor. The occurrence of headache, unpleasant taste and odor have also been reported with other nasal sprays.

Eye: very rare – glaucoma, increased intraocular pressure, cataracts. A small number of spontaneous reports was associated with long-term therapy with the drug.

Respiratory system: very common – nasal bleeding; common – dry mucous membranes in the nasal cavity and pharynx, mucous membrane irritation in the nasal cavity and pharynx (these adverse reactions and nasal bleeding were also observed when using other intranasal drugs); very rare – perforation of nasal septum (reported when using intranasal GCS).

The use of some intranasal GCS may cause systemic effects, especially when administered in high doses for a long time.

Overdose

There are no data on acute and chronic overdose of the drug.

When administered intranasally to healthy volunteers 2 mg of fluticasone propionate 2 times a day for 7 days it had no effect on the function of the hypothalamic-pituitary-adrenal system (the dose is 20 times higher than the therapeutic dose).

The use of the drug in doses higher than those recommended for a long time may lead to temporary suppression of adrenal function. In case of overdose the patient should consult a physician.

Pregnancy use

Before using Flixonase® during pregnancy and lactation it is necessary to consult a physician.

Pregnant and lactating women may use Flixonase® only when the expected benefits to the patient exceed any possible risk to the fetus or child.

Similarities

Flixotide, Nazarel, FeniWeit