Flixonase, spray 50 mcg/dose 60 doses

Name: Flixonase, spray 50 mcg/dose 60 doses
SKU: 30537
Availability: InStock

€14.61

EAN: 4602233006871 SKU: 30537 Categories: Bronchial asthma, Medicine, Respiratory system

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 and 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 phase of the allergic reaction. It has rapid anti-inflammatory effect on nasal mucosa.

Anti-allergic effect occurs 2-4 hours after the first use. It reduces sneezing, nasal itching, rhinorrhea, nasal congestion, discomfort in the sinus area and a feeling of pressure around the nose and eyes. Also relieves eye symptoms associated with allergic rhinitis.

Indications

Treatment of year-round and seasonal allergic rhinitis, including pollinosis (hay fever) in adults and children from 4 years: pain, pressure sensation in the area of the paranasal sinuses; nasal congestion, sneezing, nasal itching; lacrimation.

Active ingredient

Fluticasone

Composition

1 dose:

Fluticasone propionate (micronized) 50 mcg

Associates:

dextrose – 5 mg,

avicel RC591 (microcrystalline cellulose, sodium carmellose) – 1.5 mg,

phenylethanol – 0.25 mg,

benzalkonium chloride – 0.02 mg,

polysorbate 80 – 0.005 mg,

hydrochloric acid – up to pH 6.3-6.5,

purified water – up to 100 mg.

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 the usual dose intended for adults.

Children aged 4 to 12 years

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. The use of fluticasone propionate inhaled or intranasally and ritonavir leads to the development of side effects due to the systemic effects of GCS, including Cushing’s syndrome and inhibition of adrenal cortical 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. Caution should be exercised and long-term co-administration should be avoided if possible.

CYP3A4 inhibitors cause negligible (erythromycin) or minor (ketoconazole) increases in plasma concentrations of fluticasone propionate that do not result in any measurable 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 it is necessary to control adrenal cortex function regularly.

There are reports about systemic effects when using nasal GCS, especially in high doses for a long time. These effects are much less likely than when administered orally. Systemic effects when using nasal corticosteroids may occur in particular when using them in high doses for a long time. The probability of these effects is much lower than with oral corticosteroids, and they may vary in individual patients and between different corticosteroid preparations.

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 – nasal septum perforation (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 hypothalamic-pituitary-adrenal system (the dose is 20 times higher than therapeutic).

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 Flicksonase® during pregnancy and lactation you should consult your doctor.

Pregnant and lactating women can take Flicksonase® only if expected benefits to the patient exceed any possible risk to the fetus or child.

Similarities

Flixotide, Nazarel, FeniWeit

Additional information

Weight	0.070 kg
Shelf life	3 years
Conditions of storage	The drug should be kept out of reach of children at a temperature not exceeding 30 ° C.
Manufacturer	Glaxo Wellcome S.A., Spain
Medication form	dosed nasal spray
Brand	Glaxo Wellcome S.A.