Fliksonase
Fliksonase: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Use in the elderly
- 12. Drug interactions
- 13. Analogs
- 14. Terms and conditions of storage
- 15. Terms of dispensing from pharmacies
- 16. Reviews
- 17. Price in pharmacies
Latin name: Flixonase
ATX code: R01AD08
Active ingredient: fluticasone (fluticasone)
Producer: GlaxoSmithKline Pharmaceuticals (Poland), Glaxo Wellcome (Spain)
Description and photo update: 2019-19-08
Prices in pharmacies: from 343 rubles.
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Fliksonase is a drug that has antiallergic, decongestant, anti-inflammatory effect and is used to treat rhinitis of allergic etiology.
Release form and composition
The dosage form of Fliksonase is a dosed nasal spray: opaque, white, without foreign particles (in glass dark vials for 60 or 120 doses, in a cardboard box 1 bottle complete with a dosing device and an adapter).
Composition of 1 dose:
- active substance: micronized fluticasone propionate - 50 μg;
- additional components: microcrystalline cellulose, anhydrous dextrose, diluted hydrochloric acid, microcrystalline carboxymethyl cellulose, polysorbate 80, benzalkonium chloride solution, phenylethyl alcohol, purified water.
Pharmacological properties
Pharmacodynamics
Fluticasone propionate has an intense anti-inflammatory effect. Intranasal administration of the drug is not accompanied by a significantly pronounced systemic effect and does not lead to inhibition of the hypothalamic-pituitary-adrenal system.
After the introduction of fluticasone propionate in a daily dose of 200 μg, no significant change in the daily area under the pharmacokinetic curve of serum cortisol compared with placebo was found (the ratio was 1.01, 90% CI - confidence interval from 0.9 to 1 fourteen).
The anti-inflammatory effect of the active component of Flixonase is due to its interaction with glucocorticosteroid receptors. Fluticasone propionate inhibits the production of inflammatory mediators and other biologically active substances (cytokines, histamine, leukotrienes, prostaglandins) during the early and late phases of an allergic reaction and inhibits the proliferation of neutrophils, eosinophils, mast cells, macrophages, lymphocytes. The drug is characterized by a rapid anti-inflammatory effect on the nasal mucosa, and its anti-allergic effect is noted within 2-4 hours after the first application. Fluticasone propionate reduces discomfort in the paranasal sinuses and the feeling of pressure around the eyes and nose, helps to eliminate nasal congestion, sneezing, itching in the nose, runny nose. It also reduces the severity of eye symptoms associated with allergic rhinitis. The effect of Fliksonase, especially concerning nasal congestion, persists for 24 hours after a single injection of a spray at a dose of 200 mcg. Fluticasone propionate improves the quality of life of patients, normalizing their social and physical activity.
Pharmacokinetics
With intranasal administration of fluticasone propionate in a daily dose of 200 μg, it is impossible to quantify the maximum equilibrium plasma concentrations in most patients (they do not exceed 0.01 ng / ml). The detectable peak plasma concentration of the substance was about 0.017 ng / ml. Direct absorption of fluticasone propionate from the nasal cavity is unlikely due to the swallowing of most of the dose and low water solubility. The absolute oral bioavailability of the substance is low and is less than 1%, which is due to active participation in metabolic processes associated with the effect of the "first pass" through the liver, and incomplete absorption from the gastrointestinal tract. Thus, the total systemic absorption of Flixonase remains extremely low.
In an equilibrium state, the active substance Fliksonase has a large volume of distribution (approximately 318 liters). Its degree of binding to blood plasma proteins is quite high (about 91%).
The rapid excretion of fluticasone propionate from the systemic circulation is explained mainly by metabolic processes in the liver, as a result of which, with the participation of the CYP3A4 isoenzyme of the cytochrome P 450 system, a pharmacologically inactive carboxylic acid is formed. The metabolism of the swallowed fraction of the active component of Flixonase during the first passage through the liver is carried out in a similar way.
When fluticasone propionate is used in the dose range of 250 - 1000 mcg, its excretion is linear, and the value of plasma clearance is quite high (1.1 l / min). The maximum concentration of the substance in the blood plasma decreases by about 98% over 3-4 hours, and only if the plasma concentrations were very low, the final half-life was 7.8 hours. The renal clearance of fluticasone propionate is insignificant and does not exceed 0.2%. This indicator for carboxylic acid - an inactive metabolite - is less than 5%. The active substance and its metabolites are excreted mainly in the bile through the intestines.
Indications for use
Spray Fliksonase is prescribed for seasonal or year-round allergic rhinitis (treatment and prevention).
Contraindications
- age up to 4 years;
- individual intolerance to the components of the spray.
According to the instructions, Fliksonase is prescribed with caution and under the supervision of a physician in case of the following conditions / diseases:
- the period after operations in the nasal cavity or a recent injury to the nose;
- ulcerative lesions of the nasal mucosa;
- infections of the nasal cavity or paranasal sinuses (appropriate therapy is required; a contraindication for the use of Flixonase is not), herpes;
- combined use with inhibitors of the isoenzyme CYP3A4, including ketoconazole, ritonavir, as this can lead to an increase in plasma concentrations of fluticasone;
- combined use with other dosage forms of corticosteroids, including tablets, creams, ointments, agents for the treatment of bronchial asthma, eye or nasal drops, nasal sprays with a similar effect;
- pregnancy (use is not recommended, in cases of need for appointment, an assessment of the ratio of benefits to risks is required).
Instructions for use of Fliksonase: method and dosage
Fliksonase is intended only for regular intranasal use, which provides a full therapeutic effect.
The recommended dosage regimen (1 dose corresponds to 50 μg of fluticasone):
- adults and children from 12 years old: 1 time per day (preferably in the morning), 2 doses in each nostril. Sometimes, to achieve control of symptoms, the drug is applied for a short period 2 times a day. The daily dose of Flixonase can be reduced to 1 dose in each nostril after symptom control is achieved. The maximum is 8 doses per day. Elderly patients are prescribed the same dosage regimen;
- children 4–12 years old: 1 dose per day, 1 dose in each nostril. Maximum 4 doses per day.
The maximum therapeutic effect appears 3-4 days after the start of the use of Fliksonase.
Before use, the spray bottle must be shaken gently. Before the first use of the drug, or if the interval in its use was 7 days or longer, you need to check the operability of the nebulizer, for this, the tip is directed away from you and several presses are made (a small cloud should appear).
Before carrying out the procedure, you should clear your nose. After that, you need to close one nostril, while the tip is inserted into the other nostril. The head should be tilted slightly forward, keeping the bottle in an upright position. A single press is performed with inhalation. It is recommended to exhale through the mouth.
It is necessary to rinse the sprayer with warm water at least 1 time in 7 days. Do not use sharp objects (such as pins) to clean a clogged tip.
Side effects
Possible violations:
- allergic reactions: swelling of the face / tongue, skin rash; very rarely - anaphylactic reactions, bronchospasm;
- local reactions: burning sensation, nasal congestion, nosebleeds, dry / irritated nasopharynx, unpleasant taste and smell; very rarely - perforation of the nasal septum (especially in cases of anamnestic data on surgical interventions in the nasal cavity);
- others: headache.
There is evidence of the development of glaucoma, cataracts, an increase in intraocular pressure during long-term therapy, while no causal relationship has been identified during clinical trials for 1 year.
Overdose
There is no information on acute or chronic overdose of fluticasone propionate. In healthy volunteers, intranasal administration of Fliksonase at a dosage of 2 mg 2 times a day for 7 days did not change the function of the hypothalamic-pituitary-adrenal system (the dose was 20 times higher than the recommended one). The use of the drug in doses exceeding therapeutic doses for a long period of time can cause temporary suppression of adrenal function. If you suspect an overdose, you should consult a specialist.
special instructions
Spray Flixonase, as a rule, successfully controls the symptoms of seasonal allergic rhinitis, but sometimes in the summer, when the concentration of allergens in the air is very high, it may be necessary to prescribe additional drugs.
During a long course, you need to regularly monitor the function of the adrenal cortex.
In cases of transfer from the systemic use of corticosteroids to Flixonase, if there is reason to assume functional disorders of the adrenal glands, caution is required.
With constant use of the drug for more than 6 months, medical monitoring of the condition is required.
In order to relieve ophthalmic manifestations with successful treatment of seasonal allergic rhinitis, additional treatment may be required.
Consultation with a doctor for advice is required in cases where after 7 days of regular use of the drug there is no improvement in the condition.
Influence on the ability to drive vehicles and complex mechanisms
The results of clinical studies do not confirm the effect of Fliksonase on the ability to drive vehicles and perform work associated with complex mechanisms, but it is necessary to take into account the side effects characteristic of the drug.
Application during pregnancy and lactation
Before using Fliksonase during pregnancy and lactation, you should consult your doctor. For pregnant and lactating patients, it is prescribed only if the potential benefits of treatment significantly outweigh any possible risks to the fetus or child.
Pediatric use
Flixonase is not used in children under 4 years of age.
Use in the elderly
There is no need to adjust the dosage regimen of Fliksonase for elderly patients.
Drug interactions
The plasma concentration of fluticasone propionate in the blood after the use of Flixonase is insignificant, therefore the development of clinically significant interactions with other drugs / substances is unlikely.
When combined with ritonavir, the plasma concentration of the active substance in the blood can significantly increase, which can cause the development of adverse reactions due to the systemic action of corticosteroids, including Cushing's syndrome and suppression of the adrenal cortex function.
Analogs
Fliksonase analogues are: Sinoflurin, Fluticasone, Nazofan, Nazonex, Beconase, Nazarel, Benarin, Beclomethasone, Tafen Nazal, Nasobek, Polydex with phenylephrine, Avamis.
Terms and conditions of storage
Store at temperatures up to 30 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Available without a prescription.
Reviews of Fliksonaz
Numerous reviews of Flixonase are left by patients suffering from allergic rhinitis. Basically, they consider it to be an effective drug that significantly alleviates the symptoms of this disease. However, in some cases, the use of the drug did not lead to a complete recovery: for example, a month's course of treatment did not help restore the sense of smell and eliminate the swelling of the mucous membrane. In some patients, individual intolerance to the drug was observed, accompanied by increased swelling of the sinuses and nasal congestion, as well as profuse watery discharge.
Doctors confirm the effectiveness of Fliksonase, but remind that in order to avoid complications and the development of side effects, it is necessary to use the spray only according to indications after clarifying the diagnosis and in accordance with the treatment regimen developed by a specialist.
The price of Fliksonase in pharmacies
The average price for Fliksonase in pharmacy chains is 458-500 rubles (the bottle contains 60 doses) or 647-887 rubles (the bottle contains 120 doses).
Fliksonase: prices in online pharmacies
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Drug name Price Pharmacy |
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Fliksonase 50 mcg / dose 60 doses nasal spray dosed 1 pc. 343 r Buy |
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Fliksonase 50 mcg / dose 120 doses nasal spray dosed 1 pc. RUB 400 Buy |
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Flixonase Flixonase for allergic rhinitis, nasal spray, 50 mcg / dose, 60 doses 426 r Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
