Flixotide
Flixotide: 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. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Flixotide
ATX code: R03BA05
Active ingredient: fluticasone (fluticasone)
Producer: GlaxoSmithKline Pharmaceuticals (Poland), Glaxo Wellcome (Spain)
Description and photo updated: 2019-27-08
Prices in pharmacies: from 627 rubles.
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Flixotide is a glucocorticosteroid (GCS) for local use with antiallergic and anti-inflammatory effects.
Release form and composition
Dosage form - metered dose inhalation aerosol: an almost white or white suspension in a metal inhaler with a dosing device and a concave base equipped with a nebulizer (60 or 120 doses in an aluminum inhaler, 1 inhaler in a cardboard box and instructions for using Flixotide).
1 dose of the suspension contains:
- active substance: fluticasone propionate (micronized) - 0.05 mg, 0.125 mg or 0.25 mg;
- auxiliary component: 1,1,1,2-tetrafluoroethane.
Pharmacological properties
Pharmacodynamics
Fluticasone propionate belongs to the group of topical glucocorticosteroids. It has a pronounced antiallergic and anti-inflammatory effect when administered by inhalation in recommended doses.
Thanks to the use of Flixotide, there is a decrease in the severity of symptoms and a decrease in the frequency of exacerbations of diseases that are accompanied by obstruction of the airways - chronic bronchitis, bronchial asthma, emphysema.
The substance inhibits the proliferation of mast cells, lymphocytes, eosinophils, neutrophils, macrophages, reduces the production and release of inflammatory mediators and other biologically active substances, including histamine, prostaglandins, leukotrienes, cytokines.
The efficacy of inhaled fluticasone propionate has been confirmed in the treatment of chronic obstructive pulmonary disease (when used in combination with long-acting bronchodilators). It affects lung function, thereby reducing the severity of symptoms of the disease, the frequency and severity of exacerbations, reducing the need to prescribe additional courses of tableted glucocorticosteroids and improving the quality of life of patients in comparison with placebo.
The effect on the hypothalamic-pituitary-adrenal system when used in therapeutic doses is insignificant, this effect is not considered clinically significant.
After inhalation of the substance, the therapeutic effect develops within 24 hours, it reaches its maximum in 1–2 weeks or more, and after the withdrawal of Flixotide it persists for several days.
Pharmacokinetics
In healthy volunteers, the absolute bioavailability of fluticasone propionate when used as a metered dose inhalation aerosol is about 10.9%. Systemic exposure in chronic obstructive pulmonary disease or bronchial asthma is lower than in healthy volunteers.
Systemic absorption occurs mainly in the lungs, with the initially rapid absorption gradually slowing down. Part of the administered dose can be swallowed, but due to the poor solubility of the substance in water and intensive metabolism during the first passage through the liver, its systemic effect is minimal (when ingested, the bioavailability of fluticasone propionate is up to 1%). There is a direct relationship between the size of the inhaled dose and the systemic effect of the substance.
Fluticasone propionate has a moderately high binding to plasma proteins (91%).
In the equilibrium state, V d (volume of distribution) is large - about 300 liters.
The substance is excreted from the systemic circulation very quickly, mainly due to metabolism under the influence of the CYP3A4 isoenzyme of the cytochrome P450 system to an inactive metabolite of carboxylic acid. Since there is a possibility of increased systemic exposure to fluticasone propionate, caution should be exercised when used in combination with known CYP3A4 inhibitors.
Pharmacokinetic parameters of fluticasone propionate are characterized by high plasma clearance. The half-life is approximately 8 hours. Renal clearance is less than 0.2%. It is excreted in the urine as a metabolite up to 5% of the dose.
Indications for use
- bronchial asthma (including severe forms of the disease) - as a basic anti-inflammatory therapy in patients over one year old;
- chronic obstructive pulmonary disease (COPD) in adults - as part of combination therapy with long-acting bronchodilators (including long-acting beta-agonists).
Contraindications
- status asthmaticus (as a first-line remedy);
- acute bronchospasm;
- age up to 1 year;
- individual intolerance to the components of the drug.
Flixotide should be prescribed with caution in patients with pulmonary tuberculosis, liver cirrhosis, systemic infections of fungal, bacterial, parasitic or viral etiology, glaucoma, hypothyroidism, osteoporosis, during pregnancy and breastfeeding.
Flixotide, instructions for use: method and dosage
Aerosol Flixotide is used by oral inhalation.
The therapeutic effect is provided by regular use of the drug.
If it is difficult to take a metered aerosol, it is recommended to use a spacer.
In case of impaired renal or liver function, as well as in elderly patients, dose adjustment of Flixotide is not required.
In the treatment of bronchial asthma, the therapeutic effect occurs 4–7 days after the start of the inhalation. An improvement in the condition can occur within a day in patients who use inhaled GCS for the first time.
If the period of action of Flixotide decreases, or the patient feels a decrease in its effect, it is necessary to consult a doctor.
Inhalation is carried out 2 times a day, the initial dose of Flixotide for all age categories depends on the severity of the disease. Taking into account the individual response to therapy, the initial dose is adjusted by increasing or decreasing it to the minimum effective dose to control the disease.
The recommended single dose of Flixotide in the treatment of bronchial asthma:
- patients over 16 years of age: initial dose for mild severity - 0.1–0.25 mg, moderate severity - 0.25–0.5 mg, severe - 0.5–1 mg;
- children aged 4 years and older: 0.05-0.2 mg; use an inhaler containing 0.05 mg of fluticasone propionate in one dose. Usually, asthma control is achieved at a dose of 0.05–0.1 mg;
- children aged 1-4 years: 0.1 mg each; the drug is taken through a spacer with a face mask (for example, the "Babyhaler" spacer). The aerosol is most effective in the treatment of bronchial asthma with prolonged and frequent attacks.
Treatment of bronchial asthma should be accompanied by regular medical examination.
The use of Flixotide in the treatment of chronic obstructive pulmonary disease is indicated only with simultaneous therapy with long-acting bronchodilators. The recommended dosage for adults in the treatment of COPD is 0.5 mg 2 times a day. An inhaler should be used containing 0.25 mg of the active ingredient in a single dose.
The optimal effect is achieved after daily intake of Flixotide for 3–6 months. If there is no clinical improvement, more research is needed.
Side effects
- parasitic and infectious diseases: very often - candidal stomatitis (candidiasis of the mouth and pharynx); often - pneumonia (against the background of COPD);
- from the respiratory system, chest and mediastinal organs: often - hoarseness; very rarely - paradoxical bronchospasm;
- from the immune system: infrequently - hypersensitivity skin reactions; very rarely - angioedema (more often swelling of the oropharynx and face), anaphylactic reactions, respiratory disorders (bronchospasm and / or shortness of breath);
- on the part of the endocrine system (including systemic effects): very rarely - cushingoid symptoms, Cushing's syndrome, growth retardation, inhibition of adrenal cortex function, glaucoma, cataracts, decreased bone mineralization;
- on the part of the psyche: very rarely - sleep disturbances, anxiety, behavioral disorders, hyperactivity, irritability (more often in children);
- dermatological reactions: often - bruising;
- on the part of nutrition and metabolism: very rarely - hyperglycemia.
Overdose
The main symptoms (in case of acute overdose): temporary suppression of the function of the hypothalamic-pituitary-adrenal system, which usually does not require the use of emergency measures, since the function of the adrenal cortex is restored within a few days.
In the case of prolonged use of exceeding the recommended doses of Flixotide, a significant suppression of the function of the adrenal cortex may occur. There are very rare reports of an acute adrenal crisis in children who have received 1000 mcg of fluticasone propionate per day for months or years. Such patients had hypoglycemia, convulsions and depression of consciousness. The emergence of an acute adrenal crisis is possible against the background of the following conditions: surgery, infections, severe trauma, a sharp decrease in the dose of fluticasone propionate.
Therapy: monitoring the condition of patients receiving high doses, and gradually reducing the dose of fluticasone propionate.
special instructions
If, to control the symptoms of bronchial asthma, there is a need for more frequent intake of short-acting inhaled beta 2 -agonists, this indicates a decrease in the effect of Flixotide and the need to revise the therapy plan for the patient.
With a sudden and progressive deterioration of control over the course of bronchial asthma, the potential threat to the patient's life increases, therefore, the dose of GCS should be immediately increased. In this case, patients at risk need to perform peak flow measurements daily.
Abrupt withdrawal of Flixotide is not recommended.
Particular care is taken when treating patients with pulmonary tuberculosis in both active and inactive forms.
The physician must ensure that the patient is able to use the inhaler correctly (it is necessary to observe the synchronization of pressing the valve and inhalation, which will ensure optimal delivery of the active substance to the lungs).
Although the likelihood of developing systemic effects with prolonged use of corticosteroids by inhalation is significantly lower than when taken orally, nevertheless, after achieving a therapeutic effect, the dose of inhaled corticosteroids must be reduced to the minimum effective dose that allows you to control the course of the disease.
When treating children, regular monitoring of the dynamics of their growth is required, especially against the background of long-term use of Flixotide.
There is a risk of developing adrenal insufficiency, especially with prolonged use of high doses of GCS. This should be taken into account when performing surgical operations and in other emergency situations. Depending on the clinical situation, it is necessary to decide on the additional appointment of GCS.
To reduce the risk of developing hoarseness or candidiasis of the mouth and throat, rinse your mouth and throat with water after each inhalation. For the treatment of candidal stomatitis, concomitant therapy with topical antifungal drugs can be used.
With exacerbation of concomitant allergic pathologies previously suppressed by systemic drugs, it is recommended to prescribe symptomatic therapy with antihistamines and / or topical drugs, including GCS.
To relieve paradoxical bronchospasm with a sharp exacerbation of shortness of breath after inhalation, the patient should immediately use an inhaled bronchodilator of quick and short action. The use of Flixotide should be discontinued and a doctor should be consulted.
When the inhalation cartridge is cooled, the aerosol effect is reduced.
Patients with diabetes should take into account the possible increase in blood glucose levels during the period of use of Flixotide.
Patients with COPD have an increased risk of pneumonia, therefore, special care should be taken and their condition should be carefully monitored, given the similarity of clinical signs of exacerbation of the underlying disease and pneumonia.
Influence on the ability to drive vehicles and complex mechanisms
The influence of Flixotide on the patient's ability to drive vehicles and mechanisms is unlikely.
Application during pregnancy and lactation
Aerosol Flixotide is not prescribed during pregnancy / lactation.
Data on the use of the drug in pregnant and lactating women are limited. The use of fluticasone propionate during these periods is permissible only in cases where the potential benefit is higher than the possible risk to the fetus.
Pediatric use
Flixotide is not prescribed for patients under 1 year of age.
Drug interactions
With the simultaneous use of ritonavir, which is a highly active inhibitor of cytochrome P 450 3A4, a significant increase in the concentration of fluticasone propionate in the blood plasma and a decrease in the concentration of cortisol in the serum are possible. Therefore, this combination must be used if the expected benefit from therapy for the patient significantly exceeds the potential risk of developing systemic side effects of GCS.
In addition, it is necessary to prescribe Flixotide with caution in combination with such powerful inhibitors of cytochrome P 450 3A4 as ketoconazole.
Analogs
Flixotide analogues are: Nazarel, Fliksonase, Fluticasone propionate, Sinoflurin, Kutiveit.
Terms and conditions of storage
Keep out of the reach of children.
Store in a place protected from direct sunlight at temperatures up to 30 ° C.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Flixotide
Most reviews of Flixotide indicate its high effectiveness. The drug is considered basic for bronchial asthma, has good tolerance. Indicate that non-compliance with the dosage regimen may develop side effects. The cost is assessed as high.
Flixotide price in pharmacies
The approximate price for Flixotide at 125 or 250 mcg / dose (1 inhaler) is 781–905 or 1119–1270 rubles.
Flixotide: prices in online pharmacies
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Drug name Price Pharmacy |
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Flixotide 50 μg / dose 120 doses aerosol for inhalation metered 1 pc. 627 RUB Buy |
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Flixotide aerosol dosage. 50mcg / dose 120 doses 645 RUB Buy |
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Flixotide 125 mcg / dose 60 doses inhalation aerosol metered 1 pc. 885 RUB Buy |
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Flixotide aerosol dosage. 125mcg / dose 60 doses 1075 RUB Buy |
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Flixotide 250 mcg / dose 60 doses inhalation aerosol metered 1 pc. 1085 RUB Buy |
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Flixotide aerosol dosage. 250mcg / dose 60 doses 1341 RUB 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!
