Instruction for use: Flixotide

Active substance Fluticasone

ATX codeR03BA05 Fluticasone

Pharmacological group

Glucocorticosteroids

Nosological classification (ICD-10)

J42 Chronic bronchitis, unspecified

recurrent bronchitis, Bronchitis asthma, wheeze bronchitis, chronic Bronchitis, Inflammatory airways disease, bronchi disease, Qatar smoker, Cough in inflammatory diseases of the lung and bronchus, Exacerbation of Chronic Bronchitis, Chronic bronchitis, Chronic obstructive pulmonary disease, Chronical bronchitis, Chronic bronchitis smokers, Chronic spastic bronchitis, allergic Bronchitis

J45 Asthma

Asthma physical effort, status asthmaticus, Bronchial asthma, Asthma lung flow, Bronchial asthma with obstruction of sputum discharge, Bronchial asthma heavy currents, Bronchial asthma physical effort, hypersecretory asthma, Hormone-dependent form of bronchial asthma, Relief of asthma attacks in bronchial asthma, Non-allergic asthma, nocturnal asthma, Exacerbation of asthma, Asthma attacks, Endogenous forms of asthma, Night asthma, Cough with bronchial asthma

Composition and form of release

Aerosol inhalation dosed 1 dose

Fluticasone 50 μg\125 μg\ 250 mcg

Auxiliary substances: propellant tetrafluoroethane GR106642X (the preparation does not contain freon)

In inhalers (with a metering device); In a carton box 1 set.

Description of dosage form

A metal inhaler with a concave base and with a metering device, equipped with a sprayer. The contents of the inhaler are a white or almost white suspension.

Characteristic

SCS local action.

pharmachologic effect

Pharmacological action - antiallergic, glucocorticoid, anti-inflammatory local.

Inhibits the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of mediators of inflammation and other biologically active substances (histamine, PG, leukotrienes, cytokines).

Pharmacodynamics

Reduces the severity of symptoms and reduces the frequency of exacerbations of diseases accompanied by airway obstruction, reduces the need to prescribe additional courses of tableted GCS, characterized by an improvement in the patient's quality of life. It restores the patient's response to bronchodilators, and reduces the frequency of their use. The therapeutic effect is manifested within 24 hours after inhalation, reaches a maximum within 1-2 weeks or more after the start of treatment and persists for several days after drug discontinuation.

Pharmacokinetics

After inhalation, absolute bioavailability is 10-30% (depending on the drug delivery system). Absorbed mainly in the lungs. If a portion of the inhaled dose is swallowed, the systemic effect is minimal due to the poor solubility of the drug in the water and intensive metabolism during the "first pass" through the liver. Bioavailability of fluticasone propionate when absorbed from the gastrointestinal tract is less than 1%. There is a direct relationship between the magnitude of the inhaled dose and the systemic effect of fluticasone propionate. Binding to plasma proteins is 91%. Has a large volume of distribution (about 300 liters). Metabolised in the liver with the participation of the enzyme CYP3A4 of the cytochrome P450 system with the formation of an inactive metabolite. Kidney clearance is negligible (less than 0.2%). Has a high plasma Cl - 1150 ml / min. T1 / 2 is 8 hours. It is excreted in the urine in the form of a metabolite (less than 5%).

Indication

Bronchial asthma (basic anti-inflammatory therapy) in adults and children 1 g and older (including those with severe course of the disease, with dependence on systemic GCS), chronic obstructive pulmonary disease in adults.

Contraindications

Hypersensitivity, acute bronchospasm, asthmatic status (as a primary means), bronchitis of non-astatic nature, children's age (up to 1 year).

With caution - with cirrhosis, glaucoma, hypothyroidism, systemic infections (bacterial, fungal, parasitic, viral), osteoporosis, pulmonary tuberculosis, pregnancy and lactation.

pregnancy and lactation

With caution, only if the expected effect of therapy exceeds the potential risk to the fetus or child.

Side effects

Candidiasis of the mouth and pharynx, hoarseness (after inhalation, rinse mouth and throat with water), paradoxical bronchospasm (requires withdrawal of the drug, and continuation of therapy by other means); Rarely - the development of allergic reactions (skin rash, angioedema, dyspnea or bronchospasm, anaphylactic reactions); Possibly lowering the function of the adrenal cortex, osteoporosis, growth retardation in children, cataract, increased intraocular pressure.

Interaction

With simultaneous administration with inhibitors of CYP3A4 (ketoconazole, ritonavir), it is possible to increase the systemic effect of fluticasone propionate (caution should be exercised).

Dosing and Administration

Inhalation, after inhalation, rinse mouth with water.

Bronchial asthma. Adults and adolescents older than 16 years: 100-1000 μg 2 times a day, depending on the severity of the disease: mild asthma form - 100-250 μg, the average form - 250-500 μg, severe form - 500-1000 μg. Depending on the individual response of the patient, the initial dose is either increased to the appearance of a clinical effect or reduced to the minimum effective dose.

Children older than 4 years (only in the form of an aerosol for inhalation, dosed at 50 μg fluticasone in a single dose): the recommended dose of 50-100 μg 2 times a day.

Children from 1 to 4 years: (only in the form of an aerosol for inhalations dosed at 50 μg fluticasone in a single dose): 100 μg 2 times a day. Young children require higher doses compared to older children due to reduced intake of the drug with inhalation (use of a spacer, less bronchus clearance, intense nasal breathing). The drug is administered with the aid of an inhaler through a spacer with a face mask (Babihaler).

Chronic obstructive pulmonary disease. Adults, 500 mcg twice a day.

Overdose

Symptoms: acute - temporary decrease in the function of the adrenal cortex; Chronic - suppression of the function of the adrenal cortex.

Treatment: chronic overdose - monitoring of the reserve function of the adrenal cortex (treatment with the drug can be continued in doses sufficient to maintain therapeutic effect).

Precautionary measures

In the absence of effect or sharp exacerbation of bronchial asthma, the dose of the drug should be increased and if necessary, oral steroids and / or antibiotics should be prescribed for the development of infection. In patients taking systemic steroids, the transition to inhalation should take place against the background of a gradual withdrawal of systemic drugs. A gradual decrease in the dose of systemic glucocorticoids should be started one week after the onset of fluticasone. With a maintenance dose of prednisolone (or other glucocorticoids in equivalent doses) of less than 10 mg / day, the dose reduction should not exceed 1 mg / day and should be conducted at an interval of not less than 1 week. With a maintenance dose of prednisolone above 10 mg / day - in large doses with an interval of 1 week.

You can not abruptly stop treatment with Fliksotid. Use with caution in pulmonary tuberculosis. It is necessary to regularly monitor the dynamics of growth of children receiving the drug for a long time.

In rare cases, when transferring patients from taking systemic glucocorticoids to inhalation therapy, conditions accompanied by hypereosinophilia may develop; May also exacerbate associated allergic diseases (allergic rhinitis, eczema), which were previously suppressed by systemic drugs. In these cases, symptomatic treatment with antihistamines and / or topical preparations is necessary. If necessary, local antifungal therapy may be prescribed throughout the course of treatment.

special instructions

It is not intended for relief of attacks of bronchial asthma.

The drug should be taken regularly throughout the course of treatment, even in the absence of symptoms of the disease.

The effect is reduced by cooling the can.

storage Conditions

At a temperature not exceeding 30 ° C. Do not freeze and do not expose to direct sunlight.

Keep out of the reach of children.

Shelf life

2 years.

Do not use after the expiry date printed on the package.