Flixotide aerosol 125mkg / dose, 60 dose

basic anti-inflammatory therapy of bronchial asthma in adults and children 1 year of age and older (including patients with a severe course of the disease who are dependent on systemic corticosteroids);

treatment of chronic obstructive pulmonary disease in adults as an adjunct to therapy with long-acting bronchodilators / for example, long-acting beta-agonists LABA).

FlixotideЃ metered dose aerosol is intended for oral inhalation only. Aerosol treatment with FlixotideЃ refers to methods of preventive therapy, the drug must be used regularly, even in the absence of symptoms of the disease. For patients who find it difficult to use a metered aerosol for inhalation, it is recommended to use a spacer.

Elderly people and patients with liver or kidney disease do not need a special dose adjustment.

Bronchial asthma

The therapeutic effect after the use of FlixotideЃ occurs 4-7 days after the start of treatment. In patients who have not previously used inhaled corticosteroids, improvement may be noted as early as 24 hours after starting the drug.

If the patient believes that treatment with fast-acting bronchodilators is becoming less effective, or he needs more inhalations than usual, the doctor should pay special attention to this.

Adults and adolescents over 16 years of age: the recommended dose is 100-1000 mcg 2 times / day. The initial dose of the drug depends on the severity of the disease: with mild bronchial asthma - 100-250 mcg 2 times / day, with moderate bronchial asthma - 250-500 mcg 2 times / day, with severe bronchial asthma - 500-1000 mcg 2 times / day. Depending on the individual patient's response, the initial dose of the drug can be increased until the disease is controlled or reduced to the minimum effective dose.

Children aged 4 years and older are recommended to use FlixotideЃ, which contains 50 ?g of fluticasone propionate in one dose. The recommended dose is 50-200 mcg 2 times / day. In most children, asthma control can be achieved with doses of 50-100 mcg 2 times / day. In children with insufficiently controlled bronchial asthma, it is possible to increase the dose to 200 mcg 2 times / day. The initial dose of the drug depends on the severity of the disease. Then, depending on the individual patient's response, the initial dose of the drug can be increased until the disease is controlled or reduced to the minimum effective dose.

Children aged 1 to 4 years: The recommended dose is 100 mcg 2 times / day. The drug is administered using an inhaler through a spacer with a face mask, for example, 'Babihaler'. Dosed aerosol FlixotideЃ is especially indicated for young children with frequent and prolonged attacks of bronchial asthma.

Diagnosis and treatment of bronchial asthma should be performed with regular examination of the patient by a doctor.

Chronic obstructive pulmonary disease

For adults, the recommended dose is 500 mcg 2 times / day as an adjunct to therapy with long-acting bronchodilators (for example, LABA). It is recommended to use a metered-dose FlixotideЃ aerosol containing 250 mcg per dose.

To achieve the optimal effect, the drug is recommended to be used daily for 3-6 months. In the absence of clinical improvement after 3-6 months, a medical examination is necessary.

Aerosol for inhalation dosed in the form of a suspension of white or almost white color.

Active substance:

fluticasone propionate micronized

• hypersensitivity to any component of the drug;

• acute bronchospasm;

• status asthmaticus (as a first-line remedy);

• children's age (up to 1 year).

The drug should be used with caution in liver cirrhosis, glaucoma, hypothyroidism, systemic infections (bacterial, fungal, parasitic, viral), osteoporosis, pulmonary tuberculosis, pregnancy and lactation.

pharmachologic effect

Fluticasone propionate belongs to the group of corticosteroids of local action and, when administered by inhalation in recommended doses, has a pronounced anti-inflammatory and antiallergic effect, which leads to a decrease in the severity of symptoms and a decrease in the frequency of exacerbations of diseases accompanied by airway obstruction (bronchial asthma, chronic bronchitis, emphysema).

Fluticasone propionate inhibits the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the production and release of inflammatory mediators and other biologically active substances - histamine, prostaglandins, leukotrienes, cytokines.

In COPD, the effectiveness of the action of inhaled fluticasone propionate (when used in combination with long-acting bronchodilators) on lung function has been confirmed, which is characterized by a decrease in the severity of symptoms of the disease, the frequency and severity of exacerbations, a decrease in the need to prescribe additional courses of tableted GCS and an increase in the quality of life of patients compared with placebo ...

At therapeutic doses, the effect on the hypothalamic-pituitary-adrenal system is insignificant, and this effect is not considered clinically significant.

The therapeutic effect after inhalation of fluticasone begins within 24 hours, reaches a maximum within 1-2 weeks or more after the start of treatment, and lasts for several days after discontinuation.

Indications for FlixotideЃ

basic anti-inflammatory therapy of bronchial asthma in adults and children 1 year of age and older (including patients with a severe course of the disease who are dependent on systemic corticosteroids);

treatment of chronic obstructive pulmonary disease in adults as an adjunct to therapy with long-acting bronchodilators / for example, long-acting beta-agonists LABA).

Dosage regimen

FlixotideЃ metered dose aerosol is intended for oral inhalation only. Aerosol treatment with FlixotideЃ refers to methods of preventive therapy, the drug must be used regularly, even in the absence of symptoms of the disease. For patients who find it difficult to use a metered aerosol for inhalation, it is recommended to use a spacer.

Elderly people and patients with liver or kidney disease do not need a special dose adjustment.

Bronchial asthma

The therapeutic effect after the use of FlixotideЃ occurs 4-7 days after the start of treatment. In patients who have not previously used inhaled corticosteroids, improvement may be noted as early as 24 hours after starting the drug.

If the patient believes that treatment with fast-acting bronchodilators is becoming less effective, or he needs more inhalations than usual, the doctor should pay special attention to this.

Adults and adolescents over 16 years of age: the recommended dose is 100-1000 mcg 2 times / day. The initial dose of the drug depends on the severity of the disease: with mild bronchial asthma - 100-250 mcg 2 times / day, with moderate bronchial asthma - 250-500 mcg 2 times / day, with severe bronchial asthma - 500-1000 mcg 2 times / day. Depending on the individual patient's response, the initial dose of the drug can be increased until the disease is controlled or reduced to the minimum effective dose.

Children aged 4 years and older are recommended to use FlixotideЃ, which contains 50 ?g of fluticasone propionate in one dose. The recommended dose is 50-200 mcg 2 times / day. In most children, asthma control can be achieved with doses of 50-100 mcg 2 times / day. In children with insufficiently controlled bronchial asthma, it is possible to increase the dose to 200 mcg 2 times / day. The initial dose of the drug depends on the severity of the disease. Then, depending on the individual patient's response, the initial dose of the drug can be increased until the disease is controlled or reduced to the minimum effective dose.

Children aged 1 to 4 years: The recommended dose is 100 mcg 2 times / day. The drug is administered using an inhaler through a spacer with a face mask, for example, 'Babihaler'. Dosed aerosol FlixotideЃ is especially indicated for young children with frequent and prolonged attacks of bronchial asthma.

Diagnosis and treatment of bronchial asthma should be performed with regular examination of the patient by a doctor.

Chronic obstructive pulmonary disease

For adults, the recommended dose is 500 mcg 2 times / day as an adjunct to therapy with long-acting bronchodilators (for example, LABA). It is recommended to use a metered-dose FlixotideЃ aerosol containing 250 mcg per dose.

To achieve the optimal effect, the drug is recommended to be used daily for 3-6 months. In the absence of clinical improvement after 3-6 months, a medical examination is necessary.

Side effect

Adverse reactions are listed according to the damage to organs and systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very often> 1/10, often> 1/100 and <1/10, infrequently> 1/1000 and <1/100, rarely> 1/10000 and <1/1000 and very rarely <1 / 10000, including selected cases. Frequency categories were formed on the basis of clinical studies of the drug and post-marketing follow-up.

Infectious and parasitic diseases: very often - candidiasis of the mouth and pharynx (candidal stomatitis). Some patients may develop oral and pharyngeal candidiasis. In such cases, it is recommended to rinse your mouth and throat with water after inhalation. You can use topical antifungal drugs while continuing therapy with FlixotideЃ. Often pneumonia in patients with COPD.

On the part of the immune system (hypersensitivity reactions with the following manifestations have been described): infrequently - skin hypersensitivity reactions; very rarely - angioedema (mainly edema of the face and oropharynx), respiratory disorders (shortness of breath and / or bronchospasm) and anaphylactic reactions.

From the endocrine system (systemic effects are possible): very rarely - Cushing's syndrome, cushingoid symptoms, suppression of the adrenal cortex function, growth retardation, decreased bone mineralization, cataracts, glaucoma.

From the side of metabolism and nutrition: very rarely - hyperglycemia.

From the side of the psyche: very rarely - anxiety, sleep and behavior disorders, including hyperactivity and irritability (mainly in children).

From the respiratory system, chest and mediastinal organs: often - hoarseness (some patients may have hoarseness; it is recommended to rinse your mouth and throat with water immediately after inhalation); very rarely, paradoxical bronchospasm.

On the part of the skin and subcutaneous fat: often - bruising.

Contraindications for use

• hypersensitivity to any component of the drug;

• acute bronchospasm;

• status asthmaticus (as a first-line remedy);

• children's age (up to 1 year).

The drug should be used with caution in liver cirrhosis, glaucoma, hypothyroidism, systemic infections (bacterial, fungal, parasitic, viral), osteoporosis, pulmonary tuberculosis, pregnancy and lactation.

Application during pregnancy and lactation

Pregnancy

Data on the use of the drug in pregnant women are limited. The use of fluticasone propionate during pregnancy is permissible only if the potential benefit to the mother outweighs the possible risk to the fetus.

Reproductive studies on animals have shown that at values ??of systemic exposure exceeding those observed when using the recommended therapeutic inhalation doses, only the effects characteristic of GCS are observed.

Breastfeeding period

The excretion of fluticasone propionate in human breast milk has not been studied.

Application for violations of liver function

No dose adjustment is required in patients with impaired liver function.

Application for impaired renal function

No dose adjustment is required in patients with impaired renal function.

Application in children

Contraindication: children under 1 year of age.

Use in elderly patients

Elderly people do not need dose adjustment.

Overdose

Symptoms: an acute overdose of the drug can lead to a temporary inhibition of the function of the hypothalamic-pituitary-adrenal system, which usually does not require emergency therapy, since the function of the adrenal cortex is restored within a few days. With prolonged use of doses of the drug in excess of the recommended ones, significant suppression of the function of the adrenal cortex is possible. There have been very rare reports of the development of an acute adrenal crisis in children who received a dose of fluticasone propionate 1000 mcg / day or higher for several months or years. These patients had hypoglycemia, depression of consciousness, and seizures. An acute adrenal crisis can develop against the background of the following conditions: severe trauma, surgery, infections, a sharp decrease in the dose of fluticasone propionate.

Treatment: monitoring of patients receiving high doses is necessary, and a gradual reduction in the dose of fluticasone propionate.

Drug interactions

When fluticasone propionate is administered by inhalation, its plasma concentrations are very low due to active metabolism during the 'first pass' and high systemic clearance in the intestine and liver, with the participation of enzymes of the cytochrome P450 3A4 system. Thus, clinically significant drug interactions for fluticasone propionate are unlikely.

A drug interaction study in healthy volunteers showed that ritonavir (a highly active inhibitor of cytochrome P450 3A4) can significantly increase the plasma concentration of fluticasone propionate, which consequently leads to a decrease in serum cortisol concentration. Within the framework of post-registration use, clinically significant drug interactions were observed in patients receiving intranasal or inhalation fluticasone propionate with ritonavir, which led to systemic effects of corticosteroids. including Cushing's syndrome and adrenal suppression. Thus, concomitant use of ritonavir and fluticasone propionate should be avoided, unless the potential benefit to the patient outweighs the possible risk of systemic side effects of GCS.

Studies of other inhibitors of cytochrome P450 3A4 have shown a slight (erythromycin) and small (ketoconazole) increase in systemic exposure to fluticasone propionate without any noticeable decrease in serum cortisol concentration. However, care must be taken with the concomitant administration of potent inhibitors of cytochrome P450 3A4 (for example, ketoconazole), since there is a possibility of increasing the plasma concentration of fluticasone propionate.