Flixotide consequences after use. Flixotide: Instructions for applying aerosol and suspension

The date: 05.03.2020

GKS for inhalation.
Preparation: Flixotid
The active substance of the drug: Fluticasone
ATH encoding: R03BA05
KFG: GKS for inhalations
Registration number: P №015734 / 01
Registration date: 04/04/04
Owner reg. Entrepreneur: GlaxosmithKline Pharmaceuticals SA (Poland)

Flixotide release form, preparation packaging and composition.

Aerosol for inhalations metered in the form of a suspension of white or almost white.

1 dose
Flitazon Propionate
50 μg
-«-
125 μg
-«-
250 μg

Auxiliary substances: GR106642X propellant (not contains freon).

60 Doses - Aluminum Inhalers (1) with a metering device - cardboard boxes.
120 Doses - Aluminum Inhalers (1) with a metering device - cardboard boxes.

Description of the drug is based on officially approved instructions for use.

Pharmacological effect Flixotid

GKS for inhalation. The recommended doses have a pronounced anti-inflammatory and anti-allergic effect, which leads to a decrease in the severity of symptoms and a decrease in the frequency of exacerbations of diseases accompanied by the obstruction of the respiratory tract (bronchial asthma, chronic bronchitis, emphysema).

Fluitazon Propionate inhibits proliferation of fat cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the products and release of inflammatory mediators and other biologically active substances (histamine, prostaglandins, leukotrienes, cytokines).

With chronic obstructive pulmonary disease (COPD), the effectiveness of the inhalation fluticasone propionate on the function of the lungs is confirmed, which is characterized by a decrease in the severity of the symptoms of the disease, frequency and severity of exacerbations, a decrease in the need to assign additional GCS courses in the form of tablets and improving the quality of the life of patients.

The systematic effect of fluticasone is expressed as minimal: in therapeutic doses, it practically does not affect the hypothalamic-pituitary-adrenal system.

The drug restores the patient's reaction to broutine, allowing you to reduce the frequency of their application.

The therapeutic effect after the inhalation use of fluticasone begins within 24 hours, reaches a maximum for 1-2 weeks and more after the start of treatment and is stored within a few days after cancellation.

Pharmacokinetics of the drug.

Suction

After inhalation administration, the absolute bioavailability of the fluticasone propionate is 10-30% depending on the type of inhaler. Systemic absorption takes place mainly in the lungs. A portion of the inhaled dose can be swallowed, but its systemic effect is minimally due to the weak solubility of the drug in water and intensive metabolism at the "first passage" through the liver (the bioavailability of the fluticazone of propionate during reception inside is less than 1%). There is a direct relationship between the magnitude of the inhaled dose and the systemic effect of fluticasone propionate.

Distribution

Binding of plasma proteins is 91%.

Flicazon Propionate has a large VD - about 300 liters.

Metabolism

Fluitazone Propionate is metabolized in the liver with the participation of CYP3A4, with the formation of an inactive metabolite.

Election

Flitazone Propionate has a high plasma clearance - 1150 ml / min. T1 / 2 is about 8 hours. Kidney clearance is less than 0.2%. With urine, less than 5% is derived in the form of a metabolite.

Indications for use:

Basic anti-inflammatory therapy of bronchial asthma (incl. With a serious course of the disease and dependence on system GKS) in adults and children 1 year and older;

Treatment of chronic obstructive pulmonary disease in adults.

Dosage and method of use of the drug.

Flixotide is intended only for inhalation. Flixotide is a means of prophylactic therapy, the drug must be applied regularly, even in the absence of symptoms of the disease.

With basic anti-inflammatory therapy of bronchial asthma, the therapeutic effect of the fluxotype occurs after 4-7 days after the start of treatment. In patients who have not previously used inhalation GCS, improvement can be occurring 24 hours after the principle starts.

For adults and adolescents over 16 years old, the initial dose at the bronchial asthma of light flow - at 100-250 μg 2 times / day, moderate severity - 250-500 μg 2 times / day, severe flow - 500-1000 μg 2 times / SUT. Then, depending on the patient's individual reaction for treatment, the initial dose can be increased to the appearance of a clinical effect or reduce to a minimum effective dose.

In children over 4 years old, it is recommended to use an aerosol containing 50 μg of the fluticasone propionate in 1 dose. It is recommended to assign 50-100 μg 2 times / day. The initial dose of the drug depends on the severity of the disease. Then, depending on the patient's individual reaction for treatment, the initial dose can be increased to the appearance of a clinical effect or reduce to a minimum effective dose.

For young children, higher doses of fluxotype are required compared to older children due to a reduced receipt of the drug during inhalation administration (a smaller lumen of the bronchi, the use of spacer, intensive nasal breathing in young children).

The drug is administered using an inhaler through the spacer with a facial mask (for example, Babikhaler).

The dosage aerosol Flixotide is particularly shown to children younger with a severe stream of bronchial asthma.

For the treatment of chronic obstructive pulmonary disease, adults are recommended to assign 500 μg 2 times / day.

Patients with impaired liver or kidney function, as well as elderly, dose correction is not required.

Side effect Flixotide:

Local reactions: Candidiasis of the oral mucosa and pharynx, voice hoarse, paradoxical bronchospasm are possible.

Allergic reactions: In some cases, skin rash, angioedema edema, dysna or bronchospasm, anaphylactic reactions.

The reactions caused by the systemic effect of the drug: there is a decrease in the function of the adrenal cortex, osteoporosis, growth delay in children, cataract, an increase in intraocular pressure, Cushing syndrome. There are also very rare messages about hyperglycemia.

Contraindications for the drug:

Acute bronchospasm;

Asthmatic status (as a priority);

Bronchitis of non-asthma nature;

Children's age up to 1 year;

Increased sensitivity to the components of the drug.

The use of the drug during pregnancy is possible only when the intended benefit for the mother exceeds the potential risk to the fetus.

The removal of fluticasone with breast milk in humans has not been studied. However, after the inhalation administration of the drug in the recommended doses of the concentration of fluticazone propionate in the plasma is low.

Special guidelines for the use of flixide.

Flixotide is designed for long-term treatment of bronchial asthma, and not to relieve attacks. To relieve attacks, patients should be prescribed inhalation bright effects.

In the event of a reduction in the effectiveness of brief effects, the patient should consult a doctor in a more frequent application.

The increase in the need for the use of inhalation agonists of beta2-adrenoreceptors of a short action indicates a deterioration in the disease. In such cases, it is recommended to revise the patient's treatment plan.

A sudden and progressive deterioration in bronchial asthma may pose a threat to the patient's life, so in such situations it is necessary to urgently address the issue of increasing the dose of GKS.

Special caution should be taken in the treatment of inhalation GKS patients with active or inactive forms of lung tuberculosis.

With severe exacerbation of bronchial asthma or insufficient effectiveness of therapy, a dose of inhalation fluticasone propionate should be increased and, if necessary, prescribe a drug from the system GKS group and / or an antibiotic in the development of infection.

With prolonged use of any inhalation GCS, especially in high doses, system effects may be marked, but the likelihood of their development is significantly lower than when taking GKS inside. Possible systemic effects include a decrease in adrenal cortex function, osteoporosis, growth delay in children, cataract, glaucoma. Therefore, it is especially important that, when the therapeutic effect of the dose of inhalation GCS is reached, it has been reduced to a minimum effective dose that controls the course of the disease.

The translation of patients suffering from hormone-dependent bronchial asthma, with systemic GKS on the inhalation of Flitazone requires special attention, since the restoration of the adrenal function requires a long time. The function of the adrenal cortex should be regularly monitored and caution should be taken when the dose of systemic GKS is reduced.

A gradual decline in the dose of system GKS can be started approximately a week after the appointment of Flitazon. With a supporting dose of prednisolone (or other GCS in an equivalent dose), less than 10 mg / day decline in the dose should not exceed 1 mg / day and should be carried out at the intervals of at least 1 week. With a supporting dose of prednisolone more than 10 mg / day (in terms of day) - in high doses also at the intervals of at least 1 week.

Some patients in the period of reducing the dose of system GKS complain about general malaise against the background of stabilization or even improve the indicators of the function of external respiration. If there are no objective signs of adrenal insufficiency, patients should be convinced to continue the transition to inhalation GCS and gradual cancellation of system GKS.

In some cases, individual high sensitivity to inhalation GKS may be observed. The function of the adrenal cortex when prescribing the fluticasone propionate in the recommended doses, as a rule, remains within the normal range. The advantages of the inhalation administration of fluticasone propionate minimize the need for the appointment of systemic GKS. However, the likelihood of the development of side effects in patients who previously received or periodically receiving GCS may be preserved. When conducting resuscitation activities or surgical interventions, a specialist consultation may be required to determine the degree of adrenal insufficiency. In such stressful situations, it should always be taken into account possible adrenal insufficient failure and, if necessary, appoint GCS.

Due to the possible adrenal insufficiency, special caution should be observed and regularly monitor the functions of the adrenal cortex function when transferring patients who took GCS inside to treat inhalation fluticazone propionate. Cancellation of system GCS against the background of the inhalation fluticasone propionate should be carried out gradually, and patients must carry a card with them, indicating that they may need additional GCS reception during the stress period.

In rare cases, the translating of patients with the reception of system GCS for inhalation therapy may manifest themselves to the hyperoeosinophilia (for example, Churg-Strauss syndrome). As a rule, this happens during a dose reduction or cancellation of system GCS, but the direct causal relationship is not established.

When translating patients from the reception of system GKS for inhalation therapy, concomitant allergic diseases (for example, allergic rhinitis, eczema), which used to be suppressed by systemic drugs can also be sharpened. In such situations, it is recommended to conduct symptomatic treatment with antihistamine preparations and / or local drugs, incl. GKS for local application.

For the prevention of the development of the candidiasis, the mouth should be ringed after the use of fluxotype; If necessary, throughout the period of treatment, local antifungal therapy can be prescribed.

In the case of the development of paradoxical bronchospasm, it is necessary to immediately stop the introduction of the fluxotide, to assess the patient's condition, to conduct the necessary examination and, if necessary, to prescribe other drugs. Paradoxical bronchospasm should be immediately stopped using a high-speed inhalation broutine.

There are very rare messages to increase blood glucose levels, and it should be remembered, assigning fluticason propionate patients with diabetes mellitus.

Like most other inhalation agents in aerosol packages, this drug may be less effective when cooling the can.

Use in pediatrics

It should be regularly monitored by the growth dynamics of children receiving inhaled GCS for a long time.

Impact on the ability to driving vehicles and control mechanisms

Influence of fluticazone propionate on the ability to drive a car and working with a technique unlikely.

Overdose by the drug:

Symptoms: In case of acute overdose of the fluxotype, a temporary decrease in the function of the adrenal cortex is possible, with chronic overdose, the suppression of the function of the adrenal cortex may be occurred.

Treatment: During acute overdose, emergency therapy is not required, because The function of the adrenal cortex is restored for several days, which is confirmed by the normalization of the level of cortisol in the plasma.

The interaction of fluxotide with other drugs.

Since with the inhalation route of administration of the concentration of fluticasone propionate in the blood plasma is very low, interaction with other drugs is unlikely.

With the simultaneous use of the fluticasone of propionate and inhibitors of the CYP3A4 enzyme (for example, ketoconazole, ritonavir), it is possible to enhance the system action of the fluxotide (the use of such a combination requires caution).

Terms of sale in pharmacies.

The drug is released by the prescription.

Timing for the condition of the prediction of the drug Flixotide.

List B. The drug should be stored in an inaccessible place for children at a temperature not higher than 30 ° C; Do not freeze and not expose direct sunlight. Shelf life - 2 years.

GKS for inhalations

Active substance

Release form, composition and packaging

Auxiliary substances: 1,1,1,2-tetrafluoroethane in 1 dose - up to 60 mg, 120 doses - up to 10.6 g, in 1 g - 999.17 mg.

Inhalation aerosol dosage The form of a suspension of white or almost white.

Auxiliary substances: 1,1,1,2-tetrafluoroethane in 1 dose - up to 75 mg, 60 doses - up to 8 g, 120 doses - up to 12 g, in 1 g - 998.33 mg.

120 Doses - Aluminum Inhalers (1) with a dosing device - Cardboard packs.

Inhalation aerosol dosage In the form of a suspension of white or almost white.

Auxiliary substances: 1,1,1,2-tetrafluoroethane in 1 dose - up to 75 mg, in 60 doses - up to 8 g, 120 doses - up to 12 g, in 1 g - 996.67 mg.

60 Doses - Aluminum Inhalers (1) with a metering device - Cardboard packs.
120 Doses - Aluminum Inhalers (1) with a dosing device - Cardboard packs.

pharmachologic effect

Fluitazone Propionate refers to the GCS group of local action and with inhalation administration in the recommended doses, it has a pronounced anti-inflammatory and effect, which leads to a decrease in the severity of symptoms and a decrease in the frequency of diseases of the diseases accompanied by the obstruction of the respiratory tract (bronchial asthma, chronic bronchitis, emphysema).

Fluitazone Propionate inhibits proliferation of fat cells, eosinophils, lymphocytes, macrophages, neutrophils, reduces the products and release of inflammation mediators and other biologically active substances - histamine, prostaglandins, leukotrienes, cytokines.

COPL The effectiveness of the inhalation fluticazone of propionate was confirmed (when used in combination with long-acting armor) on the lung function, which is characterized by a decrease in the severity of the symptoms of the disease, frequency and severity of exacerbations, a decrease in the need to appoint additional courses of the GCS and improving the quality of life of patients compared to placebo .

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

The therapeutic effect after the inhalation use of fluticasone begins for 24 hours, reaches a maximum for 1-2 weeks and more after the start of treatment and is stored within a few days after cancellation.

Pharmacokinetics

Suction

The absolute bioavailability of the fluticasone propionate when used in the form of a dosage aerosol for inhalations in healthy volunteers is approximately 10.9%. In patients with chronic obstructive pulmonary disease (COPD) or bronchial asthma, the systemic exposure of the drug is less than in healthy volunteers.

Systemic absorption takes place mainly in the lungs, while absorption is initially fast with the subsequent slowdown. A portion of the inhaled dose may be swallowed, but its systemic effect is minimally due to the poor solubility of the drug in water and intensive metabolism at the "first passage" through the liver (the bioavailability of the fluticazone of propionate when taking inside is less than 1%). There is a direct relationship between the magnitude of the inhaled dose and the systemic effect of fluticasone propionate.

Distribution

Binding with proteins is moderately high, is 91%.

Fluitazone propionate has a large V D in equilibrium state - about 300 liters.

Metabolism

Fluitazone propionate is very quickly excreted from the systemic blood flow, mainly due to metabolism to an inactive carboxylic acid metabolite under the action of Cyp3a4 isoenzyme system P450. Since it is possible to increase the system exposure of the fluticasone propionate, caution should be taken with co-use with known CYP3A4 inhibitors.

Election

Pharmacokinetics of fluticazone propionate is characterized by high plasma clearance (1150 ml / min). T 1/2 is about 8 hours. Kidney clearance - less than 0.2%. With urine, less than 5% is derived in the form of a metabolite.

Indications

- Basic anti-inflammatory therapy of bronchial asthma in adults and children of 1 year and older (including patients with severe disease, which have dependence on system GKS);

- Treatment of chronic obstructive diseases of the lungs in adults as an additional means of therapy for bronchodylators of a long-acting / for example, to beta-agonists of long-term DDBA).

Contraindications

- hypersensitivity to any component of the drug;

- acute bronchospasm;

- asthmatic status (as a priority);

- Children's age (up to 1 year).

Dosage

The dosage aerosol Flixotide is intended only for inhalation through the mouth. Treatment of the flixide aerosol refers to the methods of preventive therapy, the drug must be applied regularly, even in the absence of symptoms of the disease. Patients whose use of a dosage aerosol for inhalations is difficult, it is recommended to apply a spacer.

Persons elderly and patients with liver or kidney disease Special selection of dose is not required.

Bronchial asthma

The therapeutic effect after applying the drug Flixotide comes 4-7 days after the start of treatment. In patients who have not previously used inhalation GCS, improvement can be occurring 24 hours after the start of the use of the drug.

If the patient believes that the treatment of quick-action bronchodylators becomes less efficient, or it requires a greater number of inhalations than usual, the doctor should be paid to this special attention.

Adults and teenagers older than 16 years old:the recommended dose is 100-1000 μg 2 times / day. The initial dose of the drug depends on the severity of the disease: with bronchial asthma of light severity - 100-250 μg 2 times / day, with a bronchial asthma of the average severity - 250-500 μg 2 times / day, with a bronchial asthma of severe degree - 500-1000 μg 2 times / day. Depending on the individual response of the patient, the initial dose of the drug can be increased to the achievement of control over the disease or reduce to a minimum effective dose.

Children aged 4 years and older It is recommended to use a phlixide preparation containing 50 μg of fluticazone propionate in one dose. The recommended dose is 50-200 μg 2 times / day. Most children control asthma can be achieved by applying a dose of 50-100 μg 2 times / day. In children with insufficiently controlled bronchial asthma, a dose increases to 200 μg of 2 times / day. The initial dose of the drug depends on the severity of the disease. Then, depending on the patient's individual response, the initial dose of the drug can be increased to achieve control over the disease or reduce to a minimum effective dose.

Children aged 1 to 4 years:the recommended dose is 100 μg 2 times / day. The drug is introduced using the inhaler through the spacer with a facial mask, for example, "Babikhaler". The dosage aerosol Flixotide is particularly shown to children of younger age with frequent and long-term attacks of bronchial asthma.

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

Chronic obstructive pulmonary disease

Adultsthe recommended dose is 500 μg of 2 times / day as an additional means to therapy with bronchodattoes of long-term action (for example, DDBA). It is recommended to apply a dosage aerosol of a fluxotide containing 250 μg in a dose.

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

Side effects

Unwanted reactions are listed in accordance with the damage to organs and systems and the frequency of occurrence. The frequency of occurrence is defined as follows: Very often\u003e 1/10, often\u003e 1/100 and<1/10, нечасто >1/1000 I.<1/100, редко >1/10000 I.<1/1000 и очень редко <1/10000, включая отдельные случаи. Категории частоты были сформированы на основании клинических исследований препарата и пострегистрационного наблюдения.

From the immune system (The reactions of hypersensitivity with the following manifestations were described: infrequently skin reactions of hypersensitivity; Very rarely - angioedema edema (mainly swelling of the face and rotogling), respiratory disorders (shortness of breath and / or bronchospasm) and anaphylactic reactions.

From the endocrine system (Systemic effects are possible): Very rarely - Cushing syndrome, Kushingoid symptoms, inhibition of adrenal cortex functions, growth slowdown, reduced bone mineralization, cataract, glaucoma.

From the metabolism and nutrition: Very rarely - hyperglycemia.

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

By the respiratory system, chest and mediastinal organs: Often - the hoarseness of the voice (some patients may be celebrated voice hoarse; it is recommended immediately after inhalation to rinse the mouth and throat with water); Very rare-paradsal bronchospasm.

From the side of the skin and subcutaneous fiber: Often - bruises.

Overdose

Symptoms: Acute overdose of the drug can lead to a temporary oppression of the function of the hypothalamic-pituitary and adrenal system, which usually does not require emergency therapy, since the function of the adrenal cortex is restored for several days. With long-term reception doses of the drug, exceeding the recommended, it is possible to mean a significant suppression of the function of the adrenal cortex. Very rare reports were obtained about the development of an acute adrenal crisis in children who received a dose of Flitazone of a propionate 1000 μg / day and higher for several months or years. In such patients, hypoglycemia was noted, the oppression of consciousness and convulsions. Acute adrenal crisis can develop against the background of the following states: severe injury, surgical intervention, infection, sharp decrease in the dose of fluticasone propionate.

Treatment: It is necessary to observe patients receiving high doses, and a gradual decrease in the dose of fluticasone propionate.

Medicinal interaction

With the inhalation route of administration of the fluticasone propionate concentration of it in the blood plasma is very low due to active metabolism at the "first passage" and a high systemic clearance in the intestine and liver, with the participation of the enzymes of the cytochrome R450 3A4 system. Thus, clinically significant drug interactions of the fluticasone propionate are unlikely.

The study of drug interaction in healthy volunteers showed that ritonavir (a highly active inhibitor of cytochrome P450 3A4) can significantly increase the concentration of fluticasone propionate in the plasma, which corresponds to a decrease in serum cortisol concentration. As part of the final application, clinically significant drug interactions were observed in patients receiving fluticazone propionate intranasally or inhaled together with ritonavir, which led to systemic effects of corticosteroids. Including Cushing Syndrome and the oppression of adrenal features. Thus, it is necessary to avoid the concomitant use of the drug ritonavir and fluticasone propionate, except in cases where the potential benefit for the patient outweighs the possible risk of systemic side effects of GKS.

Studies of other cytochrome P450 3A4 inhibitors demonstrated a minor () and small (ketoconazole) an increase in the system exposure of fluticasone propionate without any noticeable reduction in serum cortisol concentration. Nevertheless, care must be taken with the concomitant appointment of powerful inhibitors of cytochrome P450 3A4 (for example,), since it is possible to increase the concentration of fluticasone propionate in the plasma.

special instructions

Increasing the frequency of application of inhalation beta 2 -Gonists of short action to control the symptoms of bronchial asthma indicates a deterioration in the control over the course of the disease. In this case, the patient's treatment plan requires revision.

A sudden and progressive deterioration in control over the strength of bronchial asthma is a potential danger to the patient's life and requires an increase in the dose of GKS. Pictures relating to the risk group can be appointed daily picoflorometry.

Crane cease treatment with the drug Flixotide is not recommended.

Special caution should be taken in the treatment of inhalation GKS patients with active or inactive forms of lung tuberculosis.

It is recommended to check whether the patient can use the inhaler correctly to make sure that the inhaler actuator is performed synchronously with the breath to ensure the optimal delivery of the active substance in the lungs.

With prolonged use of any inhalation GCS, especially in high doses, system effects may be marked, but the likelihood of their development is significantly lower than when taking GKS inside. Possible systemic effects include Cushing syndrome, Kushingoid symptoms, inhibition of adrenal function, reduction of bone mineral density, growth delay in children and adolescents, cataract, glaucoma. Therefore, it is especially important that when the therapeutic effect of the dose of inhalation GCS is reached, it has been reduced to a minimum effective dose that allows you to control the course of the disease.

It is always necessary to take into account the likelihood of adrenal insufficiency in emergency situations (including surgery), as well as with planned intervention, which can cause stress, especially in patients taking high doses of GCS for a long time. This should be resolved about the need for additional purpose of the GCS, depending on the clinical situation (see Overdose section).

Due to the possible adrenal insufficiency, special caution should be observed and regularly monitor the indicators of the function of the adrenal cortex when translating patients who took GCS inside, on the treatment of fluticasone propionate in the form of an aerosol for inhalations. Cancellation of system GKS Against the background of receiving the fluticasone propionate in the form of an aerosol for inhalations should be carried out gradually, and patients must carry a card with them, indicating that they may need an additional GCS reception during the stress period.

As with other inhalation therapy, there is a possibility of developing paradoxical bronchospasm with immediate amplification of shortness of breath after inhalation. To relieve this attack, it is necessary to immediately use the inhalation bright and short action. Inhalation of fluticasone propionate should be immediately stopped, then it should be estimated to be the patient's condition and, if necessary, assign alternative therapy.

As with most means for inhalations in aerosol packages, the effect decreases when the canopy is cooled.

There are very rare messages about increasing blood concentrations, and it should be remembered, assigning fluticason propionate with diabetes mellitus.

Increased pneumonia cases in patients with COPDs received fluticasone propionate in a dose of 500 μg. It should be remembered about the possibility of pneumonia in such patients, since the clinical signs of pneumonia and exacerbation of the underlying disease can often coincide.

Impact on the ability to driving vehicles and control mechanisms

The effect of the fluticasone propionate on the ability to control the car and work with mechanisms requiring increased concentration of attention, unlikely.

Pregnancy and lactation

Fertility

There are no data on the effect on fertility in humans. In animal studies, the influence of the fluticasone propionate on the fertility of males or females was not revealed.

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 for the mother exceeds the possible risk to the fetus.

The results of a retrospective epidemiological study did not discovery the increased risk of serious congenital malformations (UNDPR) after the use of the fluticasone propionate compared to other inhaled corticosteroids during the I trimester of pregnancy.

Reproductive animal studies have shown that with the values \u200b\u200bof systemic exposure exceeding those observed when applying the recommended therapeutic inhalation doses, only effects characteristic of GCS are observed.

Period of breastfeeding

The release of fluticasone propionate with breast milk in humans has not been studied.

When, after P / k administration of the drug with laboratory rats during the lactation, a decomposition of a substance concentration in the blood plasma was obtained, fluticazone propionate was also found in breast milk. However, after the inhalation use of the fluticasone propionate in the recommended doses of its concentration in the blood plasma in patients, most likely will be low.

The use of the drug during breastfeeding period is permissible only if the potential benefit for the mother exceeds the possible risk for the child

Childcare

Contraindication: Children's age up to 1 year.

W. children older than 4 years It is recommended to use an aerosol containing 50 μg of fluticasone propionate in 1 dose. It is recommended to assign 50-100 μg 2 times / day. The initial dose of the drug depends on the severity of the disease. Then, depending on the patient's individual reaction for treatment, the initial dose can be increased to the appearance of a clinical effect or reduce to a minimum effective dose.

Children aged 1 to 4 years It is recommended to assign 100 μg 2 times / day.

The drug is administered with the help of an inhaler through the spacer with a facial mask (for example "Babichaler").

The dosage aerosol Flixotide is particularly shown to children younger with a severe stream of bronchial asthma.

With violations of the kidney function

Patients S. disorders of the kidney function Dose correction is not required.

When violations of the liver function

Patients S. violations of the functions of the liverdose correction is not required.

Application in old age

Elderly persons Dose correction is not required.

Conditions of vacation from pharmacies

The drug is released by the prescription.

RU / FLT / 0003/16 23.12.16

Terms and Storage Terms

The drug should be stored in an inaccessible place at a temperature not higher than 30 ° C; Do not freeze and not expose direct sunlight. Shelf life - 2 years.

Dosage form: & nbspinhalation aerosol dosage Composition:

New edition
COMPOSITION Dosage 50 μg
Component
	in 1 dose		in 120 doses		In 1 g
Active substance:
Flitazona propionate (Microon )	50.0 μg		8.83 mg		0.83 mg
Ancillary:
1,1,1,2- tetrafluoroethan	up to 60.0 mg		up to 10.6 g		999.17 mg
Dosage 125 μg
Component
	in 1 dose	b60 doses		in 120 doses	In 1 g
Active substance:
Flitazona propionate (Microon )	125,0 μg	13.3 mg		20.0 mg	1.67 mg
Ancillary:
1,1,1,2- tetrafluoroethan	BEFORE 75.0 mg	up to 8.0 g		up to 12.0 g	998,33 mg.
	IN 1 lose	in 60. doses		in 120 doses	in 1 g
Active substance:
Flitazone Propionate (micron-ziro)	250,0 μg	26.7 mg		40.0 mg	3.33 mg
Ancillary:
1,1,1,2- tetrafluoroethan	up to 75.0 mg	up to 8.0 g		up to 12.0 g	996,67 mg.

Description:

metal inhaler with a concave base and with a metering device equipped with a sprayer. The surface of the inhaler and the valve should not have visible defects. The content of the inhaler is a white or almost white suspension.

Pharmacotherapeutic Group:Glucocorticosteroid for local applications ATH: & NBSP

R.01.A.D.08 Fluticazon

Pharmacodynamics:

Fluitazone Propionate refers to a group of glucocorticosteroids (GKS) of local action and in inhalation administration in recommended doses has a pronounced anti-inflammatory and anti-allergic effect, which leads to a decrease in severity, symptoms and a decrease in the frequency of diseases, accompanied by the obstruction of the respiratory tract (bronchial asthma, chronic bronchitis, emphysema ).

In chronic obstructive pulmonary disease (COPD), the effectiveness of the inhalation fluticazone of propionate on the function of the lungs is confirmed, which is characterized by a decrease in the severity of the symptoms of the disease, frequency and severity of exacerbations, a decrease in the need to assign additional courses of the GCS tabletled and improving the quality of life of patients.

The systematic effect of fluticasone is expressed as minimal: in therapeutic doses, it practically does not affect the hypothalamic-pituitary-adrenal system.

The drug restores the patient's reaction to broutine, allowing you to reduce the frequency of their application.

Pharmacokinetics:

Suction

After inhalation administration, the absolute bioavailability of the fluticasone propionate is from 7.8% to 10.9% in healthy volunteers, depending on the drug delivery system. In patients with chronic obstructive pulmonary disease (COPD) or. Bronchial asthma system exposure of the drug is less than in healthy volunteers. Systemic absorption takes place mainly in the lungs, while absorption is initially fast with the subsequent slowdown. A portion of the inhaled dose may be swallowed, but its systemic effect is minimally due to the poor solubility of the drug in water and intense pre-consuming metabolism. The bioavailability of the fluticasone propionate when taking inside is less than 1%. There is a linear dependence between the magnified dose value and the systemic effect of the fluticasone propionate.

Distribution

Fluitazone propionate has a large amount of distribution in the equilibrium state (about 300 l). Communication with blood plasma proteins moderately high is 91%.

Metabolism

Fluitazone Propionate has a high plasma clearance (1150 ml / min). The final half-life is approximately 8 hours. Renal clearance of fluticasone propionate is insignificant (less than 0.2%), and less than 5% is derived from the urine as a metabolite.

Indications:

Basic anti-inflammatory therapy of bronchial asthma adults and children 1 year and older (including patients with severe course of the disease, which have dependence on system GKS);
treatment of chronic obstructive pulmonary disease in adults as an additional means to therapy with bronchodulators of long-acting (for example, to long-term beta-agonists (DDB)).

Contraindications:

Hypersensitivity to any component of the drug;
acute bronchospasm;
asthmatic status (as a priority);
children's age (up to 1 year).

Carefully: Pregnancy and lactation:

Pregnancy

Controlled clinical fluitazonepropionate in pregnant women notconducted. Influence of Fluitazonapropionate for pregnancy notstudied. Preclinical researchinfluence of fluticazone propionate onreproductive feature showed thatwith system exposure valuesexceeding observableapplication recommendedtherapeutic inhalation doses, nabfurious only characteristic of GKSeffects. Studies of genotoxicitydid not show the mutagenic potential.

However, as with the use of others drugs, applicationflicazone propionate during pregnancypossible only whenestimated benefit for motherexceeds any potential risk forfetal.

Period of breastfeeding

At the moment it is not established,do Flitazon penetrates propionate inbreast milk. Measurementfluitazone concentration of propionate inplasma of blood laboratory rats,in the period of lactation, aftersubcutaneous administration of the drug indicatefor the presence of fluticasone propionate inbreast milk. However, it is expected thatafter inhalationflitazone propionate in recommendeddoses of its blood plasma concentrationswill low.

The use of the drug Flixotide® during breastfeeding period is not recommended, except in cases where, according to the attending physician, the potential benefit for the child from continuing breastfeeding exceeds the potential risk of developing undesirable phenomena related to the presence of fluticazone in breast milk.

Method of use and dose:

The metered aerosolflixotide is intended only for inhalation through the mouth. Treatment of the flixide aerosol refers to the methods of preventive therapy, the drug must be taken regularly, even in the absence of symptoms of the disease.

Patients whose use of a dosage aerosol for inhalations is difficult, it is recommended to apply a spacer.

Special groups of patients: elderly and patients with patients with liver or kidney doses are not required.

Bronchial asthma

Therapeutic effect after applyingthe drug Flixotid® comes after 4-7 days after the start of treatment. In patientswho have not previously takeninhalation glucocorticosteroids,improvement can be celebrated24 hours after the start of usedrug.

If the patient believes that treatmentbroncharlators quick actionbecomes less efficientor to him need a greater number of inhalations thanusually, the doctor should pay for itspecial attention.

Adults and teenagers older than 16 years

Bronchial asthma easy degreegravity: 100-250 μg 2 times a day;

Bronchial asthma gravity: 250-500 μg 2 times a day;

Bronchial asthma of severe: 500-1000 μg 2 times a day.

Depending on the individual answerpatient dose of the drug can be increasedbefore achieving control over the diseaseor reduce to minimal effectivedoses.

D. weette aged 4 years and older

The recommended dose is 50-200 μg 2 times a day. Most children control asthmacan be achieved by applying a dose of 50-100 μg2 times a day. In children with not enoughcontrolled bronchial asthmaperhaps the increase in dose to 200 μg2 times a day.

The initial dose of the drug depends on the severity of the disease.Then, depending on the individualanswer the patient, the dose of the drug canincrease to achieve control overdisease or reduce to minimaleffective dose.

Children aged 1 to 4 years

Dosage aerosol Flixotide® especially indicated for children of youngerwith frequent and longattars of bronchial asthma.

Diagnosis and treatment of bronchial asthma must be performed whenregular examination of the patient by the doctor.

Chronic obstructive pulmonary disease

Adults

The recommended dose is 500 μg 2 times a day. inquality additional means for therapybronchylators longactions (eg Imer, Dzba).

To achieve optimal effectthe drug is recommended to applydaily within 3-6 months.For lack of clinical improvementafter 3-6 months needmedical inspection.

Side effects:

The unwanted reactions presented below are listed in accordance with the damage to organs and systems of organs and the frequency of occurrence. The frequency of occurrence is determined as follows: Very often (\u003e 1/10), often (\u003e 1/100 and< 1/10), нечасто (> 1/1 000 I.< 1/100), редко (> 1/10 000 I.< 1/1 000), очень редко (< 1/10 000, включая отдельные случаи). Категории частоты были сформированы на основании клинических исследований препарата и пострегистрационного наблюдения.

Frequency of occurrence of unwanted reactions

Very often: Candidia of the mouth and pharynx.

Some patients may develop candidiasis of the mouth and pharynx (candidal stomatitis). In such cases, it is recommended after inhalation rinse mouth and throat with water. Antifungal drugs can be used, while continuing the therapy with the Flixotide® drug.

Often: pneumonia (in patients with COPD).

Rarely: candidiasis of the esophagus.

Impaired immune system

The reactions of increased sensitivity with the following manifestations were described:

Infrequently: leather-sensitive increased sensitivity.

Very rarely: angioedema edema (mainly swelling of the face and rotogling), respiratory disorders (shortness of breath and / or bronchospasm) and

anaphylactic reactions.

Endocrine System Violations

Possible system effects (see "Special Instructions" section):

Very rarely: syndrom bumps, Kushingoid symptoms, inhibition of adrenal cortex functions, growth slowdown, decrease mineralization bonefabrics, cataract, glaucoma.

Disorders from metabolism andnutrition

Very rarely: hyperglycemia.

Disorders of the psyche

Very rarely: anxiety, sleep disorders and behavior, includinghyperactivity I.irritability(mostly in children).

Respiratory disorderssystems, chest organs andmediosphere

Very rarely: paradoxical bronchospasm (see section"Special instructions").

Skin disorders andsubcutaneous fabrics

Often: Bloodmeys.

Overdose:

Acute overdose of the drug can lead to a temporary oppression of the function. The hypothalamic-pituitary-adrenal system, which usually does not require emergency therapy, since the function of the adrenal cortex is restored for several days.

With long-term reception doses of the drug, exceeding the recommended, it is possible to mean a significant suppression of the function of the adrenal cortex. Very rare reports were received about the development of an acute adrenal crisis in children who received a dose of fluticasone propionate 1000 μg per day and above for several months or years. In such patients, hypoglycemia was noted, the oppression of consciousness and convulsions.

Acute adrenal crisis can develop on the background of the following states: heavy injury, surgical intervention, infection, sharp decrease in the dose of fluticazone propionate.

It is necessary to observe patients receiving high doses, and a gradual decrease in the dose of fluticasone propionate.

Interaction:

With the inhalation route of administration of the fluticazone propionate concentration in the plasma of blood is very low due to active metabolism during the first passage and high systemic clearance in the intestine and liver, with the participation of the enzymes of the cytochrome R450 C4 system. Thus, clinically significant drug interactions of the fluticasone propionate are unlikely.

The study of drug interaction in healthy volunteers showed that (a highly active inhibitor of cytochrome P450 in4) can significantly increase the concentration of the fluticasone of propionate in the plasma, which correspondively leads to a decrease in cortisol concentration "in serum. As part of the final application, clinically significant drug interactions were observed in patients receiving Fluitazon Propionate intranasally or inhaled together with ritonavir, which led to the systemic effects of corticosteroids, including Cushing syndrome and oppression of adrenal function.

Thus, it is necessary to avoid the concomitant use of the drug and the fluticasone propionate, except in cases where the potential benefit for the patient outweighs the possible risk of systemic side effects of glucocorticosteroids.

Studies of other cytochrome P450 inhibitors have demonstrated a minor () and small () increase in the system exposure of the propionate fluticazone without any noticeable decrease in serum cortisol concentration. Nevertheless, it is necessary to observe care with the concomitant purpose of the powerful inhibitors of cytochrome P450 Z4 (for example,), since it is possible to increase the concentration of fluticazone of a plasma propionate.

Special instructions:

Increased application frequency inhalation betao agonists shortactions to control symptomsbronchial asthma indicatesworsening monitoringdiseases. In this case, the treatment planthe patient requires revision.

Sudden and progressive deterioration control over the stream of bronchialasthma is a potentialdanger for the patient's life and requiresincreased dose GKS. Patientsrelating to the risk group may beappointed daily holdpicofloumetria.

Crane cease treatment with the drug Flixotide is not recommended. Special caution should be takenin the treatment of inhalation GKSpatients with active or inactiveforms of pulmonary tuberculosis.

It is recommended to check if it knows how patient to use correctlyinhaler to make sure thatinhaler actuatorit is carried out synchronously with a breath forproviding optimal deliveryactive substance in the lungs.

With long use of any inhalation GKS, especially in highdoses, systems can be celebratedeffects, however the likelihood of their developmentsignificantly lower than when taking GKSinside. Possible systemic effectsinclude Cushing syndrome,kushingoid symptoms, oppressionadrenal functions, declinemineral Density Bones Delaygrowth in children and adolescents, cataract,glaucoma. Therefore, it is especially important thatwhen the therapeutic effect is reachedthe dose of inhalation GKS was reduced tominimum effective doseallowing to control the currentdiseases.

Always need to take into account the likelihood adrenal insufficiency in B.emergency situations (includingsurgical intervention), as well asplanned intervention that canserve the cause of stress, especiallypatients taking high dosesGKS for a long time. Forthis should be resolvedneeds additionalgKS assignments depending onclinical situation (see section"Overdose"),

Due to the possible adrenal insecurity should be observedspecial caution and regularlycontrol the indicators of the function of the adrenal cortex when translating patients taking GCS inside, for treatment of fluticasone propionate in the form of an aerosol for inhalations. Cancellation of system GKS Against the background of receiving the fluticasone propionate in the form of an aerosol for inhalations should be carried out gradually, and patients must carry a card with them, indicating that they may need an additional GCS reception during the stress period.

As with other inhalation therapy, there is a possibility of developing paradoxical bronchospasm with immediate amplification of shortness of breath after inhalation. To relieve this attack, immediately applyingbright and short and short action.Inhalation of Flitazona propionate followsimmediately stop, then you should evaluate the patient's condition and, if necessary, assign alternative therapy (see the "Sidey" section).

Like most drugs for inhalations in aerosol packs,the effect decreases when coolingcaller.

There are very rare messages about increasing glucose concentrations in blood and remember to be remembered by appointedflicazone propionate patients with sugardiabetes.

There was an increase in cases of pneumonia in patients with COPD, received fluticason propionate in a dose500 μg. Should be remembered about the possibilitythe emergence of pneumoniapatients because clinicalsigns of pneumonia and exacerbationthe main disease can oftencoincide.

Impact on the ability to control the transc. cf. And Meh.:

Influence of fluticasone. Propionate on the ability to drive a car and work with mechanisms requiring increased concentration of attention, unlikely.

Release form / Dosage:

Flixotide® aerosol / for inhalations Dosed 50 μg / dose, 125 μg / dose and 250 μg / dose. "

Packaging:

For dosage 50 μg: 120 doses in an aluminum inhaler equipped with a plastic dosing device with a protective cap. The inhaler and the dosing device in the assembled form together with the instructions for medical use are placed in a cardboard pack. For 125mkg dosages and 250 μg to 60 or 120 doses into an aluminum inhaler equipped with a plastic dosing device with a protective cap.

Russia

Manufacturer: & NBSP Date of updating information: & NBSP23.10.2015 Illustrated instructions

Flixotide for inhalations, according to the instructions for use, has a complex integrated effect on the body, has many contraindications and the consequences of overdose is sometimes more dangerous because it is required to read before using the drug.

Composition, impact on the body and form

The main active flixide substance has the complex name "Fluticazone Propionate" and is a synthetic corticosteroid, mimicing one of the hormones produced by the adrenal glands.

Depending on the form, it is complemented by different substances:

Inhaler. It is an aluminum tube with a concave donkey and a sprayer, which is sick can easily carry with him in his pocket and inhalation on the clock anywhere. Inside - a white suspension without impurities and smell. Supplement here performs Norflouran - a substance used in those inhalers in which there is no freon in order to make a basic substance volatile and suitable for spraying.
Nebules. They are plastic small ampoules, translated five pieces in aluminum. They differ in doses and are used for use in a nebulizer - as a rule, for the treatment of small children. Here, the supplement is the substances that accelerate the absorption of fluticasons and make it liquid - among them sodium phosphate, sodium chloride and simple purified water.

But the main impact of the fluxotype remains unchanged, despite the form of release:

Anti-inflammatory. The drug prevents the formation and release of inflammation mediators.
Antihistamine. Removes the edema and itching, affects the immune system.

The main advantage of Flikotida, oddly enough, his bad digestibility. Inhalations, most of the larynx flows along the rear wall of the larynx and digested in the stomach. There are less than five percent of the drug in the blood, but, thanks to the fruitful interaction with plasma proteins, they all go to work and have an effect.

The first signs of the effect of the flixidide patient feels in a day, peak intensity is achieved by the end of the second week of reception. The concentration of fluxotype in the blood becomes constant, the excess is removed through the liver and the kidneys, along with the urine.

Interestingly, one of the beneficial properties of the fluxotide is the restoration of the body's sensitivity to broutine, thanks to which the patient can reduce their dosage, not suffering from a lack.

Indications and Contraindications for use

Flixotide for inhalation is used in fact only with two diseases:

Bronchial asthma. In this case, it is used to prevent inflammation and to relieve inflammatory reactions if they have already begun. Moreover, all astmatics show the use of bronchial bronchial lumen and remove spasm - they are used and at rest, and during an attack. Over time, the body adapts to their effects and need all large dosages to continue the effect. Flisotide solves this problem - supports the absorption of broutine at the same level.
Chronic obstructive disease of the lungs. The lumen of the bronchi is constantly narrowed, there is a sluggish progressive inflammation. Flixotide is applied to keep it under control, as well as remove addictive to broutine, which, in the case of obstructive disease, are also used systemically.

With other inhalation diseases with flixotide are not prescribed - the risk of developing side effects and complications is too high. Other drugs are also used if:

The patient developed an asthmatic status - that is, an attack of asthma, which cannot be stopped. In this case, systemic therapy is needed in the hospital, and inhalation with fluxotide will only worsen the situation.
The patient has bronchitis, which is not associated with Asthma. In this case, the use of fluxotype is no longer due, since other drugs are suitable for the treatment of inflammation, and the patient's bronchodulators do not use.
The patient has increased sensitivity to the components of the drug.
The patient is a child by age up to a year. All systems of its body are not yet sufficiently developed, so that inhalations with flixide have positive impact on them.

With certain circumstances, the fluxotide is used, but with caution and only after the doctor will hold all the necessary tests:

during courses for the treatment of the liver cirrhosis - drugs are not combined with each other, and the loaded liver is also unable to withdraw the flixotide normally;
when glauer, it is possible to accelerate the progress of the disease, until the onset of blindness due to the fact that the drug increases the eye pressure;
with hypothyroidism - that is, in disruption of the production of hormones of the thyroid gland, which affects the absorption of any medicines;
with infectious defeat of any character - the body is weakened;
during the courses of the treatment of tuberculosis - a loaded liver does not cope with the conclusion;
with osteoporosis, the fluxotide can exacerbate its flow;
when pregnancy and lactation - the drug enters the blood, which means that it affects the child.

If the phlixotide inhalation is needed, the doctor can find a way out, be sure to give the patient a description of the possible side effects and symptoms of overdose, as well as a guide to what to do if they develop.

Overdose and side effects

If the dose of the drug was exceeded once, as a result, nothing terrible would not happen: the liver simply displays surplus from the body. But if the dosage is higher than systematically, the patient may develop the oppression of the adrenal cortex: as a result, the body ceases to produce hormones that come to it outside and with a sharp abolition of the drug may occur by acute adrenalin crisis. Among his symptoms:

If you do not have a sick help immediately, the likelihood is that for several hours it will develop convulsions and coma, from which it will be possible only in a hospital, with the help of doctors.

The probability of the development of coma in an adult is minimal - symptoms will be marked significantly earlier than it comes to an extreme state. But for children, the danger is much more due to the fact that more and the rate of development of the crisis.

Side effects develop and without exceeding dosage during inhalations with fluxotide. In rare cases, it can develop:

candidiasis of the mouth and pharynx, in which the mucous membranes are annoyed and are covered with painful peelers with a wax;
fucking voice, as a result of frequent inhalations;
paradoxic bronchospasm, which is accompanied by a sharp narrowing of the lumen of the bronchi and choking;
allergic reactions, from innocuous rashes with itching and up to an anaphylactic shock, which, if you do not have a sick assistance, can lead to death from suffocation;
the oppression of the functions of the adrenal cortex, in which the adrenaline crisis is possible;
osteoporosis in which the bones become brittle and fragile, and the body loses flexibility;
increased intraocular pressure, which can cause a whole range of unpleasant effects - from simple pain in the eyes to the development of glaucoma.

Side effects, however, inhalations with flixotide are rarely developed, especially if the procedures are neat, adhering to the instructions.

Proper inhalation

Since there are two forms of release of fluxotype, there are two ways to conduct inhalations with it. Simplest - with aerosol:

get the inhaler, check its integrity - if there are cracks or dents, acquire another;
shake the inhaler a couple of times so that the remedy is homogeneous;
turn over the inhaler to the dyshk up, shove the socket into the mouth;
exhale, smoothly press on the trigger valve and calmly breathe the medicine;
hold breathing for five to ten seconds - you can count about yourself up to ten;
remove the inhaler and calmly exhale.

If the dosage implies the repeated use of the inhaler, you need to wait half a minute and only then repeat the entire procedure from the very beginning.

Nebules for inhalation are not so easy for use. They are used when the patient cannot use the inkjet inhaler due to too small or most of the age, due to weakness or due to the fact that the medicine breaking down from the termination is knocked down by the rhythm of breathing.

In this case, nebulizer is applied - Nebules Flixotype and are intended for it. The process must pass consistently:

get the device, connect the socket or the mask to it, connect it to the network;
get the reservoir for the medicine, open nebula and pour its contents inside;
sit down to the face of a mask or take a socket in the mouth;
include nebulizer and start a procedure - breathing must be calm, but not too slow;
when the drug is over, finish and the procedure is to get a reservoir, rinse it;
rinse also mask or fallen, rub the nebulizer itself;
remove until the next time.

It is also important to remember a few simple rules:

It is important to remember that the dosage of the fluxeotide for inhalations is prescribed exclusively the doctor - self-medication with the help of the drug is unacceptable.

Additional nuances

To use the fluxotype to be as comfortable as possible and efficient, you need to remember some important little things:

Flixotide is used exclusively for the prescription of the doctor - possible side effects and diseases are too serious, for the treatment of which it is intended to experiment with them.

But with careful use in accordance with the recommendations of the doctor and under its sensitive control, Flixotide significantly increases the standard of living of the patient.

The drug Flixotide (Latin Flixotide) is a well-known and often prescribed by doctors drug, which is able to cure inflammatory diseases. The correct use of the purified hormone (the doctor is recommended to carry out inhalation with the help of a nebulizer) helps the patient to restore the health of the respiratory organs faster, as well as get rid of the unpleasant symptoms of pathology.

However, conduct home procedures without the testimony of the doctor, and incorrectly observing the dosage of therapeutic means is prohibited, since this can have a negative effect on the health of the patient.

In one dose of fluxotype for inhalations there are 50, 125 or 250 μg of the main acting element (Fluticazone Propionate). The auxiliary substance of the hormonal medical agent is tetrafluoroetani, which does not contain freon.

The drug is produced in the form of a suspension (white or practically white shade) and aerosol, the balloon of which is made of aluminum alloy with a special device for conducting inhalations. In one package there is one culley balloon and instructions for it, familiarization with which will avoid the development of side effects, as well as familiarize themselves with the composition of Flixidide.

Pharmacological properties

The flixotide aerosol, or rather the majority of therapeutic agent, with a strict observance of the dosage, has a strong and long-effective anti-inflammatory property, which ultimately causes the elimination of unpleasant symptoms of the disease, and also lowers the probable seizures of asthma.

In adults in adults, the bioavailability of the nebulized drug (suspension) is 8%, which cannot be said about the use of aerosol - in this case it is 26%.

Flixotide absorption is carried out through respiratory organs - first it lasts quickly, and then slowly, but for a long time. The residue of the drug is swallowed by patients with minimal health risk for it, in the case of using the aerosol form of medication.

With intravenous drug administration, its main component is quickly and evenly distributed through the body along with the bloodstream.

Attention! If the components of therapeutic agent are too rapidly derived from the body, which is possible to evaluate with the help of blood fence and the lack of positive trend in treatment, it is likely to indicate a hepatic clearance.

Principle of operation of the drug

Flixotide 50 μg and other drug dosages are intended for long-term therapy of bronchial asthma, and not for short-term relief attacks of this disease. If the patient needs to be stopped to stop asthma attacks, the doctor will appoint bronchitators (inhalers), endowed with the rapid effect on the patient's health.

A flixotide is required only with a long-term treatment of the disease, since it will well stop the attacks of the disease and allows you to effectively heal the disease.

Application area

Inhalation use of medicine doctors prescribe patients in the following cases:

conducting anti-inflammatory treatment of bronchial asthma;
therapy of obstructive pathologies of the lungs occurring in the running stage (such treatment is permissible only in adults).

Instructions for the use of Spiriv Respimat

To achieve a rapidly medical effect, it is necessary to comply with the dosage of the medication and in no case begin an independent treatment of the disease. After all, incorrect diagnosis can greatly harm the condition of the patient, which will eventually cause negative consequences for health.

In which cases the drug is contraindicated

It is forbidden to prescribe a phlixide treatment in the following cases:

high sensitivity of the body to one or several components of therapeutic agent;
child age less than 1 year;
asthmatic status;
bronchospasm flowing in acute form;
nautical bronchitis.

Before starting to use therapeutic agent, it is necessary to consult with the attending physician, since if the patient does not pay attention to contraindications, it may lead to negative consequences.

Side effect

Side effects in the drug are divided into 3 species - those who often show themselves, infrequently or too often. Each patient should pay special attention to them, which will help to avoid the development of a dangerous state of state, as well as to correct the dosage of therapeutic composition on time.

Very often, when using aerosol, patients appear such a disease as candidiasis of the pharynx and the oral cavity. To treat this disease is required by a medication method - drugs will write down the doctor after examining the patient and identifying the symptoms of the disease.

Rarely patients complain about the development of allergies, which manifests itself in the form of small rashes on the body.

It is very rare, but still the appearance of the following side effects is possible:

the development of angioedema edema (as a rule, it is the edema of the rotogling and face);
glaucoma or cataract;
lowering the functioning of the adrenal cortex;
growth delay (as a rule, it is mainly observed in childhood);
temporary sleep disorder;
unfortunate irritability;
change of behavior (often observed in adolescent children);
hyperglycemia.

The inhalation form of the phlixide is capable of leading to paradoxical bronchospasm - usually it makes itself felt the appearance of wheezing after holding the next procedure. At the same time, it is important to immediately stop buying - it is done with the help of a quick action.

If paradoxical bronchospasm appears after each use of the aerosol, it is required to be replaced with another, safer to health.

Dosage and reception frequency for diseases

Flixotide, presented in the form of an aerosol, is required only to be appointed - this means that they need to carry out inhalation at home. Inside, take the medicine strictly prohibited.

If the doctor appointed a course of treatment with fluxotide, the medicine is required daily, regardless of whether the disease has symptoms or not.

People of old age and patients suffering from kidney pathologies and liver does not require an individual purpose of the drug, since the fluxotide is not capable of providing negative to health action.

Treatment of asthma

The therapeutic effect on the health of the patient can be observed after 4-7 days after the start of treatment with aerosol. In patients who have not previously taken glucocorticosteroids, the improvement of the condition can be observed within a day after the treatment of therapeutic agent.

Attention! If the patient notes that the effect of medication as the course of treatment has started to weaken, it is necessary to report this to the doctor.

Adults and adolescents, whose age for more than 16 years, is required to carry out inhalation 2 times a day, while the dosage of the fluxotype can vary from 100 to 1000 μg (the exact dose prescribes the doctor). As a rule, it depends on the severity of the disease.

Do not miss useful information: Application of atrial athalation for children and adults

After the inhalation of this drug, the patients are required to monitor the state of health, since side effects make themselves known mainly after the first procedure.

Chronic obstructive pulmonary disease

During this form of the disease for an adult, the optimal dosage is 500 μg, which is required 2 times a day. At the same time, each patient should remember that the medicine should be taken daily until a positive and sustainable result is achieved.

Usually, with this disease, the improvement in patients is observed in 3-6 months after the start of therapy. If it is not, it is necessary to inform you about this.

Attention! In the treatment of this disease, it is necessary to use the highest dosage of the drug under consideration - it is 250 μg. About how to breed the medicine, Dr. will tell.

Excess allowed dose

The description of the drug contains information that the overdose of fluxotide is capable of calling the following symptoms:

oppression of the adrenal system;
suppression of adrenal cortex;
convulsions;
oppression of consciousness;
sharp deterioration in well-being.

Since the composition of the Medication "Strong", in the overdose of the doctor, it is necessary to monitor the health of the patient, and also gradually reduce the amount of the received flixide. Otherwise, you can have a negative health effect, which will be expressed in the appearance of side effects.

Features of the treatment of pregnant and nursing

The drug during the toasting of the fetus is appointed only if it brings significant benefits in the event of the development of inflammatory diseases.

With breastfeeding, it is possible to take medicine only by the testimony of a doctor, since the penetration of its components into breast milk has not been studied. However, the doctors argue that the number of drug components in the blood at regular reception is quite low.

Child's therapy

Children to one year to take the drug strictly prohibited!

Children from 4 years are required to use 50 μg of solution per day during bronchial asthma. At the same time, the procedure should be carried out once or two per day, which depends on the severity of the disease.

If necessary, the doctor may increase the dose of therapeutic agent to continuously restore the patient's health - is usually required due to the individual characteristics of the body.

Children at the age of 1-4 years old, the dosage of therapeutic agent is 100 μg, and the number of inhalations per day - 2.

Attention! Little children, in comparison with adolescents, an increased dose of therapeutic agent is required, since they have difficulty receipt of medicine into the respiratory organs during aerosol use. At the same time, kids need to be able to choose sprays-inhalers that will help to quickly restore the operation of respiratory authorities.

Especially often the aerosol is prescribed to kids with a complicated stream of bronchial asthma. In this case, the remedy needs to be correctly sprayed and strictly follow the dispensing physician - then it will be possible to heal even such a dangerous disease.

How affects the ability to manage mechanisms

As practice and reviews of specialists shows, this therapeutic agent is not able to provide any negative effect on the concentration and attention of the patient. Therefore, patients, conducting the treatment of respiratory diseases of the phlixotide aerosol, can control vehicles or carry out any work related to attention and concentration.

Due to the unique composition, the drug is not able to negatively act on the central nervous system, but still the first few days it is better to protect yourself from the fulfillment of dangerous or hard work.

Terms of sale in pharmacies

Therapeutic agent is sold in pharmacies only by a doctor's prescription. It is determined by the fact that the incorrect use of the drug is able to have a negative effect on the health of the patient. And when visiting a specialist, he will write down the right dose of therapeutic agent, and also tell you how to properly carry out inhalations. In this case, unpleasant health consequences will be much smaller.

Storage rules

The storage of the drug is required at a temperature of no more than 30 degrees. Freeze therapeutic means is not subject to direct action on it sunlight. It is advisable to store the fluxotide in a dark place at moderate temperatures and away from children.

How many are the drug

The drug, subject to the storage conditions, is 2 years. After this period, the drug is required to dispose and in no way use when conducting treatment, even with a reduction in dosage.

Analogs of the drug

Analogues of the drug under consideration a lot. The best of them are considered:

Beklason Eco;
Nazarel;
Budoster;
Evohaler;
Ventoline;
Sinofloree;
Nebufluison;
Flisonase;
Decamazone.

The form of release of each above-mentioned drug is the nasal sprays or aerosols, due to which it will turn out to effectively cure inflammatory disease of the respiratory organs. The main thing is to use therapeutic agent only by testing the doctor and strictly observing the dose of medication.