Flixotide official instructions. With impaired renal function. Side effects of flixotide aerosol

Flixotide(Flixotide Nebula, Flixotide Diskus and Flixotide Evohaler) is a drug for inhalation use that has a pronounced anti-inflammatory effect on the lungs. Fluticasone propionate, an active ingredient, is a glucocorticosteroid drug that helps reduce the frequency of asthma attacks, reduce the severity of obstruction in patients with chronic lung diseases, and improve lung function. When using the drug Flixotide, a pronounced therapeutic effect develops on days 4-7 of therapy, although an improvement in the patient's condition may be observed already 24 hours after the start of therapy. With inhalation, the bioavailability of fluticasone propionate varies from 10 to 30%. Some of the drug enters the digestive tract during inhalation, however, given the oral bioavailability of fluticasone propionate (less than 1%), this is not significant. Systemic absorption of fluticasone when inhaled is directly proportional to the dose. Part of the drug that enters the systemic circulation is rapidly metabolized to inactive substances and excreted mainly by the kidneys. The half-life of fluticasone propionate reaches 8 hours.

Indications for use

Mode of application

The drug can be prescribed as an aerosol from a jet nebulizer. Do not use ultrasonic nebulizers. If necessary, prolonged administration or administration of small doses of fluticasone immediately before inhalation is allowed to dilute the suspension in physiological sodium chloride solution. The duration of use and dose of fluticasone is determined by the doctor.
Adults and children over 16 years of age are usually prescribed 0.5-2 mg of fluticasone twice a day. The maximum dose should be used within 7 days after an attack of bronchial asthma, after which the dose of fluticasone is recommended to be gradually reduced. After the patient's condition improves, it is allowed to switch from the use of the drug Flixotide Nebula to Flixotide Diskus or Flixotide Evohaler.
Children from 4 to 16 years of age are usually prescribed 1 mg of fluticasone twice a day.
Regardless of the form of release, discontinuation of fluticasone propionate therapy should be carried out by gradually reducing the dose.

Side effects

Contraindications

Pregnancy

Interaction with other drugs

Overdose

Storage conditions

Release form

Compound

1 dose of Flixotide Diskus 100 contains:
Microionized fluticasone propionate - 100mcg;
Additional ingredients including lactose monohydrate.

1 dose of Flixotide Diskus 250 contains:

Additional ingredients including lactose monohydrate.

1 dose of Flixotide Evohaler 50 contains:
Microionized fluticasone propionate - 50mcg;
Additional ingredients.

1 dose of Flixotide Evohaler 125 contains:
Microionized fluticasone propionate - 125mcg;
Additional ingredients.

1 dose of Flixotide Evohaler 250 contains:
Microionized fluticasone propionate - 250mcg;
Additional ingredients.

2ml suspension (1 nebula) of Flixotide Nebula contains:
Microionized fluticasone propionate - 0.5 or 2 mg;
Additional ingredients.

Main settings

Registration certificate holder:
registered by GlaxoSmithKline Trading ZAO (Russia)manufactured by GLAXO WELLCOME S.A. (Spain) or GlaxoSmithKline Pharmaceuticals S.A. (Poland)

Produced:
GLAXO WELLCOME S.A. (Spain) or GlaxoSmithKline Pharmaceuticals S.A. (Poland)

ATX code for FLIXOTID

R03BA05 (Fluticasone)

You should consult with your doctor before using FLIXOTIDE. These instructions for use are for informational purposes only. For more information, please refer to the manufacturer's annotation.

Clinical and pharmacological group

04.005 (GCS for inhalation)

Release form, composition and packaging

In the form of a suspension of white or almost white color.

Excipients: propellant GR106642X (does not contain freon).

60 doses - aluminum inhalers (1) with a dosing device - cardboard boxes. 120 doses - aluminum inhalers (1) with a dosing device - cardboard boxes.

pharmachologic effect

GCS for inhalation use. In recommended doses, it has 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 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 chronic obstructive pulmonary disease (COPD), the effectiveness of inhaled fluticasone propionate on lung function was 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 corticosteroids in the form of tablets and an increase in the quality of life of patients.

The systemic effect of fluticasone is minimally expressed: in therapeutic doses, it has practically no effect on the hypothalamic-pituitary-adrenal system.

The drug restores the patient's response to bronchodilators, allowing to reduce the frequency of their use.

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 persists for several days after withdrawal.

Pharmacokinetics

Suction

After inhalation administration, the absolute bioavailability of fluticasone propionate is 10-30%, depending on the type of inhaler. Systemic absorption occurs predominantly in the lungs. Part of the inhaled dose can be swallowed, but its systemic effect is minimal due to the poor solubility of the drug in water and intensive metabolism during the "first pass" through the liver (the oral bioavailability of fluticasone propionate is less than 1%). There is a direct relationship between the size of the inhaled dose and the systemic effect of fluticasone propionate.

Distribution

Plasma protein binding is 91%.

Fluticasone propionate has a large Vd - about 300 liters.

Metabolism

Fluticasone propionate is metabolized in the liver with the participation of CYP3A4, with the formation of an inactive metabolite.

breeding

Fluticasone propionate has a high plasma clearance of 1150 ml/min. T1 / 2 is about 8 hours. Renal clearance is less than 0.2%. Less than 5% is excreted in the urine as a metabolite.

FLIXOTIDE: DOSAGE

Flixotide is for inhalation use only. Flixotide is a preventive therapy, the drug must be used regularly, even in the absence of symptoms of the disease.

With the basic anti-inflammatory therapy of bronchial asthma, the therapeutic effect of Flixotide occurs 4-7 days after the start of treatment. In patients who have not previously used inhaled corticosteroids, improvement may be observed as early as 24 hours after the start of the drug.

For adults and adolescents over 16 years of age, the initial dose for mild bronchial asthma is 100-250 mcg 2 times / day, moderate severity - 250-500 mcg 2 times / day, severe - 500-1000 mcg 2 times / day day Then, depending on the individual response of the patient to treatment, the initial dose can be increased until a clinical effect appears or reduced to the minimum effective dose.

In children older than 4 years, it is recommended to use an aerosol containing 50 micrograms of fluticasone propionate in 1 dose. It is recommended to prescribe 50-100 mcg 2 times / day. The initial dose of the drug depends on the severity of the disease. Then, depending on the individual response of the patient to treatment, the initial dose can be increased until a clinical effect appears or reduced to the minimum effective dose.

Young children require higher doses of Flixotide compared to older children due to reduced intake of the drug when inhaled (smaller bronchial lumen, use of a spacer, intensive nasal breathing in young children).

The drug is administered using an inhaler through a spacer with a face mask (eg "Babyhaler").

Metered aerosol Flixotide is especially indicated for young children with severe bronchial asthma.

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

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

Overdose

Acute overdose of the drug can lead to a temporary decrease in the function of the adrenal cortex, which usually does not require emergency therapy, because. the function of the adrenal cortex is restored within a few days.

If Flixotide is taken in high doses for a long time, significant suppression of the function of the adrenal cortex is possible. Very rare reports have been received of the development of an adrenal crisis in children who received fluticasone propionate at a dose of 1 mg / day or more for several months or years. In such patients, hypoglycemia, depression of consciousness and convulsive states were noted.

Acute adrenal crisis can develop against the background of the following conditions: severe trauma, surgery, infection, a sharp decrease in the dose of fluticasone propionate.

In cases where the patient receives a dose higher than recommended, it should be gradually reduced.

drug interaction

Since plasma concentrations of fluticasone propionate are very low with the inhalation route of administration, interaction with other drugs is unlikely.

With the simultaneous use of fluticasone propionate and inhibitors of the CYP3A4 enzyme (for example, ketoconazole, ritonavir), the systemic action of Flixotide may be increased (the use of such a combination requires caution).

Pregnancy and lactation

The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

The excretion of fluticasone in human milk has not been studied. However, after inhalation administration of the drug at recommended doses, plasma concentrations of fluticasone propionate are low.

FLIXOTIDE: SIDE EFFECTS

Local reactions: possible candidiasis of the oral mucosa and pharynx, hoarseness, paradoxical bronchospasm.

Allergic reactions: in some cases - skin rash, angioedema, dyspnea or bronchospasm, anaphylactic reactions.

Systemic reactions: decreased function of the adrenal cortex, osteoporosis, growth retardation in children, cataracts, increased intraocular pressure, glaucoma, Cushing's syndrome, Cushingoid symptoms. There are also very rare reports of hyperglycemia.

Possible: mental disorders (anxiety, sleep disorders, changes in behavior, including hyperactivity and irritability /mainly in children/); often - bruising, pneumonia in patients with COPD.

Terms and conditions of storage

List B. The drug should be stored out of the reach of children at a temperature not exceeding 30 ° C; Do not freeze or expose to direct sunlight. Shelf life - 2 years.

Indications

• basic anti-inflammatory therapy for bronchial asthma (incl.
• in severe disease and dependence on systemic corticosteroids) in adults and children 1 year and older;
• treatment of chronic obstructive pulmonary disease in adults.

Contraindications

• acute bronchospasm;
• status asthmaticus (as a primary remedy);
• bronchitis of non-asthmatic nature;
• children's age up to 1 year;
• hypersensitivity to the components of the drug.

special instructions

Flixotide is intended for long-term treatment of bronchial asthma, and not for the relief of attacks. Short-acting inhaled bronchodilators should be given to patients to control seizures.

If the effectiveness of short-acting bronchodilators decreases or if more frequent use is needed, the patient should consult a doctor.

An increase in the need for short-acting inhaled beta2-adrenergic agonists is indicative of worsening disease. In such cases, it is recommended to review the patient's treatment plan.

Sudden and progressive worsening of bronchial asthma can pose a threat to the patient's life, therefore, in such situations, it is urgent to address the issue of increasing the dose of corticosteroids.

Special care should be taken when treating patients with active or inactive forms of pulmonary tuberculosis with inhaled corticosteroids.

In case of severe exacerbation of bronchial asthma or insufficient effectiveness of the therapy, the dose of inhaled fluticasone propionate should be increased and, if necessary, a drug from the group of systemic corticosteroids and / or an antibiotic should be prescribed if the infection develops.

With prolonged use of any inhaled corticosteroids, especially at high doses, systemic effects may be observed, but the likelihood of their development is much lower than when oral corticosteroids are taken. Possible systemic effects include decreased adrenal function, osteoporosis, growth retardation in children, cataracts, and glaucoma. Therefore, it is especially important that when a therapeutic effect is achieved, the dose of inhaled corticosteroids should be reduced to the minimum effective dose that controls the course of the disease.

The transfer of patients suffering from hormone-dependent bronchial asthma from systemic corticosteroids to fluticasone inhalation requires special attention, since the restoration of adrenal function takes a long time. You should regularly monitor the function of the adrenal cortex and be careful when reducing the dose of systemic corticosteroids.

A gradual reduction in the dose of systemic corticosteroids can begin approximately one week after the appointment of fluticasone. With a maintenance dose of prednisolone (or other corticosteroids at an equivalent dose) of less than 10 mg / day, dose reduction should not exceed 1 mg / day and should be carried out at intervals of at least 1 week. With a maintenance dose of prednisolone more than 10 mg / day (in terms of a day) - in high doses also at intervals of at least 1 week.

Some patients during the period of reducing the dose of systemic corticosteroids complain of general malaise against the background of stabilization or even improvement in respiratory function. If there are no objective signs of adrenal insufficiency, patients should be persuaded to continue the transition to inhaled corticosteroids and the gradual withdrawal of systemic corticosteroids.

In some cases, there may be an individual high sensitivity to inhaled corticosteroids. The function of the adrenal cortex in the appointment of fluticasone propionate in recommended doses, as a rule, remains within the normal range. The advantages of inhaled fluticasone propionate minimize the need for systemic corticosteroids. However, there may be a possibility of side effects in patients who have previously received or periodically take corticosteroids orally. When carrying out resuscitation or surgical interventions, it may be necessary to consult a specialist to determine the degree of adrenal insufficiency. In such stressful situations, one should always take into account possible adrenal insufficiency and, if necessary, additionally prescribe corticosteroids.

In connection with the possible adrenal insufficiency, special care should be taken and regular monitoring of the indicators of the function of the adrenal cortex when transferring patients who took GCS orally to treatment with inhaled fluticasone propionate. Withdrawal of systemic corticosteroids against the background of inhaled fluticasone propionate should be carried out gradually, and patients should carry a card indicating that they may need additional corticosteroids during a period of stress.

In rare cases, when transferring patients from taking systemic corticosteroids to inhaled therapy, conditions accompanied by hypereosinophilia (for example, Churg-Strauss syndrome) may occur. As a rule, this occurs during dose reduction or withdrawal of systemic corticosteroids, but a direct causal relationship has not been established.

When transferring patients from taking systemic corticosteroids to inhaled therapy, concomitant allergic diseases (for example, allergic rhinitis, eczema), which were previously suppressed by systemic drugs, may also be exacerbated. In such situations, it is recommended to carry out symptomatic treatment with antihistamines and / or topical drugs, incl. GCS for local use.

To prevent the development of candidiasis, you should rinse your mouth after using Flixotide; if necessary, throughout the entire period of treatment, local antifungal therapy can be prescribed.

In the event of the development of paradoxical bronchospasm, you should immediately stop the administration of Flixotide, assess the patient's condition, conduct the necessary examination and, if necessary, prescribe other drugs. Paradoxical bronchospasm should be treated immediately with a rapid-acting inhaled bronchodilator.

There are very rare reports of elevated blood glucose levels and this should be kept in mind when prescribing fluticasone propionate to diabetic patients.

Like most aerosol inhalers, this drug may be less effective at cooling the can.

Pediatric use

The growth dynamics of children receiving inhaled corticosteroids for a long time should be regularly monitored.

Influence on the ability to drive vehicles and control mechanisms

The effect of fluticasone propionate on the ability to drive and operate machinery is unlikely.

Use for impaired renal function

Patients with impaired renal function dose adjustment is not required.

Use in violation of liver function

Patients with impaired liver function dose adjustment is not required.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Registration numbers

aerosol for inhalation. dosed 125 mcg / 1 dose: inhalers 60 or 120 doses P N015734/01 (2018-05-09 - 0000-00-00) aerosol for inhalation. dosed 125 mcg / 1 dose: inhalers 60 doses or 120 doses P N015734/01 (2018-05-09 - 0000-00-00) aerosol for inhalation. dosed 250 mcg / 1 dose: inhalers 60 or 120 doses P N015734/01 (2018-05-09 - 0000-00-00) aerosol for inhalation. dosed 250 mcg / 1 dose: inhalers 60 doses or 120 doses P N015734/01 (2018-05-09 - 0000-00-00) aerosol for inhalation. dosed 50 mcg / 1 dose: inhalers 60 or 120 doses P N015734/01 (2018-05-09 - 0000-00-00) aerosol for inhalation. dosed 50 mcg/1 dose: inhalers 60 doses or 120 doses P N015734/01 (2018-05-09 - 0000-00-00)

Often, the doctor prescribes the drug Flixotide Nebula for inhalation in case of various diseases of the respiratory system. It happens that, due to excitement or other circumstances, mom or dad missed important information on the use of the prescribed medication.

We offer you help in this matter, we place the most detailed instructions for the use of Flixotide for inhalation.

A few words about the drug and its composition

Flixotide Nebula is a drug whose main active ingredient is fluticasone propionate.

To date, 2 main forms of release of the drug are known:

• metered aerosol
• rotadisks.

For children, only the second form is used - double foil blisters, which contain 4 equal doses, symmetrically located on the disk. According to the instructions, 1 dose of the drug contains 50, 100, 250, 500 mcg of the active substance.

It is possible to use such Flixotide only in special devices designed for the use of rotadisks.

For inhalation, a special suspension of Flixotide nebula has been developed.

This medicine has a pronounced anti-inflammatory effect.

Please refer to the enclosed instructions before use.

pharmachologic effect

Flixotide revealed several types of effects on the focus of the disease. Primarily, it is a glucocorticoid agent. It acts against inflammation, allergic manifestations, has a decongestant effect. Flixotide Nebula reduces the symptoms of the disease and alleviates the condition of a small patient.

This drug belongs to the drugs against asthma attacks for inhalation use.

It has been laboratory proven that improvement occurs within a week, although the removal of the acute phase of asthma attacks takes place in the first 24 hours. If a positive effect is not observed, then it is necessary first of all to check the dosage of the drug, whether it is calculated correctly, and only after that to sound the alarm about changing the drug.

In what cases is Flixotide prescribed for inhalation

The main indication for the use of the drug in nebulas is the prevention of asthma attacks.

Children are assigned with an eye to their age:

1. Children from 4 to 16 years: acute phase of bronchial asthma. Often, a traditional inhaler is not enough, so inhalers with the function of using a powdered drug or Flixotide in the form of an aerosol are used. In extremely severe cases, these methods can complement each other.
2. For children over 16 years of age, the indication for the use of the drug is the prevention of severe asthmatic attacks, when a small dosage of drugs is no longer enough.

Dosage regimen

Doses for each child are selected only individually. This takes into account the trial response of the patient to the drug.

The key to successful treatment is to follow the rules for using the drug: even during remission, it is important not to forget about inhalations.

Speaking of flixotide, it is important to know that it is impossible to abruptly quit inhalations with the drug. This drug treatment is designed for a preventive course, and not for short-term relief of seizures.

Flixotide Nebula: method of application

This drug is ready for use only in jet nebulizers. Before you add medication to the inhaler, do not be too lazy to read the instructions for the device.

Proceed according to the following algorithm:

1. Shake the medicine nebula until completely mixed.
2. Open the container by unscrewing the cap.
3. Pour the contents into the reservoir of your nebulizer, use saline to dilute if necessary.
4. Completed the procedure - pour the contents of the tank. The drug cannot be reused.

Using Flixotide in an inhaler is quite simple if you follow all the recommendations.

Inhalation can be done either using a special mouthpiece or using a face mask.

Side effects

When using nebules with flixotide, bronchospasm may develop. Rarely, candidiasis of the mouth and throat, hoarseness in the voice can occur.

Allergic reactions: rash accompanied by itching, anaphylactic shock.

To whom the drug is contraindicated

Among the main contraindications, the main one is individual intolerance to the components of the drug.

Children's age up to a year.

With caution, the medication can be used for people with tuberculosis, diabetes and kidney failure.

additional information

Treatment of children is permissible only under the supervision of doctors in a hospital or with the permission of a leading pediatrician at home.

The drug must be used regularly, even if asthma attacks have not bothered your child for a long time.

Cancellation of flixotide occurs gradually by daily dose reduction.

Flixotide Nebula is used only in inhalers. Injection use is not allowed.

If your child has been treated with this drug for a long time, you should check your baby's growth every month. This is due to the fact that in rare cases, glucocorticoid drugs adversely affect the physical development of children, in particular growth.

With all this, the drug has many positive aspects. Often parents worry that Flixotide is a hormone similar to Prednisolone. There is nothing terrible here. A hormonal drug administered by inhalation acts only on the source of the problem, and does not spread throughout the body, as is the case with tablets or injections.

Shelf life

An open container is not stored.

The purchased but unused drug is stored in a cool, dry place for 3 years.

Flixotide (Flixotide Nebula, Flixotide Diskus and Flixotide Evohaler) is an inhaled drug that has a pronounced anti-inflammatory effect on the lungs. Fluticasone propionate, an active ingredient, is a glucocorticosteroid drug that helps reduce the frequency of asthma attacks, reduce the severity of obstruction in patients with chronic lung diseases, and improve lung function.
When using the drug Flixotide, a pronounced therapeutic result develops on days 4-7 of therapy, although an improvement in the patient's condition may be noted already 24 hours after the start of therapy.
With inhalation, the bioavailability of fluticasone propionate varies from 10 to 30%. Some of the drug, when inhaled, enters the digestive tract, but given the oral bioavailability of fluticasone propionate (less than 1%), this is not significant. Systemic absorption of fluticasone with inhalation use is directly proportional to the dose. Part of the drug that enters the systemic circulation is rapidly metabolized to inactive substances and excreted mainly by the kidneys. The half-life of fluticasone propionate reaches 8 hours.

Indications for use

The drug Flixotide is intended for the treatment of patients suffering from severe bronchial asthma and moderate bronchial asthma (including patients taking systemic corticosteroids). The drug Flixotide, in this case, should be used constantly to prevent attacks of bronchial asthma.
The drug Flixotide Diskus and Flixotide Evohaler can also be prescribed to patients suffering from chronic obstructive pulmonary diseases (in order to improve lung function and reduce the severity of obstruction).

Mode of application

Flixotide Discus:
The drug is intended for inhalation use. To achieve the desired therapeutic effect, Flixotide Diskus should be used regularly, including during remission. The duration of use and dosage of fluticasone propionate is determined by the doctor.
Adults with bronchial asthma are generally prescribed 100-1000mcg of fluticasone propionate twice a day, depending on the severity of the disease. The use of the drug should begin with the minimum effective dose, if necessary, the dose is gradually increased.
If the patient has previously received beclomethasone dipropionate, then fluticasone should be administered at a daily dose corresponding to 50% of the daily dosage of beclomethasone.
The highest recommended daily dosage of Flixotide Diskus is 2000mcg.
Children over 4 years of age with bronchial asthma are generally prescribed 50-100mcg of fluticasone propionate twice a day. If necessary, the dose is gradually increased to 200mcg of fluticasone twice a day.

If after 3-6 months after the start of therapy with Flixotide Diskus there is no improvement in the patient's condition, the treatment regimen should be changed.
Flixotide Evohaler:
The drug is intended for inhalation use. To achieve the desired therapeutic effect, Flixotide Evohaler should be used regularly. Before the first use of the drug Flixotide Evohaler, and also, if the drug has not been used for more than 7 days, it is necessary to spray the drug several times to achieve uniform dosing. Shake the bottle before each use. Spraying the aerosol should be carried out during a slow breath. It is suggested to clean the mouthpiece at least once a week.
When calculating the dosage of the drug, it should be taken into account that a single dose of fluticasone should correspond to 2 sprays of the drug Flixotide Evohaler.
Adults with bronchial asthma are generally prescribed 100-1000mcg of fluticasone propionate twice a day. The use of the drug should begin with the minimum effective dose, if necessary, the dose is gradually increased.
If the patient has previously received beclomethasone dipropionate, the recommended daily dosage of fluticasone should correspond to 50% of the daily dosage of beclomethasone.
The highest recommended daily dosage of Flixotide Evohaler is 2000mcg.
Children over 4 years of age with bronchial asthma are generally prescribed 50-100mcg of fluticasone propionate twice a day. If necessary, the dose is gradually increased.
The highest recommended daily dosage for children over 4 years of age is 400mcg.
Adults with chronic obstructive pulmonary disease are generally prescribed 500mcg of fluticasone twice a day.
If after 3-6 months after the start of therapy with Flixotide Evohaler there is no improvement in the patient's condition, the treatment regimen should be changed.
Children from 1 to 4 years old with bronchial asthma are usually prescribed 100 μg of fluticasone twice a day (inhalation is carried out using the pediatric Bebihaler spacer).
Flixotide Nebula:
The drug is used for oral (using a mouthpiece) or nasal (using a face mask) inhalation. The drug can be prescribed as an aerosol from a jet nebulizer. Do not use ultrasonic nebulizers. If necessary, prolonged administration or administration of small doses of fluticasone immediately before inhalation is allowed to dilute the suspension in physiological sodium chloride solution. The duration of use and dosage of fluticasone is determined by the doctor.
Adults and children over 16 years old are generally prescribed 0.5-2 mg of fluticasone twice a day. The maximum dosage should be used within 7 days after an attack of bronchial asthma, after which the dose of fluticasone is proposed to be gradually reduced. After the patient's condition improves, it is allowed to switch from the use of the drug Flixotide Nebula to Flixotide Diskus or Flixotide Evohaler.
Children from 4 to 16 years old are generally prescribed 1 mg of fluticasone twice a day.
Regardless of the form of release, discontinuation of fluticasone propionate therapy should be carried out by gradually reducing the dosage.

Side effects

When using the drug Flixotide in patients, the development of such undesirable effects caused by fluticasone propionate was noted:
On the part of the respiratory system: hoarseness, paradoxical bronchospasm (with the development of bronchospasm, it is necessary to urgently introduce fast-acting bronchodilators).
On the part of the endocrine system and metabolism: growth retardation in children, glaucoma, cataracts, impaired mineralization of bone tissue, increased blood glucose levels. The development of Cushing's syndrome and adrenal suppression is also likely (adrenal function should be regularly monitored during therapy with fluticasone propionate).
From the side of the central nervous system: hyperactivity, irritability, sleep disturbances, a feeling of unreasonable anxiety.
Allergic reactions: urticaria, bronchospasm, shortness of breath, anaphylactic shock, angioedema.
Others: oral candidiasis (to reduce the risk of development, it is suggested to rinse the mouth with water after each use of the medicine). Fluticasone propionate may mask the symptoms of exanthema, allergic rhinitis, or other allergic conditions.

Contraindications

Flixotide should not be prescribed to patients with individual intolerance to fluticasone propionate or other components of the drug.
Flixotide is not intended for the relief of asthma attacks.
Caution is advised when prescribing corticosteroids to children (appointment is allowed only under the supervision of a physician, with regular assessment of growth).
Flixotide should be administered with caution to patients suffering from diabetes mellitus and pulmonary tuberculosis.

Pregnancy

The appointment of fluticasone propionate during pregnancy is likely in the case when the expected benefit to the mother outweighs the risks to the fetus.
Fluticasone should be used with caution during lactation.

Interaction with other drugs

Strong inhibitors of cytochrome P450 3A4 (especially ritonavir) when used in combination with the drug Flixotide lead to a significant increase in plasma concentrations of fluticasone and an increased risk of systemic effects.

Overdose

When using the drug Flixotide in doses that significantly exceed those recommended, the development of acute intoxication is likely, which is characterized by temporary inhibition of the hypothalamic-pituitary-adrenal system.
With a single overdose, no special measures are required, the function of the adrenal glands is restored independently within a few days.
In chronic overdose, the development of an acute adrenal crisis, hypoglycemia, convulsions and impaired consciousness is likely.
Treatment of chronic overdose is carried out in a hospital. The decision on the possibility of further use of fluticasone is made by the doctor.

Release form

Powder dosed for inhalation use Flixotide Diskus, 60 doses per pack.
Aerosol dosed for inhalation use Flixotide Evohaler, 60 or 120 doses in vials, 1 vial is enclosed in a cardboard box.
Suspension for inhalation Flixotide Nebules 2 ml in nebules, 5 nebules are packed in an aluminum bag, 2 aluminum bags are enclosed in a cardboard box.

Storage conditions

Flixotide Diskus 50mcg/dose is suggested to be stored no more than 1.5 years after manufacture.
Flixotide Diskus 100mcg/dose is suggested to be stored for no more than 2 years after manufacture.
Flixotide Diskus 250mcg/dose is suggested to be stored for no more than 3 years after manufacture.
Flixotide Evohaler is suggested to be stored no more than 2 years after manufacture.
Flixotide Nebula is suggested to be stored no more than 3 years after manufacture.
The drug Flixotide, regardless of the form of release, should be stored in rooms with a temperature not exceeding 25 degrees Celsius, away from direct sunlight.
Do not freeze the drug.
After opening, the nebula should be stored upright for no more than 12 hours at a temperature of 8 to 15 degrees Celsius.

Compound

1 dosage of Flixotide Diskus 50 contains:


1 dosage of Flixotide Diskus 100 contains:
Microionized fluticasone propionate - 100mcg;
Additional ingredients including lactose monohydrate.
1 dosage of Flixotide Diskus 250 contains:

Additional ingredients including lactose monohydrate.
1 dosage of Flixotide Evohaler 50 contains:
Microionized fluticasone propionate - 50mcg;
Additional ingredients.
1 dosage of Flixotide Evohaler 125 contains:
Microionized fluticasone propionate - 125mcg;
Additional ingredients.
1 dosage of Flixotide Evohaler 250 contains:
Microionized fluticasone propionate - 250mcg;
Additional ingredients.
2ml suspension (1 nebula) of Flixotide Nebula contains:
Microionized fluticasone propionate - 0.5 or 2 mg;
Additional ingredients.

Aerosol Flixotide

The excipients include propellant GR106642X.

The Flixotide inhaler may contain 60 doses or 120 doses. The drug does not contain freon .

Nebula Flixotide

1 nebula (2 ml suspension) for inhalation Flixotide may contain 0.5 and 2 ml fluticasone propionate .

Excipients include: sorbitan monolaurate, polysorbate 20, sodium phosphate monobasic dihydrate, anhydrous dibasic sodium phosphate, as well as sodium chloride and water for injection.

Release form

Aerosol Flixotide

Aerosol for inhalation Flixotide is available in the form of a white suspension, which is placed in a metal inhaler. The inhaler has a concave base and a dosing device equipped with a nebulizer. When buying this drug, make sure that there are no visible defects on the surface of the inhaler and the valve.

Aluminum inhalers, together with a dosing device and detailed instructions for use, are placed in cardboard boxes.

Nebula Flixotide

Suspension for inhalation can also be placed in 2 ml nebules, which are packed in 5 pieces in aluminum bags.

Aluminum bags of 2 pieces together with detailed instructions for use are placed in cardboard boxes.

pharmachologic effect

The drug Flixotide is a corticosteroid for inhalation, which has both a pronounced anti-inflammatory and a strong anti-allergic effect.

Experts advise using this drug in the course of treatment at various stages, emphysema , as well as other diseases that are caused by airway obstruction.

Pharmacodynamics and pharmacokinetics

fluticasone propionate affects the proliferation of not only mast cells, lymphocytes and eosinophils, but also macrophages and neutrophils. Also fluticasone helps to reduce the production of such biologically active substances as histamine prostaglandins , leukotrienes , cytokines and the release of inflammatory mediators.

The drug showed high efficiency in COPD (chronic obstructive pulmonary disease), which reduces the need to take an additional course of corticosteroids in the form of tablets and improves the patient's quality of life.

The systemic effect of fluticasone propionate is insignificant: when taken in therapeutic doses, the drug does not affect hypothalamic-pituitary-adrenal system .

The peculiarity of this drug is that fluticasone helps to restore the patient's response to bronchodilators, which can significantly reduce the frequency of their use.

The therapeutic effect after inhalation appears after 24 hours, and reaches its peak after about 2 weeks or more after the start of the drug. The withdrawal effect lasts for several days.

Suction

After inhalation bioavailability fluticasone propionate reaches 10-30% depending on what type of inhaler is used. The absorption process takes place in the lungs. Please note that part of the dose of the drug can be swallowed, but its effect is minimal, since fluticasone poorly soluble in water.

Distribution

Communication with plasma proteins is quite high and is more than 91%. Fluticasone Propionate has a large Vd, which reaches 300 liters.

Metabolism

breeding

Fluticasone characterized by a fairly high plasma clearance. It has a mark of 1150 ml / min. T1 / 2 reaches 8 hours. renal clearance fluticasone varies between 0.1 and 0.2%. The drug is excreted in the urine (less than 5%).

Indications for use

• at bronchial asthma (basic anti-inflammatory therapy);
• with chronic obstructive pulmonary disease .

Contraindications

• with acute bronchospasm ;
• at status asthmaticus (as the main drug);
• at non-asthmatic bronchitis ;
• children under the age of 1 year;
• with hypersensitivity to any of the components of the drug.

Flixotide should be used with extreme caution:

Flixotide is used only for long-term treatment bronchial asthma , and not in order to exclusively stop the attacks. To stop severe attacks, specialists prescribe inhaled bronchodilators, which have a short effect.

It should always be remembered that a sudden and highly progressive deterioration asthma can become a serious threat to life. In the event that the need for the use of short-acting bronchodilators increases, it is necessary to consult a doctor and reconsider the treatment regimen.

Doctors advise avoiding abrupt cancellation drug Flixotide.

It is imperative to check whether the patient has the skills to properly use the inhaler.

When transferring patients suffering from hormone-dependent bronchial asthma from systemic corticosteroids to fluticasone, special attention should be paid to how the process of restoring adrenal functions takes place.

Mandatory regular monitoring of the function of the adrenal cortex and the utmost care in case of lower doses of systemic corticosteroids.

Many patients, after starting to reduce the dose of systemic corticosteroids, complain of general malaise, but this should not be the reason for canceling the transition if the patient does not have signs of adrenal insufficiency.

It is recommended for the gradual cancellation of systemic corticosteroids against the background of fluticasone carry a card with you, which will indicate that in a stressful situation, an additional dose of GCS may be urgently needed.

When switching to inhalation therapy, the patient may experience severe discomfort from hypereosinophilia (for example, from Churg-Strauss syndrome ), as well as from the exacerbation of concomitant allergic diseases (for example, ).

Please note that this preparation may lose some of its properties when refrigerated.

Pediatric use

With prolonged use of inhaled corticosteroids, the growth dynamics of children should be constantly monitored.

Influence on the ability to drive vehicles and control mechanisms

Flixotide can be used when driving a car and working with machinery, since its effect on these abilities is minimal.

Side effects

In the course of treatment with Flixotide, patients may experience discomfort:

• from candidiasis oral cavity and pharynx;
• from hoarseness ;
• from paradoxical bronchospasm ;
• from the occurrence of allergic reactions ( skin rash, dyspnea or bronchospasm, anaphylactic reactions );
• from a decrease in the function of the adrenal cortex;
• from osteoporosis ;
• from growth retardation (in children);
• from ;
• from increased intraocular pressure .

Instructions for use Flixotide

Aerosol Flixotide

In accordance with the instructions for Flixotide, this drug should not be used to treat children under the age of 1 year.

In the course of treatment of children over 4 years of age, experts recommend using an aerosol that contains 50 mcg fluticasone propionate in 1 dose. It should be used 50-100 mcg 2 times a day. The initial dose should be determined by the doctor and depends on the general condition of the patient. In the course of treatment and taking into account the individual response of the patient to the drug, the dose for inhalation can be either increased or reduced.

Please note that in the treatment of young children, higher doses of the drug are needed compared to the doses used in the treatment of older children. This is due to the fact that in young children, the intake of the drug during inhalation administration is significantly reduced due to the smaller bronchial lumen, the use of a spacer, and intensive nasal breathing.

The drug must be administered using an inhaler through a spacer with a mask.

Adults and adolescents over 16 years of age are prescribed 100 micrograms to 250 micrograms of Frixotide 2 times a day as an initial dose for mild bronchial asthma . With an average course of the disease, it is recommended to take from 250 to 500 mcg 2 times a day. With a severe degree of the disease, from 500 mcg to 1000 mcg are prescribed 2 times a day. During treatment, the dose of the drug can vary both up and down.

Nebula Flixotide

Flixotide in nebules is used for both oral (using a mouthpiece) and nasal (using a face mask) inhalation. The drug is prescribed in the form of an aerosol from a nebulizer. You should use only a jet nebulizer and refuse to use ultrasonic. If necessary, it is allowed to dilute the Flixotide suspension in physiological sodium chloride solution before inhalation.

The treatment regimen for children aged 4 to 16 years includes 1 mg fluticasone 2 times a day. Adults and adolescents over 16 years of age are usually prescribed a dose that varies between 0.5 mg and 2 mg of fluticasone 2 times a day. It is recommended to use the maximum dose of the drug for only 7 days after the attack, and then the dose fluticasone should be gradually reduced.

Overdose

In acute overdose, temporary decreased function of the adrenal cortex . In this situation, emergency therapy is most often not required due to the fact that the function of the adrenal cortex can be restored over several days.

Taking Flixotide in high doses for a long time can greatly damage the functions of the adrenal cortex. Very rare, but still present, reports that taking the drug for several years or months provoked the development in children adrenal crisis which is characterized by symptoms such as convulsive state, oppression of consciousness And hypoglycemia .

Please note that the cause of acute adrenal crisis severe injury, surgery, infection, and sudden dose reduction may occur fluticasone .

If the patient receives a dose that exceeds the recommended one, then it must be gradually reduced.

Interaction

The interaction of Flixotide with other drugs is minimal due to the fact that the concentration fluticasone propionate in plasma is quite low.

Flixotide should be taken with extreme caution in conjunction with CYP3A4 enzyme inhibitors , as this may cause an increase in the systemic effects of Flixotide.

Terms of sale

Flixotide can be purchased at a pharmacy with a doctor's prescription.

Storage conditions

Regardless of the form in which Flixotide is released, it must be stored in rooms where the temperature does not exceed 25 ° C, away from direct sunlight.

In no case should you freeze the drug, as it will completely lose its effectiveness.

Nebulas that are taken out of the aluminum bag must be used within 28 days and stored exclusively in a place protected from sunlight.

Once the nebula has been opened, it can be stored upright for a maximum of 12 hours at a temperature not exceeding 15°C.

Best before date

Flixotide is stored for 2 years, subject to storage conditions.

Analogues

Coincidence in the ATX code of the 4th level:

At the moment, the most popular analogues of the drug Flixotide are: Soderm, Desoxycorticosterone trimethylacetate And Fluorometholone . Also performed well Fluorohydrocortisone acetate And Dexocort .