fluticasone furoate (fluticasone furoate)

Release form

Dosage inhaled aerosol.

Packing

Bottle 60 doses.

Pharmacological action

Pharmaceutical group: which is characterized by a decrease in the severity of disease symptoms, the frequency and severity of exacerbations, a decrease in the need to prescribe additional courses of GCS in the form of tablets, and an increase in the quality of life of patients.

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

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

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

Pharmacokinetics: with the formation of an inactive metabolite.

Excretion

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% of the metabolite is excreted in the urine.

Indications

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

Contraindications

Hypersensitivity, acute bronchospasm, asthmatic status (as a priority), non-asthmatic bronchitis, children's age (up to 1 year).

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

Special instructions

Flixotide is intended for the long-term treatment of bronchial asthma, and not for the relief of attacks. To stop attacks, patients should be prescribed short-acting inhaled bronchodilators.

In the event of a decrease in the effectiveness of short-acting bronchodilators or the need for more frequent use, the patient should consult a doctor.

An increased need for short-acting beta2-adrenoreceptor inhalation agonists indicates a worsening of the disease. In such cases, it is recommended that the patient's treatment plan be reviewed.

A sudden and progressive worsening of bronchial asthma can pose a threat to the patient’s life, so in such situations it is urgent to decide whether to increase the dose of GCS.

Abruptly discontinuing treatment with Flixotide is not recommended.

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 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.

It is recommended to check whether the patient is able to use the inhaler correctly.

With prolonged use of any inhaled GCS, especially in high doses, systemic effects may be noted, but the likelihood of their development is significantly lower than when taking GCS by mouth. Possible systemic effects include decreased adrenal cortex function, osteoporosis, growth retardation in children, cataracts, glaucoma. Therefore, it is especially important that when the therapeutic effect is achieved, the dose of inhaled GCS should be reduced to the minimum effective dose that controls the course of the disease.

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

A gradual decrease in the dose of systemic corticosteroids can begin about a week after the administration of fluticasone. With a maintenance dose of prednisolone (or other corticosteroids in an equivalent dose) less than 10 mg / day. dose reduction should not exceed 1 mg / day. and should be performed at intervals of at least 1 week. With a maintenance dose of prednisone greater than 10 mg / day. (in terms of day) - in high doses also with intervals of at least 1 week.

Some patients during a period of lowering the dose of systemic corticosteroids complain of general malaise amid 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 GCS and the gradual abolition of systemic GCS.

In some cases, individual high sensitivity to inhaled corticosteroids may be noted. The function of the adrenal cortex in the appointment of fluticasone propionate in recommended doses, as a rule, remains within normal limits. The benefits of inhaled fluticasone propionate administration minimize the need for systemic corticosteroids. However, the likelihood of side effects may remain in patients who have previously received or periodically take GCS inside. During resuscitation or surgical interventions, you may need to consult a specialist to determine the degree of adrenal insufficiency. In such stressful situations, possible adrenal insufficiency should always be considered and, if necessary, additionally prescribed GCS.

In connection with the possible adrenal insufficiency, special care should be taken and regular monitoring of the adrenal cortex function should be carried out when transferring patients who have taken corticosteroids into the treatment of inhaled fluticasone with propionate. Cancellation of systemic corticosteroids against the background of inhaled fluticasone propionate should be carried out gradually, and patients should carry a card with them indicating that they may require additional administration of corticosteroids during stress.

In rare cases, when patients are transferred from taking systemic corticosteroids to inhalation therapy, conditions accompanied by hypereosinophilia (for example, Cherge-Strauss syndrome) may occur. As a rule, this happens during a dose reduction or cancellation of systemic corticosteroids, however, a direct causal relationship has not been established.

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

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

To prevent hoarseness, it is recommended to rinse your mouth and throat with water immediately after inhalation.

If paradoxical bronchospasm develops, you should immediately stop administering Flixotide, assess the condition of the patient, conduct the necessary examination and, if necessary, prescribe other medications. Paradoxical bronchospasm should be immediately stopped with a fast-acting inhaled bronchodilator.

There are very rare reports of an increase in blood glucose, and this should be remembered when prescribing fluticasone propionate in patients with diabetes mellitus.

Like most other aerosol inhalants, this medicine may be less effective in cooling the can.

Pediatric use

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

Influence on the ability to drive vehicles and operate machinery

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

Composition

1 dose contains:

fluticasone 125 mcg,

excipients:

propellant tetrafluoroethane GR106642X (the product does not contain freon).

Side effects

Candidiasis of the oral cavity and pharynx, hoarseness (after inhalation, rinse your mouth and throat with water), paradoxical bronchospasm (requires drug withdrawal, and continued treatment with other drugs)

rarely - the development of allergic reactions (skin rash, angioedema, dyspnea or bronchospasm, anaphylactic reactions) may decrease the function of the adrenal cortex, osteoporosis, growth retardation in children, cataracts, increased intraocular pressure.

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 enzyme CYP3A4 (for example, ketoconazole, ritonavir), the systemic effect of Flixotide may be enhanced (the use of such a combination requires caution).

overdose

An acute overdose of the drug can lead to a temporary decrease in adrenal cortex function, which usually does not require emergency therapy, as it is not recommended. 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 adrenal cortex may occur. Very rare reports have been received of the development of adrenal crisis in children receiving fluticasone propionate at a dose of 1 mg / day. and higher for months or years. In such patients, hypoglycemia, depression of consciousness, and seizure conditions were noted.

Acute adrenal crises can develop on 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 above the recommended dose, it should be gradually reduced.

Storage Conditions

In a dark place at a temperature not exceeding 25 ° C.

Shelf life

2 years.

Deystvuyushtee substance

fluticasone furoate

Terms and conditions

prescription

dosage form

aerosol for inhalation



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