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Instruction for use: Fluticasone (Fluticasonum)

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Pharmacological group

Glucocorticosteroids

Nosological classification (ICD-10)

H04.9 Disease lacrimal system, unspecified

Insufficient production of tear fluid, Insufficient tearing, red-eye syndrome, lacrimation, Dryness of the front surface of the eye

J00 Acute nasopharyngitis [runny nose]

Viral rhinitis, Inflammation of the nasopharynx, Inflammatory diseases of the nose, purulent rhinitis, Nasal congestion, Nasal congestion with colds and flu, The difficulty of nasal breathing, The difficulty of nasal breathing for colds, Difficulty in nasal breathing, Difficulty in nasal breathing in colds, nasal, hypersecretion, cold, ARI with rhinitis phenomena, coryza, Acute rhinitis of various origins, Acute rhinitis with thick purulent mucous exudate, Acute nasopharyngitis, Swelling of the mucosa of the nasopharynx, Rhinitis, rhinorrhea, Infectious-inflammatory diseases of ENT organs, heavy cold, rhinopharyngitis, nasopharyngitis

J30 Vasomotor and allergic rhinitis

Allergic rinopatiya, Allergic rhinosinusopathy, Allergic respiratory diseases, Allergic rhinitis, nasal allergy, Seasonal Allergic Rhinitis, Vasomotor rhinitis, Long-allergic rhinitis, Perennial allergic rhinitis, Perennial allergic rhinitis, Year-round or seasonal allergic rhinitis, Year-round allergic rhinitis nature, Rhinitis allergic vasomotor, Exacerbation of pollen allergy in the form of Syndrome rinokonyunktivalnogo, Acute allergic rhinitis, Edema of the nasal mucosa, Edema of the nasal mucosa, Swelling of the mucosa of the nasal cavity, Swelling of the nasal mucosa, Swelling of the nasal mucosa, pollen disease, Permanent allergic rhinitis, rhinoconjunctivitis, rhinosinusitis,rhinosinusopathy, Seasonal allergic rhinitis, Seasonal Allergic Rhinitis, Haymarket rhinitis, Chronic allergic rhinitis, Allergic respiratory diseases

J30.1 Allergic rhinitis caused by the pollen

hay fever, Hypersensitivity to pollen, Polypoid allergic rhinosinusitis, Seasonal hay fever, rhinitis

J44.9 Chronic obstructive pulmonary disease, unspecified

Obstructive pulmonary diseases, Bronchial obstruction, bronchial obstruction, Exacerbation of chronic obstructive pulmonary disease, reversible airflow obstruction, Reversible airway obstruction, panbronchiolitis, Panbronhit, COPD, Chronic pulmonary infection, Chronic infection of the lower respiratory tract, Chronic obstructive pulmonary disease, Chronic obstructive pneumonia, Chronic lung disease, Chronic obstructive pulmonary disease, Chronic bronchopulmonary disease, Chronic broncho-pulmonary diseases, Airway obstruction

J45 Asthma

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

L20 Atopic dermatitis

Itchy atopic eczema, Common neurodermatitis, Allergic skin diseases, Allergic skin diseases of non-infectious etiology, Allergic skin diseases of non-microbial etiology, Allergic skin diseases, Allergic skin lesions, Allergic manifestations on the skin, Allergic dermatitis, Allergic diathesis, Allergic itching dermatosis, Allergic Skin Disease, Allergic skin irritation, Dermatitis allergic, Atopic dermatitis, Dermatosis allergic, Diathesis exudative, Skin Allergic Disease, Skin allergic reaction to medicinal and chemical preparations, Skin reaction to medication, Skin and allergic disease, Acute eczema, Chronic atopic dermatitis, Exudative diathesis, Itching allergic dermatosis

L21 Seborrheic dermatitis

Dermatitis seborrheic, Increased sebum separation, Seborrheic Eczema, Seborrheic dermatitis of the scalp, Seborrheic pyodermatitis, Seborrhea, Eczema seborrheic

L23 Allergic contact dermatitis

Allergic dermatitis, Purulent allergic dermatopathies, Contact allergic reaction, Contact allergic dermatitis, Photoallergic contact dermatitis

L25 Contact dermatitis, unspecified

Intertriginous dermatitis, Contact Eczema, Contact dermatitis, Contact dermatitis of non-microbial etiology, Contact dermatitis, Skin wetting surface, Fractures, Intertrigo,Skin Difficulty, Subacute and chronic contact dermatitis, Phlebotoderma, Simple contact dermatitis complicated by impetigo

L28.0 Simple chronic lichen

Common lichen, Chronic and simple lichen, Chronic lichen

L30.9 Dermatitis, unspecified

Allergic dermatoses complicated by a secondary bacterial infection, Anal eczema, Bacterial maturation, Varicose Eczema, Venous dermatitis, Inflammation of the skin, Inflammation of the skin upon contact with plants, Inflammatory Skin Diseases, Inflammatory skin reactions, Inflammatory processes of the skin, Hypostatic dermatitis, Fungal Eczema, Fungal dermatosis, Dermatitis, Dermatitis is stagnant, Dermatitis and eczema in the anal area, Dermatitis acute contact, Perianal dermatitis, Dermatosis, Dermatosis of the scalp, Dermatosis of psoriasis, Dermatosis with persistent itching, Dermatoses, Dermatoses itchy, Other itching dermatoses, Significant eczematous manifestations, Itching with, dermatoses, Itching eczema, True eczema, Skin reaction to insect bites,Skin itching with dermatosis, Constitutional eczema, Weeping eczema, Drowsing inflammatory skin disease, Dying Infectious-Inflammatory Skin Disease, Non-allergic dermatitis, Nummular eczema, Acute contact eczema, Acute inflammatory skin disease, Acute dermatosis, Acute severe dermatosis, Perianal dermatitis, Superficial dermatosis, Subacute Contact Eczema, Simple dermatitis, Occupational dermatitis, Psychogenic dermatosis, Bubble dermatitis of newborns, Pustular eruptions, Irritation and redness of the skin, Low-flammable eczema, Dry atrophic eczema, Dry eczema, Toxic dermatitis, Ear eczema like dermatitis, Chronic eczema, Chronic dermatosis, Chronic common dermatosis, Scaly papular dermatosis, Eczema, Eczema anal region, Eczema of the hands, Eczema Contact, Eczema lichenized, Eczema Nummular, Eczema acute, Eczema acute contact, Eczema subacute, Eczematous dermatitis, Eczema-like rashes, Ecome exogenous, Endogenous eczema, Gluteal dermatitis, Restricted itchy dermatitis

L40 Psoriasis

Chronic psoriasis with diffuse plaques, Generalized psoriasis, Psoriasis of the scalp, Psoriasis of the scalp, Generalized form of psoriasis, Psoriasis dermatitis, Psoriasis complicated by erythroderma, Invalidative psoriasis, Isolated psoriatic plaque, Exfoliative psoriasis, Psoriatic Erythroderma, Psoriasis with eczematosis, Hyperkeratosis in psoriasis,Inverse psoriasis,Psoriasis eczematous, Dermatosis of psoriasis, Psoriasis of the genitals, Psoriasis with lesions of hairy areas of skin, Erythrodermal psoriasis, Chronic psoriasis of the scalp, Chronic psoriasis, Ordinary psoriasis, Refractory psoriasis, Kebner phenomenon, Scaly lichen

L43 Red Leaf Flat

Lishay Wilson, Erosive-ulcerative form of red flat lichen, Warty forms of red lichen, Red lichen, Flat lichen, Kebner phenomenon

L53 Other erythematous conditions

Variable erythrokeratodermia, Malignant exudative erythema, Erythema, Erythematous, Erythroderma, Erythema from diapers

L93.0 Discoid lupus erythematosus

Chronic discoid lupus erythematosus, Red discoid lupus, Discoid lupus, Discoid erythematosis

R06.7 Sneezing

Sneezing

W57 Bite or sting with non-toxic insect and other non-venous arthropods

Allergic reaction to insect bites, Skin reaction after insect bite, Reactions to insect bites, Mosquito bite, Bite of bloodsucking insects, A bite of an insect, The bite of the wasp

Code CAS 90566-53-3

Pharmacology

Pharmacological action - anti-inflammatory, antiallergic, glucocorticoid.

Pharmacodynamics

Fluticasone is characterized by high selectivity and affinity for GCS (glucocorticosteroids) -receptors. Inhibits the proliferation of mast cells, eosinophils, lymphocytes, macrophages, neutrophils; Reduces the production and release of mediators of inflammation and other biologically active substances (histamine, PG (prostaglandins), RT (leukotrienes), cytokines) during the early and late phases of an allergic reaction.

With topical application in therapeutic doses, there is no marked systemic effect and suppression of the hypothalamic-pituitary-adrenal system. Does not cause hormonal disorders, does not have a significant effect on the central nervous system, peripheral nervous system, gastrointestinal tract, cardiovascular system and respiratory system.

Bioavailability of fluticasone during ingestion is low due to the very low level of absorption in the gastrointestinal tract and extensive metabolism during the first passage through the liver, which provides a low level of systemic exposure to accidental ingestion.

When inhaled in the recommended doses, it has a pronounced anti-inflammatory effect, which leads to a decrease in the severity of symptoms and a reduction in the frequency of exacerbations of diseases accompanied by airway obstruction (bronchial asthma, chronic bronchitis, emphysema).

In COPD (chronic obstructive pulmonary disease), the efficacy of inhalation fluticasone (in combination with long-acting bronchodilators) has been confirmed for pulmonary function, which is characterized by a decrease in the severity of the symptoms of the disease, the frequency and severity of exacerbations, and improved quality of life of patients compared with placebo.

The therapeutic effect after inhalation begins within 24 hours, reaches a maximum within 1-2 weeks or more after the start of treatment.

With intranasal administration, it has a quick anti-inflammatory effect on the nasal mucosa, and the antiallergic effect is manifested as early as 2-4 hours after the first application. Reduces sneezing, itching in the nose, runny nose, stuffy nose, discomfort in the sinuses and a feeling of pressure around the nose and eyes. In addition, it alleviates eye symptoms associated with allergic rhinitis. Reduction in the severity of symptoms (especially nasal congestion) persists for 24 hours after a single application at a dose of 200 μg. Improves the quality of life of patients, including physical and social activity. After administration of fluticasone propionate at a dose of 200 μg / day, there was no significant change in the daily AUC of serum cortisol compared with placebo (ratio 1.01, 90% CI: 0.9, 1.14).

When topical application fluticasin has anti-inflammatory, antipruritic and vasoconstrictive effect.

Pharmacokinetics

Suction. Absolute bioavailability of fluticasone when administered in the form of inhalations in healthy volunteers is approximately 10.9%. In patients with bronchial asthma or COPD, systemic exposure is less than that of healthy volunteers. Systemic absorption occurs predominantly in the lungs, while the absorption is initially rapid with subsequent deceleration. Part of the inhaled dose may be swallowed, but its systemic effect is minimal due to poor solubility in water and intensive pre-systemic metabolism. Bioavailability of fluticasone for oral administration is less than 1%. There is a linear relationship between the magnitude of the inhaled dose and the systemic effect.

After intranasal administration at a dose of 200 μg / day, equilibrium Cmax in plasma is not quantitated in most patients (less than 0.01 ng / ml). The highest plasma concentration was recorded at 0.017 ng / ml. Direct absorption from the nasal cavity is unlikely due to low water solubility and the ingestion of most of the dose. Absolute oral bioavailability is low (<1%) as a result of a combination of incomplete absorption from the gastrointestinal tract and active metabolism during the first passage through the liver. The total systemic suction is thus extremely low.

With topical application, the bioavailability of fluticasone is very low due to limited absorption through the skin.

Distribution. Vss (the volume of distribution in the equilibrium state) with inhalation is about 300 liters, with intranasal application - approximately 318 liters. The connection with blood plasma proteins is -91%. After entering the systemic circulation, fluticasone rapidly enters the bile and is eliminated through the intestine. Fluticasone does not accumulate in the tissues and does not bind to melanin.

Metabolism. According to the results of preclinical and clinical studies, fluticasone has a high metabolic clearance. Fluticasone is very rapidly excreted from the systemic blood stream, mainly as a result of metabolism to the inactive metabolite of a carboxylic acid under the action of the CYP3A4 isoenzyme of the cytochrome P450 system. Metabolism of the swallowed fraction of fluticasone during the first passage through the liver occurs in the same way.

Excretion. The pharmacokinetics of fluticasone are characterized by high plasma clearance (1150 ml / min), renal clearance of fluticasone is negligible (<0.2%), less than 5% is excreted in the urine as a metabolite. The elimination of fluticasone is linear in the dose range from 250 to 1000 μg. Cmax in blood plasma is reduced by approximately 98% within 3-4 hours, and only at very low concentrations in the plasma there is a final T1 / 2 of 7.8 hours. Fluticasone and its metabolites are excreted mainly with bile through the intestine.

Use of Fluticasone

Inhalation: bronchial asthma (basic anti-inflammatory therapy of adults and children 1 year and older, including patients with severe disease, who have a dependence on systemic SCS (glucocorticosteroids)); Chronic obstructive pulmonary disease in adults (as an additional remedy for long-acting bronchodilator therapy, for example, long-acting beta-agonists).

Intranasally: year-round and seasonal allergic rhinitis, including pollinosis (hay fever) in adults and children from age 4 (elimination of symptoms such as pain and sensation of pressure in the paranasal sinuses, nasal congestion, runny nose, sneezing, itching in the nose, lachrymation).

Locally: acute and chronic dermatoses in adults and children aged 6 months (ointment) or from 1 year (cream) and older for relief of inflammation and itching in dermatoses sensitive to glucocorticosteroid therapy, such as atopic (including Children), numeral (discoidia eczema) or seborrheic dermatitis, psoriasis (with the exception of common plaque), simple chronic lichen, lichen planus, contact or allergic contact dermatitis, discoid lupus erythematosus, erythroderma (as an adjunct to the systemic SCS-te FIPA); Inflammatory reactions to insect bites; Chronic form of atopic dermatitis, if there was a therapeutic effect in the treatment of the acute phase of the disease (to reduce the risk of recurrence of the disease).

Contraindications

Hypersensitivity.

Additionally

Inhalation: acute bronchospasm; Asthmatic status (as a primary means); Children's age to 1 year.

Intranasally: a recent nasal trauma or an operation in the nasal cavity; Children under 4 years.

Locally: primary skin lesions of bacterial, viral and fungal etiology; Rosacea; Common acne; Perioral dermatitis; Perianal and genital itching; Itching without symptoms of inflammation; Children's age to 6 months (ointment) or 1 year (cream).

Restrictions

Inhalation: cirrhosis of the liver; glaucoma; Hypothyroidism; Systemic infections (bacterial, fungal, parasitic, viral); osteoporosis; pulmonary tuberculosis; pregnancy; The period of breastfeeding.

Intranasally: simultaneous use with drugs for the treatment of HIV infection (eg ritonavir), GCS for the treatment of bronchial asthma, allergies, skin rashes, drugs for the treatment of fungal infections (eg ketoconazole), other strong inhibitors of the CYP3A isoenzyme (eg itraconazole); glaucoma; cataract; Infections of the nasal cavity or paranasal sinuses (require appropriate treatment, but are not contraindicated); Ulceration of the nasal mucosa.

Locally: psoriasis, renal and hepatic insufficiency, elderly age, children age from 6 months to 12 years.

pregnancy and lactation

Action category for fetus by FDA - C.

Data on the use of fluticasone in pregnant women are limited, and its use during pregnancy is only permissible if the potential benefit to the mother exceeds the possible risk to the fetus.

The results of the retrospective epidemiological study did not reveal an increased risk of serious congenital malformations after the use of fluticasone compared with other inhaled glucocorticosteroids during the first trimester of pregnancy.

Reproductive studies in animals have shown that at systemic exposure values that are higher than those observed with the recommended therapeutic inhalation doses, only effects characteristic of GCS are noted.

As a result of preclinical studies, it was found that external application of GCS in pregnant animals can cause a deviation of embryonic development, but the significance of this phenomenon for humans has not been established. In topical application in pregnant women, it is necessary to apply fluticasone in a minimal amount and use the shortest period of time sufficient for manifesting the clinical effect.

The use of fluticasone during breastfeeding is only permissible if the potential benefit to the mother exceeds the possible risk to the child.

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

When after subcutaneous administration of laboratory rats during the lactation period, measurable concentrations of the substance in the blood plasma were obtained, fluticasone was also found in breast milk. However, after inhalation at recommended doses, its plasma concentration in patients is likely to be low.

The safety of GCS therapy for topical application during breastfeeding has not been established. There are no available data to confirm the possibility of systemic absorption of GCS for topical application in an amount sufficient for their detection in breast milk. With external application of fluticasone during breastfeeding, it should not be applied to the area of the mammary glands to prevent accidental swallowing by the baby.

Side effects

The undesirable reactions presented below are listed in accordance with the damage to organs and organ systems and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1 / 10); Often (≥1 / 100 and <1/10); Infrequently (≥1 / 1000 and <1/100); Rarely (≥1 / 10000 and <1/1000); Very rarely (<1/10000, including individual cases). Frequency categories were formed on the basis of clinical studies and post-registration surveillance.

Infectious and parasitic diseases: very often candidiasis of the mouth and pharynx (candidiasis stomatitis, in such cases it is recommended after inhalation to rinse the mouth and throat with water, it is possible to use antifungal agents of local action); Often - pneumonia (in patients with COPD); Rarely - esophageal candidiasis; Very rarely opportunistic infections.

From the side of the immune system: infrequently - skin reactions of increased sensitivity (itching, rash, edema); Very rarely - angioedema (mainly face and oropharynx), respiratory disorders (dyspnea and / or bronchospasm); Anaphylactic and anaphylactoid reactions.

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

Mental disturbance: very rarely - anxiety, sleep and behavior disorders, including hyperactivity and irritability (mainly in children).

From the nervous system: often - headache, a sense of unpleasant taste and smell.

On the part of the respiratory, thorax and mediastinal organs: very often - nosebleeds (with intranasal application); Often hoarseness of the voice (it is recommended immediately after inhalation to rinse the mouth and throat with water), dryness, irritation of the mucous membrane in the nasal cavity and pharynx; Very rarely - paradoxical bronchospasm (see "Precautions"), perforation of the nasal septum (reported with intranasal SCS).

From the skin and subcutaneous tissues: often - bruising, itching at the site of application; Infrequent - burning in the place of external application; Very rarely - thinning of the skin, atrophy, striae, telangiectasia, hypopigmentation, hypertrichosis, allergic contact dermatitis, exacerbation of the symptoms of the underlying disease, pustular psoriasis, erythema, rash, urticaria.

Systemic effects (see "Precautions"): very rarely - oppression of the hypothalamic-pituitary-adrenal system (weight gain or obesity, slow weight gain or growth retardation in children, Cushing's syndrome, Cushing's symptoms (eg, lunate face, central obesity) , Decreased BMD, decreased endogenous cortisol, hyperglycemia or glucosuria, hypertension, osteoporosis, cataract, glaucoma, increased IOP (intraocular pressure)).

Interaction

Clinically significant drug interactions with topical application of fluticasone are unlikely.

However, concomitant drug therapy, which has an inhibitory effect on the isoenzyme CYP3A4 (eg ritonavir, itraconazole, erythromycin), may lead to inhibition of GCS metabolism, which is accompanied by an increased systemic effect. The degree of clinical significance of such interactions depends on the activity of the inhibitor of the isoenzyme CYP3A4, the dose and mode of administration of GCS.

The study of drug interaction in healthy volunteers showed that ritonavir (a highly active inhibitor of CYP3A4) can significantly increase the concentration of fluticasone in the plasma, which consequently leads to a decrease in the concentration of cortisol in the serum. In the post-marketing application, clinically significant drug interactions were observed in patients receiving fluticasone intranasally or inhaled together with ritonavir, which resulted in systemic effects of GCS, including Itenko-Cushing syndrome and suppression of adrenal function.

Thus, concomitant use of ritonavir and fluticasone should be avoided, unless the potential benefit to the patient outweighs the possible risk of systemic side effects of GCS.

Studies of other CYP3A4 inhibitors demonstrated a slight (erythromycin) and small (ketoconazole) increase in systemic exposure to fluticasone without any significant reduction in serum cortisol concentrations. Nevertheless, care should be taken when concomitantly administering strong inhibitors of CYP3A4 (eg ketoconazole), since it is possible to increase the concentration of fluticasone in the plasma.

Overdose

Symptoms: Acute overdose can lead to a temporary depression of the hypothalamic-pituitary-adrenal system, which usually does not require emergency therapy, because The function of the adrenal cortex is restored within a few days.

With prolonged use of doses exceeding the recommended, possible significant suppression of the function of the adrenal cortex. Very rare reports were received about the development of acute adrenal crisis in children who received a dose of fluticasone 1000 μg / day and higher for several months or years. In such patients hypoglycemia, oppression of consciousness and convulsions were noted.

Acute adrenal crisis can develop against the background of such conditions as severe trauma, surgical intervention, infection, a sharp decrease in the dose of fluticasone.

There is no evidence of acute or chronic overdose of fluticasone with intranasal administration. In healthy volunteers, the intranasal administration of 2 mg of fluticasone 2 times a day for 7 days did not affect the function of the hypothalamic-pituitary-adrenal system (a dose 20 times higher than the therapeutic dose).

With external application, fluticasone can be absorbed in sufficient quantities to manifest systemic action. The likelihood of an acute overdose is extremely low, but chronic overdose or improper application may develop signs of hypercorticism (Itenko-Cushing syndrome).

Treatment: observation of patients receiving high doses of fluticasone is necessary. In case of an overdose of fluticasone, the withdrawal of treatment is gradually carried out by reducing the frequency of application or switching to a less active GCS in order to avoid the risk of developing glucocorticoid insufficiency. When developing a clinical picture of an overdose, symptomatic therapy is indicated.

Routes of administration

Inhalation, intranasal, topical.

Precautions

With long-term topical application of any SCS, especially in high doses, systemic effects may be noted, but the likelihood of their development is significantly lower than when ingesting GCS inside. Possible systemic effects include Itenko-Cushing syndrome, cushingoid symptoms, suppression of adrenal function, decreased BMD, growth retardation in children and adolescents, cataracts, glaucoma, and less often a number of psychological or behavioral effects, including psychomotor hyperactivity, sleep disorders, anxiety, depression or aggressiveness (Especially in children). Therefore, it is especially important that when a therapeutic effect is achieved, the dose of GCS for topical administration is reduced to a minimum effective, allowing to control the course of the disease.

It is recommended to regularly monitor the dynamics of the growth of children receiving local GCS for a long time. If the growth is slowed, treatment should be reviewed to reduce the dose of SCS, if possible to a minimum, to maintain effective control over the symptoms, and contact the pediatrician.

An increase in the frequency of the use of short-acting inhaled beta2-agonists to control the symptoms of bronchial asthma during the inhalation period of fluticasone indicates a worsening of the control over the course of the disease. In this case, the patient's treatment plan needs to be revised.

Sudden and progressive deterioration of control over the course of bronchial asthma is a potential danger to the life of the patient and requires an increase in the dose of GCS. Patients at risk may be assigned a daily peak flow measurement.

To abruptly stop the inhalation treatment with fluticasone is not recommended.

Special care should be taken when treating inhaled GCS patients with active or inactive forms of pulmonary tuberculosis. It is recommended to check whether the patient can correctly use the inhaler to make sure that the inhalation of the inhaler is synchronized with the inhalation in order to ensure the optimal delivery of the active substance to the lungs.

It is always necessary to consider the likelihood of adrenal insufficiency in emergency situations (including surgery), as well as with planned interventions that can cause stress, especially in patients taking high doses of GCS for a long time. In this case, the question of the need for additional prescription of the GCS depending on the clinical situation (see "Overdose") should be addressed.

In connection with a possible adrenal insufficiency, special care should be taken and the adrenocortical function indicators should be regularly monitored when transferring patients taking SCS inward to fluticasone in the form of inhalations. The abolition of systemic SCS on the background of inhalation of fluticasone should be gradual, and patients should carry a card indicating that they may need additional SCS during stress periods.

When transferring patients from receiving systemic GCS to inhalation therapy, associated allergic diseases (for example, allergic rhinitis, eczema), which were suppressed by systemic SCS, may also worsen.

As with other inhalation therapies, there is a possibility of developing paradoxical bronchospasm with an immediate increase in dyspnea after inhalation. To stop this attack, immediate application of an inhaled bronchodilator of a quick and short action is necessary. Inhalation of fluticasone should be discontinued immediately, assess the patient's condition and, if necessary, prescribe an alternative therapy (see "Side effects").

There are very rare reports of an increase in the concentration of glucose in the blood, and this should be remembered by prescribing fluticasone to diabetic patients.

There was an increase in the incidence of pneumonia in patients with COPD who received fluticasone at a dose of 500 mcg. One should remember about the possibility of pneumonia in such patients, because the clinical signs of pneumonia and the exacerbation of the underlying disease can often coincide.

Intranasal application of fluticasone should not last more than 3 months for adults and children from 12 years and more than 2 months for children from 4 to 12 years. With prolonged use, regular monitoring of the function of the adrenal cortex is necessary.

The simultaneous use of ritonavir and fluticasone should be avoided except in those cases where the potential benefit to the patient exceeds the possible risk of developing adverse systemic effects of GCS (see "Interaction").

The full effect of fluticasone with intranasal administration may occur only after 3-4 days of treatment. It is recommended to stop using and get medical advice if there is no improvement within 4 days. A doctor's consultation is also necessary if new symptoms have appeared, such as severe facial pain, thick discharge from the nose, which may indicate infection and are not associated with allergies. Infections of the nasal cavity or paranasal sinuses require appropriate treatment, but are not a contraindication to intranasal application of fluticasone.

In most patients, intranasal application eliminates the symptoms of seasonal allergic rhinitis, but in some cases, with very high concentrations in the air of allergens, additional therapy may be necessary. To relieve the symptoms from the eyes against the background of successful therapy of seasonal allergic rhinitis, additional therapy may be required. To achieve maximum therapeutic effect, it is necessary to adhere to a regular scheme of application.

Care must be taken when transferring patients from systemic GCS therapy to intranasal treatment, especially if there is a violation of adrenal function against a background of regular monitoring.

When contacting patients with chicken pox, measles and in case of changes in vision, it is recommended to stop treatment and consult a doctor.

Outwardly, fluticasone should be used with caution in patients who have a history of local reactions of hypersensitivity to other GCS. Local reactions of hypersensitivity (see "Side effects") can resemble the symptoms of the underlying disease.

Manifestations of hypercorticism (Itenko-Cushing syndrome) and reversible inhibition of the hypothalamic-pituitary-adrenal system, leading to glucocorticoid insufficiency, in some cases arise as a result of increased systemic absorption of GCS for external use. In such cases, it is necessary to gradually stop treatment, reducing the frequency of application, or replace fluticasone with a less active SCS. A sudden cessation of treatment can lead to glucocorticoid insufficiency (see "Side effects").

Risk factors for the development of severe systemic reactions are the activity and dosage form of GCS for topical application, the duration of treatment, application to large areas of the skin, application of the skin to occluded areas, occlusive dressings (for children, an occlusive dressing may be a diaper), increased hydration Horny layer of the dermis, application on areas with thin skin, such as face, damaged skin, or other conditions potentially accompanied by damage to cutaneous arera. Compared with adults, children are likely to absorb more GCS for external use, thus increasing the risk of developing systemic adverse reactions. This is due to the immaturity of the skin barrier and a higher ratio of body surface area to body weight in children compared to adults.

In children from 6 months to 12 years of age, avoid prolonged continuous therapy with GCS for topical use, as long as possible. There is a possibility of suppression of adrenal function.

Caution should be exercised when administering GCS for topical use in the treatment of psoriasis, There are reports of early relapses, addiction, the risk of generalized pustular psoriasis and local or systemic toxicity due to impaired skin barrier function. The use of psoriasis requires careful monitoring of the course of the disease in the patient.

Long-term use fluticasone on the face is undesirable, because The skin in this area is more prone to atrophic changes.

When applying fluticasone on the eyelids, care should be taken not to get into the eyes, as repeated contact with the mucous membrane of the eye can lead to the development of cataracts and glaucoma.

With secondary infection of skin lesions, appropriate antibiotic therapy should be prescribed. In case of signs of spread of infection, SCS should be discontinued for topical application and appropriate antibiotic therapy should be prescribed.

Bacterial infections are easier to develop in warm and humid conditions in natural folds of the skin or under occlusive dressings, so every time before applying a new bandage, the skin should be thoroughly cleaned.

SCC therapy for topical administration is sometimes used to treat dermatitis developing around chronic ulcers of the lower limbs. However, this may be associated with a higher incidence of local hypersensitivity reactions and infectious complications.

The apparent oppression of the hypothalamic-pituitary-adrenal system (cortisol level in the blood plasma in the morning <5 μg / dL) in adults is unlikely with external application of fluticasone in the recommended doses, except for application to an area more than 50% larger than the surface area of the body, And in an amount of more than 20 g / day.

Influence on the ability to drive a car or work with machinery. The influence of fluticasone on the ability to drive and work with mechanisms requiring increased concentration of attention is unlikely, but it should take into account the side effects that it can cause.

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