Instructions for use FTOROCORT

Fluorocort - description of the product

The drug belongs to the group of local glucocorticosteroids (for external use). release form - ointment

0.1%, color - white, white-gray, homogeneous, practically odorless. The weight of the drug is 15 g, sold in pharmacies in aluminum tubes, with cardboard packaging on top.

The main active ingredient is the corticosteroid triamcinolone acetonide. It is a synthetic GCS that can be used in different forms. In the ointment described, it is used in the form of salt.

Auxiliary components of the drug:

• cetyl alcohol;
• filtered water;
• methyl parahydroxybenzoate;
• stearic acid;
• liquid paraffin;
• glycerol;
• polysorbate 60.

Even before searching for information about what Ftorokot ointment is used for, you should know that this is a hormonal product and cannot be used uncontrollably. All glucocorticosteroids are synthetic steroid hormones, analogues of those produced in the body by the adrenal glands. Despite the minimal impact, mainly local, a number of significant side effects are possible.

Fluorocort ointment 15g No. 1

Name

Fluorocort ointment in tubes 15g per pack. No. 1

Main active ingredient

Triamcinolone

Release form

ointment

Compound

Active ingredient: triamcinolone acetonide 15 mg. Excipients: methyl parahydroxybenzoate, stearic acid, polysorbate 60, cetyl alcohol, liquid paraffin, glycerol (85%), purified water.

Description

White or almost white, homogeneous ointment, practically odorless.

Dosage

15g

Pharmacological properties

Pharmacodynamics

Triamcinolone acetonide is a strong fluorinated corticosteroid with anti-inflammatory, antipruritic and antiallergic effects. The pharmacological effect of glucocorticoids is based on the control of the synthesis of specific proteins in the body. This multiple biological effect serves to physiologically adapt the body to stressful situations: decreased glucose absorption and glucose consumption, increased gluconeogenesis (hyperglycemia). Glycogen accumulation increases (mainly in the liver) due to increased insulin secretion caused by increased blood sugar levels (anabolic effect). Protein synthesis decreases, proteolysis increases in muscles (catabolic effect), in bones (osteoporosis) and in the skin. Glucocorticoids have a permissive effect on lipolysis. They reduce vasodilation, vascular permeability, and edema formation. A large number of glucocorticoid receptors are found in the tissues of the brain and heart. In the lungs, they enhance the beta-adrenergic receptor response, bronchodilation and reduce pulmonary vascular resistance. When administered in higher doses, glucocorticoids suppress corticotropin secretion; in cases of adrenal insufficiency, they increase glomerular filtration and diuresis, as well as the incidence of ulcers. They exhibit their antiallergic and anti-inflammatory effects in doses exceeding physiological ones. Esterification of corticosteroids with fatty acids at positions 17 or 21 usually increases activity in the skin. The formation of cyclic acetonides at positions 16 and 17 further increases local anti-inflammatory activity, generally without increasing systemic glucocorticoid action, and the local action of fluorinated corticosteroids was also generally enhanced.

Pharmacokinetics

Corticosteroids are well absorbed from topical sites. The penetrating ability of the active substance depends on the method of application, the location of application and the condition of the skin. When used locally, especially under occlusive dressings or when the integrity of the skin is broken, or when used as an enema, sufficient amounts of corticosteroids can be absorbed, producing a systemic effect. After cutaneous application of triamcinolone acetonide, 70-90% remains on the skin surface. Up to 30% of the steroid penetrates into the normal stratum corneum. Effective intradermal concentrations are achieved only after 30 minutes. Concentrations in the epidermis and dermis are maintained for 16 hours. In pathologically altered areas of the skin, as a result of reduced barrier function, 3-10 times higher concentrations of substances are found in the dermis and epidermis. Less than 1% of the administered dose penetrates through intact skin, after damage to the stratum corneum about 3% and about 10% under occlusive dressings. Effective absorption is much more pronounced in areas of the skin with a thin stratum corneum (forearm) or in the area of ​​sweat glands, hair follicles, and natural skin folds. Corticosteroids are quickly distributed throughout all tissues of the body. About 80% of triamcinolone is bound to serum albumin and transcortin. Triamcinolone is metabolized in the liver by conjugation with glucuronic acid. The main metabolite of triamcinolone is 6-beta-hydroxy-triamcinolone. Approximately 70-80% is excreted in bile, and about 20% is excreted from the body through the kidneys. The plasma half-life is approximately 5 hours, and the biological half-life is 18-36 hours. The slower metabolism of synthetic corticosteroids with their lower protein binding affinity explains their increased effectiveness compared to natural corticosteroids.

Indications for use

Skin diseases sensitive to glucocorticosteroids (eczema, vulgar psoriasis, allergic dermatitis).

Contraindications

First trimester of pregnancy. Hypersensitivity to the active substance or to any of the excipients of the ointment. Contact of the drug with the eyes or periorbital area should be avoided. The drug should not be used for fungal or bacterial skin infections without concomitant appropriate antibacterial therapy. The drug is contraindicated for tuberculosis and acute viral skin lesions (herpes simplex, herpes zoster, chicken pox). The drug is contraindicated for skin infections caused by parasites (for example, scabies). The drug should not be used to treat leg ulcers, rosacea or facial acne, perioral or diaper dermatitis, dry flaky skin, reactions to vaccines, syphilis (skin lesions), widespread plaque psoriasis, within 2-8 weeks after vaccination , and it is also contraindicated to apply to the skin of the breast immediately before breastfeeding. The drug should not be prescribed to children under 1 year of age.

Use during pregnancy and lactation

Pregnancy Fluorocort ointment should not be used in the first trimester of pregnancy; in the future it can only be used after a careful assessment of the expected benefits and possible risks. In animal studies, fetotoxic effects (teratogenicity, embryotoxicity) were observed. There is insufficient evidence regarding the safety of use in human pregnancy. Topical use of corticosteroids in pregnant animals can cause fetal abnormalities, including cleft palate and intrauterine growth retardation. Therefore, there is a very small risk of such effects in the human fetus. The half-life of glucocorticoids increases during pregnancy, and plasma clearance is less in neonates than in children and adults. Breastfeeding Systemic corticosteroids are excreted into breast milk and may adversely affect adrenal function in the neonate and cause undesirable effects such as growth suppression. If long-term use or treatment of a large surface area of ​​the body is necessary, breastfeeding should be discontinued as a precaution. Contact of the infant with the treated skin surface should be avoided. Do not apply the drug to the skin of the breast before breastfeeding. During pregnancy and breastfeeding, it is not recommended to apply the drug to large areas of the skin, use it for a long time, or use occlusive dressings.

Directions for use and doses

Adults: A thin layer of ointment should be spread over the affected area of ​​skin two or three times a day (maximum 15 g ointment per day) or under an occlusive dressing (maximum 10 g ointment per day). Children and adolescents: Fluorocort should not be used to treat children under 1 year of age. For children over one year of age, the ointment may be applied to the affected area a maximum of twice daily to reduce the possibility of unwanted effects. Treatment can last for no more than 5 days. Application under an occlusive dressing is not recommended. Elderly: Corticosteroids should be used with caution and for short periods of time because skin thinning occurs naturally in older adults. Directions for use: For external use only.

Side effect

Topical steroid treatment is potentially associated with the development of local adverse reactions. Systemic effects should also be expected depending on the amount of steroids absorbed through the skin. Adrenal suppression can occur with prolonged topical use of corticosteroids over large areas of the skin. The risk of suppression of adrenal function is especially high when used in pediatric patients, as well as when applying Fluorocort ointment under occlusive dressings. Protein catabolism can lead to a negative nitrogen balance. There are no data available on the incidence of adverse effects, so their frequency is unknown (cannot be determined based on available data). Systemic organ class Adverse reactions Infectious and parasitic diseases Exacerbation of latent infections Hiding current infections Opportunistic infections Immune system disorders Hypersensitivity reactions Metabolic and nutritional disorders Secondary adrenal insufficiency (suppression of adrenal cortex function) Hypokalemic alkalosis Fluid and sodium retention Hypokalemia Mental disorders Insomnia Nervous system disorders Mental disorders Convulsions Dizziness Headache Increased intracranial pressure Visual disorders Cataract* Subcapsular cataract Exophthalmos Glaucoma Papillary edema Ulcerative keratitis Chorioretinopathy Blurred vision ((see also section “Precautions”) side of the heart Heart failure Vascular disorders Arterial hypertension Gastrointestinal disorders Gastric bleeding Gastrointestinal bleeding Gastrointestinal perforation Esophagitis Pancreatitis Peptic ulcer Skin and subcutaneous tissue disorders Dermatitis Burning sensation of the skin Folliculitis at the site of application Acne dermatitis Contact dermatitis Thinning, dry skin Erythema Hirsutism Hyperhidrosis Diaper rash Itching Skin atrophy Skin hypopigmentation Skin irritation Striae Telangiectasia Musculoskeletal and connective tissue disorders Growth retardation Steroid myopathy Osteonecrosis Osteoporosis General disorders and reactions at the injection site Impaired wound healing Laboratory and instrumental studies Increased intraocular pressure Negative nitrogen balance Negative skin test* The likelihood of cataract formation is higher in pediatric patients. If the listed adverse reactions occur, as well as reactions not listed in the instructions for medical use, you should consult a doctor.

Overdose

Although there have been no reports of any cases of overdose, overdose can cause local and systemic effects, depending on the amount of steroids in the body. With recommended topical use, overdose is not expected. Possible symptoms of overdose: With prolonged use (more than 4 weeks) and/or over a large area (more than 20%) - especially on damaged skin with reduced barrier function or under an occlusive dressing - the active substance may be available systemically in higher quantities and lead to known systemic side effects of glucocorticoids (suppression of the hypothalamic-pituitary-adrenal axis, Cushing's syndrome). Treatment Symptomatic (systemic side effects). In case of overdose, treatment should not be stopped suddenly; therapy should be discontinued gradually. If adrenal insufficiency develops, intravenous hydrocortisone may be required.

Interaction with other drugs

Interaction studies of Fluorocort ointment with other drugs have not been conducted. When steroids are used topically, their interactions with other drugs are unknown.

Precautionary measures

If irritation develops, use of the drug should be discontinued and appropriate treatment administered. If large areas are treated or an occlusive dressing is used, this will increase the systemic absorption of corticosteroids and appropriate precautions should be taken, especially in children and infants. Microorganisms, primarily pyogenic microorganisms, penetrate more easily through the weakened stratum corneum, causing various pyodermas during treatment. If an infection develops at the site of application of the drug, appropriate antibacterial or antifungal therapy should be prescribed. In rare cases, bleeding may occur under an occlusive dressing. Use on the same area of ​​skin for a long period of time, especially in young people, can lead to the development of atrophy. When used for psoriasis, topical steroid treatment may be associated with several risk factors (eg, rebound effects, steroid dependence, risk of developing generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function). Thus, for psoriasis, treatment with topical steroids should be carried out under strict medical supervision. Visual impairment Visual impairment may occur with systemic and local use of corticosteroids. If patients experience symptoms such as blurred vision or other visual disturbances, consultation with an ophthalmologist should be considered to rule out causes such as cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR), which have been reported after systemic or local use of corticosteroids. Long-term use of ointment on the face should be avoided. It is not recommended to apply the ointment to the skin around the eyes, since use in the periorbital area increases the risk of complications such as cataracts, glaucoma, the spread of herpetic infections, and the development of bacterial or fungal infections. Damaged skin on the face, forearms, and back are especially susceptible to corticosteroids because they are exposed to sunlight, which can lead to increased side effects. With prolonged use of the ointment (more than 3-4 weeks) or over large areas (more than 20% of the body surface), especially near the eyes, the possibility of absorption cannot be excluded. In these cases, all precautions characteristic of systemic therapy with glucocorticosteroids should be observed. In case of a long period of treatment and/or on large areas of skin - in particular, under occlusive dressings - the functional state of the hypothalamic-pituitary-adrenal system should be periodically monitored. The use of the drug in the genital and anal area may lead to a decrease in the strength of condoms and thus affect their safety due to the presence of paraffin and glycerin in the ointment. Use in children The drug can be prescribed to children only in exceptional circumstances! Children may be more responsive to topical corticosteroids and susceptible to systemic toxicity due to their larger skin surface area relative to body weight and increased skin permeability. Chronic corticosteroid therapy may interfere with the growth and development of children. The ointment should be used in children only for a short time and on a small body surface area (less than 10% of the body surface area). Courses of therapy should not exceed 5 days, and occlusive dressings should not be used. The methyl parahydroxybenzoate (known as paraben) contained in the drug may cause allergic reactions in susceptible people. The cetyl alcohol contained in the drug may cause local skin reactions (for example, contact dermatitis).

Storage conditions

Store at a temperature not exceeding 25 °C, do not freeze. Keep out of the reach of children

Pharmacological action of the drug

Like other corticosteroids, triamcinolone has antiallergic, antiedematous, antiproliferative, and anti-inflammatory effects. All these properties of this dosage form manifest themselves locally.

After application to the skin, the active component of Fluorocort ointment has the following effects:

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1. Reduces the rate of release of interleukins 1 and 2. These substances are mediators of inflammation, synthesized by a number of body cells, primarily macrophages and fibroblasts.
2. Inhibits the production of interferon gamma from macrophages and lymphocytes.
3. Stabilizes mast cell membranes, thereby reducing the risk of edema.

After using Fluorocort ointment, the number of cells that participate in the inflammatory reaction - eosinophils, T-lymphocytes, macrophages in the affected area quickly decreases, therefore, the course of the body's immune response is disrupted. In the case of infectious processes, this is unacceptable, therefore, in case of active bacterial, fungal, or viral inflammation, the use of the product is prohibited.

Accumulating in the upper layer of the skin, Fluorocort reduces itching and exudation, so its main indication is autoimmune reactions and allergies.

The drug is excreted by the intestines and kidneys in the form of metabolites. The half-life is 5 hours, it is released from tissues in 18-36 hours. Impaired skin integrity and the use of dressings can increase the intensity of absorption of the active substance.

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Indications for Fluorocort

The main indications of this drug are various dermatological diseases of immune-inflammatory etiology:

• atopic dermatitis
  - a chronic disease that occurs in individuals with a predisposition to atopy;
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• psoriasis
  - non-contagious skin dermatosis of a non-infectious autoimmune nature;

• eczema
  - rash, burning, inflammation of the skin, prone to frequent relapses;

• allergic and contact dermatitis
  are inflammatory dermatological diseases caused by hypersensitivity reactions.

What else is Fluorocort used for? It quickly eliminates itching, photodermatosis rash, cold rash, and helps in the treatment of lichen planus, which is also of an immune nature. In case of severe irritation as a result of bites of midges and other insects, the application of Fluorocort will help eliminate itching and swelling. The ointment is also used to reduce or eliminate hypertrophic and keloid scars on the skin. In complex therapy, the drug is used for the cutaneous form of systemic lupus erythematosus.

Instructions for use and contraindications

The ointment is applied externally to the affected area of ​​the skin. The layer of product should be thin; strong rubbing is not necessary. The maximum dose for an adult is 15 g of product/day, frequency of use is 2-3 times/day. In cases of lichenification, when the skin becomes rough and thickened, Fluorocort can be applied under occlusive dressings.

It is not recommended to use the product for longer than 28 days; usually the course is 5-10 days, if the course of the pathology is persistent - 21 days.

Contraindications to the use of any GCS must be strictly observed. If there is an infectious process on the skin, due to the application of GCS and a decrease in the immune response, the pathology may progress to a more serious stage. It is also contraindicated to be treated with Fluorocort if:

• cutaneous form of tuberculosis;
• skin syphilis;
• perioral (perioral) dermatitis;
• oncological diseases of the skin.

Contraindications include hypersensitivity to triamcinolone or additional components, pregnancy, lactation. Do not apply the product to the eye area or open wounds. If the pathology is complicated by a secondary fungal or bacterial infection, the parallel use of Fluorocort and a special antimicrobial, antimycotic drug is allowed.

Instructions for use FTOROCORT

If irritation develops, use of the drug should be discontinued and appropriate treatment administered.

If large areas are treated or an occlusive dressing is used, this will increase the systemic absorption of corticosteroids and appropriate precautions should be taken, especially in children and infants.

Microorganisms, primarily pyogenic microorganisms, penetrate more easily through the weakened stratum corneum, causing various pyodermas during treatment. However, it can be easily controlled by using antiseptics. Blastomycosis can also develop. In rare cases, bleeding may occur under an occlusive dressing. Use on the same area of ​​skin for a long period of time, especially in young people, can lead to the development of atrophy.

When used for psoriasis, topical steroid treatment may be associated with several risk factors (eg, rebound effects, steroid dependence, risk of developing generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function). Thus, for psoriasis, treatment with topical steroids should be carried out under strict medical supervision.

Long-term use of ointment on the face should be avoided.

It is recommended to apply the ointment away from the eyes, because... use of the drug on the periorbital area of ​​the face can provoke ocular complications, which include cataracts, glaucoma, corneal damage, the spread of herpetic infections and an increased risk of bacterial and fungal infections.

Damaged skin of the face, forearms and back is especially susceptible to corticosteroids, because they are exposed to sunlight, which may increase side effects.

There are reports of sporadic cases of central serous chorioretinopathy when using corticosteroids, regardless of the route of administration (systemic, local or external) with a latent period from several days to several years.

With prolonged use of the ointment (more than 3-4 weeks) or over large areas (more than 20% of the body surface), especially near the eyes, the possibility of absorption cannot be excluded. In these cases, all precautions characteristic of systemic GCS therapy should be observed.

In case of long periods of treatment and/or on large areas of skin - in particular, under occlusive dressings - the functional state of the hypothalamic-pituitary-adrenal system should be periodically monitored.

The use of the drug in the genital and anal area may reduce the strength of condoms and thus affect their safety due to the presence of paraffin and glycerin in the ointment.

The methyl parahydroxybenzoate (known as paraben) contained in the drug may cause allergic reactions in susceptible people.

The cetyl alcohol contained in the drug may cause local skin reactions (for example, contact dermatitis).

Use in pediatrics

The drug can be prescribed to children only in exceptional cases.

Children may be more responsive to topical corticosteroids and susceptible to systemic toxicity due to their larger skin surface area relative to body weight and increased skin permeability. Chronic corticosteroid therapy may interfere with the growth and development of children. The ointment should be used in children only for a short time and on a small body surface area (less than 10% of the body surface area).

Courses of therapy should not exceed 5 days, and occlusive dressings should not be used.

Impact on the ability to drive vehicles and operate machinery

Fluorocort does not affect the ability to drive vehicles or operate machinery.

Analogs and other important information

The price of the drug is about 240 rubles. There are a number of products that are more expensive and cheaper, but independent replacement of ointments with GCS is not allowed! Analogs of Ftorokort are given below.

Among the side effects that are noted with long-term use, the instructions indicate erythema, the development of secondary skin lesions by infection, and skin atrophy. This usually occurs when the ointment is abused, especially in children or when applied under bandages. It is not advisable to apply the product to large areas of the body.

The course of therapy in children should not exceed 5 days; in addition, it is necessary to take into account the body area in relation to the size of the treated area in order to exclude systemic side effects (diabetes mellitus, immunodeficiency, stomach ulcers, thrombosis, osteoporosis, etc.).

Fluorocort 0.1% 15g ointment

pharmachologic effect

GCS for external use. When applied topically, it has anti-inflammatory, antiallergic, anti-edematous and antiproliferative effects. When exposed to the skin, the marginal accumulation of neutrophils is prevented, which leads to a decrease in exudation, cytokine production, inhibition of macrophage migration, ultimately leading to a decrease in the processes of infiltration and granulation.

Composition and release form Fluorocort 0.1% 15g ointment

Ointment - 1 g:

• Active substance: triamcinolone acetonide 1 mg.
• Excipients: methyl parahydroxybenzoate - 2 mg, stearic acid - 25 mg, polysorbate 60 - 35 mg, cetyl alcohol - 60 mg, liquid paraffin - 120 mg, glycerol 85% - 180 mg, purified water - 577 mg.

15 g - aluminum tubes (1) - cardboard packs.

Description of the dosage form

Ointment for external use 0.1% white or almost white, homogeneous, practically odorless.

Directions for use and doses

Externally.

The drug is applied in a thin layer to the affected areas of the skin 2-3 times a day (maximum daily dose 15 g). It is possible to use an occlusive dressing, but the maximum amount of ointment should not exceed 10 g.

The course of treatment is usually 5-10 days, with a persistent course - up to 25 days; use for more than 4 weeks is not recommended.

Pharmacokinetics

Triamcinolone is rapidly distributed into body tissues. The main metabolite of triamcinolone is 6-β-hydroxytriamcinolone. It is excreted through the intestines and kidneys in equal proportions. T1/2 of triamcinolone from plasma is about 5 hours, T1/2 from tissues is 18-36 hours.

Indications for use Fluorocort 0.1% 15g ointment

Skin diseases sensitive to GCS:

• acute and chronic eczema;
• neurodermatitis;
• contact dermatitis;
• lichen planus;
• psoriasis;
• exfoliative erythroderma;
• Leiner's disease;
• external otitis, not complicated by infection;
• insect bites.

Contraindications

• Hypersensitivity to the components of the drug;
• viral, bacterial (including tuberculosis) and fungal skin infections;
• trophic ulcer of the leg;
• rosacea;
• acne vulgaris;
• perioral dermatitis;
• intertrigo;
• cannot be applied to wounds;
• children under 2 years of age.

With caution: pregnancy.

Use of Fluorocort 0.1% 15g ointment during pregnancy and breastfeeding

The use of Fluorocort in pregnant women is permitted in cases where the potential benefit to the mother outweighs the possible risk to the fetus.

It is not known whether the drug is excreted in breast milk, so breastfeeding should be avoided during lactation.

Use in children

Contraindicated for use in children under 2 years of age.

special instructions

If side effects occur, you should stop using the drug Fluorocort.

Like other corticosteroids for external use, Ftorokort cannot be applied to the skin in the eye area, as well as to wound surfaces. When using occlusive dressings and used on large surfaces of the body, a systemic effect of the drug is possible - in such cases, increased caution is required, especially when treating children.

If the course of the disease is complicated by the development of a secondary bacterial or fungal infection, a specific antibacterial or antifungal agent must be added to therapy with Fluorocort.

The drug should be used with extreme caution on the skin of the face.

Use in pediatrics

Use in children should be done with caution. It must be taken into account that in young children, skin folds and diapers can have an effect similar to the effect of an occlusive dressing and increase systemic resorption of the drug. In addition, in children, a greater degree of systemic resorption is possible due to the relationship between the surface of the skin and body weight, as well as the connection with insufficient skin maturity.

The duration of treatment in children should not exceed 5 days. Longer use of the drug should be carried out under the supervision of a physician. The use of occlusive dressings is not recommended for children.

Impact on the ability to drive vehicles and machinery

The drug does not affect the ability to drive a car or operate machinery.

Overdose

Symptoms: systemic action of GCS. Treatment: symptomatic therapy.

Side effects Fluorocort 0.1% 15g ointment

Side effects when used externally are rare and reversible.

Possible: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform rash, hypopigmentation, perioral dermatitis, allergic or contact dermatitis, skin maceration, secondary infection, skin atrophy, stretch marks, prickly heat.

Drug interactions

When GCS is used externally, interaction with other drugs is unknown.