Fluorocort ointment 15g №1

Name:
Fluorocort ointment in tubes 15g in a pack. No. 1 Main active ingredient Triamcinolone Release form ointment Composition 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 15 g Pharmacological properties Pharmacodynamics Triamcinolone acetonide is a strong fluorinated corticosteroid with anti-inflammatory, antipruritic and anti-allergic effects. The pharmacological effect of glucocorticoids is based on the control of the synthesis of specific body proteins. This multiple biological effect serves for the physiological adaptation of the body to stressful situations: a decrease in glucose absorption and glucose consumption, an increase in gluconeogenesis (hyperglycemia). The accumulation of glycogen (mainly in the liver) increases due to an increase in insulin secretion caused by an increase in blood sugar levels (anabolic effect). Protein synthesis is reduced, proteolysis is increased in the muscles (catabolic effect), in the 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 increase the response of beta-adrenergic receptors, bronchodilation and reduce pulmonary vascular resistance. When administered in higher doses, glucocorticoids suppress the secretion of corticotropin, in case of insufficiency of the adrenal cortex, they increase glomerular filtration and diuresis, as well as the incidence of ulcers. They show their anti-allergic and anti-inflammatory effects in doses exceeding physiological ones. Esterification of corticosteroids with 17- or 21-fatty acids generally increases skin activity. Formation of cyclic acetonides at positions 16 and 17 further increased local anti-inflammatory activity, generally without increasing systemic glucocorticoid action, and local action of fluorinated corticosteroids was also generally enhanced. Pharmacokinetics Corticosteroids are well absorbed from topical sites. The penetrating power of the active substance depends on the method of application, the site of application and the condition of the skin. When applied by topical application, especially under occlusive dressings or in violation of the integrity of the skin, as well as when applied as an enema, a sufficient amount of corticosteroids can be absorbed, providing a systemic effect. After skin application of triamcinolone acetonide, 70-90% remains on the surface of the skin. Up to 30% of the steroid penetrates into the normal stratum corneum. Effective intradermal concentrations are reached only after 30 minutes. Concentrations in the epidermis and dermis persist for 16 hours. In pathologically altered areas of the skin, as a result of a reduced barrier function, 3-10 times higher concentrations of substances in the dermis and epidermis are found. 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 skin areas with a thin stratum corneum (forearm) or in the area of sweat glands, hair follicles, natural skin folds. Corticosteroids are rapidly distributed to all body tissues. About 80% of triamcinolone is associated with 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 with bile, and about 20% is excreted from the body through the kidneys. The plasma half-life is about 5 hours, the biological half-life is 18-36 hours. The slower metabolism of synthetic corticosteroids, with their lower protein-binding affinity, explains their increased efficacy compared to natural corticosteroids. Indications for use Skin diseases sensitive to glucocorticosteroids (eczema, psoriasis vulgaris, allergic dermatitis). Contraindications First trimester of pregnancy. Hypersensitivity to the active substance or to any of the excipients of the ointment. Avoid contact of the drug with the eyes or periorbital area. Do not use the drug for fungal or bacterial infections of the skin without concomitant appropriate antibiotic therapy. The drug is contraindicated in tuberculosis and acute viral skin lesions (herpes simplex, herpes zoster, chicken pox). The drug is contraindicated in skin infections caused by parasites (for example, scabies). The drug should not be used to treat ulcers on the legs, rosacea or acne on the face, perioral dermatitis or diaper dermatitis, dry scaly skin, reactions to vaccines, syphilis (skin lesion), 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 given to children under 1 year of age. Application 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 thorough assessment of the expected benefits and possible risks. Fetotoxic effects (teratogenicity, embryotoxicity) have been observed in animal studies. There is insufficient evidence on the safety of use in human pregnancy. Topical application 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 Period Systemic corticosteroids are excreted in breast milk and may adversely affect neonatal adrenal function and cause adverse effects such as growth suppression. If prolonged use or treatment of a large body surface area is necessary, breastfeeding should be discontinued as a precautionary measure. 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 lactation, it is not recommended to apply the drug to large areas of the skin, use it for a long time or use occlusive dressings. Dosage and administrationAdults: A thin layer of ointment should be distributed on the affected area of the skin two or three times a day (maximum 15 g of ointment per day) or under an occlusive dressing (maximum 10 g of ointment per day). Children and adolescents: Fluorocort should not be used in children under 1 year of age. For children older than one year, the ointment can be applied to the affected area a maximum of twice a day 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 Patients: Corticosteroids should be used with caution and for short periods of time as natural thinning of the skin occurs in the elderly. Method of application For external use only. Side effects Local treatment with steroids is potentially associated with the development of local adverse reactions. Systemic effects should also be expected depending on the amount of steroids penetrating the skin. Suppression of adrenal function may occur with prolonged topical use of corticosteroids over large areas of the skin. The risk of adrenal suppression 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 is no data on the frequency of development of undesirable effects, therefore their frequency is unknown (impossible to determine based on the available data). System 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 Psychiatric disorders Insomnia Nervous system disorders Psychiatric disorders Convulsions Dizziness Headache Increased intracranial pressure Eye disorders Cataract* Subcapsular cataract Exophthalmos Glaucoma Papillary edema Ulcerative keratitis Chorioretinopathy Blurred vision ((see also Precautions section) side of the heart Heart failure Vascular disorders Arterial hypertension Gastrointestinal disorders Gastric bleeding Stomach 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 Teleangiectasia Skin disorders of the musculoskeletal system and connective tissue Growth retardation Steroid myopathy Osteonecrosis Osteoporosis General disorders and reactions at the injection site Impaired wound healing Laboratory and instrumental studies Elevated 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 may cause local and systemic effects, depending on the amount of steroids ingested. With the recommended topical application, an 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 a reduced barrier function or under an occlusive dressing – the active substance may be available systemically in higher amounts and lead to known systemic side effects of glucocorticoids (suppression of the hypothalamic-pituitary-adrenal system, Cushing’s syndrome). Treatment Symptomatic (systemic side effects). In case of overdose, treatment should not be stopped abruptly; 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 topical steroids are used, their interactions with other drugs are unknown. Precautionary measures If irritation develops, the use of the drug should be discontinued and appropriate treatment should be carried out. If large areas are treated or an occlusive dressing is used that will increase the systemic absorption of corticosteroids, appropriate precautions should be taken, especially in children and infants. Through the weakened stratum corneum, microorganisms, primarily pyogenic microorganisms, penetrate more easily, causing various pyoderma 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 the occlusive dressing. The use on the same area of the skin for a long period of time, especially in young people, can lead to the development of atrophy. When used in 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 intoxication due to impaired skin barrier function). Thus, in psoriasis, treatment with topical steroids should be carried out under strict medical supervision. Visual disturbances Vision disturbances may occur with systemic and local use of corticosteroids. If patients develop symptoms such as blurred vision or other visual disturbances, consideration should be given to consulting an ophthalmologist to rule out causes such as cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy (CSCR) reported after systemic or local the use of corticosteroids. Long-term use of the 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 region increases the risk of complications such as cataracts, glaucoma, the spread of herpes infection, the development of a bacterial or fungal infection. Damaged skin of the face, forearms and back is especially susceptible to corticosteroids, as they are exposed to sunlight, which can lead to increased side effects. With prolonged use of the ointment (more than 3-4 weeks) or on large areas (more than 20% of the body surface), especially near the eyes, the possibility of absorption cannot be ruled out. In these cases, all precautions specific to systemic glucocorticosteroid therapy should be observed. In the case of a long period of treatment and / or on large areas of the 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 can lead to a decrease in the strength of condoms and thus affect their safety due to the presence of paraffin and glycerin in the composition of the ointment. Use in children The drug may be administered to children only in exceptional circumstances! Children may be more susceptible to topical corticosteroids and sensitive to their systemic toxicity due to the greater 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 preparation can cause allergic reactions in predisposed people. The cetyl alcohol contained in the preparation 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 Buy Fluorocort ointment 15g No. 1