Instructions for Focort-Darnitsa cream 1 mg/g tube 15 g
Composition
active ingredient: triamcinolone;
1 g of cream contains 1 mg of micronized triamcinolone acetonide;
excipients: cetylpyridinium chloride, propylene glycol, white soft paraffin, liquid paraffin, hard paraffin, cetostearyl alcohol, purified water.
Dosage form
Cream.
Main physicochemical properties: white cream of uniform consistency.
Pharmacotherapeutic group
Corticosteroids for use in dermatology. Triamcinolone. ATX code D07A B09.
Pharmacological properties
Pharmacodynamics
The active ingredient of the cream is triamcinolone acetonide, a glucocorticosteroid that contains fluorine and, when applied topically, exhibits anti-inflammatory, antiallergic, and antipruritic effects.
The pharmacological action of glucocorticosteroids is based on the regulation of the synthesis of specific proteins of the body and ensuring the body's adaptability to stressful situations by reducing glucose utilization and enhancing gluconeogenesis. They contribute to the deposition of glycogen, primarily in the liver, by increasing insulin secretion in conditions of hyperglycemia. They reduce the synthesis and increase the catabolism of proteins of muscle, skin and bone tissues; promote lipolysis. They narrow blood vessels, reduce their permeability and swelling of tissues.
Numerous glucocorticosteroid receptors are also found in brain and heart tissues. Glucocorticosteroids enhance β-adrenergic responses in the lungs, promote bronchodilation, and reduce vascular resistance in the lungs.
Esterification of the glucocorticosteroid molecule with fatty acids at positions 17 and 21 significantly enhances its effect on the skin. The location of the cyclic acetonide at positions 16 and 17 enhances the local anti-inflammatory effect without affecting the systemic effect of glucocorticosteroids. Fluorine contributes to a further increase in the local activity of the drug.
Pharmacokinetics
Triamcinolone penetrates well into the deep layers of the skin, partially enters the bloodstream. When applying an occlusive dressing to the affected skin areas, it is absorbed in an amount sufficient to provide a systemic effect. Glucocorticosteroids are rapidly distributed in the tissues of the body. The main metabolite of triamcinolone is 6-β-hydroxytriamcinolone, which is excreted by the liver, kidneys, feces and urine in equal proportions. The half-life from blood plasma is about 5 hours, the half-life is 18-36 hours.
Indication
Skin diseases for which treatment with corticosteroids is indicated (eczema, vulgar psoriasis, allergic dermatitis).
Contraindication
Hypersensitivity to triamcinolone acetonide or to any of the excipients of the drug. Tuberculosis, viral skin lesions, especially herpes simplex and chickenpox; skin manifestations of syphilis, skin reactions after vaccination, perianal and genital itching, widespread plaque psoriasis, varicose veins, leg ulcers; facial skin lesions (rosacea, acne vulgaris, perioral dermatitis); diaper rash caused by wet diapers; use as monotherapy without specific treatment for fungal and bacterial skin infections, treatment of dry skin peeling, skin cancer, children under 1 year of age.
Interaction with other medicinal products and other types of interactions
When topical steroids are used, interactions with other drugs are unknown.
Application features
If skin irritation occurs, you should stop using Focort®-Darnitsa cream and continue treatment with another medication.
When using occlusive dressings and treating large body surfaces, systemic effects of the drug are possible - in such cases, special caution is required.
During application of the cream, microorganisms present on the skin (primarily pyogenic microorganisms, sometimes blastomycetes) can penetrate through the loosened stratum corneum and cause various pyodermas, which are treated with washable disinfectants. Fungal diseases are possible. Sometimes bruises may appear under the occlusive dressing. With prolonged use of the cream on the same area of the body, especially in young patients, atrophy of this area of the skin may develop. Prolonged use of the drug on the skin of the face is not recommended due to the risk of skin atrophy.
Some areas of the body, such as the armpits, inguinal folds (where there is natural occlusion and the skin is more delicate and thin) are more prone to the development of stretch marks and easily noticeable atrophy of this area of skin, which is irreversible. Therefore, the application of the cream on these areas of skin should be short-term.
In the event of the development of a fungal or bacterial skin infection, additional local or systemic therapy is necessary.
It is not recommended to use the cream on the scalp.
In the treatment of psoriasis, withdrawal syndrome, steroid dependence, development of generalized pustular psoriasis, and development of local or systemic toxicity due to impaired skin barrier function are possible. Treatment of patients with psoriasis with topical corticosteroids is possible only under strict medical supervision.
The cream can be prescribed to children over 1 year of age only in exceptional cases. The duration of use of the drug in children should not exceed 5 days. The use of an occlusive dressing in children is contraindicated.
When used in children, it is necessary to take into account the possibility of signs of hypothalamic-pituitary-adrenal system suppression and Cushing's syndrome, which occur more often in children than in adult patients due to a larger ratio of skin surface area to body weight and, accordingly, children are more susceptible to systemic toxicity. Acute adrenal insufficiency, Cushing's syndrome, and increased intracranial pressure have been reported in children receiving topical corticosteroids.
Use during pregnancy or breastfeeding
The use of the cream in the first trimester of pregnancy is contraindicated. Data confirming the safety of the drug during pregnancy in the second and third trimesters are insufficient. The question of the use of the drug during pregnancy in the second and third trimesters of pregnancy and during breastfeeding is decided by the doctor in each case individually, carefully weighing the ratio of the expected effect of treatment for the mother and the potential risk to the fetus/child. Data confirming the safety of the drug during pregnancy are insufficient.
The absorption of glucocorticosteroids into the circulatory system is accompanied by their penetration into the mother's breast milk and their effect on the adrenal cortex and the growth of the child.
It is contraindicated to apply the cream to the mammary glands immediately before breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
There are no reports at this time. However, it is recommended to exercise extreme caution when driving or operating other machinery, given the possibility of developing adverse reactions from the nervous system.
Method of administration and doses
For external use.
Adults: apply a thin layer of cream 2-3 times a day to the affected area of skin (maximum dose - for adults no more than 15 g of cream per day) or apply the medicine under an occlusive dressing (maximum dose - no more than 10 g of cream per day).
The duration of treatment is determined by the doctor individually.
Children: from 1 year of age, apply a thin layer of cream to the affected area of skin no more than 2 times a day. The duration of use of the drug in children should not exceed 5 days. The use of an occlusive dressing in children is contraindicated.
The cream should only be prescribed to children in exceptional cases.
The drug should be used with caution and for a short time in elderly patients, as it should be borne in mind that the skin in this category of patients is thinner.
Children
The cream is contraindicated for children under 1 year of age.
Overdose
Depending on the amount of corticosteroid that has entered the body, both local and systemic adverse reactions may develop. In case of overdose with the drug, treatment should not be stopped abruptly - this should be done gradually, reducing the dose of the drug. If symptoms of adrenal insufficiency develop, intravenous administration of hydrocortisone may be required.
Adverse reactions
Glucocorticosteroid drugs when used topically are characterized by local adverse reactions, however, depending on the amount of substance that enters the systemic bloodstream, systemic effects are possible.
With prolonged use on large surfaces, suppression of the function of the adrenal cortex is possible, especially in children, as well as when using occlusive dressings; negative nitrogen balance is possible due to increased protein breakdown.
Immune system disorders: hypersensitivity reactions.
From the side of water and electrolyte metabolism: suppression of the function of the adrenal cortex (secondary adrenal insufficiency), hypokalemic alkalosis, water and sodium retention in the body, hypokalemia, arterial hypertension.
From the side of the central nervous system: mental disorders, convulsions, dizziness, headache, increased intracranial pressure, insomnia.
On the part of the organs of vision: cataract, posterior subcapsular cataract, exophthalmos, glaucoma, optic nerve head swelling, corneal ulcer, exophthalmos. The probability of developing cataracts is higher in children.
Cardiovascular system: heart failure, arterial hypertension.
On the part of the digestive system: gastric bleeding, gastrointestinal bleeding, gastrointestinal perforation, esophagitis, pancreatitis, peptic ulcer.
Musculoskeletal system: growth retardation in children, steroid myopathy, osteoporosis, osteonecrosis, aseptic necrosis.
Laboratory abnormalities: increased intraocular pressure, negative nitrogen balance, slowed reactions to skin tests.
Infections and parasitic diseases: activation of latent infections, masking of the course of infections, opportunistic infections.
Expiration date
2 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
15 g in a tube; 1 tube in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
