Fokort-Darnitsa

General characteristics. Structure:

Active ingredient: triamcinolone;

1 g of cream contains Triamcinolonum of acetonide of the micronized 1 mg;

excipients: cetylpyridinium chloride, propylene glycol, paraffin white soft, liquid paraffin, paraffin solid, cetostearyl alcohol, the water purified.

Pharmacological properties:

Pharmacodynamics. Active agent of ointment is acetonide Triamcinolonum – a glucocorticosteroid, containing fluorine, at topical administration shows antiinflammatory, antiallergic and antipruritic action.

Pharmacological action of glucocorticosteroids is based on regulation of synthesis of specific proteins of an organism and ensuring adaptability of an organism to stressful situations due to decrease in utilization of glucose and strengthening of a gluconeogenesis. They promote adjournment of a glycogen, first of all in a liver, due to strengthening of secretion of insulin in the conditions of a hyperglycemia. Reduce synthesis and strengthen a catabolism of proteins of muscular, skin and bone fabrics; promote a lipolysis. Narrow vessels, reduce their permeability and puffiness of fabrics.

Numerous receptors of glucocorticosteroids are also in tissues of a brain and heart. Glucocorticosteroids strengthen β-adrenergic reactions in lungs, expand bronchial tubes and reduce vascular resistance in lungs.

In high doses slow down corticotropin secretion, at adrenokortikosteroidny insufficiency strengthen glomerular filtering and a diuresis; cause cankers of mucous membranes. In high doses show antiallergic and antiinflammatory properties.

Esterification of a molecule of a glucocorticosteroid fatty acids in 17 and 21 positions significantly strengthens its impact on skin. The arrangement of cyclic acetonide in 16 and 17 positions strengthens local antiinflammatory action, without influencing system effect of glucocorticosteroids. Fluorine promotes further increase in local activity of drug.

Pharmacokinetics. Triamcinolonum well gets into deep layers of skin, partially comes to blood. At use of an occlusive bandage on the struck skin sites it is soaked up in the quantity sufficient for rendering system effect. Glucocorticosteroids are quickly distributed in body tissues. The main metabolite of Triamcinolonum – 6-β-гидрокситриамцинолон, is removed by a liver, kidneys, with a stake and urine in equal ratios. Plasma elimination half-life of blood makes about 5 hours, half-life – 18-36 hours.

 

Pharmaceutical characteristics.

Main physical and chemical properties: cream of white color of a homogeneous consistence.

Indications to use:

All types of chronic and acute eczema irrespective of localization; neurodermatitis; contact dermatitis irrespective of an etiology, red flat deprive; vulgar psoriasis; exfoliative erythrosis; Leyner's disease; the otitis of outside acoustical pass which is not complicated by an infection; lupus erythematosus.

Route of administration and doses:

For external use.

Adult: a thin film of cream is applied by 2-3 times a day on an affected area of skin (the maximum dose – no more than 15 g of cream a day) or use drug under an occlusive bandage (the maximum dose – no more than 10 g of cream a day). Duration of treatment is defined by the doctor individually.

To children: 1 years are more senior a thin film of cream is applied by at most 2 times a day on an affected area of skin. Drug use duration to children should not exceed 5 days. Use of an occlusive bandage is contraindicated to children.

Purpose of cream  to children is possible only in exceptional cases.

Patients of advanced age need to use drug carefully and within a short period of time as it must be kept in mind that at this category of patients skin is thinner.

Features of use:

Use during pregnancy or feeding by a breast.

Breast the doctor solves a question of use of drug during pregnancy or feeding in each case individually, carefully weighing a ratio of the expected effect of treatment for mother and potential risk for the fruit/child. The data confirming safety of drug during pregnancy are not enough.

Absorption of glucocorticosteroids in the blood circulatory system is followed by their penetration into breast milk and influence on bark of adrenal glands and growth of the baby.

Putting cream on a breast just before feeding by a breast is contraindicated.

 

Children.

Fokort®-Darnitsa cream use to children is more senior than 1 year perhaps when the expected advantage exceeds risk of emergence of side effects. It is necessary to avoid prolonged use to children irrespective of age. At prolonged use for prevention of local infectious complications use in combination with antimicrobic medicines is possible.

It is not recommended to apply on big surfaces. It is necessary to remember that the more the area of putting drug, the is higher probability of development of side reactions. At drug use children need to consider possibility of signs of oppression гипоталамо - pituitary and adrenal system which arise at children more often than at adult patients that is connected with bigger absorption of drug at children through bigger value of a ratio of the area of integuments to body weight.

At the children receiving corticosteroids for topical administration oppression of function of adrenal glands, Cushing's syndrome, a growth inhibition, an insufficient gain of body weight, increase in intracranial pressure was noted.

Do not use drug in ophthalmologic practice. It is impossible to allow hits of medicine in eyes, and also it is not necessary to apply cream on skin around eyes as at the same time development of glaucoma, cataract, fungal infections of eyes and an aggravation of a herpes infection is possible.

At emergence of irritation of skin or emergence of signs of hypersensitivity in connection with cream use treatment the patient should stop and pick up adequate therapy. Use of cream under occlusive bandages and prolonged use of drug on face skin as strengthening of side effect is possible is not recommended. Cream is not applied to treatment of varicose ulcers.
In case of prolonged use of medicine when using occlusive bandages, and at treatment of a big body surface, especially at children, system side effects from endocrine system are possible. These side reactions develop exclusively seldom, have reversible character and disappear right after medicine phase-out. Regular control of function гипоталамо - pituitary and adrenal system is necessary for such patients during use of cream. At emergence of symptoms of oppression of function гипоталамо - pituitary and adrenal system it is necessary to cancel drug or to increase intervals between cream applications.
Use of local steroids for treatment of psoriasis can lead in certain cases to a disease recurrence, tolerance development, to increase risk of generalized pustulous psoriasis and to development local or system (reversible oppression гипоталамо - pituitary and adrenal system) toxicity, in connection with the lowered barrier function of skin. Therefore at treatment of psoriasis drug careful observation of the patient is important.

Some body parts, such as axillary hollows, inguinal folds (where there is natural occlusion), are more subject to risk of emergence of extensions. Therefore use of drug on these sites has to be short. In case of development of fungal or bacterial superinfection of skin additional use of antifungal or antibacterial agent is necessary.
Use of cream on a pilar part of the head is not recommended.
Ability to influence speed of response at control of motor transport or work with other mechanisms.

Usually drug does not influence the speed of response of the patient at control of motor transport or other mechanisms.

Side effects:

From skin: a hyperemia, an itch, a burning sensation, irritation, dryness, hypersensitivity, thinning of skin, a folliculitis, a hirsutism, akneformny rashes, hypopigmentation, perioral dermatitis, an erythema of the person and a teleangiectasia, the increased sweating, formation of extensions, allergic contact dermatitis, an intertrigo, consecutive infections, delay of healing of wounds, a skin atrophy, delay of reactions at skin tests, contact eczema, steroid eels, a purpura.

Depending on amount of the substance which came to a system blood stream system effects are possible.

System manifestations: at certain patients development of system side effects is possible: suppression of function of bark of adrenal glands, decrease in tolerance to carbohydrates, an Icenco-Cushing syndrome; at children oppression of function of bark of adrenal glands can arise more often, and is shown by a growth inhibition, increase in intracranial pressure, a body degrowth, decrease in level of cortisol in a blood plasma and urine, lack of the response to stimulation of adrenocorticotropic hormone, displays of intracranial hypertensia (protrusion of a fontanel, a headache and bilateral hypostasis of an optic nerve).

Interaction with other medicines:

Glucocorticosteroid drugs of systemic action strengthen effects of Fokort®-Darnitsa cream. Combined use with germicides of topical administration promotes prevention of consecutive infection at prolonged use of drug.

Contraindications:

Hypersensitivity to Triamcinolonum to acetonide or to drug excipients. Tuberculosis, virus damages of skin, especially at a herpes simplex and chicken pox, skin displays of syphilis, skin reactions after vaccination, the pereanalny and genital itch extended blyashechny psoriasis, a varicose phlebectasia, shin ulcers; damages of face skin (pink eels, vulgar eels, perioral dermatitis); the skin intertrigo caused by wet diapers; use as monotherapy without performing specific treatment at fungal and bacterial skin infections. Carcinoma cutaneum.

Overdose:

Depending on quantity of the corticosteroid which came to an organism development of both local, and system side reactions is possible. At overdose of drug it is impossible to stop sharply treatment – it is done gradually, reducing a drug dose. At development of symptoms of insufficiency of bark of adrenal glands introduction of a hydrocortisone can be required.

Storage conditions:

Period of validity. 2 years. To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

On 15 g in a tuba; on 1 tuba in a pack.