Fokort®-darnitsa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FOCORT®-DARNITSA (FOCORT-DARNITSA)

Composition:

Active substance: triamcinolone;

1 g of cream contains micronized triamcinolone acetonide 1 mg;

Excipients: cetylpyridinium chloride, propylene glycol, soft white paraffin, liquid paraffin, hard paraffin, cetearyl alcohol, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: white homogeneous cream.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Triamcinolone. ATC code D07AB09.

Pharmacological properties.

Pharmacodynamics.

The active ingredient of the cream is triamcinolone acetonide – a fluorinated glucocorticosteroid that, when applied topically, exhibits anti-inflammatory, antiallergic, and antipruritic effects.

The pharmacological action of glucocorticosteroids is based on the regulation of synthesis of specific proteins in the body and ensuring the body's adaptation to stressful situations through reduced glucose utilization and enhanced gluconeogenesis. They promote glycogen deposition, primarily in the liver, by enhancing insulin secretion under conditions of hyperglycemia. They reduce protein synthesis and enhance catabolism of proteins in muscle, skin, and bone tissues; promote lipolysis. They constrict blood vessels, reduce their permeability, and decrease tissue edema.

Numerous glucocorticosteroid receptors are also present in brain and heart tissues. Glucocorticosteroids enhance β-adrenergic responses in the lungs, promote bronchodilation, and reduce pulmonary vascular resistance.

In high doses, they suppress corticotropin secretion; in adrenal corticosteroid insufficiency, they enhance glomerular filtration and diuresis; may cause ulceration of mucous membranes. In larger doses, they exhibit antiallergic and anti-inflammatory properties.

Esterification of the glucocorticosteroid molecule with fatty acids at the 17 and 21 positions significantly enhances its effect on the skin. The presence of a cyclic acetonide group at the 16 and 17 positions enhances the local anti-inflammatory effect without affecting the systemic glucocorticosteroid activity. Fluorine further increases the local activity of the drug.

Pharmacokinetics.

Triamcinolone readily penetrates into the deeper layers of the skin and is partially absorbed into the bloodstream. When an occlusive dressing is applied to affected skin areas, it is absorbed in amounts sufficient to produce a systemic effect. Glucocorticosteroids are rapidly distributed in body tissues. The main metabolite of triamcinolone – 6-β-hydroxytriamcinolone – is excreted by the liver, kidneys, feces, and urine in equal proportions. The plasma elimination half-life is approximately 5 hours, while the terminal half-life is 18–36 hours.

Clinical characteristics.

Indications.

Skin diseases in which corticosteroid treatment is indicated (eczema, vulgar psoriasis, allergic dermatitis).

Contraindications.

Hypersensitivity to triamcinolone acetonide or to excipients of the medicinal product. The drug must not be applied to the eyes or to skin areas near the eyes. Tuberculosis, viral skin infections, particularly herpes simplex and varicella; parasitic skin infections (scabies), cutaneous manifestations of syphilis, skin reactions following vaccination, perianal and genital pruritus, generalized plaque psoriasis, varicose veins, leg ulcers; facial skin lesions (rosacea, vulgar acne, perioral dermatitis); skin intertrigo caused by wet diapers; use as monotherapy without concomitant specific treatment in fungal and bacterial skin infections, treatment of dry desquamation of the skin, skin cancer, children under 1 year of age. Do not apply the ointment to the breasts immediately before breastfeeding.

Interaction with other medicinal products and other types of interactions.

With topical application of corticosteroids, interactions with other medicinal products are unknown.

Special precautions for use.

If skin irritation occurs, discontinue use of Fokort®-Darnytsia cream and continue treatment with another medicinal product.

When using occlusive dressings or treating large body surface areas, systemic effects of the drug may occur; in such cases, particular caution is required, especially in children.

During application of the cream, microorganisms present on the skin (primarily pyogenic microorganisms, sometimes budding yeast fungi) may penetrate through the loosened stratum corneum and cause various pyodermas, which should be treated with washable disinfectants. Fungal infections are possible; occasionally, under occlusive dressings, bruising may appear. Prolonged use of the cream on the same skin area, especially in young patients, may lead to atrophy of that skin area.

Certain body areas, such as axillae and inguinal folds (where natural occlusion exists and the skin is more delicate and thinner), are more prone to development of striae and easily noticeable, irreversible skin atrophy. Therefore, application of the cream to these areas should be short-term.

If fungal or bacterial skin infection develops, additional local or systemic therapy is required.

The cream is not recommended for use on the scalp.

Prolonged use of the drug on the facial skin is not recommended due to the risk of skin atrophy. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly with plenty of running water and consult a physician.

In psoriasis treatment, withdrawal syndrome, steroid dependence, development of generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function are possible. Treatment of patients with psoriasis using topical corticosteroids is possible only under strict medical supervision.

Prescribing the cream to children over 1 year of age is possible only in exceptional cases. The duration of treatment in children should not exceed 5 days. Use of occlusive dressings in children is contraindicated.

When using the cream in children, possible signs of suppression of the hypothalamic-pituitary-adrenal (HPA) axis and Cushing's syndrome should be considered, as these occur more frequently in children than in adults due to the higher ratio of skin surface area to body weight; thus, children are more susceptible to systemic toxicity. In children treated with topical corticosteroids, acute adrenal insufficiency, Cushing's syndrome, and increased intracranial pressure have been reported.

Visual disturbances

Visual disturbances may occur with both systemic and topical use of corticosteroids. If a patient develops symptoms such as blurred vision or other visual disturbances, they should be referred to an ophthalmologist for evaluation of possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy (CSCR), which have been reported with systemic and topical corticosteroid use.

Topical steroid withdrawal syndrome

Prolonged continuous or inappropriate use of topical corticosteroids may lead to recurrent flare-ups after discontinuation of treatment (topical steroid withdrawal syndrome). A severe rebound flare may develop, presenting as dermatitis with intense redness, stinging, and burning sensations, which may extend beyond the original treatment area. Rebound flare is more likely when treating sensitive skin areas such as the face and skin folds. If recurrence occurs within days or weeks after successful treatment, withdrawal reaction should be suspected. Reinitiating treatment requires caution—consultation with a specialist or consideration of alternative therapies is recommended.

Use during pregnancy or breastfeeding.

Use of the cream during the first trimester of pregnancy is contraindicated. There is insufficient data to confirm the safety of the drug during the second and third trimesters of pregnancy. The decision regarding use of the drug during the second and third trimesters of pregnancy and during breastfeeding must be made by the physician on an individual basis, carefully weighing the expected therapeutic benefit against the potential risk to the fetus.

Breastfeeding period. Systemic absorption of glucocorticoids is associated with their passage into breast milk and potential effects on the infant's adrenal cortex function and growth.

Topical use of triamcinolone during breastfeeding is not recommended.

Application of the cream to the breasts immediately before breastfeeding is contraindicated (see section "Contraindications").

Ability to affect reaction speed when driving or operating machinery.

Currently, no reports are available. However, when driving vehicles or operating machinery, particular caution is recommended, taking into account the possibility of adverse reactions affecting the nervous system.

Method of Administration and Dosage

For external use only.

Adults: apply a thin layer of cream 2–3 times daily to the affected area of skin (maximum dose – no more than 15 g of cream per day), or apply the medicinal product under an occlusive dressing (maximum dose – no more than 10 g of cream per day).

The duration of treatment is determined individually by a physician.

Children: from 1 year of age, apply a thin layer of cream up to 2 times daily to the affected area of skin. The duration of treatment in children should not exceed 5 days. The use of occlusive dressings in children is contraindicated.

The cream may be prescribed to children only in exceptional cases.

Elderly patients: the medicinal product should be used cautiously and for short periods, bearing in mind that skin in this patient group is typically thinner.

Children.

The cream is contraindicated in children under 1 year of age.

Overdose.

Depending on the amount of corticosteroid absorbed into the body, both local and systemic adverse reactions may occur. In case of overdose, treatment should not be abruptly discontinued; instead, the dose should be gradually reduced. If symptoms of adrenal insufficiency develop, intravenous hydrocortisone may be required.

Adverse reactions.

Local adverse reactions are typical for glucocorticosteroid preparations when applied topically; however, depending on the amount of substance absorbed into systemic circulation, systemic effects are possible.

With prolonged use over large body surface areas, suppression of adrenal cortex function may occur, especially in children, as well as when occlusive dressings are used; negative nitrogen balance due to enhanced protein catabolism is also possible.

The frequency of the adverse reactions listed below is unknown, as adequate data are not available (cannot be estimated from the available data).

Infections and parasitic diseases: infection, masking of infectious disease symptoms, opportunistic infections.

Immune system disorders: hypersensitivity.

Endocrine disorders: adrenal cortex suppression (secondary adrenal insufficiency).

Metabolism and nutrition disorders: hypokalemic alkalosis, fluid and sodium retention, hypokalemia.

Psychiatric disorders: insomnia, psychiatric disturbances.

Nervous system disorders: seizures, dizziness, headache, increased intracranial pressure.

Eye disorders: cataract, subcapsular cataract, exophthalmos, glaucoma, optic disc edema, ulcerative keratitis, chorioretinopathy, blurred vision (see section "Special precautions for use").

Cardiac disorders: heart failure.

Vascular disorders: arterial hypertension.

Gastrointestinal disorders: gastric bleeding, gastrointestinal bleeding, gastrointestinal perforation, esophagitis, pancreatitis, peptic ulcer.

Skin and subcutaneous tissue disorders: dermatitis, skin burning sensation, folliculitis, acneiform eruptions, contact dermatitis, dryness and thinning of the skin, erythema, hirsutism, increased sweating, intertrigo, pruritus, skin atrophy, hypopigmentation, irritation, striae, telangiectasia. Withdrawal reactions: skin redness which may spread beyond the initial affected area, burning or prickling sensation, itching, skin desquamation, oozing pustules (see section "Special precautions for use").

Musculoskeletal and connective tissue disorders: steroid myopathy, osteoporosis, osteonecrosis, aseptic necrosis.

General disorders and administration site conditions: delayed wound healing.

Investigations: increased intraocular pressure, negative nitrogen balance, negative skin tests.

Children

Eye disorders: higher likelihood of cataract development in children.

Musculoskeletal and connective tissue disorders: growth retardation.

Reporting of suspected adverse reactions.

Reporting suspected adverse reactions after medicine registration is important. It allows ongoing monitoring of the benefit-risk balance of the medicine. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and/or lack of efficacy of the medicine via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging.

15 g in a tube; 1 tube per carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's location and address of its place of business.

13, Boryspylska Street, Kyiv, 02093, Ukraine.