Sinaphlan forte-darnitsa

INSTRUCTIONS for medical use of the medicinal product Synaflan Forte-Darnitsia (Synaflan Forte-Darnitsia)

Composition:

Active substance: fluocinolone acetonide;

1 g of cream contains fluocinolone acetonide 1 mg;

Excipients: methyl p-hydroxybenzoate (E 218), propylene glycol, white soft paraffin, mineral oil, paraffin, cetostearyl alcohol (type A) emulsifying, disodium edetate, purified water.

Pharmaceutical form. Cream.

Main physicochemical properties: homogeneous white cream.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Simple corticosteroid preparations. Potent corticosteroids (group III). Fluocinolone acetonide.

ATC code D07AC04.

Pharmacological properties.

Pharmacodynamics.

Synaflan Forte-Darnytsia contains a synthetic fluorinated corticosteroid for topical use. Its mechanism of action involves reduction of inflammatory processes by inhibiting the production of prostaglandins and leukotrienes due to suppression of phospholipase A2 activity and decreased release of arachidonic acid from cell membrane phospholipids.

Glucocorticosteroids inhibit the release of cytokines (interleukins 1 and 2, and gamma-interferon) from lymphocytes and macrophages, suppress the release of inflammatory mediators from eosinophils, and reduce the metabolism of arachidonic acid. They decrease vascular permeability and inhibit phagocytosis.

The antiallergic effect is due to suppression of local allergic reactions. Due to its local vasoconstrictive action, the drug reduces protein synthesis, collagen deposition, accelerates protein breakdown in the skin, and inhibits proliferative processes. It also suppresses normal cell division; therefore, it is used in the treatment of keloids and psoriasis.

By stimulating steroid receptors, the drug promotes the formation of lipocortin proteins, which possess anti-edematous activity.

Fluocinolone acetonide has pronounced anti-inflammatory, antiallergic, anti-exudative, and antipruritic effects. Even at low concentrations, it rapidly exerts anti-inflammatory and antipruritic actions.

Pharmacokinetics.

Fluocinolone acetonide readily penetrates the skin through its outer keratinized layer.

Absorption of fluocinolone acetonide through the skin is enhanced when applied to sensitive skin areas such as skin folds, facial skin, and areas with damaged epidermis or inflammatory processes. The use of occlusive dressings increases skin temperature and humidity, which also enhances the absorption of fluocinolone acetonide. In addition, absorption is increased with frequent application of the drug and over large skin surface areas.

Skin absorption is higher in children than in adults.

After absorption (absorption not exceeding 1%) through the skin, the drug is predominantly metabolized in the liver.

Minimal absorption of the drug does not produce systemic effects and does not suppress adrenal cortex function. However, the use of occlusive dressings significantly increases bioavailability, potentially leading to the development of systemic resorptive effects typical of fluorinated glucocorticosteroids.

The drug is excreted in urine and to a minor extent in bile, mainly as glucuronide conjugates and in unchanged form.

Clinical characteristics.

Indications.

Short-term local treatment of acute and severe non-infectious skin diseases (dry forms), scalp psoriasis, seborrheic dermatitis, lichen planus.

Contraindications.

Hypersensitivity to the active substance or to other components of the medicinal product; infectious skin diseases (bacterial, viral, fungal), including cutaneous manifestations of syphilis, cutaneous tuberculosis, pyoderma, varicella, herpes, actinomycosis, blastomycosis, sporotrichosis; rosacea and common acne; diaper dermatitis; perioral dermatitis; perianal and genital pruritus; skin neoplasms, skin tumors; nevus; atheroma; hemangioma; xanthoma; wounds and ulcerative skin lesions, wounds at application sites; numerous psoriatic plaques, leg trophic ulcers associated with varicose vein enlargement; erosive-ulcerative lesions of the gastrointestinal tract. Do not use after prophylactic vaccinations.

Interaction with other medicinal products and other types of interactions.

The medicinal product may be used concomitantly with topical or systemic antimicrobial agents.

Concomitant use with systemic glucocorticosteroids increases the efficacy of Synaflan Forte-Darnitsia, but also increases the likelihood of adverse effects.

Concomitant use of the medicinal product with non-steroidal anti-inflammatory agents increases the risk of developing systemic and local adverse effects.

Synaflan Forte-Darnitsia may enhance the effect of immunosuppressive medicinal products and suppress the effect of immunostimulating, antihypertensive, diuretic, antiarrhythmic medicinal products, and potassium preparations.

Diuretic medicinal products (except potassium-sparing diuretics) increase the risk of hypokalemia.

Minimal absorption of Synaflan Forte-Darnitsia following topical application does not cause interactions with other medicinal products.

During treatment with this medicinal product, vaccination against smallpox and other types of immunization (especially during prolonged use over large skin areas) are not recommended due to the possible lack of an adequate immunological response, such as production of specific antibodies.

Special precautions for use.

Treatment should be carried out under medical supervision.

The medicinal product should be used only in short courses (do not use continuously for more than 10 days) and on small areas of skin. Prolonged use on large skin areas increases the frequency of adverse effects and the risk of developing edema, arterial hypertension, hyperglycemia, and reduced resistance.

Before each reapplication, residual amounts of the previous dose should be washed off with warm soapy water or an antiseptic solution. Loose-fitting clothing is recommended during treatment.

Use with caution on body areas with thin skin (face, groin, axillae), as increased absorption and a high risk of adverse effects (telangiectasias, perioral dermatitis) are possible, even after short-term use.

Do not apply to the skin of the mammary glands.

Do not use the cream simultaneously with other topical medicinal products.

Avoid contact of the medicinal product with the eyes.

If skin irritation occurs at the site of cream application, discontinue use.

If infection develops at the site of cream application, appropriate antibacterial or antifungal treatment should be administered.

With topical application of the medicinal product, the following may occur: reduced production of adrenocorticotropic hormone by the pituitary due to suppression of the hypothalamic-pituitary-adrenal axis, decreased blood cortisol levels, and development of iatrogenic Cushing's syndrome, which resolves after discontinuation of the medicinal product.

Periodic monitoring of adrenal cortex function should be performed by measuring cortisol levels in blood and urine, and by ACTH stimulation test during prolonged therapy.

Use the medicinal product with caution in patients with psoriasis, as topical application of glucocorticosteroids to psoriatic lesions may lead to exacerbation of relapse due to development of tolerance, risk of generalized pustular psoriasis, and systemic toxicity caused by skin dysfunction.

Use the medicinal product with caution in the presence of subcutaneous atrophy, especially in elderly patients.

Avoid applying the medicinal product to the eyelids or periorbital skin in patients with closed-angle or open-angle glaucoma, as well as in patients with cataracts, due to the potential worsening of disease symptoms.

Vaccination against smallpox and other types of immunization are not recommended during treatment.

Local adverse reactions have been observed with topical corticosteroids, which may also occur with the use of fluocinolone acetonide.

The medicinal product contains parahydroxybenzoates, which may cause allergic reactions (possibly delayed).

The medicinal product contains propylene glycol, which may cause skin irritation.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy or breastfeeding.

Ability to influence reaction rate when driving or operating machinery.

The medicinal product does not impair mental or motor performance, or the ability to drive vehicles or operate machinery.

Method of administration and dosage.

The medicinal product is intended for topical use.

Adults and children aged 16 years and older: apply the medicinal product 1–2 times daily as a thin layer to the affected area, gently rubbing it into the skin. The maximum duration of treatment should not exceed 10 days; on the facial skin, no longer than 1 week.

Use with caution, under physician supervision, in children aged 16 years and older—only once daily and on a small skin area; do not apply to the child’s facial skin.

During one week, no more than 15 g of cream (1 tube) is recommended for use.

The medicinal product should not be used under occlusive dressings. Only in the case of psoriasis may a closed dressing be used, which should be changed daily.

Children.

The medicinal product must not be used in children under 16 years of age.

Overdose.

With prolonged use over large skin areas, systemic signs of overdose may occur, manifested by an increase in adverse effects.

Symptoms: edema, arterial hypertension, hyperglycemia, glucosuria, increased susceptibility to infections, and in severe cases—Cushing's syndrome; local symptoms include itching and burning of the skin at the site of application.

Treatment: discontinue the medicinal product; symptomatic therapy.

Adverse Reactions.

Ocular side effects: When applied topically to the skin of the eyelids, cataract or glaucoma may occasionally develop.

Immune system side effects: Allergic reactions or hypersensitivity reactions are possible, including maculopapular rash, urticaria, and secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of infection, development of opportunistic infections).

Skin and subcutaneous tissue side effects: Burning, skin itching, dermatitis (including contact and perioral dermatitis), worsening of eczema (rebound phenomenon), inflammation of hair follicles, steroid acne, striae, skin irritation and dryness, maceration of the skin, folliculitis; with prolonged use – skin atrophy and impaired skin integrity, atrophy of subcutaneous tissue, atrophic streaks, suppression of epidermal growth, local hirsutism, hypertrichosis, telangiectasia, post-steroid purpura, disturbances in skin pigmentation, alopecia (especially in women). Exacerbation of pre-existing skin disorders is possible.

General disorders and site injection reactions: Local adverse reactions may occur with topical application.

Systemic adverse effects with prolonged use over large skin areas: Edema, arterial hypertension, development or exacerbation of chronic gastritis, steroid-induced gastric ulcer, steroid-induced diabetes mellitus, hyperglycemia, glucosuria, delayed wound healing, adrenal insufficiency, growth and developmental retardation in children, Cushing's syndrome.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

15 g in tubes; 1 tube per carton.

Prescription status. Prescription only.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address and place of business.

13, Borispilska Street, Kyiv, 02093, Ukraine.