Sinaphlan

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SINAFLAN

Composition:

Active substance: fluocinolone acetonide;

1 g of ointment contains fluocinolone acetonide 0.25 mg;

Excipients: propylene glycol, paraffin, lanolin, ceresin.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: ointment ranging from light yellow to yellow in color.

Pharmacotherapeutic group. Corticosteroids for dermatological use.

ATC code D07AC04.

Pharmacological Properties

Pharmacodynamics. The active ingredient is a synthetic fluorinated glucocorticosteroid for topical use – fluocinolone acetonide. The drug exerts anti-inflammatory, antiallergic, anti-exudative, and antipruritic effects. It reduces and eliminates inflammatory skin reactions. It inhibits accumulation of macrophages and leukocytes at the site of inflammation, suppresses the formation of T- and B-lymphocytes, disrupts their interaction, reduces vascular-tissue permeability, thereby preventing the development of inflammatory edema. It also suppresses phagocytosis and the release of microsomal enzymes and inflammatory mediators.

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 areas of skin, such as skin folds and facial skin, as well as to skin with damaged epidermis or inflammatory processes. The use of occlusive dressings increases skin temperature and moisture, which also enhances absorption of fluocinolone acetonide. Furthermore, absorption is increased with frequent application of the drug and over large skin areas. Skin absorption is higher in adolescents than in adults. The drug is metabolized primarily in the liver. Minimal absorption does not produce systemic effects and does not suppress adrenal cortex function. However, the use of occlusive dressings substantially increases bioavailability, potentially leading to the development of generalized resorptive effects typical of fluorinated glucocorticosteroids.

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

Clinical characteristics.

Indications.

Allergic and inflammatory skin diseases of non-microbial etiology (seborrheic dermatitis, eczema of various origins and localizations, psoriasis).

Contraindications.

Individual hypersensitivity to any component of the medicinal product.

Confirmed hypersensitivity to other glucocorticosteroids, numerous psoriatic plaques, perianal and genital pruritus, thrombophlebitis, common acne. Bacterial, viral, fungal infections. Anogenital pruritus, perioral dermatitis, pyoderma, varicella, herpes, actinomycosis, blastomycosis, sporotrichosis, skin tumors. Infectious skin diseases, cutaneous manifestations of syphilis, cutaneous tuberculosis, diaper dermatitis, rosacea; trophic ulcers associated with varicose vein enlargement; erosive-ulcerative lesions of the gastrointestinal tract, wounds at application sites, skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma. Do not use after vaccination. The drug should not be applied to large areas of skin, especially to chronic non-healing wounds such as deep burn wounds. Not for ophthalmological use.

Interaction with other medicinal products and other types of interactions.

Systemic-acting glucocorticosteroid drugs enhance the efficacy of the medicinal product, but simultaneously increase the likelihood of adverse effects. Concomitant use with nonsteroidal anti-inflammatory agents increases the risk of systemic and local adverse effects. The drug may be used in combination with antimicrobial medicinal products of local or systemic action. Reduces the activity of antihypertensive, diuretic, antiarrhythmic drugs, and potassium supplements. Diuretic drugs (except potassium-sparing diuretics) increase the risk of hypokalemia. The drug may potentiate the effects of immunosuppressive agents and suppress the effects of immunostimulating agents.

During treatment, vaccination against smallpox and other types of immunization should not be performed (especially during prolonged use on large skin areas) due to the possible lack of an adequate immunological response in the form of production of specific antibodies.

Special precautions for use.

Treatment should be carried out under medical supervision.

Before each reapplication, any residue of the ointment from the previous application should be washed off with a soap solution or an antiseptic solution.

Do not use concomitantly with other topical medicinal products. Use only in short courses and on limited areas of skin. The medicinal product should not be applied to the face. Avoid contact with eyes. During treatment, it is recommended to wear loose-fitting clothing. For the treatment of skin disorders associated with infection, it is recommended to prescribe the drug in combination with antimicrobial agents. If signs of infection do not resolve, the use of the drug should be discontinued during the period of infection treatment.

When occlusive dressings are used, increased bioavailability may lead to systemic absorption effects typical of glucocorticoids. With topical application of the drug, the following may occur: reduced production of adrenocorticotropic hormone by the pituitary due to suppression of the "adrenal glands–pituitary" system, decreased blood cortisol levels, and development of iatrogenic Cushing's syndrome, which resolves after discontinuation of the drug. Periodic monitoring of adrenal gland function by measuring cortisol levels in blood and urine after adrenal stimulation with adrenocorticotropic hormone is recommended during prolonged use. Do not use continuously for longer than 2 weeks. Prolonged use over large skin areas increases the frequency of adverse effects and the risk of developing edema, arterial hypertension, hyperglycemia, and reduced body resistance.

The drug should be used with caution in patients with psoriasis, as local application of glucocorticoids to psoriatic lesions may lead to disease spread, recurrence due to development of tolerance, generalized pustular psoriasis, and systemic toxicity caused by skin dysfunction.

If infection develops at the site of application, treatment should be discontinued and appropriate antibacterial or antifungal therapy initiated.

Avoid applying the ointment to the eyelids or periorbital skin in patients with closed-angle and open-angle glaucoma, as well as in patients with cataracts, due to the possibility of worsening symptoms. Visual disturbances may occur during systemic and topical corticosteroid use. If symptoms such as blurred vision or other visual disturbances occur, patients should consult an ophthalmologist to evaluate possible causes, including cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported with systemic and topical corticosteroid use.

The drug should be used on facial and groin areas only if absolutely necessary, as increased absorption and adverse effects (e.g., telangiectasia, perioral dermatitis) may occur even after short-term use.

Use with caution in patients with subcutaneous tissue atrophy, particularly elderly patients.

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

Do not apply to the skin of the breasts.

The drug should be discontinued in patients who develop symptoms of irritation, allergy (itching, burning, redness), or superinfection.

Avoid contact of the ointment with mucous membranes, application over large skin areas, use under occlusive dressings, and avoid use in children. Compared to adults, children may absorb a proportionally larger amount of topical corticosteroid and are therefore more susceptible to systemic adverse effects. This is due to children having an underdeveloped skin barrier and a larger skin surface area relative to body mass compared to adults.

Since the medicinal product contains propylene glycol, skin irritation may occur upon use.

Lanolin contained in the medicinal product may cause local reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding. The medicinal product should not be used during pregnancy or breastfeeding.

Ability to affect reaction speed when driving or operating machinery. No effect.

Method of Administration and Dosage.

The medicinal product is intended for topical use only. Apply a small amount of the ointment once or twice daily and gently rub in. The duration of treatment depends on the nature of the disease and usually lasts 5–10 days; in cases of prolonged course of the disease, treatment should not exceed 2 weeks. In children aged 2 years and older, use with caution once daily under medical supervision. Do not apply the ointment under occlusive dressing—except in psoriasis, when the drug may be used under an occlusive dressing, which should be changed daily. Do not apply to facial skin for longer than 1 day. The ointment is primarily recommended for dry forms of dermatoses. The duration of treatment in children should not exceed 5 days.

Children. Use the medicinal product in children aged 2 years and older with caution, under medical supervision, once daily, only on small areas of skin; do not apply to the child's facial skin.

Overdose.

With prolonged use over large areas of skin, symptoms of overdose may occur, manifested by an increase in adverse effects (edema, arterial hypertension, decreased resistance to infections). Possible pruritus, burning sensation at the site of ointment application, hyperglycemia, glucosuria, and Cushing's syndrome. Treatment is symptomatic, with gradual discontinuation of the drug.

Adverse Reactions.

Skin and subcutaneous tissue disorders. Rash, acneiform lesions. Suppression of epidermal growth. Atrophy of subcutaneous tissue. Exacerbation of pre-existing skin disorders, urticaria, allergic contact dermatitis, skin irritation, atrophic striae, maculopapular rash, skin maceration at application sites, skin integrity impairment, hyperkeratosis, perioral dermatitis, furunculosis. Secondary infectious skin lesions and atrophic changes in the skin (burning sensation, pruritus, dry skin, steroid acne, folliculitis) may develop. With prolonged use, skin atrophy, local hirsutism, telangiectasia, purpura, pigmentary disturbances, depigmentation, hyperpigmentation, acneiform eruptions, exacerbation of eczema, purpura (including steroid-induced), hypertrichosis, alopecia (especially in women) are possible.

Gastrointestinal disorders. When applied to large areas of skin, gastritis and steroid-induced peptic ulcer may occur.

Endocrine system disorders. Hyperglycemia. When applied to large skin areas, systemic effects are possible: adrenal insufficiency, Cushing's syndrome, steroid-induced diabetes mellitus, glucosuria, and disturbances of the hypothalamic-pituitary-adrenal axis.

Immune system disorders. Hypersensitivity reactions, decreased body immunity. With prolonged use, secondary immunodeficiency (exacerbation of chronic infections, generalization of infectious processes, development of opportunistic infections) and delayed reparative processes are possible.

Cardiovascular system disorders. Arterial hypertension, possible development of edema.

Eye disorders. Cataract or glaucoma. Possible visual clouding (see section "Special Instructions").

Shelf life. 24 months.

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

Storage conditions. Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

15 g in a tube.

Prescription status. Prescription only.

Manufacturer.

LLC "FZ "STADA".

Manufacturer's location and address of operations.

37, Kyivska St., Bila Tserkva, Kyiv Oblast, 09100, Ukraine.