SINAPHLAN OINTMENT

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SYNAFLAN OINTMENT (SYNAFLANI UNGUENTUM)

Composition:

Active substance: fluocinolone acetonide;

1 g of ointment contains fluocinolone acetonide 0.25 mg;

Excipients: propylene glycol, anhydrous lanolin, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical properties: light yellow or yellow ointment with a characteristic odour.

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

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 skin inflammatory reactions. It inhibits accumulation of macrophages and leukocytes at the site of inflammation, suppresses formation of T- and B-lymphocytes, disrupts their interaction, reduces vascular-tissue permeability, thus preventing development of inflammatory edema. It suppresses phagocytosis, 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 anatomical folds and facial areas, as well as to skin with damaged epidermis or inflammatory processes. Use of occlusive dressings increases skin temperature and moisture, which also enhances absorption of fluocinolone acetonide. In addition, absorption is increased with frequent application of the drug and when applied over large skin areas. Absorption through the skin is higher in adolescents than in adults. The drug is metabolized mainly in the liver. Minimal absorption of the drug does not produce systemic effects and does not suppress adrenal cortex function. Use of occlusive dressings substantially increases bioavailability, which may lead to development of systemic resorptive effects typical of fluorinated glucocorticosteroids.

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

Clinical characteristics.

Indications.

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

Contraindications.

Hypersensitivity to the active substance or to other glucocorticosteroids and other components of the medicinal product; skin infections (bacterial, viral, fungal), including skin manifestations of syphilis, cutaneous tuberculosis, pyoderma, varicella, herpes, actinomycosis, blastomycosis, sporotrichosis; rosacea and common acne; diaper dermatitis; perioral dermatitis; anogenital pruritus; skin neoplasms, skin tumors, including nevus, atheroma, melanoma, sarcoma, hemangioma, xanthoma; wounds and ulcerative skin lesions, wounds at application sites, trophic ulcers of the leg associated with varicose veins; numerous psoriatic plaques; erosive-ulcerative lesions of the gastrointestinal tract. Do not use after preventive vaccinations. The drug is not used in ophthalmology.

Interaction with other medicinal products and other types of interactions.

The drug may enhance the effect of immunosuppressive medicinal products and suppress the effect of immunostimulating, antihypertensive, diuretic, antiarrhythmic drugs, and potassium preparations.

The drug may be used concomitantly with antimicrobial agents of local and systemic action.

Concomitant use with systemic-acting glucocorticosteroids increases the efficacy of the drug, but also increases the risk of adverse effects.

Concomitant use of the drug with nonsteroidal anti-inflammatory agents increases the risk of systemic and local adverse effects.

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

Minimal absorption of Synalar ointment upon topical application does not lead to interactions with other drugs.

During treatment with the drug, vaccination against smallpox and other types of immunization should not be performed (especially during prolonged use over 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.

The drug should be used only in short courses (do not use continuously for more than 10 days) and applied to small skin areas only. Prolonged application over 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 ointment from previous application 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 (telangiectasia, perioral dermatitis) are possible even after short-term use.

Do not apply to the skin of the mammary glands.

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

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.

Avoid contact of the drug with the eyes.

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

If an infection develops at the application site, appropriate antibacterial or antifungal treatment should be initiated. If infection symptoms do not resolve, discontinue the drug during infection treatment.

With topical use of the drug, suppression of adrenocorticotropic hormone production by the pituitary due to inhibition of the hypothalamic-pituitary-adrenal axis, decreased blood cortisol levels, and development of iatrogenic Cushing's syndrome may occur; these effects are reversible upon discontinuation of the drug.

During prolonged use, periodic monitoring of adrenal cortex function should be performed by measuring blood and urinary cortisol levels following adrenal stimulation with adrenocorticotropic hormone.

Use the drug with special caution in patients with psoriasis, as local application of glucocorticosteroids to psoriatic lesions may lead to relapse spread due to tolerance development, generalized pustular psoriasis, and systemic toxicity caused by skin dysfunction.

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

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

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

Since the medicinal product contains lanolin, it may cause local reactions (e.g., contact dermatitis).

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy. Breastfeeding must be discontinued during treatment with this drug.

Ability to influence reaction rate while driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

The medicinal product is intended for topical use only. Apply a small amount of the drug and gently rub in 1–2 times daily. The duration of treatment is determined individually by a physician and depends on the nature of the disease, usually 5–10 days, but not longer than 2 weeks.

For children aged 2 years and older, use with caution once daily under medical supervision. The duration of treatment in children should not exceed 5 days.

The ointment should not be used under occlusive dressing; however, in the case of psoriasis, application under an occlusive dressing is permitted, which must be changed daily.

The ointment must not be applied to the facial skin for longer than 1 day.

The ointment is preferably recommended for dry forms of dermatoses.

Children.

The drug should be used with caution in children aged 2 years and older, under medical supervision, once daily, and only on a small area of skin. Do not apply the ointment to the child's facial skin.

Overdose.

Prolonged use over large areas of skin may lead to symptoms of overdose, 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: symptomatic treatment along with gradual discontinuation of the drug.

Side effects.

Skin and subcutaneous tissue disorders: urticaria, allergic contact dermatitis, skin irritation, atrophic striae, maculopapular rash, skin maceration at the application site, impairment of skin integrity, hyperkeratosis, perioral dermatitis, furunculosis. Secondary infectious skin lesions and atrophic changes in the skin (burning, itching, dryness, steroid acne, folliculitis) may develop. With prolonged use, skin atrophy, local hirsutism, telangiectasias, exacerbation of eczema, purpura, pigmentary disturbances, hypertrichosis, alopecia (especially in women) are possible.

Eye disorders: possible blurred vision; cataract or glaucoma.

Gastrointestinal disorders: when applied to large skin areas, gastritis and steroid-induced peptic ulcer of the stomach are possible.

Endocrine system disorders: hyperglycemia. When applied to large skin areas, systemic effects are possible: adrenal insufficiency, growth and developmental suppression in children, Cushing's syndrome, steroid diabetes.

Immune system disorders: reduced resistance of the body. With prolonged use: secondary immunodeficiency (exacerbation of chronic infections, generalization of infectious processes, development of opportunistic infections), delayed reparative processes.

Cardiovascular system disorders: arterial hypertension, possible development of edema.

Shelf life. 5 years.

Storage conditions.

Store at a temperature not exceeding 25°C, in a place inaccessible to children.

Packaging.

10 g or 15 g in a tube; 1 tube per carton.

Prescription status.

Prescription only.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4, Korolyova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.