Sinoderm (Ointment, Cream, Gel) Instructions for Use

ATC Code

D07AC04 (Fluocinolone acetonide)

Active Substance

Fluocinolone acetonide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Topical corticosteroids for external use

Pharmacotherapeutic Group

Topical glucocorticosteroid

Pharmacological Action

A topical glucocorticosteroid; it inhibits the release of inflammatory mediators. When applied to the skin, it prevents the marginal accumulation of neutrophils, leading to a reduction in inflammatory exudate and cytokine production; it inhibits macrophage migration and reduces infiltration and granulation processes.

It has anti-inflammatory, anti-allergic, anti-exudative, and antipruritic effects. It reduces or eliminates inflammatory skin reactions.

Pharmacokinetics

Fluocinolone acetonide easily penetrates the stratum corneum of the epidermis upon topical application, does not undergo biotransformation, and accumulates.

Absorption of fluocinolone is enhanced when applied to thin skin in the fold areas or on the face, as well as on areas with damaged epidermis or skin affected by an inflammatory process.

When using an occlusive dressing, frequent application, or application to a large skin surface, the percutaneous absorption of fluocinolone increases. In children, the absorption of fluocinolone through the skin is more pronounced than in adults.

It is metabolized in the liver to form inactive metabolites. It is excreted by the kidneys and, to a lesser extent, through the intestines with bile, mainly as compounds with glucuronic acid, and also in small amounts unchanged.

Indications

Acute and chronic inflammatory and allergic skin diseases of non-microbial etiology, sensitive to glucocorticosteroids, including seborrheic dermatitis, atopic dermatitis, eczema of various origins and locations, skin itching, psoriasis; sunburns; insect bites.

ICD codes

Dosage Regimen

Apply a thin layer of the ointment, cream, or gel to the affected skin areas one to three times daily.

The frequency of application depends on the severity of the condition and the specific dosage form used.

Limit the duration of treatment to the shortest period necessary to achieve therapeutic control.

For adult patients, apply the minimum amount required to cover the affected area.

In pediatric patients over 2 years of age, use only under direct medical supervision.

Restrict application in children to small skin areas and limit the treatment course to a maximum of five days.

Avoid application to the face, intertriginous areas, or under occlusive dressings unless specifically directed by a physician.

Discontinue treatment gradually after prolonged use to prevent a rebound effect.

Do not apply to large body surface areas, broken skin, or open wounds due to increased risk of systemic absorption.

Monitor for signs of skin atrophy or adrenal suppression during extended therapy.

If no clinical improvement is observed within a reasonable period, re-evaluate the diagnosis.

Adverse Reactions

Possibleburning, skin itching, dry skin, steroid acne, folliculitis; development of secondary infectious skin lesions and atrophic changes in the skin.

With long-term use — secondary immunodeficiency, hypertrichosis, alopecia (especially in women), skin atrophy, hirsutism, telangiectasias, purpura, pigmentation disorders.

When applied to large surfaces, systemic manifestations are possible ( gastritis, steroid gastric ulcer, adrenal insufficiency, Cushing’s syndrome, steroid diabetes, striae, slowing of reparative processes); with topical use of glucocorticosteroids, systemic reactions such as blurred vision have been noted. When applied to the skin of the eyelids, the development of glaucoma or cataract is possible; rarely – central serous chorioretinopathy.

Contraindications

Hypersensitivity to fluocinolone acetonide or other glucocorticosteroids; bacterial, fungal, and viral infections, skin manifestations of syphilis, acne, rosacea, perioral dermatitis, anogenital itching, skin tuberculosis, skin cancer, burns, wounds, trophic leg ulcers; post-vaccination reactions; pregnancy, breastfeeding; children under 2 years of age.

With caution

Application to large areas of skin, damaged skin, use of large doses, long-term therapy (especially in children over 2 years of age); application to the skin of the face, areas with thin skin and intertriginous skin (skin folds, armpits, groin area, bends of arms and legs); application to the skin around the eyes or eyelids (risk of developing glaucoma, cataract), including in patients with glaucoma or cataract. Atrophic changes in the subcutaneous tissue, especially in the elderly. Use in girls during puberty.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding). If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided. It is not recommended to apply the product to the skin of the mammary glands.

Pediatric Use

Contraindicated for use in children under 2 years of age. In children over 2 years of age, it should be used with caution, under medical supervision, with minimal effective doses, on small areas of the skin, in short courses (no more than 5 days); it should not be applied to the skin of the face. It should be used with caution in girls during puberty.

Geriatric Use

Should be prescribed with caution to elderly patients due to atrophic changes in the subcutaneous tissue in this category of patients.

Special Precautions

Fluocinolone acetonide is recommended to be used in short courses on small areas of the skin. With long-term use and/or application to large skin surfaces, damaged skin, when using large doses, when using occlusive dressings, and during therapy in children, systemic absorption of fluocinolone acetonide is possible; suppression of the hypothalamic-pituitary-adrenal system function and the development of symptoms of hypercortisolism are possible.

On the skin of the face, more often than on other body surfaces, atrophic changes may appear after long-term topical use of glucocorticosteroids.

During long-term therapy with glucocorticosteroids, sudden discontinuation of therapy may lead to the development of a “rebound syndrome”, manifested in the form of dermatitis with intense skin redness and a burning sensation. Therefore, after long-term treatment, discontinuation of fluocinolone acetonide should be carried out gradually, for example, by switching to an intermittent treatment regimen before completely stopping it.

During therapy with fluocinolone acetonide, periodic monitoring of adrenal cortex function is necessary, with determination of cortisol levels in the blood and urine after adrenal stimulation with ACTH.

In patients with common or rosacea acne, exacerbation of the disease is possible during therapy with fluocinolone acetonide. To prevent local infectious complications, it is recommended to prescribe it in combination with antimicrobial agents.

If during the use of fluocinolone acetonide the patient experiences symptoms such as blurred vision or other visual disturbances, an ophthalmologist consultation is recommended to determine the possible causes of the disorders, which may include cataract, glaucoma, or rare diseases such as central serous chorioretinopathy.

Fluocinolone acetonide should be used with particular caution in patients with psoriasis due to the possible relapse of the disease caused by the development of tolerance, the risk of generalized pustular psoriasis, and general toxicity due to pressure sores.

Fluocinolone acetonide is compatible with antimicrobial agents.

Use in pediatrics

Fluocinolone acetonide can be used in children over 2 years of age. It must be taken into account that in young children, skin folds, diapers, and nappies can have an effect similar to that of an occlusive dressing and increase the systemic absorption of fluocinolone acetonide. Furthermore, in children, a greater degree of systemic absorption is possible due to the ratio between body surface area and body weight, as well as due to insufficient skin maturity. Long-term use of glucocorticosteroids in children can lead to disturbances in their growth and development. Fluocinolone acetonide is used with caution in girls during puberty.

Long-term use of fluocinolone acetonide in children is possible only under medical supervision, in the minimum dose sufficient to achieve the effect. In children, the course of treatment should not exceed 5 days.

Drug Interactions

With simultaneous use, Fluocinolone acetonide reduces the activity of antihypertensive, diuretic, antiarrhythmic drugs, and potassium preparations.

With simultaneous use of diuretics (except potassium-sparing ones), the risk of hypokalemia increases.

During treatment with glucocorticosteroids, vaccination and immunization should not be carried out due to the immunosuppressive effect of these agents. Fluocinolone acetonide may enhance the effect of immunosuppressive drugs and weaken the effect of immunostimulating drugs.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.