Sinaflan 0.025% Ointment 15 g

Indications

Acute and chronic inflammatory and allergic skin diseases of non-microbial etiology, accompanied by dry skin: seborrheic dermatitis, eczema of various genesis and localization, atopic dermatitis, pruritus, psoriasis, sunburn, insect bites.

Application method and doses

For external use. Adults and children over 2 years old apply a small amount of the preparation to the skin, previously wiped with a cotton pad soaked in antiseptic solution, and gently rub in (for adults - 2-4 times a day, for children over 2 years old - once a day).
Children are prescribed with caution on small areas of skin.
For limited areas of lesions, to enhance the effect, the ointment can be applied under an occlusive dressing. It is not allowed to apply more than 2 g of ointment per day under the dressing. The duration of treatment depends on the nature of the disease and the effectiveness of therapy, usually lasting 5-10 days. In cases of persistent disease, the treatment course may be extended up to 25 days. In children, it is recommended to use the minimum effective doses for no more than 5 days.
If there is no improvement after treatment, you should consult a doctor. Use the preparation only according to the method of application and in the doses specified in the instructions. If necessary, please consult a doctor before using the medication.

Section: Composition

In 100 g of the ointment contains:
Active ingredient: fluocinolone acetonide - 0.025 g
Excipients: propylene glycol, petroleum jelly, anhydrous lanolin, ceresin.

Homogeneous ointment from light yellow to yellow in color.

Section: Contraindications

Increased sensitivity to fluocinolone acetonide or to other components of the drug; rosacea; acne; perioral dermatitis; skin infections caused by bacteria, viruses, fungi; syphilis; skin tuberculosis; post-vaccination reactions; trophic ulcers of the lower leg; anogenital itching; skin cancer; age under 2 years; pregnancy, breastfeeding period.
With caution
In girls during puberty; in children over 2 years old; in patients with atrophic skin changes, especially in elderly people; when applied to the face, folds, areas of natural bends, on areas with thin skin.
Use during pregnancy and breastfeeding
The drug is contraindicated for use during pregnancy and breastfeeding. If the drug needs to be used during breastfeeding, it is recommended to discontinue breastfeeding during the treatment period, as it is unknown to what extent fluocinolone acetonide penetrates into breast milk when applied topically. Only in exceptional cases, after consulting a doctor, the drug may be used for a short time and on limited areas of skin. It is not recommended to apply the drug on the skin of the mammary glands.

Section: Special Instructions

Use only for short courses on small areas of skin. Avoid contact of the drug with the eyes. During treatment, it is recommended to wear loose clothing. In patients with common or rosacea-like acne, exacerbation of the condition may occur during treatment. To prevent local infectious complications, it is recommended to prescribe in combination with antimicrobial agents. Use with caution in individuals with significant atrophic changes in the skin, especially in the elderly. If signs of increased sensitivity or skin irritation related to the use of the drug are observed, treatment should be discontinued and a doctor consulted. With prolonged treatment, when applying the drug to extensive areas of skin, when using occlusive dressings, as well as in children, systemic absorption of glucocorticosteroids may occur; suppression of the hypothalamic-pituitary-adrenal system function and development of symptoms of hypercortisolism are possible. On the facial skin, more often than on other body surfaces, after prolonged treatment with topical glucocorticosteroids, atrophic changes may manifest; in this case, the treatment course should not exceed 5 days.
Caution should be exercised when applying the drug to the face, folds, areas of natural flexion, and areas with thin skin. Do not apply the drug to mucous membranes. It should be noted that glucocorticosteroids can alter the manifestations of certain skin diseases, which may complicate diagnosis. Additionally, the use of glucocorticosteroids may cause delayed wound healing. With prolonged therapy with glucocorticosteroids, sudden discontinuation of therapy may lead to the development of "rebound syndrome," manifesting as dermatitis with intense redness of the skin and a burning sensation. Therefore, after prolonged treatment, the discontinuation of the drug should be done gradually, for example, transitioning to an intermittent treatment regimen before completely stopping it.
Propylene glycol and lanolin, included in the drug, may cause irritation at the application site. In such cases, the use of the drug should be discontinued.
Use in pediatrics. The drug can be used in children from 2 years of age. It should be considered that in small children, skin folds, diapers, and nappies may have an effect similar to that of an occlusive dressing, increasing systemic absorption of glucocorticosteroids. Additionally, in children, a greater degree of systemic absorption is possible due to the ratio between the surface area of the skin and body weight, as well as due to the immaturity of the skin. Prolonged treatment of children with glucocorticosteroids may lead to disturbances in their growth and development. Therefore, prolonged use of the drug should be conducted under the supervision of a physician. Children should receive the minimum dose of the drug sufficient to achieve the effect. In children, the treatment course should not exceed 5 days.
The effect of the drug on the ability to drive vehicles and operate machinery has not been studied.

Section: Side Effects

Burning, skin itching, dry skin, "steroid" acne, folliculitis. Possible development of secondary infectious skin lesions and atrophic changes in it. With prolonged use - secondary immunodeficiency, hypertrichosis, alopecia, especially in women, skin atrophy, hirsutism at the site of application, telangiectasia, purpura, pigmentation disorders.
When applied to extensive surfaces, systemic manifestations may occur (gastritis, "steroid" gastric ulcer, adrenal insufficiency, Cushing's syndrome, "steroid" diabetes mellitus, striae, delayed reparative processes).
If you experience side effects listed in the instructions, or if they worsen, or if you notice any other side effects not listed in the instructions, inform your doctor.

Section: Overdose

Acute overdose is unlikely; however, when the drug is applied to large areas of affected skin with increased absorption capacity, for an extended period, or with the use of an occlusive dressing, chronic overdose may occur, accompanied by signs of hypercorticism: hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Cushing's syndrome.
Treatment: symptomatic, if necessary, correction of water-electrolyte balance, discontinuation of the drug (in case of long-term therapy - gradual).

Interaction

Pharmacodynamic: the drug is compatible with antimicrobial medications. It reduces the activity of antihypertensive, diuretic, antiarrhythmic medications, and potassium preparations. Diuretic medications (except for potassium-sparing ones) increase the risk of developing hypokalemia. During treatment with glucocorticosteroids, vaccinations and immunizations should not be performed due to the immunosuppressive effect of the drug. It is necessary to consult a doctor if you are taking other medications.

Pharmacodynamics

Glucocorticosteroid (GCS) for external use; 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 the migration of macrophages, reduces infiltration and granulation processes. It has anti-inflammatory and anti-allergic effects.

Pharmacokinetics

After absorption from the skin surface, it binds to plasma proteins, is metabolized in the liver to form inactive metabolites. It is primarily excreted by the kidneys.