Sinaflan ointment 0.025% 10g №1

Name:
Sinaflan ointment for nar. 0.025% in tubes 10g per pack. №1
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Ointment from light yellow to yellow. The main active ingredient Fluocinolone acetonide Product form ointment Dosage 0.025% 10g Pharmacological action Glucocorticosteroid for external use. It has anti-inflammatory, antiallergic, antiexudative and antipruritic action. Reduces manifestations and eliminates the inflammatory skin reaction. Pharmacokinetics After absorption from the skin surface, it binds to plasma proteins and is metabolized in the liver to form inactive metabolites. It is excreted mainly by the kidneys. Indications for use For the short-term treatment of inflammatory and allergic skin diseases that respond to local glucocorticosteroids and proceed with persistent itching or hyperkeratosis. Anhydrous, fat-containing ointment Sinaflan is preferred for dry skin and chronic processes. Dosage and administration The drug is intended for topical use only. Apply a small amount of the drug 1-2 times a day and lightly rub. Children over 2 years of age are used with caution 1 time per day under medical supervision. The duration of treatment depends on the nature of the disease and is usually 5-10 days, with a long course of the disease – no more than 2-3 weeks. Avoid applying the drug to large (more than 20% of the body surface) lesions. Perhaps the combined use of Sinaflan ointment with non-drug ointment, while Sinaflan ointment is applied once a day 12 hours after applying the non-drug ointment. Do not apply ointment under an occlusive dressing. Children are more sensitive than adults: with topical application of glucocorticosteroids, the drug may enter the body. Therefore, Sinaflan ointment is used briefly (no more than 5 days) and with the lowest effective dose in children. In children, the drug should be used only for small areas of the skin (up to 10% of the body surface area). It is not allowed to apply ointment on the face of a child. Use during pregnancy and lactation The use of the drug during pregnancy and lactation is contraindicated. Use in children Due to the fact that the ratio of the surface / body weight in children is higher than in adults, they are at higher risk of systemic side effects of glucocorticosteroids, including dysfunction of the hypothalamic-pituitary-adrenal axis and Cushing’s syndrome. Corticosteroid therapy can have side effects on the growth and development of children. Periodic monitoring of the function of the adrenal cortex is shown by determining cortisol in the blood and in the urine after stimulation of the adrenal glands with ACTH. The use of the drug in children under the age of 2 years is contraindicated. Precautions Use the drug with caution in girls during puberty. Apply only in short courses on small areas of the skin. It is recommended to wear loose clothing during treatment. In patients with acne vulgaris or rosacea during treatment, an exacerbation of the disease is possible. To prevent local infectious complications, it is recommended to prescribe in combination with antimicrobial agents. If the drug causes symptoms of irritation or allergic skin reactions (skin itching, burning or redness), its use should be stopped immediately. With prolonged use on a large surface of the body, the frequency of manifestation of side effects and the possibility of developing edema, hypertension, hyperglycemia, and a decrease in body resistance increase. When using occlusive dressings, due to increased bioavailability, it is possible to develop general resorptive effects characteristic of GCS. With external use of the drug, the following are possible: a decrease in the production of ACTH by the pituitary gland, inhibition of the adrenal glands-pituitary gland, a decrease in the level of cortisol in the blood and the development of Itsenko-Cushing’s iatrogenic syndrome, which disappears after discontinuation of the drug. Periodic monitoring of adrenal function is shown by determining cortisol in the blood and urine after stimulation of the adrenal glands with ACTH with prolonged use. If an infection develops at the site of application of the drug, treatment should be discontinued and appropriate antibacterial or antifungal treatment should be carried out. The drug should be used with caution in the presence of subcutaneous tissue atrophy, mainly in elderly patients. Avoid getting the drug in the eyes, mucous membranes and wounds. Do not use on breast skin. Use with extreme caution in the treatment of patients with psoriasis, since topical use of glucocorticosteroids in psoriasis can be dangerous due to recurrence of the disease caused by the development of drug resistance, the risk of generalized pustular psoriasis and systemic toxicity caused by skin dysfunction. On the skin of the face, as well as on the skin of the groin and armpits, apply only in cases of special need, taking into account the increased absorption and the high risk of side effects (telangiectasia, oral dermatitis), even after short-term use. During treatment, it is not recommended to vaccinate against smallpox, as well as to carry out other types of immunization (especially with prolonged use on large areas of the skin) due to the possible lack of an adequate immunological response in the form of the production of appropriate antibodies. Contains lanolin. May cause local skin reactions (eg contact dermatitis). Contains propylene glycol. May cause skin irritation. When using the ointment in the genital or anal area, due to the Vaseline excipient, a decrease in strength and rupture of latex condoms may occur. Interaction with other drugs Compatible with antimicrobial drugs. Reduces the activity of antihypertensive, diuretic, antiarrhythmic drugs, potassium preparations. Diuretic drugs (other than potassium-sparing ones) increase the risk of hypokalemia. Contraindications Hypersensitivity to the components of the drug; bacterial, viral, fungal skin diseases – pyoderma, chicken pox, herpes, actinomycosis, blastomycosis, sporotrichosis; skin manifestations of syphilis, skin tuberculosis, diaper rash, rosacea, extensive psoriatic rashes (plaques), anogenital itching; trophic ulcers of the lower leg associated with varicose veins, erosive and ulcerative lesions of the gastrointestinal tract, wounds at the application sites; skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma; pregnancy and lactation, children’s age (up to 2 years). Composition 1 g of ointment contains: active ingredient: fluocinolone acetonide – 0.25 mg, excipients: propylene glycol – 49.75 mg, ceresin – 50.00 mg, lanolin – 50.00 mg, vaseline – up to 1.0 g. itching, burning of the skin at the site of application of the drug, gynerglycemia, glucosuria, Itsenko-Cushing’s syndrome. Treatment: symptomatic against the background of the gradual withdrawal of the drug. Side effect Evaluation of undesirable effects is based on the following data on the frequency of occurrence: very often (? 1/10), often (? 1/100 to < 1/10), infrequently (? 1/1000 to < 1/100), rarely (? 1/10000 to < 1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). On the part of the skin and subcutaneous tissue: Infrequently: urticaria, allergic contact dermatitis, skin irritation, striae (band-like skin atrophy), maculopapular rash, skin maceration at the application site, perioral dermatitis, furunculosis. It is possible to develop secondary infectious skin lesions and atrophic changes in it (burning, itching, dry skin, steroid acne, folliculitis). With prolonged use, skin atrophy, local hirsutism, telangiectasia, purpura, pigmentation disorders, hypertrichosis, alopecia are possible, especially in women. From the digestive system: Unknown: when applied to large areas of the skin, gastritis, steroid stomach ulcers are possible. From the endocrine system: Not known: hyperglycemia. When applied to large areas of the skin, systemic manifestations are possible: adrenal insufficiency, Itsenko-Cushing's syndrome, steroid diabetes mellitus. On the part of the immune system: Not known: a decrease in the body's resistance. With prolonged use, the following are possible: secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of the infectious process, development of opportunistic infections), slowing down of reparative processes. From the side of the cardiovascular system: Not known: arterial hypertension, edema may develop. In the event of adverse reactions, including those not listed in this leaflet, you should stop using the drug and consult a doctor. Storage conditions At a temperature not higher than 20 °C. Keep out of the reach of children. Buy Sinaflan ointment 0.025% 10g №1 Price for Sinaflan ointment 0.025% 10g №1