Sinaf ointment 0.25mg/g 15g №1

Name:
Sinaf ointment dnar.approx. 0.25 mg in tubes 15 g in pack No. 1
Description:
Ointment from white to yellow, homogeneous consistency. The main active ingredient of Fluocinolone acetonide Product form ointment for external use Dosage 0.025% 15 g Pharmacological properties Pharmacodynamics Fluocinolone acetonide is a highly active synthetic corticosteroid for topical use. It has anti-inflammatory, anti-allergic, antipruritic effect. Due to the local vasoconstrictor effect, it prevents the development of exudative reactions. It inhibits the release of inflammatory mediators, the production of cytokines, the migration of leukocytes to the focus of inflammation, and inhibits proliferation processes. Pharmacokinetics Absorption is enhanced when applied to sensitive skin in the face and anatomical folds of the body, skin with damaged epidermis or inflammation, as well as when applied under an occlusive dressing. In children, absorption through the skin is higher than in adults. 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 Sinaf ointment 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. 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 weeks. Avoid applying the drug to large (more than 20% of the body surface) lesions. Joint use with non-drug ointment is possible: if Sinaf ointment is applied once a day, after 12 hours it is possible to apply a non-drug ointment. Ointment should not be used under an occlusive dressing, only for psoriasis it is allowed to use the drug under a closed dressing, which should be changed every day. Do not use on the face for more than 5 days. The ointment is mainly recommended for use in dry forms of dermatoses. Children Children are more sensitive than adults: with topical application of glucocorticosteroids, the drug may penetrate the body, therefore Sinaf 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. Children over 2 years of age are used with caution 1 time per day under medical supervision. In children under 2 years of age, the drug is not used. There have been no specific studies in children. Use during pregnancy and lactation The drug should not be used during pregnancy and lactation. Pregnancy Animal studies have shown that fluocinolone acetonide has an embryotoxic and teratogenic effect. In preclinical studies, it has been confirmed that topical use of glucocorticosteroids can cause intrauterine developmental disorders (eg, cleft palate, fetal growth retardation). Controlled studies to evaluate the possible teratogenic effect in pregnant women with topical application have not been conducted, the potential risk to humans is unknown. Lactation It is not known whether fluocinolone acetonide passes into breast milk after topical application. Other glucocorticoids are excreted in breast milk. If prolonged use or treatment of a large body surface area is necessary, breastfeeding should be discontinued. Contact of the infant with the treated skin surface should be avoided. Precautions If the drug causes symptoms of irritation or allergic skin reactions (skin itching, burning or redness), its use should be stopped immediately. Do not use continuously for more than 2 weeks. 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. For the treatment of skin diseases accompanied by infection, it is recommended to prescribe the drug along with antimicrobial agents. When using occlusive dressings, due to increased bioavailability, it is possible to develop general resorptive effects characteristic of glucocorticosteroids. With external use of the drug, the following are possible: a decrease in the production of adrenocorticotropic hormone (ACTH) by the pituitary gland, inhibition of the adrenal gland-pituitary gland, a decrease in the level of cortisol in the blood and the development of Itsenko-Cushing’s iatrogenic syndrome, which disappears after drug withdrawal. 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. Since corticosteroids can be absorbed through the skin. Long-term treatment, use on large areas of the skin under an occlusive dressing in children should be avoided. Because children have a higher surface-to-body weight ratio than adults, they are at higher risk for systemic side effects of glucocorticosteroids, including hypothalamic-pituitary-adrenal axis dysfunction 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. If an infection develops at the site of application of the ointment, appropriate antibacterial or antifungal treatment should be carried out. If the symptoms of the infection persist, the ointment should be discontinued while the infection is being treated. The drug should be used with caution in the presence of subcutaneous tissue atrophy, mainly in elderly patients. It is necessary to avoid getting the drug into the eyes, mucous membranes and wounds. Do not use the drug in the area around the eyes, due to the risk of glaucoma or cataracts. Use with extreme caution in the treatment of patients with psoriasis, since topical use of glucocorticosteroids in psoriasis can be dangerous due to relapse caused by the development of drug resistance, the risk of generalized pustular psoriasis and systemic toxicity caused by impaired skin barrier function. 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, dermatitis perioralis), even after a short application. 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. The use of corticosteroids can change the appearance of some skin lesions, making the diagnosis difficult. The drug should be used in the smallest amount for the shortest possible time necessary to achieve a therapeutic effect. It is necessary to stop treatment gradually, increasing the intervals between applications. Contains propylene glycol. May cause skin irritation. Due to the content of lanolin, it may cause local skin reactions (eg contact dermatitis). 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. The drug can enhance the effect of immunosuppressive and weaken the effect of immunostimulatory drugs. Contraindications Hypersensitivity to the active substance or other components of the drug. Bacterial, viral, fungal infections of the skin (including skin manifestations of syphilis, skin tuberculosis, pyoderma, chicken pox, herpes, actinomycosis, blastomycosis, sporotrichosis). Rosacea and acne vulgaris, diaper dermatitis, perioral dermatitis, anogenital itching, post-vaccination reactions, wounds and ulcerative skin lesions at the application sites, trophic ulcers associated with varicose veins. Skin tumors (including nevus, hemangioma, xanthoma, atheroma, skin cancer, melanoma, sarcoma). Pregnancy, lactation period, children under 2 years of age. The drug is not used in ophthalmology. Composition Each tube (15 g) contains: active ingredient: fluocinolone acetonide – 3.75 mg; excipients: propylene glycol, soft white paraffin, anhydrous lanolin, ceresin. Overdose Symptoms: itching and burning of the skin at the site of application of the drug, hyperglycemia, glucosuria, Itsenko-Cushing’s syndrome. Treatment: symptomatic against the background of the gradual withdrawal of the drug. Side effects Adverse reactions are listed according to the classification of undesirable side effects in accordance with the damage to organs and organ systems and the frequency of their occurrence: very often (? 1/10), often (? 1/100 to < 1/10), infrequently (? 1/1000 up to < 1/100), rarely (? 1/10000 to < 1/1000), very rarely (< 1/10000), the frequency is 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. On the part of the organ of vision: unknown: when applied to the skin of the eyelids, cataracts or glaucoma may develop. On the part of the digestive system: unknown: when applied to large areas of the skin, gastritis, steroid stomach ulcers are possible. From the endocrine system: unknown: hyperglycemia. When applied to large areas of the skin, systemic manifestations are possible: adrenal insufficiency, Itsenko-Cushing's syndrome, steroid diabetes mellitus. From the immune system: unknown: decreased body 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: unknown: arterial hypertension, edema may develop. Storage conditions At temperatures from 8 ° C to 15 ° C. Keep out of the reach of children. Buy Sinaf ointment 0.25 mg/g 15g №1 Price for Sinaf ointment 0.25 mg/g 15g №1