Diprosalic ointment (0.5mg+30mg)/1g 30g №1

Name:
Diprosalik ointment (0.5mg + 30mg) 1g in tubes 30g in pack No. 1
Description:
Homogeneous, soft consistency ointment, almost white, without impurities. The main active ingredient Betamethasone + salicylic acid Product form ointment Dosage 30 g Pharmacological properties Pharmacodynamics Betamethasone dipropionate Betamethasone in the form of dipropionate is a potent corticosteroid (action class III) with anti-inflammatory, antipruritic and vasoconstrictive effects. However, topical corticosteroid treatment is not etiotropic; recurrence of the disease is possible after discontinuation of treatment. Salicylic acid Salicylic acid, due to its keratolytic properties, makes the deep layers more accessible to betamethasone dipropionate and increases its absorption. Pharmacokinetics There are no data on the pharmacokinetics of Diprosalik®. The rate of percutaneous absorption and absorption with topical application of a corticosteroid depends on the area of the body, the condition of the skin, dosage form, age and method of application. Under normal conditions, when applied topically, only a part of betamethasone enters the systemic circulation. It should be noted that the salicylic acid contained in the drug enhances the absorption and percutaneous absorption of the corticosteroid. The rate of percutaneous absorption of salicylic acid depends on the condition of the skin. Percutaneous absorption, among other things, increases with psoriatic erythroderma or dermatoses associated with inflammatory and erosive changes in the skin. The metabolism of salicylic acid occurs in the liver. In the normal dose range, the elimination half-life is 2 to 3 hours. Indications for use To reduce the inflammatory symptoms of non-infected subacute and chronic dry and hyperkeratic dermatoses sensitive to corticosteroid therapy: psoriasis, chronic atopic dermatitis, neurodermatitis (chronic lichen simplex), lichen planus, eczema (including nummular eczema, eczema of the hands, eczematous dermatitis), dyshidrosis (“dropsy”), seborrheic dermatitis of the scalp, common ichthyosis and other ichthyotic conditions. Dosage and administration For adults and children, the ointment is applied in a thin layer twice a day – in the morning and in the evening, completely covering the affected skin. In some patients, a satisfactory effect can be achieved with less frequent use of the drug. The duration of treatment is determined by the severity and course of the disease. Maximum daily dose: the lowest dose should be selected at which control of the symptoms of the disease will be possible. Use during pregnancy and lactation The safety of the use of local glucocorticosteroids in pregnant women has not been proven, therefore, the appointment of this group of drugs during pregnancy is justified only if the potential benefit to the woman outweighs the potential risk to the fetus. During pregnancy, drugs in this group should not be used in large doses or for a long time. It is not known whether topical application of corticosteroids through systemic absorption can lead to their appearance in breast milk. The decision to stop breastfeeding or discontinue the drug should be made taking into account the need for the drug in the mother. Precautions If skin irritation or hypersensitivity occurs during the use of the drug, treatment should be discontinued. In case of infection, appropriate therapy should be prescribed. Side effects characteristic of systemic corticosteroids, including suppression of the function of the adrenal cortex, can also be observed with excessive and prolonged topical use of corticosteroids, especially in pediatric practice. Systemic absorption of topical corticosteroids and salicylic acid is increased when large areas of skin are treated and when occlusive dressings are used. Avoid applying salicylic acid to open wounds or damaged skin. These precautions should also be followed for long-term use, especially when treating children. In case of skin irritation, including excessive dryness of the skin, the drug should be discontinued. The period of continuous use, if possible, should not exceed 2-3 weeks. Very strong, strong and moderate corticosteroids should be used on the face and in the genital area with extreme caution and for no longer than 1 week. In the area near the eyes, only weak corticosteroids are allowed to be used (risk of developing glaucoma). Corticosteroids may mask the symptoms of an allergic skin reaction to the drug’s ingredients. The patient should be instructed to use the drug only to treat their current skin condition and not to give the drug to others. With the use of systemic and local corticosteroids (including intranasal, inhalation and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of visual impairment, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which have been reported after corticosteroid use systemic and local action. Pediatric use Children may experience more frequent signs of depression of the hypothalamic-pituitary-adrenal system and the appearance of external corticosteroid effects under the influence of local corticosteroids than in adult patients. This is due to the higher absorption of the drug in children due to the greater ratio of surface area to body weight. Children treated with topical corticosteroids may experience depression of the hypothalamic-pituitary-adrenal system, Cushing’s syndrome, linear growth retardation, lag in weight gain, increased intracranial pressure. Manifestations of adrenal suppression in children: low plasma cortisol levels and lack of response to ACTH stimulation. An increase in intracranial pressure is manifested by bulging of the fontanel, headache, bilateral edema of the optic discs. Interaction with other drugs Salicylic acid may enhance the penetration of other locally applied drugs. Therefore, other medicinal or cosmetic products should not be applied to the treated areas of the skin at the same time. Mild oxidizing agents and strong alkaline compounds can degrade corticosteroids. Salicylic acid is incompatible with phenols and zinc oxide. Contraindications Hypersensitivity to any component of the drug. Skin infections of bacterial, viral (herpes, chicken pox, shingles, molluscum contagiosum) or fungal etiology; tuberculosis, syphilis, skin post-vaccination reactions. Acne vulgaris, acne, rosacea, perioral dermatitis. Avoid contact of the drug with wounds, ulcers and mucous membranes. Do not use Diprosalik® in ophthalmology, around the eyes and under occlusive dressings. Composition 1 g of ointment contains active ingredients: 0.5 mg of betamethasone (in the form of dipropionate) and 30 mg of salicylic acid; excipients: liquid paraffin, white soft paraffin. OverdoseSymptoms: Excessive or prolonged use of topical corticosteroids can lead to suppression of the function of the pituitary-adrenal system, which can lead to the development of secondary adrenal insufficiency and the appearance of symptoms of hypercortisolism, including Cushing’s disease. Excessive or prolonged use of topical preparations containing salicylic acid may cause symptoms of salicylism. Treatment: Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. In case of chronic toxic effects, slow withdrawal of corticosteroids is recommended. Treatment of salicylism is symptomatic. Take measures to more quickly remove salicylates from the body. Orally, sodium bicarbonate is used to alkalinize urine and increase diuresis. Side effects The local adverse reactions presented below are typical for locally applied corticosteroids, so they are possible when using the drug Diprosalik®. The frequency of occurrence of undesirable effects cannot be specified, since these cases were registered only after the release of the drug on the market. Early treatment Immune system: hypersensitivity reactions. Skin: skin irritation, burning, itching, dryness. Longer use Skin: skin atrophy, telangiectasias, skin hemorrhages, striae, acne, rosacea-like (perioral) dermatitis. When applied over large areas and / or with prolonged use under an occlusive dressing Infections: infections. Endocrine system: suppression of the synthesis of endogenous corticosteroids, Itsenko-Cushing’s syndrome with edema. Metabolism: diabetes mellitus (manifestation of a previously latent form). Skin: stretch marks. Musculoskeletal system: osteoporosis, growth retardation (in children). General disorders and reactions at the injection site: edema. Systemic adverse reactions, such as blurred vision, have also been reported with topical corticosteroids. In the event of the occurrence of the listed adverse reactions, as well as reactions not listed in the instructions for use, you should consult a doctor. Storage conditions Keep out of the reach of children at a temperature not exceeding 25 ° C. Buy Diprosalic ointment (0.5 mg + 30 mg) / 1g 30g No. 1 ointment (0.5mg+30mg)/1g 30g №1