C-derm ointment 1mg/g 30g №1

Name:
C-derm ointment for nar.prim.1mg/g in tubes 30g in pack No. 1
Description:
Ointment of white or white color with a yellowish tint, odorless. The main active substance Betamethasone Form of release ointment Dosage 30 g Pharmacological properties The drug “C-derm®” ointment has a local anti-inflammatory, anti-allergic and antipruritic effect. Indications for use The drug “C-derm®” ointment is indicated to reduce the inflammatory manifestations of dermatoses sensitive to glucocorticosteroid therapy, such as: dermatitis (contact, exfoliative, seborrheic, solar, radiation, intertriginous); neurodermatitis; eczema (atopic, coin-like); psoriasis (with the exception of common psoriasis); discoid lupus erythematosus; generalized erythroderma (as part of complex therapy). Method of application and doses The drug “C-derm®” ointment is applied in a thin layer on the affected skin 1-3 times a day, depending on the severity of the condition. In most cases, to achieve the effect, it is enough to apply 1-2 times a day. The frequency of application of the drug is determined according to the severity of the disease. With a mild severity of the disease, the drug can be applied once a day. In case of more severe lesions, the frequency of application must be increased. The most appropriate use of the drug betamethasone valerate in this dosage form (ointment) in patients with dry lichen or scaly skin lesions. Do not use under occlusive dressings, as side effects of the drug may increase. After achieving a therapeutic effect, it is necessary to reduce the frequency of using the drug “C-derm®” ointment or switch to a less active corticosteroid for topical use and continue maintenance therapy with a gradual withdrawal of the drug. If the condition does not improve or worsens within 2-4 weeks of therapy, it is necessary to re-examine and reconsider treatment. Continuous use of the drug should not exceed 4 weeks. In children and in patients with lesions of the skin of the face, the course of treatment should not exceed 5 days. Cover bandages are not recommended. Use during pregnancy and lactation Animal studies of betamethasone valerate have shown reproductive toxicity. Ointment “C-derm®” is not recommended for use in the first trimester of pregnancy. Due to the fact that the safety of the use of local glucocorticosteroids in pregnant women has not yet been thoroughly studied, the appointment of drugs of this class during pregnancy can only be justified if the benefit to the mother clearly outweighs the possible harm to the fetus. Given this, the drug “C-derm®” ointment should not be used in pregnant women in high doses and for a long time. To date, there is also no data on the possibility of penetration of glucocorticosteroids after their topical application into breast milk, which gives reason to make a decision either to stop breastfeeding or to discontinue the drug, depending on the degree of need for local hormone therapy for a nursing mother. Precautions If irritation or a hypersensitivity reaction is noted during the use of the drug, treatment should be discontinued and the patient should be given adequate therapy. With a secondary fungal or bacterial infection, appropriate drugs should be prescribed. In the absence of a rapid positive effect, the use of the drug should be discontinued until all signs of the infectious process are eliminated. With prolonged use of the drug, especially in the treatment of large surfaces of the body and when using closing dressings, when applied to areas of the skin with diaper rash, erosions and on the skin of the face, the risk of systemic adverse reactions increases. The drug “C-derm®” ointment is indicated for use only in dermatological practice and is not intended for use in ophthalmology. The drug “C-derm®” ointment should not be applied to the eyelids due to the risk of developing glaucoma or subcapsular cataracts. The drug “C-derm®” ointment should be used with extreme caution in patients with psoriasis due to the likelihood of recurrence of the disease, the development of tolerance, the risk of generalization of pustular psoriasis and the development of local or systemic toxicity due to impaired skin barrier function. Patients with psoriasis should be closely monitored when topical corticosteroids are used. Prolonged use of strong corticosteroids can lead to the development of atrophic changes, especially on the skin of the face and other sensitive areas of the skin. This circumstance should be taken into account in the treatment of diseases such as psoriasis, systemic lupus erythematosus and severe eczema. As with all potent glucocorticoid-based drugs, the use of C-derm® ointment for a long time should be avoided, on large areas of the skin, as well as on the face and skin folds. Avoid getting the drug on wounds and mucous membranes. Glucocorticoids can change the appearance of some skin lesions, making the diagnosis difficult. Any side effects that occur with systemic use of glucocorticoids, including suppression of the adrenal cortex, may also occur with their topical application. 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. Use in children Clinical data on the use of the drug in children is not enough. The use of the drug in children under 1 year of age is contraindicated. In children older than 1 year, the duration of the drug should not exceed 5 days, occlusive dressings should not be used. Use in children is possible only in case of emergency, at the lowest possible dose, which provides therapeutic efficacy. In children, as a rule, one application per day is sufficient, the treatment area should not exceed 10% of the body surface. Children may be more susceptible to topical glucocorticosteroids than adult patients in terms of the possibility of depression of the hypothalamic-pituitary-adrenal system. This may be due to increased absorption of betamethasone valerate from the site of application due to the greater ratio of surface area to body weight in children. At the same time, children may have Cushing’s syndrome, linear growth retardation, lag in weight gain and / or increased intracranial pressure. Influence on the ability to drive vehicles or work with moving mechanisms Studies to evaluate the effect of the use of the drug on the ability to drive a car or work with machinery have not been conducted. Given the profile of adverse reactions, the effect on the speed of reaction when driving vehicles or working with other mechanisms is not expected. Interaction with other drugs There is no information on possible interactions. Contraindications The drug “C-derm®” ointment, like other betamethasone-containing drugs intended for topical use (ointments, creams, lotions), is contraindicated in patients with hypersensitivity to the active substance or any of the auxiliary components of the drug. In addition, drugs of this type are not recommended for: skin manifestations of syphilis and tuberculosis; bacterial, viral, and fungal skin diseases (pyoderma, herpes simplex, herpes zoster, chickenpox, warts vulgaris (condylomas), molluscum contagiosum, parasitic infections (eg, scabies); skin ulcers, skin wounds; skin tumors (skin cancer, nevus , atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma); the presence of acne (pink, common), post-vaccination skin reactions; ichthyosis, plantar dermatosis of minors; anogenital itching; increased permeability of the walls of skin blood vessels, skin atrophy, the presence of adverse reactions after use of corticosteroids.Contraindicated in children under 1 year of age. Composition 1 g of ointment contains 1 mg of betamethasone valerate as an active ingredient in terms of betamethasone. Excipients: liquid paraffin, soft white paraffin. Overdose Excessive or prolonged use of local glucocorticosteroids can cause depression of the function of the hypothalamic-pituitary-adrenal system, which can cause the development of secondary adrenal insufficiency and the appearance of symptoms of hypercorticism, including Cushing’s syndrome (edema, puffiness of the face, increased blood pressure). If such phenomena occur, symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, the electrolyte balance is corrected. In the case of chronic toxic effects, a gradual withdrawal of the glucocorticosteroid drug is recommended. Side effects Undesirable reactions are presented in accordance with the classification of organ systems and the frequency of occurrence: very often (? 1/10); often (? 1/100 to < 1/10); infrequently (? 1/1000 to < 1/100); rare (? 1/10,000 to < 1/1,000); very rarely (< 1/10000); frequency unknown (cannot be estimated from available data). From the skin and subcutaneous tissue: often - burning sensation, itching, irritation, dryness, folliculitis, hypertrichosis, acne-like rashes, hypopigmentation, perioral dermatitis, allergic contact dermatitis; infrequently - mainly when used under occlusive dressings: skin maceration, skin atrophy, stretch marks, prickly heat. Infections and invasions: infrequently - secondary infection (especially when used under occlusive dressings). Particularly sensitive to the development of local adverse reactions are the skin of the face, the surface of the skin with hairline and the skin of the genital organs. After long-term use for the treatment of dermatoses, the withdrawal of potent topical corticosteroids, which include betamethasone, may aggravate the signs and symptoms of the disease and lead to dependence on topical corticosteroids. All adverse events that have been reported with the appointment of systemic glucocorticoids, including inhibition of the function of the hypothalamic-pituitary system, can develop with the appointment of potent glucocorticoids for topical use. Systemic adverse reactions, such as blurred vision, have also been reported with topical corticosteroids. Reporting adverse reactions If you experience any adverse reactions, it is recommended that you consult your doctor. This recommendation applies to any possible adverse reactions, including those not listed in the package leaflet for medical use of the medicinal product. You can report adverse reactions directly to the Adverse Drug Reactions Information Database; you can also report the ineffectiveness of the drug. By reporting adverse reactions, you help to get more information about the safety of the medicine. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of reach of children. 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