C-derm A ointment (0.5mg+1000me)/g 30g №1

Name C-derm A. Release form Cream. INN Betamethasone + gentamicin. FTG Glucocorticosteroid + antibiotic aminoglycoside. Composition 1 g of ointment contains as active ingredients betamethasone (in the form of betamethasone dipropionate) 0.5 mg, gentamicin (in the form of gentamicin sulfate) 1050 IU. Excipients: liquid paraffin, lanolin alcohol, cetostearyl alcohol, soft paraffin, white. Inflammatory and allergic dermatoses complicated by secondary infection or suspected secondary infection: psoriasis, contact dermatitis, atopic dermatitis, allergic contact dermatitis, eczema, neurodermatitis, intertriginous dermatitis, seborrheic dermatitis, solar dermatitis, erythroderma, radiation dermatitis, simple chronic lichen, skin form of lupus erythematosus, polymorphic erythema. Given the presence of a potent glucocorticosteroid in its composition, the ointment must be applied at the beginning of treatment, for a short time, on a small surface of the skin. Contraindications Hypersensitivity to corticosteroids, gentamicin or ointment base components. Viral, fungal or tuberculous skin diseases, skin neoplasms, rosacea and juvenile acne, chicken pox, phlebitis and trophic ulcers. Do not use on areas of extensive skin lesions, especially those that violate the integrity of the skin, for example, with burns. Do not use for a long time due to developing bacterial resistance. Do not apply on the face. Do not use in children under 12 years of age. Do not use the drug in the anal and genital areas, and in case of inflammation of the skin around the mouth. Pregnancy and lactation Safety of use during pregnancy: category C. In animal studies, it has been established that glucocorticosteroids are teratogenic even when used in small doses inside. The teratogenic effect has also been confirmed in animals after the application of strong glucocorticosteroids to the skin. No controlled studies have been conducted regarding the possible teratogenic effects of betamethasone dipropionate in pregnant women after topical application to the skin. Betamethasone dipropionate is a strong glucocorticosteroid and it is not recommended to use C-derm A ointment in pregnant women. It is not known to what extent betamethasone dipropionate is excreted in breast milk after topical application. Betamethasone dipropionate is a strong glucocorticosteroid, and it is not recommended to use C-derm ointment in women during breastfeeding. Method of administration and doses Locally apply a small amount of C-derm A ointment to the affected skin surface, 1-2 times a day. Do not apply ointment under an occlusive dressing. If it is absolutely necessary to use a bandage, it is necessary to apply a bandage that allows air to pass through and not to use a pressure, oilcloth bandage. Treatment should not be carried out for more than 2 weeks, without a break. Do not use more than 45 g of ointment within one week. Do not use in children under 12 years of age. Side effects Diseases of the skin and subcutaneous tissue Acne, steroid purpura, epidermal growth inhibition, subcutaneous tissue atrophy, dry skin, depigmentation or hyperpigmentation of the skin, atrophy and stretching of the skin, inflammation of the hair follicles, excessive hair growth on the skin, allergic contact inflammation of the skin. Sometimes hives or a rash may appear. After application on the skin of the face, it can cause inflammation around the lips. Endocrine disorders With prolonged use of the drug (more than 2 weeks), when applied to large areas of skin or to damaged skin, in the case of closed compresses, as well as in case of use in children, as a result of increased absorption of betamethasone dipropionate by the circulatory system, general undesirable symptoms may appear caused by the action of corticosteroids. Common undesirable symptoms characteristic of corticosteroids include inhibition of the hypothalamic-pituitary-adrenal system, Cushing’s syndrome, inhibition of developmental growth in children, hyperglycemia, sugar in the urine, edema, hypertension, decreased immunity. Immune disorders Signs of hypersensitivity may appear. If symptoms of hypersensitivity appear, treatment should be stopped immediately. Eye diseases After topical application on the skin of the eyelids, sometimes there may be an increase in the symptoms of glaucoma or an acceleration in the development of cataracts. Vascular disease Dilation of superficial blood vessels may occur. Ear problems Due to the fact that the drug contains gentamicin, symptoms of ototoxicity may occur, especially if the drug is applied to a large area of skin or to damaged skin. Diseases of the kidneys and urinary tract Due to the fact that the drug contains gentamicin, there is a risk of kidney damage, especially in the case of simultaneous use of nephrotoxic drugs, as well as in kidney disease. The preparation contains cetostearyl alcohol, which may cause a local skin reaction (eg contact dermatitis). In children, in addition, the following side effects may occur due to the use of betamethasone: suppression of the function of the hypothalamic-pituitary-adrenal system, Itsenko-Cushing’s syndrome, growth retardation, lag in weight gain, increased intracranial pressure. Symptoms of adrenal suppression in children include a decrease in plasma cortisol concentration and a lack of response to adrenocorticotropic hormone (ACTH) stimulation. An increase in intracranial pressure is manifested by bulging of the fontanel, headache, and bilateral edema of the optic nerve head. Overdose With a single application of 7 g of the ointment, a reversible release of adrenocorticotropic hormone (ACTH) by the pituitary gland may occur as a result of inhibition of the adrenal pituitary system. In case of prolonged or improper use, symptoms of Cushing’s disease may appear. In this case, it is necessary to cancel the use of C-derm A ointment. Due to the risk of acute adrenal insufficiency, this should be done under medical supervision. There is also the possibility of systemic side effects of gentamicin, such as hearing loss and the risk of kidney damage. Interaction with other drugs During treatment with glucocorticosteroids should not be vaccinated against smallpox. Other types of immunization should also not be carried out, especially with prolonged use on large areas of the skin, due to the risk of an immunological deficiency in the form of detection of antibodies. The drug may increase the effect of immunosuppressive drugs and weaken the effect of immunostimulating drugs. Application features Avoid getting the drug in the eyes. The use of the drug under occlusive dressings is not recommended. If skin hypersensitivity reactions (itching, burning and redness) develop during the first use of the drug, the drug should be immediately discontinued. Patients with impaired liver function and patients who require long-term treatment need careful medical supervision, as they may have increased absorption of betamethasone and the development of systemic adverse reactions. Some areas of the body, such as the groin, armpits, and perianal region, where there is a kind of natural occlusion, are more susceptible to the appearance of striae when the cream is applied externally, so the use of the drug in these areas of the skin should be as limited as possible. Influence on the ability to drive vehicles and maintain moving mechanisms The drug does not limit psychophysical activity, the ability to drive vehicles and maintain moving mechanisms. Precautions Long-term use should be avoided as this increases the incidence of side effects and may develop bacterial resistance to gentamicin sulfate. In case of activation of the infection at the site of application of the ointment, it is necessary to apply additional antimicrobial or antifungal treatment. If the symptoms of the infection do not go away, it is necessary to stop using the ointment for the period of complete cure of the infection. Do not use the drug on the skin of the face due to the possibility of telangiectasia, dermatitis perioralis, even after a short use. On the skin in the armpit and inguinal region, apply the ointment only in cases of emergency, given the increased absorption. Do not use ointment under an occlusive dressing, as this can lead to atrophy of the epidermis, the appearance of striae, and the development of superinfection. Use with caution in pre-existing subcutaneous tissue atrophy, especially in the elderly. It is necessary to avoid contact of the drug with the mucous membrane of the eyes and the skin of the eyelids due to the risk of developing glaucoma and cataracts. Given that corticosteroids and gentamicin are absorbed through the skin, there is a risk of systemic side effects of corticosteroids (suppression of adrenal function) and gentamicin (oto- and nephrotoxicity, especially in people with impaired renal function) during the use of C-derm A ointment. Therefore, the use of the drug in large doses, on large areas of the skin, on damaged skin in patients with impaired liver and kidney function and in children should be avoided. It should be used with extreme caution in patients with psoriasis, since topical application of glucocorticosteroids in psoriasis can be dangerous due to relapse of the disease with the development of tolerance, the risk of generalization of pustular psoriasis and general toxic effects associated with a violation of the integrity of the skin. Any side effects of systemic glucocorticosteroids, including adrenal suppression, may also occur with the use of topical glucocorticosteroids, especially in children. Systemic absorption of local glucocorticosteroids may increase with prolonged use, treatment of large body surfaces and the use of occlusive dressings. In such cases, especially in children, appropriate precautions should be observed, including the possibility of discontinuing the drug, determined by the doctor, depending on the severity of the disease. Systemic absorption of gentamicin when applied topically may increase if applied to large areas of the skin, especially with prolonged treatment or in the presence of skin cracks. In such cases, the development of adverse events characteristic of gentamicin in its systemic use is possible (see the section “Side Effects”), therefore, careful use is recommended, especially in children, providing for the doctor to determine the frequency of use and duration of therapy. Cross-allergic reactions to antibiotics from the aminoglycoside group were observed. With prolonged topical use of gentamicin, the growth of insensitive microflora, including fungal, may occasionally be observed. In this case, as with the development of irritation, hypersensitivity reactions and superinfection, treatment should be stopped and appropriate therapy prescribed. The ointment is indicated for external use only and is not intended for use in ophthalmology. Release form: 30.0 g in tubes, placed together with the package leaflet in cardboard packs. Storage conditionsAt a temperature not higher than 25°C. Keep out of the reach of children. Shelf life 2 years. The expiration date is indicated on the packaging. This medicinal product must not be used after the date indicated on the package. Conditions for dispensing from pharmacies. derm A ointment (0.5mg+1000me)/g 30g №1