Name:
Betaderm ointment for nar. approx. (0.5mg+1mg)/g in tubes 15g in pack №1
Description:
White or almost white translucent oily soft mass. The main active substance Betamethasone + gentamicin Release form ointment Dosage 1 g of ointment contains 0.5 mg of betamethasone Pharmacological properties Preparation for topical use. The components of the Betaderm ointment have a combined effect in the treatment of inflammatory skin changes that occur with excessive keratosis, allergic etiology, further complicated by bacterial infection. Betamethasone dipropionate is a synthetic fluoride derivative of hydrocortisone. Easily penetrates the skin, providing a strong local anti-inflammatory, antipruritic and anti-allergic effect. Eliminates the causes of the formation of inflammatory processes, prevents the release of histamine and the appearance of local allergy symptoms. Due to the local vasoconstrictor action, it reduces exudative reactions. Betamethasone dipropionate is not biotransformed in the skin. After penetration through the skin into the body, it is biotransformed in the liver and excreted mainly in the urine and, to a lesser extent, in the bile. The absorption of betamethasone dipropionate through the skin increases when applied to delicate skin in the area of u200bu200bfolds, when used on skin with damaged epidermis or skin damaged by an inflammatory process. In addition, absorption increases with frequent use of the drug or after application to a large surface of the skin. The absorption of betamethasone dipropionate through the skin in young people is more pronounced than in adults. Gentamicin sulfate is a broad-spectrum antibiotic. Shows antibacterial action in relation to gram-negative bacteria and some gram-positive bacteria. Indications for its use in the form of an ointment are secondary infections in skin diseases, if the infection is caused by bacteria sensitive to gentamicin, and also if such an infection is suspected. Gentamicin sulfate after topical application on intact skin is not absorbed, but after application on skin damaged by trauma, burns and ulcerations, it may be subject to systemic absorption. Gentamicin sulfate is not biotransformed in the body and is excreted in the urine unchanged. Indications for use Betaderm in the form of an ointment is applied topically in dry inflammatory conditions of the skin (dermatosis), especially with an allergic onset, complicated by a secondary bacterial infection and proceeding with excessive keratosis, itching or severe allergic reactions, mainly in: atopic dermatitis, seborrheic dermatitis, simple chronic lichen, keratinizing eczema, psoriasis, allergic contact dermatitis, skin form of lupus erythematosus, erythema multiforme. Dosage and administration Locally, apply a small amount of ointment to the affected skin surface, 1-2 times a day. Do not apply ointment under an occlusive dressing. If there is an urgent need to apply a bandage, then you should apply a bandage that allows air to pass through and do not use a sealing, 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 for one week. Use in children Do not use in children under 12 years of age. Use during pregnancy and lactation It is not recommended to use Betaderm in pregnant women and during lactation. Precautions The drug should be used only as directed by the physician. After applying the ointment to the skin, do not use an oilcloth bandage that increases the moisture and temperature of the skin. The drug should be used only for those diseases that are indicated by the doctor. The patient should inform the doctor about all side effects that appeared during the use of the drug. Do not use the drug for longer than prescribed by your doctor. With prolonged use on a large surface of the body, its absorption increases and the incidence of side effects increases, such as edema, hypertension, an increase in blood glucose, and a decrease in the body’s immunological response. In case of increased infection at the site of application of the ointment, the doctor may apply additional antimicrobial or antifungal treatment. You should follow the recommendation and do not use the drug on the skin of the face due to the risk of side effects in the form of prolonged expansion of small blood vessels, atrophy of the subcutaneous tissue in the lips even after short-term use. Use with caution in already existing atrophic conditions of the subcutaneous tissue, especially in the elderly. It is necessary to avoid contact of the drug with the surfaces of the eyes and the skin of the eyelids. Do not apply to or around the eyes due to the risk of 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 damage to the kidneys) during the use of Betaderm ointment. Therefore, the use of the drug on large areas of the skin, on damaged skin, use in large doses, use in patients with damage to the liver, kidneys, and in children should be avoided. Particular caution should be used in patients with psoriasis, because topical corticosteroids can be dangerous due to the development of tolerance of disease recurrence, the risk of generalized pustular psoriasis and the general toxic effect caused by disruption of the skin. Avoid getting the drug in the eyes, open wounds and mucous membranes. If the drug gets into the eyes or mucous membranes, it is recommended to rinse them with plenty of water. As in the case of the use of systemic glucocorticosteroids, cataracts and glaucoma or such a rare disease as central serous chorioretinopathy (CSC) may develop after external use of the drug. Consult your doctor if you experience blurred vision or other visual disturbances. Due to the fact that the composition contains cetostearyl alcohol, butylhydroxytoluene and butylhydroxyaniline, the drug may cause local skin reactions (for example, contact dermatitis). Interaction with other drugs During treatment with glucocorticosteroids should not be vaccinated against smallpox. Other types of immunization should not be carried out during treatment. 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 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. Active ingredient 1 g of ointment contains 0.5 mg of betamethasone (in the form of betamethasone dipropionate) and 1 mg of gentamicin (in the form of gentamicin sulfate). Excipients liquid paraffin 250 mg, lanolin alcohol 30 mg, cetostearyl alcohol 20 mg, butylhydroxytoluene 0.05 mg, butylhydroxyanisole 0.05 mg, white petrolatum up to 1 g the 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 Betaderma 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. 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 growth and development 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. Blurred vision may occur with an unknown frequency. Vascular disease Dilation of superficial blood vessels may occur. Ear diseases 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 u200bu200bthe 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 administration of nephrotoxic drugs, as well as in kidney diseases. If any of the above side effects get worse, or you notice any other side effects not listed in the instructions, tell your doctor. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. Shelf life – 3 years. Do not use the drug after the expiration date. Buy Betaderm ointment (0.5mg+1mg)/g 15g №1 Price for Betaderm ointment (0.5mg+1mg)/g 15g №1 )/g 15g №1
INN | GENTAMYCIN + BETAMETASONE |
---|---|
The code | 13 968 |
Barcode | 5 904 398 474 090 |
Dosage | 0.5mg/0.1mg |
Active substance | Betamethasone, gentamicin |
Manufacturer | BAUSCH HEALTH LLC, pr-no Pharmaceutical plant Elfa SA, Poland |
Importer | Closed Joint Stock Company "BAUSH HEALTH", 220073, Minsk, st. Olshevsky, 22, room 22 |
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