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Description
The instruction for medical use of Belosalik Torgovoye medicine a name Belosalik Mezhdunarodnoye the unlicensed name Is not present the Dosage form Ointment for external use Structure 1 g of drug contains active agents: betamethasone Dipropionas of 0.640 mg (0.500 mg of betamethasone are equivalent), salicylic acid of 30.0 mg. excipients: liquid paraffin, white soft paraffin the Description White translucent uniform ointment Pharmacotherapeutic group Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids in a combination with other drugs. Corticosteroids strong in a combination with other drugs. Betamethasone in a combination with other drugs. ATH D07XC01 code the Pharmacological Pharmacokinetics Absorption On properties absorption of betamethasone and salicylic acid influence many factors, including a condition of epidermis and existence of occlusion. Locally applied corticosteroids in an insignificant measure can be absorbed through the normal, uninjured skin whereas inflammations of the skin and use of occlusive bandages can increase absorption volume. System absorption after topical administration is 12-14%. Salicylic acid at topical administration reaches the maximum concentration in plasma in 6-12 hours, at topical administration under occlusion – in 5 hours. Distribution About 64% of betamethasone contacts proteins of plasma, and the volume of distribution is 1.4 l/kg. Metabolism Metabolism of betamethasone happens in a liver. Removal Corticosteroids are removed through kidneys. Some corticosteroids and their metabolites are also allocated with bile. The most part from total amount of the absorbed salicylic acid is removed in the form of metabolites, about 6% are removed through urine in not changed look. The pharmacodynamics Drug represents a combination of a strong corticosteroid of betamethasone of Dipropionas and salicylic acid for external use. Betamethasone Dipropionas, synthetic fluorinated adrenokortikosteroid for topical administration, renders the significant anti-inflammatory, immunosuppressive and anti-proliferative action. Topical corticosteroids, such as betamethasone Dipropionas, are effective at treatment of different types of a dermatosis due to anti-inflammatory, antipruritic and vasopressor action. Salicylic acid has keratolytic effect, facilitating penetration of corticosteroids into skin, provides antimicrobial and antifungal effect. Indications – the inflammatory dermatosis sensitive to local a corticosteroid ache to therapy and salicylic acid, followed by a hyperkeratosis and peeling – psoriasis of a hairy part of the head – chronic blyashechny psoriasis on skin of hands and legs the Route of administration and doses Outwardly. Adult Belosalik, ointment for external use, puts 1 – 2 time a day. In most cases it should be put twice a day in the form of a pellicle to cover an affected area. For some patients the adequate maintenance therapy can be reached at less frequent putting drug. It is recommended to appoint drug to two weeks then the therapeutic effect is checked. The maximum week dose should not exceed 60 g. Children Duration of use of medicine at treatment of children has to be no more than 5 days. Side effects Drug, as a rule, is well transferred and side effects meet seldom and are reversible: – burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneform rash, hypopigmentation, hyperpegmentation or depigmentation of skin, depigmentation of hair, perioral dermatitis and allergic contact dermatitis. Long use without interruption can lead to a local atrophy of skin, extensions and superficial vascular dilatation, especially on a face. When using occlusive bandages the following symptoms most often develop: maceration of skin, consecutive infection, atrophy of skin, extension and heat rash. Besides, prolonged use of drugs of salicylic acid can cause dermatitis. Contraindications – hypersensitivity to substances as a part of drug: Bitam to a tazon, salicylic acid or excipients – a tuberculosis cutis – virus damages of skin, in particular infections a virus of a herpes simplex, cow and chicken pox – perioral dermatitis – a parianalny and genital itching – pink eels – an acne – pregnancy and the period of a lactation – the children’s age till 1 year Medicinal interactions is not available clinically significant interactions with other medicines. Special instructions Should be applied with care in a liver failure, diabetes, tuberculosis. It is necessary to avoid hit in eyes and on mucous membranes. It is necessary to avoid use of drug in anogenitalny area. Use of drug under an occlusive bandage, except for cases is not recommended, when necessary. At development of fungal or bacterial microflora on skin, additional use of antibacterial or antifungal agent is necessary. System absorption of betamethasone of Dipropionas and salicylic acid can increase at use of medicine on big sites of skin and in skin folds, after long use or use of a large amount of medicine. In the specified cases it is necessary to observe precautionary measures, in particular at treatment of children. At emergence of irritation, the increased dryness or hypersensitivity of skin, treatment has to be stopped. All side effects arising at system treatment by steroids, including suppression of function of adrenal glands, can appear also after topical administration of corticosteroids, in particular at treatment of children. Use in pediatrics is not recommended use Belosalik, ointments for external use for treatment of patients are younger than 12 years without the corresponding indications. In comparison with adult patients, children are more subject to the suppression of an axis of NRA (gipotalamo – a hypophysial and adrenal axis) caused by topical corticosteroids and to other actions of exogenous corticosteroids because of the increased absorption which is observed because of more extensive surface of skin in comparison with body weight. At the children accepting topical corticosteroids the suppression of an axis of HPA, Cushing’s syndrome, growth delay, the delayed increase in body weight and increase in intracranial pressure was recorded. Suppression of function of adrenal glands at children is expressed in the low level of cortisol in plasma and lack of reaction at stimulation by adrenocorticotropic hormone (ACTH). Intracranial hypertensia is manifested in camber of a fontanel, headaches and bilateral papillary hypostasis. Pregnancy and the period of a lactation is not available the corresponding and well controlled researches about potential teratogenic impact of locally applied corticosteroids and salicylic acid at treatment of pregnant women, however it is known that at local use they can be soaked up. There are no data on whether causes local use of corticosteroids, including betamethasone, absorption adequately that you – to call measurable concentration of these drugs in breast milk. There are data that systemically the applied corticosteroids are allocated in breast milk in the quantity which is not rendering harm for babies. Influence on ability of control of vehicles and mechanisms Data on an adverse effect of the drug Belosalik on ability to run vehicles and mechanisms are absent. Overdose At long continuous use of a combination of betamethasone and salicylic acid, especially at children, on the extensive surfaces of skin, when drawing on skin with the broken integrity or when using under an occlusive bandage, the strengthened absorption of active components and manifestation of system effects is not excluded. Symptoms: secondary adrenal insufficiency, hypercorticoidism, Cushing’s syndrome. Treatment: drug withdrawal and symptomatic therapy. A form of release and packing Ointment for external use. On 15 g or 30 g of drug in a tuba aluminum with a membrane, with internal varnish coating, the membranes which are closed a polyethylene cap with a pin for piercing. On 1 tuba together with the instruction for use in the state and Russian languages place in a pack from cardboard. To Store storage conditions at a temperature not higher than 25 wasps. To store out of children’s reach! A period of storage 4 years not to use drug after an expiration date. Prescription status According to the prescription BELUPO Producer, drugs and cosmetics of of, the Republic of Croatia, 48000, Mr. Koprivnitsa, Danits St., 5. The owner of the registration certificate of BELUPO, medicine and cosmetics of of, the Republic of Croatia the Address of the organization accepting in the territory of the Republic of Kazakhstan claims of consumers on quality of the products (goods) responsible for post-registration observation of safety of medicine Representative office “BELUPO, drugs and cosmetics of of” in Republic of Kazakhstan Almaty, Zheltoksan St., 87, office 24, 25, 26.
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