The instruction for medical use of Belosalik medicine lotion the Trade name Belosalik lotion the International unlicensed name Is not present the Dosage form Solution for external use, 50 ml and 100 ml Structure of 1 g of drug contain active agents: betamethasone Dipropionas of 0.640 mg (0.500 mg of betamethasone are equivalent), salicylic acid of 20.0 mg. excipients: dinatrium edetat, a gipromelloza 4000 srz, sodium hydroxide, isopropanol, water purified. The description Transparent, colourless, viscous solution with an isopropanol smell. 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 – seborrheal dermatitis of a hairy part of the head – psoriasis of a hairy part of the head – psoriasis defeats of other localization – a dermatosis at which corticosteroid therapy the Route of administration and doses Outwardly is shown. Adults Belosalik lotion should be used 1 – 2 time a day. In most cases lotion is applied on an affected area, slightly rubbing in skin a thin layer, twice a day. For achievement of the corresponding effect at treatment of some patients of rather less frequent putting medicine. The recommended duration of treatment should not exceed two weeks then it is necessary to execute assessment of its results. The maximum week dose makes 60 g. Children Duration of use of medicine at treatment of children has to be no more than 5 days. Side effects – burning, an itching, irritation, dryness, a folliculitis, a hypertrichosis, acneform rashes, hypopigmentation, perioral dermatitis – allergic contact dermatitis – maceration of skin, consecutive infection, an atrophy of skin, a striya, a heat rash (at use of occlusive bandages) – a skin atrophy, a local hirsutism, teleangiectasias, a purpura (at prolonged use) – a growth inhibition, an Icenco-Cushing syndrome, benign increase in intracranial pressure after the end of treatment, a hyperglycemia, a glucosuria, a hypopotassemia, increase in the ABP (system manifestations of side effects of betamethasone of Dipropionas when drawing on big surfaces) – pallor, increased fatigue, drowsiness, a hyperventilation against the background of a tachypnea, nausea, vomiting, a hearing disorder, confusion of consciousness (system manifestations of side effects of salicylates when drawing on big surfaces) Side effects at children. – function oppression gipotalamo – a hypophysial and adrenal system – Cushing’s syndrome of the Contraindication – hypersensitivity to substances as a part of drug: to betamethasone, salicylic acid or excipients – a rozatsea – an acne – perioral dermatitis – a parianalny and genital itching – a tuberculosis cutis – virus damages of skin, in particular infections a virus of a herpes simplex, chicken pox – skin tumors – a diaper dermatitis – fungal or bacterial infections of skin without simultaneous use of the corresponding anti-infectious treatment – pregnancy and the period of a lactation – the children’s age till 1 year – skin vaccine-challenged reactions 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 of lotion for treatment of patients 12 years without the corresponding medical observation are younger. 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 protrusion of a fontanel, headaches and bilateral papillary hypostasis (papilledema). 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. The form of release and packing On 50 ml and 100 ml of drug place in the bottles from polyethylene of high density with a dropper corked by the screw-on stopper from polyethylene of low density. The stopper has a ring for control of the first opening. The bottle together with the instruction for use in the state and Russian languages is placed in a cardboard pack. To Store storage conditions at a temperature not higher than 25 wasps. To store out of children’s reach! A period of storage 2 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 products (goods): Representative office “BELUPO, drugs and cosmetics of of” in Republic of Kazakhstan Almaty, Zheltoksan St., 87, office 24, 25, 26.