The instruction for medical use of Akriderm Torgovoye medicine a name Akriderm Mezhdunarodnoye the unlicensed name Betamethasone Dosage Form Cream for external use of 0.05% 15 g or 30 g Structure of 100 g of cream contain active agent – betamethasone (in the form of Dipropionas betamethasone) – 0.05 g, excipients: methylparahydroxybenzoate (nipagin), hard paraffin, vaseline, propylene glycol, liquid paraffin (liquid paraffin), wax emulsion, dinatrium edetat (Trilonum B), sodium sulfite anhydrous, the water purified. Description Cream of white or almost white color. The pharmacotherapeutic Glucocorticosteroid group for topical administration. The ATX D07AC01 code the Pharmacotherapeutic Pharmacokinetics Degree properties of transdermal absorption of local corticosteroids is defined by many factors, including filler, integrity of an epidermal barrier and use of occlusive bandages. Local corticosteroids can be soaked up through the normal, uninjured skin. Inflammation and (or) other pathological processes in skin can increase transdermal absorption. Occlusive bandages significantly increase transdermal absorption of local corticosteroids. After dermal absorption the local corticosteroids join in the pharmacokinetic ways similar to that for systemically the entered corticosteroids. Corticosteroids contact proteins of plasma in various degree, are metabolized mainly in a liver and removed by kidneys. Some local corticosteroids and their metabolites are also removed with bile. The pharmacodynamics Akriderm contains dipropionic ether of betamethasone which is the glucocorticoid having usual properties of corticosteroids. In pharmacological doses the corticosteroids are used mainly in connection with their anti-inflammatory and (or) immunodepressantny action. Local corticosteroids, such as betamethasone Dipropionas, are effective at treatment of a number of a dermatosis in connection with their anti-inflammatory, antipruritic and vasoconstrictive action. However, while physiological, pharmacological and clinical action of corticosteroids is well studied, exact mechanisms of their action in each disease are not clear. Indications Akriderm treats the synthetic fluorinated corticosteroids. He possesses local action and is shown at: – eczemas and dermatitis of all types, including in atopic eczema, a photodermatitis – red flat herpes, simple herpes – knotty to a prurigo, a diskoidny lupus erythematosus – a lipoid necrobiosis, a pretibialny myxedema and in an erythrosis – psoriasis of head skin and chronic blyashechny psoriasis of brushes and feet, except for widespread blyashechny psoriasis. Route of administration and doses Adults and children: From one to two times a day. In most cases it is necessary to put the Akriderm cream pellicle, covering affected areas, twice a day. At some patients the effect of the supporting treatment is reached at more rare putting drug. Akriderm, external use cream appoint to children carefully and to the shortest term. When using betamethasone at children and at elderly or on face skin, the course of treatment should not exceed 5 days. Akriderm cream is especially effective when drawing on the damp and becoming wet surfaces. Side effect Skin dosage forms of the drug Akriderm are usually well transferred, and side effects are observed seldom. System absorption of betamethasone of Dipropionas can increase if drug is applied on sites with big surface area or skin folds throughout long spans or in a large number. Under these circumstances it is necessary to observe the appropriate measures of precaution, especially at babies and children. Local undesirable reactions: – burning, an itching, irritation of skin, dryness – a folliculitis, a hypertrichosis – acneform rash, hypopigmentation – perioral dermatitis, allergic contact dermatitis, maceration of skin – consecutive infection – striya, a heat rash. Prolonged use of drug can lead to local skin changes, striya, a teleangiectasia, especially on face skin. Contraindications – pink eels, an acne, vulgar eels, a rozatsea – perioral dermatitis – a perianal and genital skin itching – hypersensitivity to any of ingredients of dosage forms of the drug Akriderm – tuberculosis and the majority of virus damages of skin, in particular – viruses of a herpes simplex, a variolovaccine, chicken pox – children’s age till 1 year – viral, bacterial and fungus skin diseases – skin manifestations of syphilis – skin vaccine-challenged reactions – open wounds – trophic ulcers of a shin – pregnancy and the period of a lactation – a carcinoma cutaneum, a melanoma, an atheroma, sarcoma, a xanthoma Akriderm (heat rash) should not apply at irritation of skin from diapers and also in fungal or bacterial skin infections without the corresponding accompanying anti-infectious therapy. Medicinal interactions of Interaction of drug with other medicines are not revealed. Special indications of Manifestation of local and system toxicity are observed often, especially at prolonged continuous use on big sites of the injured skin, on folds or under a polyethylene covering. Courses of use for children or on face skin have to be limited for 5 days. At all patients, irrespective of age, it is necessary to avoid long-term continuous treatment. It is not necessary to use occlusive bandages. Local corticosteroids can be dangerous in psoriasis for a number of reasons, including in view of a return recurrence after stability development, owing to risk of developing generalized pustulous psoriasis and local system toxicity in connection with broken by barrier function of skin. It is important to watch the patient carefully. General aspects: System absorption of local corticosteroids can cause reversible oppression gipotalamo – hypophysial and adrenal system (HPA) with a potential of glucocorticosteroid insufficiency after treatment cancellation. System absorption of local corticosteroids during treatment can cause manifestations of a syndrome of Cushing in some patients also. It is noted that the patients receiving a high dose of a powerful local corticosteroid on the big site should be examined periodically on existence of oppression of HPA, it is necessary to make attempts of drug withdrawal, reduction of frequency of its drawing or its replacement by less powerful corticosteroid. After drug withdrawal usually there is a fast and complete recovery of the HPA function. In rare instances there can be signs and symptoms of cancellation demanding additional treatment by system corticosteroids. They can have more sensitive to system toxicity patients children at equivalent doses in connection with existence of higher ratio of surface area of skin to body weight. At emergence of irritation treatment it is necessary to interrupt and appoint the corresponding therapy. Akriderm is not intended for use in ophthalmology. Use for children: At patients children higher sensitivity to the oppression of HPA caused by a local corticosteroid and an exogenous corticosteroid and also to influence of an exogenous corticosteroid, than at adult patients, in connection with more significant absorption of drug in view of higher ratio of surface area of skin to body weight can be observed. The patients children receiving local corticosteroids, oppressions of HPA, Cushing’s syndrome and increase in intracranial pressure have messages about emergence. Manifestations of oppression of adrenal glands at patients children include linear delay of growth, a delay of gain of body weight, low levels of cortisol in plasma and lack of the response to stimulation of AKTG. Manifestations of increase in intracranial pressure include protrusion of a fontanel, headaches and a bilateral papilledema. Features of influence of drug on genital function, pregnancy and a lactation it was not conducted adequate and sufficiently controlled researches of teratogenic potential of locally applied corticosteroids at pregnant women. Therefore local steroids should be applied during pregnancy only when the potential advantage justifies potential risk for a fruit. It is unknown whether leads topical administration of corticosteroids to significant system absorption with accumulation of the defined amounts of drug in breast milk. Systemically the entered corticosteroids cosecrete in breast milk in quantities which adverse effect on the baby is improbable. Nevertheless, the decision on whether it is necessary to interrupt drug use, has to be accepted taking into account importance of drug for health of mother. There Is no feature of influence of drug on ability to run the vehicle or potentially dangerous mechanisms data Overdose Excess prolonged use of local corticosteroids can cause oppression of functions of a hypophysial and adrenal system and result in secondary insufficiency of adrenal glands which is usually reversible. In such cases the corresponding symptomatic treatment is shown. At emergence of signs of oppression of HPA it is necessary to make an attempt of drug withdrawal, reduction of frequency of its drawing or its replacement by less powerful corticosteroid. Steroid content in each tuba is so low that at accidental hit of drug in an oral cavity the manifestation of its toxic action is improbable. A form of release and packing On 15 g or 30 g in a tuba aluminum or import. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack from cardboard for a retail container. 4 years not to use a period of storage after an expiration date. Storage conditions At a temperature from 15 wasps up to 25 wasps. To store out of children’s reach! Prescription status According to the prescription the Producer/packer Joint-stock company “Chemical and pharmaceutical plant “AKRIKHIN” (JSC AKRIKHIN), Russia 142450, the Moscow region, the Noginsk district. Old Kupavna, Kirov St., 29, phone number / fax: +7 (495) 702-95-03. Owner of the registration certificate Joint-stock company “Chemical and pharmaceutical plant “AKRIKHIN” (JSC AKRIKHIN), Russia 142450, Moscow region, Noginsk district. Old Kupavna, Kirov St., 29, phone number / fax: +7 (495) 702-95-03.