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Akriderm HA 0.05% + 0.1% + 1% 15g of the cream in the tube




The instruction for medical use of medicine of Akriderm GK Torgovoye nazvaniye Akriderm GK the International unlicensed name Is not present the Dosage form external use Cream of 0.05% + 0.1% + 1% the Structure of 100 g of drug contains: active agents: Dipropionas betamethasone (in terms of 100% substance) 0.064 g that is equivalent to 0.05 g of betamethasone of Clotrimazolum (in terms of 100% substance) 1.000 g of Gentamycin (in the form of Gentamycini sulfas) 0.100 g excipients: vaseline, propylene glycol, paraffin liquid, cetostearyl alcohol (cetyl alcohol of 60%, stearyl alcohol of 40%), a macrogoal tsetostearat (a macrogoal-20 cetostearyl ether), dinatrium edetat, dihydrophosphate sodium a dihydrate, the water purified. Description Cream of white or almost white color. Pharmacotherapeutic group: Drugs for treatment of diseases of skin. Glucocorticosteroids of 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 code: D07XC01 the Pharmacological Pharmacokinetics Researches properties of absorption after topical administration of drug were not conducted. Betamethasone In normal conditions at topical administration comes to a system blood stream only a part of betamethasone. The share of penetration depends on a part of the body, a condition of skin, a dosage form, age of the patient and a way of drawing. Gentamycin When putting gentamycin on the uninjured skin the absorption is improbable. However at damage of a keratinaceous layer, inflammations, use under an occlusive bandage or drawing on the extensive square it is necessary to expect the strengthened transdermal absorption. Clotrimazolum After drawing the most part of Clotrimazolum remains in a corneal layer, and absorption in a system blood stream is insignificant. In 6 hours after drawing 1% of radioactive Clotrimazolum for healthy skin and also on skin with an acute inflammation, the following concentration of drug were defined: a corneal layer – 100 mkg/cm ³, a reticular layer – 0.5–1 mkg/cm ³, hypodermic cellulose – 0.1 mkg/cm ³. The pharmacodynamics the Mechanism of action of Preparat Akriderm GK possesses three mechanisms of action: anti-inflammatory effect of betamethasone of Dipropionas, antibacterial effect of gentamycin and antifungal effect of Clotrimazolum. Pharmacodynamics. Betamethasone Dipropionas is a strong corticosteroid (class of action III) with anti-inflammatory, antiallergic and antipruritic action. Gentamycin is an aminoglikozidny antibiotic with bactericidal action. Its action is based on suppression of protein synthesis of sensitive microorganisms. Gentamycin influences many aerobic gram-negative and some gram-positive bacteria. In vitro gentamycin, in concentration of 1-8 mkg/ml suppresses growth of the majority of sensitive strains of Escherichia coli (colibacillus), Haemophilus influenzae (hemophilic stick), Moraxella lacunata (Moraks’s sticks — Aksenfelda), Neisseria (neysseriya), an indole – positive and an indole – negative a protea, Pseudomonas (pseudo-monads) (including the majority of strains of Pseudomonas aeruginosa (pyocyanic stick)), Staphylococcus aureus (golden staphylococcus), Staphylococcus epidermidis (epidermal staphylococcus) and Serratia (serration). Different types and strains of the same types can show big differences of sensitivity in the conditions of in vitro. Besides, the sensitivity of in vitro not always correlates with sensitivity of in Vivo. Gentamycin is not effective concerning the majority of anaerobic bacteria, mushrooms and viruses. Gentamycin makes only the minimum impact on streptococci. The resistance to gentamycin can develop as at gram-negative, and gram-positive bacteria. Clotrimazolum is synthetic antifungal means – to imidazole derivatives. The range of its action covers a number of the mushrooms which are pathogenic for the person. Clotrimazolum is effective against dermatophytes, barmy and mold mushrooms. During analyses of in vitro Clotrimazolum showed efficiency against fungi of Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis and fungi of the sort Candida, including Candida albicans. According to knowledge which is available today, the antifungal effect of Clotrimazolum is explained by ergosterol synthesis suppression. Ergosterol is the vital component of a cellular membrane of mushrooms. Indications – treatment of a dermatosis which is sensitive to corticosteroids, at existence or suspicion of a bacterial and/or fungal infection – treatment of disturbances in the exudative period. Route of administration and doses Teenagers and adults: To apply cream of Akriderm GK with a thin layer on the struck surface of skin 2 times a day (in the morning and in the evening) and to rub slightly, at the same time it is necessary to cover both all affected area, and the healthy skin surrounding it. Duration of treatment depends on results of clinical effect and also clinical and microbiological data. At a dermatofitiya of feet there can be necessary longer course of treatment (2–4 weeks). Children aged from 2 up to 12 years: To apply drug of Akriderm GK with a thin layer only on the struck surface and to rub slightly. Cream in enough should be applied not more often than 2 times a day with the minimum break between appliques at 6-12 o’clock. To put cream on a face, a neck, head skin, areas of genitalias, rectal area and folds of skin follows under observation of the doctor. Duration of treatment is limited for 5-7 days. You watch the sections Special Instructions and Use for Patients of Children’s Age. Side effects of Disturbance from skin Seldom: – irritation, burning sensation, an itching, xeroderma, – hypersensitivity reactions on any of drug ingredients, – discoloration of skin. At use on the extensive areas of skin, under an occlusive bandage and/or at prolonged use At use on the extensive areas of skin, under an occlusive bandage and/or at prolonged use, local changes of skin are possible. When drawing on the extensive areas of skin there is a probability of system influence (suppression of function of bark of adrenal glands). It is necessary to remember that because of the lowered local resilience to infections there is an increased risk of developing of consecutive infections. Disturbances from skin: – local changes of skin, such as atrophy (especially on a face), teleangiectasias, striya, extensions, skin hemorrhages, a purpura, steroid an acne, rozatseapodobny / perioral dermatitis, a hypertrichosis, discoloration of skin. It is unknown whether discoloration of skin has reversible character. Infrequently: – contact sensitivity to gentamycin, – a photosensitization (however this effect does not renew at repeated putting gentamycin with the subsequent influence of UF of radiation). Disturbances from an endocrine system: – suppression of synthesis of endogenous corticosteroids, – hyperactivity of adrenal glands with hypostases. Disturbances from metabolism: – manifestations of latent diabetes. Disturbances from hearing, an inner ear / kidneys: If drug of Akriderm GK is used on the extensive areas of skin or on sites of the injured skin, at simultaneous system use of aminoglikozidny antibiotics it is necessary to expect cumulative ototoxicity / nephrotoxicity. Disturbances from a skeletal and muscular system: – osteoporosis, – a growth inhibition (at children). Contraindications – hypersensitivity to active agents or any excipient of drug (a cross allergy with gentamycin) and/or (a cross allergy with Clotrimazolum) – skin infections (virus, bacterial [incl. tuberculosis] and also a fungal etiology) – reactions to vaccines – skin ulcers and an acne – a rozatse, perioral dermatitis – not to apply under an occlusive bandage – it is impossible to apply on mucous membranes, eyes and skin around eyes – pregnancy, the lactation period – children’s age up to 2 years Medicinal interactions At use of drug of Akriderm GK in genital or anal area such excipients as vaseline and liquid paraffin, can lead to reduction of durability of at the same time used latex condom and, therefore, to decrease in its reliability. At topical administration Clotrimazolum can have antagonistic effect in relation to Amphotericinum and other half-yen antibiotics. Special instructions At emergence of irritation or a sensitization because of use of cream of Akriderm GK treatment it is necessary to stop and begin the corresponding therapy. Absorption of the active agents intended for topical administration in a system blood stream can amplify if cream of Akriderm GK is applied on the big square, in particular at prolonged use or when drawing on the injured skin. In these conditions the emergence of the undesirable effects characteristic of system use of active agents is possible. At use for children in such cases it is recommended to show extra care. At simultaneous use of aminoglikozidny antibiotics of systemic action, it is necessary to remember possibility of cumulative toxic effect (ototoxicity, nephrotoxicity) in case of the increased transdermal absorption. In particular, it is necessary to consider cross-reaction probability on other aminoglikozidny antibiotics. Emergence of the following side reactions connected with use of the excipients which are a part of drug is possible: – cetostearyl alcohol: local skin reactions (contact dermatitis), – propylene glycol: irritation of skin. At long-term treatment by the drugs containing antibiotics insensitive microorganisms can appear. In that case, or at emergence of superinfection, it is necessary to begin the corresponding therapy. Use in high doses, drawing on extensive sites of skin or under an occlusive bandage of strong or very strong corticosteroid has to be carried out only under regular observation of the doctor, especially taking into account suppression of development of endogenous corticosteroids and possible metabolic effect. It is necessary to avoid use on open wounds and the damaged sites of skin. The term of continuous use which is 2–3 weeks, whenever possible should not be exceeded. It is necessary to apply corticosteroids of very strong, strong and moderate action on a face and in genitals with exclusive care not longer than 1 week. Around eyes only low-dose corticosteroids (glaucoma) are applied. Corticosteroids can mask symptoms of allergic reaction to any ingredient of drug. The patient should explain that this drug should be used only for treatment of his current disease of skin and not to give drug to other persons. Use for patients of children’s age is not recommended to use This drug at children under 2 years. At patients of children’s age the manifestation bigger, than at adult patients, sensitivity to suppression gipotalamo – the hypophysial and adrenal axis and activity of exogenous corticosteroids (caused by corticosteroids for topical administration) as because of the bigger relation of surface area of skin to body weight the absorption is more intensive is possible. About suppression gipotalamo – a hypophysial and adrenal axis, Cushing’s syndrome, delay of linear growth, delay of increase in body weight and increase in intracranial pressure it was reported when using corticosteroids for topical administration at children. Symptoms of suppression of function of adrenal glands at children include: low level of cortisol in blood plasma and lack of reaction to stimulation of AKTG. Symptoms of increase in intracranial pressure include protrusion of fontanels, a headache and a bilateral papilledema. Pregnancy and the period of a lactation Pregnancy Is not present data on use of drug for pregnant women. Aminoglycosides, at use by the pregnant woman, get through a placental barrier and can have negative impact on a fruit. Messages about full, irreversible, bilateral congenital deafness at children whose mothers during pregnancy received aminoglycosides, including gentamycin arrived. There are no sufficient data on topical administration of gentamycin during pregnancy. There are no sufficient data on use of Clotrimazolum during pregnancy. Cream of Akriderm GK should not be applied on the extensive areas of skin, in large numbers or for a long time. The lactation of Data on discharge of gentamycin, Clotrimazolum and corticosteroids for topical administration in breast milk is not present. However corticosteroids of systemic action get into breast milk. Drug of Akriderm GK is contraindicated to the feeding women if it needs to be applied to skin of mammary glands. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms influence of drug on ability to run motor transport and mechanisms was not studied. Overdose Symptoms. At prolonged or excessive use of local corticosteroids the oppression of hypophysial and adrenal function with development of secondary adrenal insufficiency and emergence of symptoms of hyperactivity of bark of adrenal glands, including Cushing’s syndrome is possible. It is impossible to exclude that the single overdose of gentamycin can induce development of such symptoms. Excessive or prolonged topical administration of gentamycin can lead to the excess growth of fungi or microorganisms, insensitive to an antibiotic, in the place of damage of skin. Treatment. Appoint the corresponding symptomatic therapy. Symptoms of acute hyperactivity of bark of adrenal glands are usually reversible. If it is necessary, carry out correction of an electrolytic imbalance. In case of chronic toxic action the gradual cancellation of corticosteroids is recommended. With an excess growth of insensitive microorganisms it is recommended to stop treatment by AkridermGK cream and to appoint the corresponding antifungal or antibacterial treatment. A form of release and packing On 15 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 of subgroups chromic or chrome ersatz. To Store storage conditions in original packing at a temperature from 15 to 25 °C. To store out of children’s reach! Period of storage 2 years. Not to apply after an expiration date. Prescription status According to the prescription the Name and the country of the organization 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. The name and the country of the owner of the registration certificate of JSC Khimfarm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan, the accepting claim (offer) on quality of medicines from consumers of JSC Khimfarm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number +7 7252 (610151) the E-mail address of the Name, the address and a contact information of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of JSC Khimfarm, Republic of Kazakhstan, Shymkent, Rashidov St., 81 Phone number +7 7252 (610150)
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