Akritsil 0.05% + 3% 15g ointment tube for external use
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Instruction for medical use of Akritsil Torgovoye medicine name: Akritsil Mezhdunarodnoye unlicensed name: There is no Dosage form: ointment for external use Structure of 100 g of ointment is contained: active agents: betamethasone Dipropionas in terms of 100% of substance – 0.064 g that is equivalent to 0.05 g of betamethasone, salicylic acid in terms of 100% of substance – 3 g, excipients: liquid paraffin (liquid paraffin) – 10 g, vaseline – up to 100 g. The description Translucent ointment from color, white to white with a yellowish shade. Existence of a slight specific smell is allowed. Pharmacotherapeutic group: Drugs for treatment of diseases of skin. 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 Code: D07XC01 the Pharmacological Pharmacokinetics Later properties of topical administration salicylic acid has only local effect. Extent of transdermal absorption at topical administration of a corticosteroid is defined by many factors, including a drug basis, integrity of an epidermal barrier and use of an occlusive bandage. Local corticosteroids can be absorbed through intact, healthy skin. Inflammation and/or other pathological processes of skin can strengthen transdermal absorption. Use of an occlusive bandage considerably strengthens transdermal absorption of corticosteroids at topical administration. After absorption through skin the local corticosteroids enter the pharmacokinetic processes similar to those at use of corticosteroids of systemic action. Corticosteroids in various degree contact proteins of blood plasma, are metabolized mainly in a liver and removed by kidneys. Some local corticosteroids and their metabolites are also removed with bile. The pharmacodynamics is a part of the drug Akritsil dipropionatny ether of betamethasone (the glucocorticoid having the general properties of corticosteroids) and the salicylic acid having keratolytic properties. Betamethasone Dipropionas is the synthetic fluorinated corticosteroid. Salicylic acid is applied locally at treatment of the states which are followed by a hyperkeratosis and peeling when keratolytic action facilitates penetration of a corticosteroid. In pharmacological doses the corticosteroids are used first of all for obtaining anti-inflammatory and/or immunooverwhelming effects. Local corticosteroids, such as betamethasone Dipropionas, are effective in treatment of a dermatosis owing to their anti-inflammatory, antipruritic and vasoconstrictive action. In spite of the fact that physiological, pharmacological and clinical effects of corticosteroids are well-known, the exact mechanism of action in each disease is unknown. Indications – an inflammatory dermatosis which is sensitive to therapy by local corticosteroids, – psoriasis of skin of a hairy part of the head, – chronic blyashkovidny psoriasis of brushes and feet (an exception: widespread blyashkovidny psoriasis), – a condition of skin, the demanding flakings of the keratosic epithelium and desquamation of epidermis, – the giperkeratichesky, dry dermatosis sensitive to corticosteroids. A route of administration and doses Adult 1–2 once a day. In most cases drug should be applied with a thin layer on affected areas of skin 2 times a day. At some patients the adequate supporting treatment can be reached at less frequent use of drug. It is recommended to use the drug Akritsil for 2 weeks, then to consider a question of therapy continuation. The maximum week dose should not exceed 60 g. Children the Course of treatment for children makes no more than 5 days. Side effects Dosage forms of the drug Akritsil for skin use it is transferred, as a rule, well, and side reactions arise seldom. At prolonged use: – a local atrophy of skin, – striya, – expansion of superficial vessels, especially on a face, – dermatitis. At topical administration: – burning sensation, – an itching, irritation, dryness, – a folliculitis, – a hypertrichosis, – acneform rashes, – hypopigmentation, – perioral dermatitis, allergic contact dermatitis. When using under an occlusive bandage: – maceration of skin, – consecutive infection, – an atrophy of skin, a striya, – a heat rash. At emergence of the side reactions which are not described in the instruction it is necessary to see a doctor. Contraindications – hypersensitivity to any of drug components, – tubercular damage of skin, – perioral dermatitis, – a perianal and genital itching, – pink eels (rozatsea) and ordinary eels, – trophic ulcers against the background of chronic venous insufficiency, – skin tumors (carcinoma cutaneum, a nevus, an atheroma, an epithelioma, a melanoma, a hemangioma, a xanthoma, sarcoma), – skin manifestations of syphilis, – chicken pox, – a herpes simplex, – skin vaccine-challenged reactions, – fungal or viral infections of skin if the corresponding anti-infectious treatment at the same time is not carried out, – a diaper dermatitis. – open wounds, – the lactation period, – children’s age till 1 year. Medicinal interactions Medicinal interactions are not established. Special instructions Salicylic acid at topical administration possesses keratolytic action and can lead to strengthening of absorption of a corticosteroid therefore it is impossible to apply an occlusive bandage. Often there is local and systemic toxic action, especially after prolonged use on extensive sites of the affected skin, pleated skins or under a polyethylene occlusive bandage. At children and at patients with damage of face skin the course of treatment should not exceed 5 days. It is necessary to avoid long-term continuous treatment at all patients, irrespective of their age. Local corticosteroids can be potentially dangerous in psoriasis for several reasons, including repetition of aggravation after development of tolerance, risk of developing generalized pustulous psoriasis and local or system toxicity because of deterioration in barrier function of skin. Careful observation of a condition of the patient is necessary. The contact of drug with eyes represents danger. It is necessary to avoid hit of drug in eyes and on mucous covers. System absorption of betamethasone of Dipropionas and salicylic acid can increase if drug is used on extensive sites of skin or folds of skin throughout a long span or at use of excessive quantities of corticosteroids. In such conditions it is necessary to observe the appropriate measures of precaution, especially at use of drug for newborns and children. At emergence of dryness, irritation of skin or a hyper sensitization it is necessary to stop drug use. At topical administration of corticosteroids, especially at newborns and children, the side effects characteristic of system corticosteroids, including oppression of function of bark of adrenal glands can develop. At emergence of excessive xeroderma or strengthening of irritation of skin the drug treatment should be stopped. Use in pediatrics Children are more subject to risk of oppression of function gipotalamo – a hypophysial and adrenal system owing to use of local corticosteroids and to emergence of effects of exogenous corticosteroids, than adults, because of a bigger ratio of body surface area at them both weight and, respectively, the increased drug absorption. There were messages about function suppression gipotalamo – a hypophysial and adrenal system, a hypercorticoidism syndrome, a growth inhibition, lag in a body weight increase, increase in intracranial pressure for the children receiving corticosteroids for topical administration. Function suppression gipotalamo – a hypophysial and adrenal system at children is defined by the low level of cortisol in plasma and lack of the response to stimulation of AKTG. Increase in intracranial pressure is shown by protrusion of a fontanel, headaches, a bilateral papilledema. To children since 1 drug is appointed only according to strict indications and under medical control as development of the system side effects connected with betamethasone is possible. Pregnancy and the period of a lactation Because safety of use of local corticosteroids at pregnancy is not established, purpose of this class of medicines is justified only if the potential advantage for mother exceeds potetsialny risk for a fruit. During pregnancy, drugs of this group should not be used in high doses or long time. As so far it is not found out whether the level of system absorption of corticosteroids is sufficient for emergence of their defined concentration in breast milk, for the period of treatment it is necessary to stop either breastfeeding, or drug use, considering as far as it is necessary for mother. Influence on ability of control of vehicles or difficult technical devices is not established to feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms. Overdose Symptoms: excessive or long use of glucocorticosteroids for topical administration can cause the oppression of function of a hypophysial and adrenal system leading to secondary insufficiency of function of adrenal glands and the phenomena of a hypercorticoidism including Cushing’s disease. Treatment: symptomatic therapy. Acute symptoms of a hypercorticoidism are usually reversible. If necessary to carry out correction of an electrolytic imbalance. In case of chronic manifestation of symptoms of overdose the slow cancellation of corticosteroids is recommended. Prolonged broad use of the drugs containing salicylic acid can cause emergence of symptoms of a salitsilizm. Symptomatic treatment. At manifestation of symptoms of a salitsilizm take measures for faster removal of salicylates from an organism. Orally apply Natrii hydrocarbonas to alkalifying of urine and strengthening of a diuresis. Steroid content in each tuba very low, and toxic effect is absent or small therefore the overdose at accidental intake is improbable. A form of release and packing Ointment for external use, 0.05%+3%. On 15 or 30 g in a tuba aluminum. Each tuba together with the instruction for medical use in the state and Russian languages is placed in a pack from cardboard. Period of storage 3 years. Not to apply after an expiration date. Storage conditions At a temperature from 15 to 25 °C. To store out of children’s reach! Prescription status According to the prescription the Name and the address of the manufacturing organization 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 address of the owner of the registration certificate of JSC Khimfarm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 Phone number 7252 (610151) the E-mail address of firstname.lastname@example.org the Name and the address of the organization, the accepting claim (offer) on quality of medicine in the territory of the Republic of Kazakhstan JSC Khimfarm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 Phone number +7 7252 (610151) the E-mail address of email@example.com the Name and the address 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)
to Develop the E-mail address of firstname.lastname@example.org, email@example.com
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