The instruction for medical use of NOBETAZON medicine the Trade name of NOBETAZON the International unlicensed name Betamethasone Dosage Form Cream for external use of 0.1% Structure of 1 g of cream contains active agent – betamethasone of valerate of 1.22 mg (it is equivalent to betamethasone of 1 mg) excipients: tsetomakrogol 1000, chlorcresol, sodium dihydrophosphate monohydrate, sodium hydroxide, phosphoric acid, vaseline white, liquid paraffin, cetostearyl alcohol, the water purified. The description Uniform cream from white till almost white color, free from foreign inclusions. Pharmacotherapeutic group Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids. Glucocorticosteroids active (group 3). Betamethasone. The ATX D07AC01 code the Pharmacological Pharmacokinetics Data properties about pharmacokinetics of the drug Nobetazon are absent. The pharmacodynamics Nobetazon has anti-inflammatory, antipruritic and vasoconstrictive effect. Betamethasone slows down release of cytokines and mediators of inflammation, reduces metabolism of arachidonic acid, initiates formation of the lipokortin having antiedematous activity, reduces permeability of vessels. Indications – – atopic dermatitis (including children’s atopic dermatitis) – monetovidny dermatitis (eczema monetovidny) – allergic contact dermatitis – seborrheal dermatitis – neurodermatitis, solar dermatitis – exfoliative dermatitis – stagnant dermatitis – radiation dermatitis – intertriginozny dermatitis – external otitis – psoriasis – red flat deprive inflammatory manifestations at the dermatosis sensitive to corticosteroid therapy – a diskoidny lupus erythematosus – an anogenitalny and senile itching – reactions at stings of insects Nobetazon apply the Route of administration and doses with a thin layer on affected areas of skin of 1 – 3 time a day, depending on weight of a state, and accurately rub. In most cases for achievement of effect it is enough to put 1 – 2 time a day. Frequency of putting drug is determined according to extent of defeat. At easy degree the defeats drug can be inflicted once a day, in case of more severe defeats the frequency of putting drug needs to be increased. Duration of a course of treatment is determined by the doctor depending on weight and a course of the disease until improvements, but become noticeable no more than 4 weeks. Treatment Nobetazon should be finished with cream gradually as soon as the effect is reached, maintenance therapy by putting cream once a day and not more often than 2 times a week further is recommended. At the sharp termination of drug treatment, the dermatosis can be shown again. The route of administration at children matches that at adults, but the course of treatment has to be short and less active in comparison with adults (see sections of Contraindication and Special Instructions). Side effects – burning sensation – irritation of skin – naggers – xeroderma – a folliculitis – a hypertrichosis – acneform rashes – hypopigmentation – perioral dermatitis – allergic contact dermatitis – maceration of skin – consecutive infection – a skin atrophy – striya – myalgia Side effects at children – function oppression gipotalamo – a hypophysial and adrenal system – Cushing’s syndrome – a growth inhibition – lag in a weight increase – increase in intracranial pressure. Contraindications – hypersensitivity to any component of drug – children’s age up to 6 months – pregnancy (use of high doses, long-term treatment) and the lactation period – the raw skin infections – youthful eels Medicinal interactions the Concomitant use of drugs which can inhibit CYP3A4 (for example, ritonavir, itrakonazol) as a rule inhibit metabolism of corticosteroids and lead to increase in system influence. Degree in which this interaction is clinically significant depends on a dose and methods of administration of corticosteroids and also potential CYP3A4 inhibitor. The special instructions Drug it is not intended for use in ophthalmology. When using drug in the field of a century, be convinced that drug did not get into eyes as development of a cataract and glaucoma as a result of repeated influence is possible. If at use of drug the irritation or hypersensitivity is noted, treatment the patient should stop and pick up other therapy. In the presence of an infection it is necessary to appoint antifungal or antibacterial agents, respectively. If at the same time the desirable effect does not occur quickly, use of corticosteroids needs to be stopped before elimination of symptoms of an infection. Any by-effects which meet at system use of glucocorticoids including suppression of bark of adrenal glands, can arise also at their topical administration, especially at babies and children. System absorption of local corticosteroids can increase at their use for a long time, at treatment of a big body surface or when using occlusive bandages. Use in pediatrics Children can be more susceptible to action of the local glucocorticosteroids causing oppression gipotalamo – a hypophysial and adrenal system, than patients of advanced age. It is connected with higher absorption of drug at children owing to the bigger size of a ratio of surface area and body weight. At babies and children the system absorption of local glucocorticosteroids at their prolonged use can increase, at treatment of extensive body surfaces or when using of the closing bandages. Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms Drug does not affect ability to run vehicles or difficult technical devices. Overdose Symptoms. Excessive or prolonged use of local glucocorticosteroids can cause oppression of hypophysial and adrenal function that there can be the reason of development of secondary insufficiency of bark of adrenal glands and emergence of symptoms of a hypercorticoidism, including Cushing’s syndrome. Treatment: Symptomatic treatment. If necessary correction of an electrolytic imbalance is shown. In case of chronic toxic action the gradual cancellation of glucocorticosteroids is recommended. The form of release and packing On 15 g and 30 g of drug place in the aluminum tubas corked by a plastic cover. On 1 tuba together with the instruction for medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer. To Store storage conditions at a temperature not above 25 °C, in the dry, protected from light place. To store out of children’s reach! A period of storage 2 years not to use drug after expiry date. Prescription status According to the prescription Republic of Kazakhstan JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Producer, Almaty, Shevchenko St. 162 E. The owner of the registration certificate of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika the Republic of Kazakhstan the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E. Address of the organization responsible for post-registration observation of safety of medicine: JSC Nobel Almatinskaya Pharmatsevticheskaya Fabrika Republic of Kazakhstan, Almaty, Shevchenko St. 162 E.