Mometasone Santo 0.1g of 30% cream for topical use

The instruction for medical use of Mometazon Santo Torgovoye medicine a name Mometazon Santo the International unlicensed name Mometazon Lekarstvennaya a form Cream for external use of 0.1% contain Structure of 100 g of cream: active agent: a mometazona of furoate, in terms of 100% substance of 0.1 g, excipients: hexyleneglycol, glyceryl monostearate 40-55, cetostearyl alcohol, a macrogoal tsetostearat (a macrogoal the 20th cetostearyl ether), white beeswax, the titan dioxide, starch aluminum octenylsuccinate, water the purified, phosphoric acid the diluted or phosphoric acid concentrated in the form of 10% of solution, vaseline. Description Cream of white or almost white color. Pharmacotherapeutic group Glucocorticosteroids for topical treatment of diseases of skin. Glucocorticosteroids. Glucocorticosteroids active (group III). Mometazon. The ATX D07AC13 code the Pharmacological Pharmacokinetics Absorption properties of Mometazon Santo cream it is insignificant. In 8 hours after drawing on the uninjured skin (without occlusive bandage) in a system blood-groove about 0.4% of drug are found. Mometazon's pharmacodynamics furoate – a synthetic glucocorticosteroid (GKS) possessing anti-inflammatory, antipruritic and anti-exudative action. GKS induces discharge of the proteins inhibiting a phospholipase of A2 and known under the general name of a lipokortina which control biosynthesis of such mediators of inflammation as prostaglandins and leukotrienes, by slowing down of release of their common precursor, arachidonic acid. Indications - the inflammatory phenomena and an itching in psoriasis (except widespread psoriasis) and atopic dermatitis. Route of administration and doses Outwardly. A thin film of Mometazon Santo cream is applied on affected areas of skin once a day. The course of treatment depends on disease severity and is defined by the attending physician. Use of local corticosteroids at children or in a face should be limited to the effective mode of therapy, minimum, necessary for achievement. Duration of treatment should not exceed 5 days. Side effects Undesirable reactions are given according to occurrence frequency: very often (≥1/10), it is frequent (≥1/100, ˂1/10), infrequently (≥1/1000, ˂1/100), is rare (≥1/10000, ˂1/1000), is very rare (˂1/10000), frequency is not established (it cannot be defined on the basis of the available data). Very seldom - a folliculitis - local reactions in the form of burning and the nagger Chastota is not established - bacterial infections, a furunculosis - paresthesia - contact dermatitis, hypoxanthopathy, a hypertrichosis, skin striya, acneform rashes, a skin atrophy - pain and local reactions on the site of use of drug Are available data on emergence of local side reactions owing to use of topical dermatological corticosteroids, such as: - the dryness and irritation of skin - dermatitis, perioral dermatitis - maceration of skin - a heat rash and telangiectasias At use of the GKS external forms for a long time and/or when drawing on big sites of skin, or with use of occlusive bandages, especially at children and teenagers can arise the side effects characteristic of GKS of systemic action, including adrenal insufficiency and an Icenco-Cushing syndrome. Contraindications - hypersensitivity to any component of drug or to glucocorticosteroid means, - pink eels, perioral dermatitis, - a skin atrophy, - injuries of skin (wounds, ulcerations), - bacterial, virus (a herpes virus, chicken pox) or a fungal infection of skin, - tuberculosis, syphilis, - vaccine-challenged reactions, - children's age up to 2 years, Medicinal interactions Medicinal interactions are not described. The special instructions Drug it is intended only for external use. 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 a dermatological infection it is necessary to appoint the corresponding antifungal or antibacterial therapy. When drawing on big sites of skin for a long time, especially at use of occlusive bandages, development of systemic action of GKS is possible. Considering it, patients have to be observed concerning signs of suppression of function gipotalamo - the hypophysial and adrenal system and development of an Icenco-Cushing syndrome. It is necessary to consider that GKS are capable to change manifestations of some diseases of skin that can complicate diagnosis. Besides, use of GKS can be the cause of a delay of healing of wounds. At long therapy of GKS the sudden termination of therapy can lead ment of a syndrome of the ricochet which is shown in the form of dermatitis with intensive erubescence and burning sensation. Therefore after a long course of treatment the drug withdrawal should be made gradually, for example, passing to the intermittent scheme of treatment before completely to stop it. The propylene glycol which is a part of drug can cause irritation of skin. Use in pediatrics Safety of use of a mometazon for children for more than 6 weeks was not studied. Owing to lack of data on safety and efficiency the prescribing of the drug Mometazon Santo is not recommended to children 2 years are younger. Because children have a size of a ratio of surface area and body weight it is more, than at adults, children are subject to bigger risk of suppression of function gipotalamo - the hypophysial and adrenal system and development of an Icenco-Cushing syndrome at use of any GKS of local action. Long-term treatment of children of GKS can lead to disturbances of their growth and development. Use of local corticosteroids at children has to be limited to minimum effective amount of drug and the minimum period of use. Pregnancy and the period of a lactation Safety of use of Mometazon Santo cream during pregnancy and a lactation is not studied. Glucocorticosteroids get through a placental barrier. It is necessary to avoid long-term treatment and use of high doses during pregnancy in connection with threat of negative impact on fetation. Glucocorticosteroids are allocated with breast milk. In case use of GKS in high doses and/or is supposed for a long time, it is necessary to stop breastfeeding. The feature of influence of medicine on ability to run the vehicle and other potentially dangerous mechanisms of Influence of medicine on ability to drive the car or moving mechanisms is noted. Overdose Symptoms: excessive or prolonged use of local glucocorticosteroids can cause function oppression gipotalamo - a hypophysial and adrenal system that can become the reason of development of secondary adrenal insufficiency. Treatment: symptomatic. Acute symptoms of a hypercorticoidism are usually reversible. If necessary correction of an electrolytic imbalance is shown. In case of chronic toxic action the gradual cancellation of glucocorticosteroids is recommended. A form of release and packing On 15 g or 30 g in a tuba aluminum. Each tuba together with the instruction for medical use in the state and Russian languages will prevent in a pack from cardboard. To Store storage conditions at a temperature not above 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 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. The name and the country of the owner of the registration certificate of JSC Khimpharm, the Republic of Kazakhstan the Name and the country of the organization packer Joint-stock company 'Chemical and pharmaceutical plant 'AKRIKHIN' (JSC AKRIKHIN), Russia
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) of JSC Khimpharm, Shymkent, Republic of Kazakhstan, Rashidov St., 81 the Address of the organization in the territory of the Republic of Kazakhstan responsible for post-registration observation of safety of medicine of JSC Khimpharm Republic of Kazakhstan, Shymkent, Rashidov St., 81