DescriptionWhite or almost white color, soft consistency, homogeneous cream, without foreign inclusions. The main active substance Mometasone Release form cream Dosage 15 g Pharmacological properties Pharmacodynamics Mometasone furoate is a synthetic corticosteroid with anti-inflammatory, antipruritic, vasoconstrictive effects. Pharmacokinetics The degree of penetration of topical corticosteroids through the skin depends on many factors, including the composition of the drug and the integrity of the epidermal barrier. Inflammation and other processes occurring in the skin can lead to increased penetration of the drug through the skin. Skin absorption of mometasone furoate 0.1% cream has been studied in humans by applying a single application of 3H-mometasone furoate radioactively labeled 0.1% cream to intact skin for 8 hours. Based on a 5-day study, which estimated the amount of isotope excreted in feces and urine, about 0.4% of the applied dose was subject to systemic absorption. During the study, the content of the radioactive substance in plasma and erythrocytes remained slightly higher than the initial level, which corresponded to the concentration ? 0.1 ng/ml. Indications for use Topical treatment of symptoms of inflammation and itching in corticosteroid-responsive skin conditions, including psoriasis and atopic dermatitis. Dosage and administration Elocom is applied in a thin layer to the affected areas of the skin 1 time per day. The duration of treatment is determined by the severity, course of the disease and is determined individually. The use of topical corticosteroids in children and adults on the face should not exceed 5 days. Continuous use of the drug should not exceed 2-3 weeks. Children Elokom should be used with caution in children over 2 years of age. There are limited data on the use of the drug for the treatment of children under 2 years of age. Use during pregnancy and lactation The safety of the use of local glucocorticosteroids in pregnant women has not been proven, therefore, the appointment of this group of drugs during pregnancy is justified only if the potential benefit to the woman outweighs the potential risk to the fetus. During pregnancy, drugs of this group should not be used in large doses or for a long time. When prescribing Elokom to a pregnant woman, glucocorticoids may cross the placenta and affect the fetus. It has not been clarified whether topical application of corticosteroids due to systemic absorption can lead to their appearance in mother’s milk. The decision to stop breastfeeding or discontinue the drug should be made taking into account the need for the drug in the mother. If you have to use the drug for a long time or on large areas of the skin, you must stop breastfeeding. Precautions Elocom is indicated for dermatological use only and is not intended for ophthalmic use. If irritation or hypersensitivity is noted during the use of the drug, treatment should be discontinued and appropriate therapy instituted. If infection develops, appropriate antifungal or antibiotic treatment should be given. If within a short time it is not possible to achieve a positive effect, you should stop using the drug until the signs of infection are eliminated. Any side effects of systemic glucocorticosteroids, including suppression of the function of the adrenal cortex, can also be observed with topical application of glucocorticosteroids, especially in young children. When using the drug on a large surface of the body or in high doses, it is recommended to periodically monitor the function of the adrenal glands. It should be used with extreme caution in patients with psoriasis, since topical application of glucocorticosteroids in psoriasis can be dangerous due to relapse of the disease with the development of tolerance, the risk of generalization of pustular psoriasis and the development of local or systemic toxicity due to impaired skin barrier function. Systemic absorption of glucocorticosteroids when applied topically will be higher if the treatment is carried out on extensive body surfaces or when used under occlusive dressings. In such cases, as well as with prolonged use of the drug, precautions should be taken. As with all potent glucocorticoid-based drugs, the use of Elocom under occlusive dressings should be avoided for a long time; on large areas of the skin, as well as on the face and skin folds (axillary and groin). Avoid getting the drug into the eyes (including the eyelid area), wounds and mucous membranes. Glucocorticoids can change the appearance of some skin lesions, making the diagnosis difficult. The drug should not be used in the eyelid area due to the risk of developing glaucoma and subcapsular cataracts. The drug should be used in the smallest amount for the minimum short period necessary to achieve a therapeutic effect. As with the use of other potent glucocorticosteroids, to prevent the development of a withdrawal syndrome, it is necessary to stop treatment gradually, increasing the intervals between applications. With the use of systemic and local corticosteroids (including intranasal, inhalation and intraocular administration), visual disturbances may occur. If symptoms such as blurred vision or other visual disturbances occur, the patient should be evaluated by an ophthalmologist to evaluate possible causes of visual impairment, which may include cataracts, glaucoma, or rare diseases such as central serous chorioretinopathy, which have been reported after corticosteroid use systemic and local action. Application in pediatrics. In children, there may be more frequent manifestation of signs of depression of the hypothalamic-pituitary-adrenal system and Cushing’s syndrome under the influence of local corticosteroids than in adults, which is associated with a higher absorption of the drug through a greater ratio of skin surface area to body weight. In this regard, the use of topical corticosteroids in children should be limited to the minimum effective amount of the drug. Chronic corticosteroid therapy can lead to impaired growth and development in children. Elokom should not be applied to areas of the skin under diapers or waterproof panties, as in this case the drug gets under the occlusive dressing. There are limited data on the use of the drug for the treatment of children under 2 years of age. The use of Elok in children older than 2 years should not last more than 5 days. Interaction with other drugs Interaction is not known. Contraindications Elocom is contraindicated in patients with hypersensitivity to any component of the drug. As well as other glucocorticoids, Elokom is contraindicated in patients with acne vulgaris, rosacea, perioral dermatitis, perianal and genital itching, diaper rash, bacterial skin infections (for example, impetigo, pyoderma), viral (herpes simplex, shingles, chicken pox, vulgar warts, genital warts, molluscum contagiosum) and fungal (for example, caused by yeast-like fungi and dermatophytes) etiology, parasitic infestations, patients with tuberculosis, syphilis, post-vaccination reactions. The drug should not be applied to wounds, ulcerations, areas of atrophied skin. Composition 1 g of cream contains the active substance: 1 mg of mometasone furoate; excipients: hexylene glycol, purified water, phosphoric acid, hydrogenated phosphatidylcholine, titanium dioxide, aluminum salt of starch octenyl succinate, white wax, white petrolatum. OverdoseSymptoms: excessive, prolonged use of local glucocorticosteroids can cause depression of the pituitary-adrenal system, which can lead to the development of secondary adrenal insufficiency. Treatment. Appropriate symptomatic treatment is indicated. Acute symptoms of hypercortisolism are usually reversible. If necessary, correction of electrolyte imbalance is indicated. In case of long-term use, gradual withdrawal of corticosteroids is recommended. Side effects After using the drug Elocom, there were reports of the following local adverse reactions: tingling / tingling, itching, signs of skin atrophy, burning, folliculitis, acne, papules, pustules and telangiectasias (frequency – very rare). The following adverse reactions have also been reported (frequency cannot be estimated from the available data): infections, boils, contact dermatitis, hypopigmentation, paresthesia, hypertrichosis, atrophic skin streaks, acneiform dermatitis, pain at the application site. The following local adverse reactions have been reported with the use / fugue of potent glucocorticoids, they are possible with the use of the drug Elokom: skin irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, stretch marks, prickly heat (frequency – rarely). Systemic adverse reactions may occur (see section “Precautions”) when applying the cream to large areas of the skin for a long time, especially when used under occlusive dressings. All adverse events that have been reported with the appointment of systemic glucocorticoids, including inhibition of the function of the hypothalamic-pituitary system, can develop with the appointment of potent glucocorticoids, especially in infants and children (see section “Use in Pediatrics”). Systemic adverse reactions, such as blurred vision, have also been reported with topical corticosteroids. Storage conditionsKeep out of the reach of children at a temperature not exceeding 25°C. Shelf life – 2 years. It is not recommended to use the drug after the expiration date indicated on the package. Buy Elocom cream 1 mg/g 15g No. 1
INN | MOMETASONE |
---|---|
The code | 148 813 |
Barcode | 4 814 366 000 354 |
Active substance | Mometasone |
Manufacturer | Schering-Plough Labo N.V., Belgium |
Importer | Additional Liability Company "Farmin", 220125 Minsk, Independence Avenue, 177, room 62; IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2; Trade and production republican unitary enterprise "Minsk Pharmacy", 220039, Minsk, Chkalova st., 5; Mogilev Trade and Production Republican Unitary Enterprise "Pharmacy", 212030 Mogilev, Pervomayskaya st., 59; Grodno Trade and Production Republican Unitary Enterprise "Pharmacy", 230023 Grodno, Ozheshko St., 11; Gomel Trade and Production Republican Unitary Enterprise "Pharmacy", 246027, Gomel, Mozyrskaya st., 16A; Vitebsk Trade and Production Republican Unitary Enterprise "Pharmacy", 210016 Vitebsk, Velikoluksky Trakt, 63; Brest Trade and Production Republican Unitary Enterprise "Pharmacy", 224032, Brest, Ya. Kupala st., 104; Trade and production republican unitary enterprise "BELPHARMATSIYA", 220005, Belarus, Minsk, st. V. Khoruzhey, 11; Closed Joint Stock Company "BEROLINA", 220114, Minsk, Nezavisimosti Ave., 143/1-3n; Private Trade Unitary Enterprise "HEALTH", Republic of Belarus, Minsk, Melezha str., 1 office 1501; IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2; Private Trade Unitary Enterprise "HEALTH", Republic of Belarus, Minsk, Melezha str., 1 office 1501; Trade and production republican unitary enterprise "BELPHARMATSIYA", 220005, Belarus, Minsk, st. V. Khoruzhey, 11; [x] Additional Liability Company "Farmin", 220125 Minsk, Nezalezhnosti Avenue, 177, room 62; [x] Mogilev Trade and Production Republican Unitary Enterprise "Pharmacy", 212030 Mogilev, Pervomayskaya st., 59; [x] Brest Trade and Production Republican Unitary Enterprise "Pharmacy", 224032, Brest, Ya. Kupala st., 104; [x] Gomel Trade and Production Republican Unitary Enterprise "Pharmacy", 246027, Gomel, Mozyrskaya st., 16A; [x] Closed Joint Stock Company "BEROLINA", 220114, Minsk, Nezavisimosti Ave., 143/1-3n; [x] Vitebsk Trade and Production Republican Unitary Enterprise "Pharmacy", 210016 Vitebsk, Velikoluksky Trakt, 63; [x] Grodno Trade and Production Republican Unitary Enterprise "Pharmacia", 230023 Grodno, Ozheshko St., 11; [x] Trade and production republican unitary enterprise "Minsk Pharmacy", 220039, Minsk, Chkalova st., 5 |
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