Elocom 15g cream

Form

kremi

Pack

1

General characteristics: International and chemical names: Mometasone; 9,21-dichloro-17[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methylpregna-1,4-diene-3,20-dione monohydrate; Main physical and chemical properties: White or almost white, homogeneous cream of soft consistency, free of foreign inclusions. Composition: 1 g of cream contains 1 mg of mometasone furoate; Excipients: hexylene glycol, purified water, phosphoric acid, propylene glycol stearate, stearyl alcohol and ceteareth-20, titanium dioxide, aluminum salt of octenyl succinate starch, white beeswax, white petrolatum. See blog: Elocom: Benefits and potential risks — What to know about the preparation. Pharmacological properties. Pharmacodynamics. Mometasone furoate is a synthetic corticosteroid with anti-inflammatory, antipruritic, and vasoconstrictive effects. Pharmacokinetics. The degree of skin penetration of topical corticosteroids depends on many factors, including the composition of the preparation and the integrity of the epidermal barrier. Inflammation and other processes in the skin can increase the penetration of the preparation through the skin. A study of the percutaneous absorption of 0.1% mometasone furoate cream in humans was conducted using a single application of 0.1% cream containing radioactive 3H-mometasone furoate to intact skin, which remained on it for 8 hours. According to data from 5-day observations, in which the amount of isotope excreted in feces and urine was assessed, approximately 0.4% of the applied dose underwent systemic absorption. During the study, the content of radioactive substances in plasma and erythrocytes remained slightly higher compared to the initial amount, corresponding to a concentration of ≤0.1 ng/mL. Indications for use. Local treatment of inflammatory and pruritic symptoms of skin diseases that are amenable to corticosteroid treatment, including psoriasis and atopic dermatitis. Method of administration and dosage. Elocom is applied to the affected skin areas, once a day. The duration of treatment is determined individually depending on the severity and course of the disease. The duration of topical corticosteroid use on the face in children and adults should not exceed 5 days. The duration of continuous use of the preparation should not exceed 2-3 weeks. Side effects. After the use of Elocom preparation, the following local reactions were reported: paresthesia, itching, signs of skin atrophy, burning, folliculitis, acne-like reaction, papules, pustules, and telangiectasia (frequency - very rare). With the use of other potent corticosteroid preparations, the following local side reactions were registered, which may also occur during the use of Elocom preparation: skin irritation, hypertrichosis, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, stretch marks, and skin exfoliation (frequency - rare). Systemic side effects are possible (see section "Features of use") when the ointment is used on large surfaces, for a long time, especially under an occlusive dressing. All adverse events registered with systemic glucocorticosteroids, including suppression of the hypothalamic-pituitary system, can develop with the administration of potent glucocorticosteroids, especially in infants and children (see section "Use in pediatrics"). Contraindications. Elocom is contraindicated in patients with hypersensitivity to any component of the preparation. Like other glucocorticosteroids, Elocom is contraindicated in patients with vulgar acne, acne, rosacea, perioral dermatitis, perianal and genital itching, bacterial or viral skin infections (herpes, chickenpox, shingles) or fungal etiology, patients with tuberculosis, syphilis, and post-vaccination reactions. Overdose. Symptoms: Excessive or prolonged use of topical glucocorticosteroids can lead to suppression of pituitary-adrenal system function, which can cause secondary adrenal insufficiency. Treatment: Appropriate symptomatic treatment is indicated. Acute symptoms of hypercorticism are usually reversible. Correction of electrolyte imbalance is indicated if necessary. With prolonged use, gradual withdrawal of corticosteroids is recommended. Features of use. Elocom is indicated for dermatological use only and is not intended for ophthalmological use. If irritation or increased sensitivity is observed during the use of the preparation, treatment should be discontinued and appropriate therapy prescribed. In case of infection development, an appropriate antifungal or antibacterial agent should be used. If a positive effect cannot be achieved in a short period, the use of the preparation should be discontinued until the signs of infection are eliminated. Any side effects of systemic glucocorticosteroids, including suppression of adrenal cortex function, may also be observed with topical glucocorticosteroid use, especially in young children. When using the preparation over a large area of the body or in high doses, periodic monitoring of adrenal function by determining cortisol concentration in blood and urine, and after stimulation of the adrenal cortex with adrenocorticotropic hormone, is recommended. Special caution is required in patients with psoriasis, as topical use of glucocorticosteroids in psoriasis may pose a risk of disease recurrence due to the development of tolerance, the risk of generalization of pustular psoriasis, and the development of local or systemic toxicity as a result of impaired skin barrier function. Systemic absorption of glucocorticosteroids with topical use will be higher if treatment is carried out on a large area of the skin or occlusive dressings are used. In such cases, as well as with prolonged use of the preparation, caution should be exercised. As with all potent glucocorticosteroid preparations, prolonged use of Elocom under an occlusive dressing, as well as on the face and in skin folds (axillary and inguinal regions), should be avoided. The preparation should not come into contact with the eyes (including eyelids), wounds, and mucous membranes. Glucocorticosteroids can alter the appearance of some skin lesions, making diagnosis difficult. Elocom contains propylene glycol, which can cause skin irritation. Elocom contains stearyl alcohol, which can cause local reactions (e.g., eczema). Use in pediatrics. Signs of suppression of the hypothalamic-pituitary-adrenal system and Cushing's syndrome in children may be more common than in adults under the influence of topical corticosteroids, which is related to higher absorption of the preparation due to a larger ratio of skin surface area to body mass. Therefore, the use of topical corticosteroids in children should be limited to the minimum effective amount of the preparation. Chronic corticosteroid therapy can cause growth and developmental disorders in children. Elocom should not be used under diapers or waterproof underwear, as in this case the preparation is under an occlusive dressing. There is limited data on the use of the preparation in children under 2 years of age. In children over 2 years of age, the duration of Elocom use should not exceed 5 days. Pregnancy and lactation. The safety of topical glucocorticosteroid use in pregnant women has not been established, therefore, the administration of drugs of this group during pregnancy is justified only when the potential benefit to the woman outweighs the potential risk to the fetus. During pregnancy, preparations of this group should not be used in high doses or for a long time. When prescribing Elocom to pregnant women, the possibility of glucocorticosteroids penetrating the placenta and affecting the fetus should be considered. It is unclear whether topical corticosteroid use can lead to their excretion into breast milk through systemic absorption. When deciding to discontinue breastfeeding or withdraw the preparation, the necessity of using the preparation for the mother should be taken into account. Effect on ability to drive and operate machinery. Elocom does not affect the ability to drive a car and operate moving machinery. Interaction with other drugs. Interactions are not known. Storage conditions and shelf life. Store in a place inaccessible to children, at a temperature not exceeding 25°C. Shelf life - 2 years. Use of the preparation after the expiry date indicated on the packaging is not recommended. Conditions of dispensing from pharmacies. Pharmaceutical product group III, dispensed without a prescription. Packaging. 15 g tube in a cardboard box #1.