ADVANTAN ointment for external use 0.1% 15g

Name:
Advantan ointment for nar.prim. 0.1% in tubes 15g in pack No. 1
Description:
White to yellowish ointment, slight heterogeneity is possible. The main active ingredient is methylprednisolone aceponate. Release form Ointment Dosage 1 g of ointment contains: active ingredient – methylprednisolone aceponate 1 mg subjective sensations (itching, burning, pain). Methylprednisolone aceponate (especially its main metabolite, 6?-methylprednisolone-17-propionate) binds to intracellular glucocorticoid receptors. The steroid-receptor complex binds to specific regions of DNA, thus causing a series of biological effects. In particular, the binding of the steroid-receptor complex to DNA leads to the induction of macrocortin synthesis. Macrocortin inhibits the release of arachidonic acid and thus the formation of inflammatory mediators such as prostaglandins and leukotrienes. The immunosuppressive effect of glucocorticoids can be explained by the inhibition of cytokine synthesis and antimitotic effect, which is still not well understood. Inhibition of the synthesis of vasodilating prostaglandins by glucocorticoids or potentiation of the vasoconstrictive action of adrenaline ultimately leads to a vasoconstrictor effect. Pharmacokinetics Methylprednisolone aceponate penetrates the skin from the basis of the dosage form. Its concentration decreases in the direction from the stratum corneum to the inner layers of the skin. Methylprednisolone aceponate is hydrolyzed in the epidermis and dermis. The main and most active metabolite is 6β-methylprednisolone-17-propionate, which binds more strongly to the corticoid receptors of the skin compared to the parent drug, which indicates the presence of its “bioactivation” in the skin. The degree and intensity of percutaneous absorption depends on many factors, such as the chemical structure of the active substance, the composition of the basis of the dosage form, the concentration of the active substance in the basis of the dosage form, the conditions when applying the drug (area of application, duration of exposure, on an open skin area or under an occlusive dressing) and skin condition (type and severity of the disease, anatomical localization). After open application of Advantan™ ointment twice daily for 8 days, absorption was estimated at 0.65% and corticoid load at 4 µg/kg/day. Percutaneous absorption of methylprednisolone aceponate through damaged skin when the stratum corneum is removed leads to a clear increase in the degree of absorption (13-27% of the dose). After entering the systemic circulation, the primary hydrolysis product b-methylprednisolone-17-propionate is quickly conjugated with glucuronic acid, and thus inactivated. Metabolites of methylprednisolone aceponate (the main of which is 6?-methylprednisolone-17-propionate-21-glucuronide) are eliminated mainly by the kidneys with a half-life of about 16 hours. After intravenous administration, urinary and fecal excretion was completed within 7 days. Methylprednisolone aceponate and its metabolites do not accumulate in the body. Indications for use Acute inflammatory skin diseases in adults and children, starting from 4 months of age: endogenous eczema (atopic dermatitis, neurodermatitis) contact eczema vulgar eczema dyshidrotic eczema in children Method of application and dose The drug is applied once a day with a thin layer on the affected skin. The duration of daily treatment with Advantan ointment should not exceed 12 weeks for adults. Advantan™ ointment provides the skin with the proper level of oil without blocking perspiration and heat transfer. Advantan™ ointment is widely used for skin characterized by not too pronounced fatty secretion, and for skin that is not very dry. Pediatric patients Advantan™ is used in children from 4 months of age. Dose adjustment is not required. The duration of treatment should be minimal and not exceed 4 weeks. Use during pregnancy and lactation If you are pregnant or breastfeeding, think you are pregnant, or plan to become pregnant, consult your doctor before using the drug. Sufficient data on the use of the drug during pregnancy are not available. Experimental animal studies with methylprednisolone aceponate have shown embryotoxic and teratogenic effects. When clinically indicated for the treatment of Advantan ointment during pregnancy and lactation, the potential risk and expected benefit of treatment should be carefully weighed. Avoid applying the drug to large areas of the skin, long-term use or application under an occlusive dressing. Nursing mothers should not apply the drug to the mammary glands. Use in the first trimester of pregnancy should be avoided. Precautions Corticosteroids should only be used at the lowest possible dose, especially in children, and only for the period absolutely necessary to achieve and maintain the desired therapeutic effect. In the case of treatment of large areas of skin, the duration of therapy should be determined accordingly. In the treatment of skin diseases accompanied by bacterial and / or fungal infections, specific therapy is required. Local skin infections may be exacerbated by the use of glucocorticoids. In the presence of bacterial dermatosis and / or dermatomycosis, in addition to therapy with Advantan ointment, it is necessary to carry out specific antibacterial or antimycotic treatment. Care should be taken to avoid getting the drug into the eyes, deep open wounds and mucous membranes. In studies using the drug on 60% of the skin surface for 22 hours under an occlusive dressing, suppression of plasma cortisol levels and an effect on the circadian rhythm in healthy adult volunteers was observed. The application of excessively large amounts of topical corticosteroids to large areas of the skin or for a long time, especially under an occlusive dressing, can significantly increase the risk of systemic adverse effects. It should be borne in mind that diapers may have an occlusive effect. In the case of treatment of large body surfaces, the duration of treatment should be as short as possible, since the possibility of absorption or systemic effects cannot be completely excluded. As with all corticosteroids, improper use of the ointment may mask clinical symptoms. As with systemic corticosteroids, glaucoma may develop with topical corticosteroids (eg, after high doses, or after extensive application of the drug for a long time, the use of occlusive dressings, or the application of the drug to the skin around the eyes). The use of the drug, especially for a long time, can lead to sensitization. In this case, treatment should be stopped and appropriate therapy initiated. Pediatric patients Advantan ointment should not be used under an occlusive dressing. It should be borne in mind that diapers can create an occlusive effect. A risk-benefit assessment is required when used in children from 4 months of age to 3 years of age. Interaction with other drugs Not established Contraindications hypersensitivity to the active substance or to any of the excipients of the drug tuberculous or syphilitic processes in the area of application of the drug post-vaccination skin reactions in the area of application of the drug, skin diseases accompanied by a bacterial or fungal infection. The composition of 1 g of ointment contains: active ingredient – methylprednisolone aceponate 1 mg; excipients: white beeswax (E901), liquid paraffin, Degimuls E, white soft paraffin, purified water. Overdose In the event of skin atrophy caused by an overdose of the drug when applied topically, treatment should be discontinued. Symptoms usually resolve within 10-14 days. When studying the acute toxicity of the drug, no risk of acute intoxication was found with excessive single skin application (application of the drug over a large area under conditions favorable for absorption) or inadvertent ingestion. Side effects When using Advantan ointment with the indicated frequency, the following adverse reactions may occur: Often: itching, burning. Uncommon: erythema, dryness, blistering, irritation, eczema, peripheral edema, skin atrophy, ecchymosis, impetigo, oily skin. Frequency unknown: folliculitis, hypertrichosis, drug hypersensitivity, acne, telangiectasia, striae, perioral dermatitis, skin discoloration, allergic skin reactions. Systemic effects of corticosteroids can be observed when applied topically due to absorption of the drug. Reporting adverse reactions If you experience any adverse reactions, please consult your physician. This recommendation applies to any possible adverse reactions, including those not listed in the package insert. You can also report adverse reactions to the adverse drug reactions (actions) information database, including reports of drug failures. By reporting adverse reactions, you help to get more information about the safety of the drug. Storage conditions At a temperature not exceeding 25 ° C, out of the reach of children. Buy ADVANTAN ointment for external use 0.1% 15g Price for ADVANTAN ointment for external use 0.1% 15g 15g