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Active ingredients
Clobetasol
Release form
Cream
Composition
Active ingredient: Clobetasol Concentration of active ingredient (g): 0.05g
Pharmacological effect
GKS for external use. Warns neutrophil regional accumulation, reduces inflammatory exudation and production of lymphokines, inhibits macrophage migration, reduces the intensity of infiltration and granulation processes, has a local anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects.
Pharmacokinetics
Absorption for external use may be subjected to systemic absorption from intact healthy skin. The degree of percutaneous absorption of GCS for external use is determined by several factors, including the basis of the drug and the integrity of the epidermal barrier. Occlusion, inflammation and / or other pathological processes on the part of the skin can also increase percutaneous absorption. The average Cmax of clobetasol in plasma is achieved 13 hours after the first application and 8 hours after repeated application to healthy skin of 30 g of clobetasol in the form of 0.05% ointment and is 0.63 ng / ml. 10 hours after application of the second dose (30 g) of clobetasol as a cream, its Cmax slightly exceeds that of the ointment. In a separate study, 3 hours after a single application of 25 g of 0.05% clobetasol ointment in patients with psoriasis and eczema, Cmax is 2.3 ng / ml and 4.6 ng / ml, respectively. Distribution Using pharmacodynamic endpoints to evaluate systemic GCS exposure for external use is necessary due to that the concentration of the drug circulating in the blood was significantly below the detection limit. Metabolism After absorption through the skin, GCS for external use is metabolized by the same pharmacokinetic routes that and GCS for system use. They are metabolized mainly in the liver.
Indications
Comprehensive treatment of acute and chronic inflammatory diseases of the nasal cavity, paranasal sinuses and nasopharynx: • acute and chronic rhinitis; • acute and chronic sinusitis; • acute and chronic adenoiditis; • allergic rhinitis; • atrophic rhinitis. - Comprehensive treatment of SARS and influenza - Prevention of ARVI and flu during the epidemic period .- Nasal care: • after surgical interventions; • cleansing from bacteria, viruses, dust, pollen, smoke; • to prepare the mucous membrane for the use of drugs • long-term therapy topical kimi corticosteroids
Contraindications
Pink acneCapital acneCapsules
Use during pregnancy and lactation
Dermovayt drug should be used with caution in patients with a history of local hypersensitivity to GCS or to any excipient, which is part of the drug. Local hypersensitivity reactions may be similar to the symptoms of the disease. In some individuals, as a result of increased systemic absorption of corticosteroids for external use, manifestations of hypercorticism (Itsenko-Cushing syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal system leading to the development of glucocorticoid insufficiency may occur. If any of the above is observed, the drug should be discontinued, gradually reducing the frequency of its application, or replace it with a less active GCS. Sudden cessation of treatment can lead to the development of glucocorticosteroid insufficiency. The risk factors for enhancing systemic effects include: GCS activity and the composition of the drug for external use, duration of use, application of the drug to large areas of the skin, use in closed areas of the skin (i.e. zones or under occlusive dressings (diapers and diapers in infants can play the role of an occlusive dressing)), increased hydration of the horny layer of the skin, use on the tyah with thin skin such as the face, applying to the damaged skin or other conditions which may involve a breach of the skin barrier integrity. Compared with adults, children and infants may have a higher percentage of GCS absorption for external use, and therefore this category of patients is more at risk of developing systemic side effects. This is due to the fact that children have an immature skin barrier and a greater ratio of body surface area to body weight as compared with adults. Use in children If possible, avoid using GCS for external use for a long time in children under 12 years old, becauseprolonged use of corticosteroids for external use may cause suppression of adrenal function. In children, more often than adults, atrophic skin changes occur when external use of corticosteroids. If clobetasol is prescribed to children, the course of treatment should be limited to a few days; observation by a doctor is required at least 1 time per week. Use for psoriasis local or systemic toxicity due to impaired barrier function of the skin, so careful monitoring of the patient is especially important. Concomitant infection and joining secondary infection should be appropriate antibiotic therapy. For any signs of generalization of the infection, it is necessary to stop the external use of GCS and to conduct appropriate treatment with antibacterial drugs. The risk of developing an infection during occlusion. For external use, it is sometimes used to treat dermatitis around chronic leg ulcers. However, such use may be accompanied by an increased incidence of local hypersensitivity reactions and an increased risk of developing local infections. Applying to the skin of the face Applying to the skin of the face is undesirable because This area is more susceptible to the development of atrophic changes. In the case of application to the skin of the face, treatment should be limited to several days. Mechanisms Studies have not been conducted to study the effect of clobetasol on the ability to drive vehicles or work with mechanisms. Based on the profile of side reactions of clobetasol for external use, no adverse effect on such activities is expected.
Dosage and administration
Cream and ointment is applied with a thin layer on the affected skin once or twice a day until the effect is obtained. Treatment can not be carried out for more than 4 weeks without assessing the need for its continuation.For the treatment of exacerbations of skin diseases, you can conduct repeated short courses Dermovate. If continuation of therapy with glucocorticosteroids is necessary, less active drugs should be used. In especially resistant cases, especially in the presence of hyperkeratosis, the anti-inflammatory effect of the cream and ointment Dermovate can be enhanced by applying overnight on the scope of the preparation of a plastic film dressing, which is usually accompanied by a positive effect . In the future, the achieved effect can be maintained without the use of an occlusive dressing.
Side effects
It was shown that the simultaneous use of drugs capable of inhibiting the CYP3A4 isoenzyme (for example, ritonavir and itraconazole), inhibits GCS metabolism, leading to an increase in their systemic exposure. The degree of clinical significance of this interaction depends on the dose and method of using GCS and the activity of the CYP3A4 isoenzyme inhibitor.
Overdose
Prolonged administration of glucocorticosteroids for topical use in large doses or applying them to large areas of the skin may be accompanied by systemic absorption, followed by the development of symptoms of hypercorticism. The risk of developing this complication is increased in children, especially when using an occlusive dressing, while the diaper can play the role of such a dressing. With the appointment of Dermovate ointment to adult patients at a dosage of not more than 50 g per week, the suppression of the function of the pituitary and adrenal glands has a transient nature recovery immediately after the end of the course of treatment. Long-term treatment with high-level glucocorticosteroids for local use in large doses can cause atrophic changes in the skin, in particular, its The presence of atrophic bands (striae), the dilatation of the superficial blood vessels, especially when applying occlusive dressings and applying the preparation on skin areas with folds. Skin pigmentation and hypertrichosis may develop. In rare cases, the treatment of psoriasis with glucocorticosteroids for local use (or their cancellation) provokes the development of pustular psoriasis. Sometimes Dermovey can cause an exacerbation of the symptoms of the disease.
Interaction with other drugs
Precautionary measures
special instructions
Symptoms: Dermovate, when applied externally, can be absorbed in quantities sufficient to cause the development of systemic effects. The development of acute overdose is unlikely. However, in case of chronic overdose or improper use of Dermovate, symptoms of hypercorticism may develop. Treatment: In case of overdose of Dermovate, the drug should be gradually discontinued, reducing the frequency of application or replacing the less active GCS, under the supervision of a physician due to the risk of adrenal insufficiency. taking into account the clinical situation or in accordance with the recommendations of the poison control centers, if any.