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Active ingredients
Clobetasol
Release form
Ointment
Composition
Active ingredient: clobetasol propionate Auxiliary substances: propylene glycol, sorbitan sesquioleate, white paraffin soft. Concentration of active ingredient: 50 mg
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 SARS and influenza during the epidemic. - Nasal cavity care: • after surgical interventions; • purification from bacteria, viruses, dust, pollen, smoke; • to prepare the mucosa for the use of drugs • long-term therapy with topical corticosteroids.
Contraindications
- Pink acne; - Acne vulgaris; - Skin cancer; - Hyde's nodular scab; - Perioral dermatitis; - Perianal and genital itching; - Bacterial, viral and fungal skin diseases (including herpes simplex, chicken pox, skin tuberculosis, actinomycosis); - common plaque and pustular psoriasis; - age up to 1 year; - lactation period; - hypersensitivity to the drug components.
Use during pregnancy and lactation
There is insufficient data on the use of clobetasol in pregnant women. According to preclinical studies, clobetasol may adversely affect the development of the fetus. The significance of this data for a person has not been studied. fetus. In the case of the appointment of the drug during pregnancy, you should use the minimum amount of ointment for a minimum time. The use of the drug during breastfeeding Hania is contraindicated.
Dosage and administration
Ointment or cream should be applied with a thin layer to the affected skin 1-2 times / day before the onset of improvement. The course of treatment is no more than 4 weeks. The need for a longer course the doctor determines individually. For the treatment of exacerbations of skin diseases can be carried out short follow-up courses. If you need to continue treatment of GCS, then less active drugs should be used. to be strengthened by applying overnight over the area of use of the drug bandages of plastic film, 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
On the part of the endocrine system: the long-term administration of GCS for external use in high doses or applying them to large areas of skin may be accompanied by systemic absorption with the subsequent development of symptoms of hypercorticism.The risk of developing this complication is increased in children, especially when using an occlusive dressing, and the diaper can serve as such a dressing. Provided that Dermowate is prescribed to adult patients at a dose of no more than 50 g per week, the suppression of the function of the pituitary and adrenal glands has a transient character with their rapid recovery immediately after the end of the course of treatment. the skin, in particular its thinning, the appearance of atrophic strips, the dilatation of the superficial blood vessels, especially when applying occlusive dressings and when applied and preparation on the skin with wrinkles. Pigmentation of the skin and hypertrichosis are possible. In rare cases, the treatment of psoriasis GKS for external use (or their cancellation) provokes the development of pustular psoriasis. Sometimes Dermovey causes an aggravation of the symptoms of the disease.
Overdose
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.
Interaction with other drugs
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.
special instructions
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 the following: GCS activity and composition of the drug for external use, duration of use, application of the drug to large areas of skin, use in closed areas of the skin (i.e. intertriginous zones or under occlusive dressings (diapers and diapers in infants can play the role of an occlusive dressing)), increased hydration of the stratum corneum of the skin, used on areas with thin skin, such as face, application to damaged skin or in other conditions that may be accompanied by violation of the integrity of the skin barrier. 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, treatment of GCS for external use for a long time in children under 12 years old should be avoided, because long-term external use of corticosteroids can cause suppression of adrenal function. Children more often than adults have atrophic skin changes with 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 the spread of infection, it is necessary to discontinue external use of the GCS and 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. If applied to the skin of the face, treatment should be limited to a few 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.