Name:
Clobetasol
Description:
White or almost white cream of uniform consistency with a slight specific odor. The main active ingredient Clobetasol Release form 25 g in aluminum tubes. Each tube, together with the leaflet, is placed in a cardboard box (packaging No. 1). Dosage0.05% Special instructionsPharmacological actionPharmacodynamicsMechanism of action Glucocorticosteroid for external use. It prevents the marginal accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, and has local anti-inflammatory, antipruritic, antiallergic and antiexudative effects. Pharmacokinetics Absorption External glucocorticosteroids may be subject to systemic absorption from intact (healthy) skin. The degree of percutaneous absorption of topical glucocorticosteroids is determined by a number of factors, including the drug base and the integrity of the epidermal barrier. Occlusion, inflammation and/or other pathological process on the part of the skin can also increase percutaneous absorption. The average maximum concentration of clobetasol in plasma (Cmax) is reached 13 hours after the first application and 8 hours after repeated application to healthy skin of 30 g of clobetasol in the form of a cream for external use 0.5 mg / g, and is 0.63 ng / ml . 10 hours after the application of the second dose (30 g) of clobetasol in the form of a cream, its Cmax slightly exceeds the Cmax of the ointment. In a separate study, 3 hours after a single application of 25 g as Clobetasol, topical cream 0.5 mg/g in patients with psoriasis, and eczema, Cmax is 2.3 ng/ml and 4.6 ng/ml, respectively. . Distribution The use of pharmacodynamic endpoints to assess the systemic exposure of topical glucocorticosteroids is necessary because the concentration of clobetasol circulating in the blood was well below the detection limit. Metabolism After absorption through the skin, glucocorticosteroids for external use are metabolized by the same pharmacokinetic pathways as glucocorticosteroids for systemic use. They are metabolized mainly in the liver. Indications for use Clobetasol is a very potent topical corticosteroid indicated for use in adults, the elderly and children over 1 year of age for the short-term treatment of persistent symptoms of inflammation and pruritus in glucocorticosteroid-responsive dermatoses, in the event of treatment failure with less potent corticosteroids. glucocorticosteroids. Psoriasis (excluding common plaque psoriasis); eczema (various forms); lichen planus; discoid lupus erythematosus; dermatoses resistant to therapy with less active glucocorticosteroids for external use. Dosage and administration Externally. Applying the cream is particularly useful on damp or wet surfaces. The cream is applied in a thin layer in an amount not more than required to cover the entire affected area, once or twice a day, gently rubbed. Duration of application – until the effect appears or, if necessary, up to 4 weeks. You can not carry out treatment for more than 4 weeks. If prolonged treatment is necessary, the frequency of application should be gradually reduced or less active drugs should be used. After each application of the drug Clobetasol, before applying the emollient, it is necessary to allow sufficient time for absorption. To prevent exacerbations of skin diseases, short (intermittent) courses of the drug Clobetasol are carried out. In particularly resistant cases, especially in the presence of hyperkeratosis, the effect of the drug Clobetasol, cream for external use 0.5 mg / g, if necessary, can be enhanced by applying an occlusive dressing (polyethylene film) to the area of application of the drug at night, which is usually accompanied by positive dynamics of symptoms. In the future, the achieved effect can usually be maintained without the use of an occlusive dressing. If the condition worsens or does not improve within 2-4 weeks, the diagnosis and treatment should be reviewed. The maximum weekly dose should not exceed 50 g/week. Clobetasol drug treatment should be gradually withdrawn immediately after disease control is achieved, and treatment with an emollient should be continued as maintenance therapy. Sudden withdrawal of the drug Clobetasol can lead to recurrence of previously existing dermatoses. When applied to the face, occlusive dressings should not be used, the duration of treatment, if possible, should be limited to five days. Dermatoses characterized by persistent course Patients with frequent relapses of the disease In case of acute disease, once the effect of a continuous course of treatment with glucocorticosteroid is achieved, the possibility of its intermittent use (once a day, twice a week, without an occlusive dressing) can be considered . This treatment has been shown to be effective in reducing recurrence rates. The application of the drug should be continued on all previously affected areas of the skin or on known areas of potential exacerbation. This regimen should be combined with the routine daily use of emollients. Regular assessment of the condition, as well as the benefits and risks of continuing treatment, should be carried out. Special groups of patients Children Use in children under the age of one year is contraindicated. Children are more likely to develop local and systemic side effects with topical glucocorticosteroids and generally require shorter courses of treatment using less active agents than adults. If possible, the duration of treatment in children should not exceed five days, the need for further use should be regularly assessed. In children, the drug should not be used under occlusive dressings. Care should be taken when using the drug Clobetasol in children to ensure that it is applied in the minimum amount that provides a therapeutic effect. Elderly patients Clinical studies have not revealed any differences in the effectiveness of the drug in elderly and younger patients. The high prevalence of reduced liver or kidney function in elderly patients may lead to a slower elimination of the drug in case of systemic absorption. Therefore, it should be used in elderly patients in a minimal amount and for the shortest possible period, while still achieving the desired clinical effect. Patients with impaired renal and / or hepatic function In the case of systemic absorption of the drug (when applied to large surfaces of the skin for an extended period), its metabolism and excretion may slow down, leading to an increased risk of systemic toxicity. Therefore, it should be used in such patients in the minimum amount and for the shortest possible period, while still achieving the desired clinical effect. Use during pregnancy and lactation There are 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 these data for humans has not been studied. The drug should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. If the drug is prescribed during pregnancy, the minimum amount of cream should be used for the shortest possible time. The use of the drug during breastfeeding is contraindicated. Precautions The drug Clobetasol should be used with caution in patients with a history of local hypersensitivity to glucocorticosteroids or to any excipient that is part of the drug. Local hypersensitivity reactions may resemble the symptoms of an ongoing disease. In some individuals, as a result of increased systemic absorption of glucocorticosteroids for external use, manifestations of hypercorticism (Itsenko-Cushing’s syndrome) and reversible inhibition of the hypothalamic-pituitary-adrenal system, leading to the development of glucocorticosteroid insufficiency, may occur. If any of the above is observed, the drug should be discontinued, gradually reducing the frequency of its application, or replaced with a less active glucocorticosteroid. Sudden discontinuation of treatment may lead to the development of glucocorticosteroid insufficiency. Risk factors for increased systemic effects include: the activity of the glucocorticosteroid and the composition of the topical drug, the duration of use, the application of the drug to large areas of the skin, the use in closed areas of the skin (i.e. in intertriginous areas or under occlusive dressings (diapers and diapers may act as an occlusive dressing in infants), increased hydration of the stratum corneum, use on thin skin areas such as the face; application to damaged skin or other conditions that may be accompanied by a violation of the integrity of the skin barrier. Compared with adults, children and infants may have a higher percentage of absorption of topical glucocorticosteroids, and therefore this category of patients is more at risk of developing systemic side effects. This is because children have an immature skin barrier and a greater body surface area to body weight ratio than adults. Warm and humid conditions created in skin folds or when an occlusive dressing is applied encourage bacterial infection, so be sure to thoroughly clean the skin before applying an occlusive dressing. If an infection develops at the site of application of the cream, appropriate antibacterial or antifungal therapy should be prescribed. If the symptoms of the infection do not go away, the drug should be discontinued until the infection is completely cured. Avoid contact of the drug with mucous membranes and wounds. Application to the skin of the face is undesirable, since this area is more susceptible to the development of atrophic changes. If it is necessary to use the drug on the skin of the face, the duration of treatment should be limited to five days. When applied to the eyelid area, care must be taken to ensure that the drug does not get into the eyes, as there is a risk of developing cataracts and glaucoma. In case of contact with the drug in the eyes, they should be washed with plenty of water. Caution should be exercised in the treatment of psoriasis with topical corticosteroids, as recurrence of symptoms, development of drug resistance, development of generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function have been reported in some cases. Therefore, when using the drug in psoriasis, it is especially important to carefully monitor the patient. Due to the content of propylene glycol, the drug may cause skin irritation. Due to the content of chlorocresol, allergic reactions are possible. Given the content of cetearyl alcohol, the drug may cause a local skin reaction (eg contact dermatitis). Long-term use of topical glucocorticosteroids should be avoided in children under 12 years of age, as long-term topical use of glucocorticosteroids may cause adrenal suppression. In children, more often than in adults, atrophic skin changes occur with the external use of glucocorticosteroids. In the case of prescribing clobetasol to children, the course of treatment should be limited to several days, supervision by a doctor is required at least once a week. Interaction with other drugs It has been shown that the simultaneous use of a drug that can inhibit the CYP3A4 isoenzyme (for example, ritonavir and itraconazole) inhibits the metabolism of glucocorticosteroids, leading to an increase in their systemic exposure. The degree of clinical significance of this interaction depends on the dose and method of application of glucocorticosteroids and the activity of the CYP3A4 isoenzyme inhibitor. Contraindications Bacterial, viral and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, actinomycosis); rosacea (rosacea); acne skin cancer; knotty pruritus Hyde; perioral dermatitis; pruritus in the absence of inflammation; perianal and genital itching; widespread plaque psoriasis; hypersensitivity to the active and excipients of the drug; age up to 1 year; lactation period. Composition One gram of cream contains: active ingredient: clobetasol propionate – 0.5 mg; excipients: glycerol monostearate, propylene glycol glyceryl oleate, synthetic wax, cetostearyl alcohol, propylene glycol, chlorocresol, sodium citrate, citric acid monohydrate, purified water. Overdose Symptoms and signs The drug Clobetasol, 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 misuse of Clobetasol, symptoms of hypercortisolism may develop. Treatment In case of overdose, the drug should be gradually withdrawn, reducing the frequency of application or replacing with a less active glucocorticosteroid, under the supervision of a physician due to the risk of adrenal insufficiency. Further treatment should be carried out taking into account the clinical situation or in accordance with the recommendations of poison control centers, if available. Side effects The undesirable effects presented below are listed depending on the anatomical and physiological classification and frequency, occurrence. The frequency of occurrence is defined as follows: very often (≥ 1/10), often (≥1/100 and <1/10), infrequently (≥1/1000 and <1/100), rarely (≥1/10000 and <1 /1000), very rarely (<1/10000, including isolated cases). Frequency categories were formed on the basis of clinical trials of the medicinal product and post-marketing surveillance. Frequency of occurrence of adverse events Infectious and parasitic diseases Very rare: infection caused by opportunistic organisms. Immune system disorders Very rare: hypersensitivity. Endocrine system disorders Very rare: depression of the hypothalamic-pituitary-adrenal system. Cushingoid features (moon face, central obesity), delayed weight gain and/or growth retardation in children, osteoporosis, glaucoma, hyperglycemia and/or glucosuria, cataracts, hypertension, weight gain or obesity, decreased endogenous cortisol levels, alopecia, fragility of hair. Skin and subcutaneous tissue disorders Common: Itching, burning or soreness. Uncommon: local skin atrophy*, striae*, telangiectasia*. Very rare: thinning*, skin wrinkling, dry skin*, discoloration*, hypertrichosis, aggravation of symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria. General disorders and administration site conditions Very rare: Irritation and/or soreness at the site of application. *Skin manifestations are secondary to local and/or systemic effects of depression of the hypothalamic-pituitary-adrenal system. When applied, to large surfaces, for a long period of time (for example, more than 2 weeks), patients may develop systemic side effects: gastritis, ulceration of the mucous membrane of the gastrointestinal tract, increased intraocular pressure; symptoms of hypercortisolism. Storage conditions At a temperature not higher than 25 ºС. Keep out of the reach of children. Shelf life 2 years. The drug should not be used after the expiration date. Buy Clobetasol cream 0.5 mg/g 25g №1 Price for Clobetasol cream 0.5 mg/g 25g №1
INN | CLOBETAZOL |
---|---|
The code | 105 968 |
Barcode | 4 810 201 017 303 |
Dosage | 0.5mg/g 25g |
Active substance | Clobetasol |
Manufacturer | Borisovsky ZMP, Belarus |
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