GlaxoSmithKline #Dermatology #Diseases #Psoriasis #HEALTH_CARE
Indications
Psoriasis (with the exception of widespread plaque psoriasis), dermatoses that are difficult to treat, lichen planus, discoid lupus erythematosus and other diseases that cannot be treated with less active corticosteroids.
Application
Ointment or cream is applied in a thin layer to the affected areas of the skin 1 or 2 times a day. when control of the disease is achieved, the use of clobetasol should be gradually discontinued. in conditions of a good response to treatment, control of the disease can be achieved in a few days. treatment should not last more than 4 weeks. the maximum dose should not exceed 50 g per week. if there is no improvement within 2–4 weeks, the diagnosis and treatment should be reassessed. to control exacerbations, repeated short courses of therapy with Dermovate can be carried out. if long-term permanent treatment is necessary, less active corticosteroids should be used.
In resistant skin lesions, especially in the case of hyperkeratosis, the anti-inflammatory effect of Dermovate can be enhanced by covering the application site with plastic wrap. To achieve a positive result, an airtight bandage is applied all night. The already achieved effect is maintained by simply applying the preparation to the skin without film coating.
Contraindications
Hypersensitivity to the components of the preparation, untreated skin infections, rosacea, acne vulgaris, itching without inflammation, perianal and genital itching, perioral dermatitis. Dermovate is not indicated for the treatment of dermatoses in children under 1 year of age, including dermatitis and diaper rash.
Side effects
Side effects are classified by organs and systems and by frequency of occurrence. by frequency are distributed into the following categories: very often (≥1/10), often (≥1/100 and 1/10), infrequently (≥1/1000 and 1/100), rarely (≥1/10,000 and 1/100) 1000), very rarely (1/10,000, including isolated cases).
Infections and invasions: very rarely - opportunistic infections.
Immune system: very rarely - locally hypersensitivity.
Endocrine system: very rarely - depression of the hypothalamic-pituitary-adrenal system: cushingoid signs (for example, moon-like face, central obesity), delayed weight gain / height in children, osteoporosis, glaucoma, hyperglycemia / glucosuria, cataracts, hypertension, weight gain / obesity, decreased levels of endogenous cortisol, alopecia, brittle hair.
Skin and subcutaneous tissues: often - itching, local burning sensation / pain in the skin; infrequently - local skin atrophy *, atrophic stripes on the skin *, telangiectasias *; very rarely - thinning of the skin *, wrinkling of the skin *, drying of the skin *, pigmentation changes *, hypertrichosis, exacerbation of the main symptoms, allergic contact dermatitis / dermatitis, pustular psoriasis, erythema, rashes, urticaria, acne.
General disorders and disorders at the site of application: very rarely - irritation / pain at the site of application.
*Skin disorders secondary to local and/or systemic hypothalamic-pituitary-adrenal depression.
special instructions
The preparation is used with caution in the treatment of patients with a history of local hypersensitivity reactions to corticosteroids or other substances. local hypersensitivity reactions (see Adverse Reactions) may resemble the symptoms of the disease being treated.
The manifestation of hypercortisolism (Cushing's syndrome) and reverse suppression of the hypothalamic-pituitary-adrenal system with suppression of adrenal function in some patients may be the result of increased systemic absorption of topical steroids. In the event of any of the above symptoms, the use of the preparation should be gradually discontinued by reducing the frequency of application or replacing with a less strong corticosteroid. Sudden discontinuation of treatment may provoke glucocorticosteroid insufficiency (see ADVERSE REACTIONS).
Risk factors for systemic effects: potency and composition of the topical steroid; duration of application; application to a large area of the skin; application on skin surfaces that are in contact, for example, in areas of diaper rash or in places where an occlusive dressing is applied (in newborns, diapers can play the role of an occlusive dressing); increased hydration of the stratum corneum; use on areas with thin skin, such as the face; application on areas of damaged skin or under other conditions when the skin barrier is broken.
Compared with adults, children may absorb proportionally more topical corticosteroid and are therefore more susceptible to systemic adverse reactions. This is due to the fact that children have an underdeveloped skin barrier and a larger skin surface relative to body weight compared to adults.
Children. Where possible, long-term use of topical corticosteroids should be avoided in neonates and children under 12 years of age, as they are more likely to experience adrenal suppression.
Children are more likely to develop atrophic changes with topical corticosteroids. Treatment of children with Dermovate should, if possible, last no more than 5 days. The advisability of continuing treatment should be reviewed weekly.
Risk of infection when applying an occlusive dressing. The risk of bacterial infections increases in the warm and humid conditions that can occur under occlusive dressings, so the skin must be carefully cleaned before applying a new dressing.
Treatment of psoriasis. Topical corticosteroids should be used with caution in the treatment of psoriasis, as relapses, tolerance, the risk of generalization of pustular psoriasis, and the development of symptoms of local or systemic toxicity due to impaired skin barrier function have been reported in some cases. If used for the treatment of psoriasis, the patient should be under close medical supervision.
associated infections. Each time in the treatment of inflammatory lesions that become infected, it is necessary to prescribe the appropriate antibacterial preparations. If infection spreads, topical corticosteroids should be discontinued and appropriate antibiotic therapy instituted.
Chronic leg ulcers. Topical corticosteroids are sometimes used to treat dermatitis that occurs around chronic leg ulcers. However, such use is associated with an increased incidence of local hypersensitivity reactions and the risk of local infections.
Application to the face. Applying an ointment / cream to the skin of the face is undesirable, since this area is most prone to atrophic changes. If necessary, use should be limited to 5 days.
Application on the eyelids. When applying the ointment / cream on the eyelids, avoid getting the preparation into the eyes, since repeated use can provoke cataracts and glaucoma.
During pregnancy and breastfeeding
Pregnancy. There are limited data on the use of Dermovate in pregnant women.
Topical application of corticosteroids in pregnant animals can provoke intrauterine developmental disorders. There is no such data for humans. Dermovate should be used during pregnancy only if the expected benefit to the mother outweighs the risk to the fetus. Apply the minimum amount of the preparation during the minimum period of treatment.
Lactation. The safety of clobetasol propionate during lactation has not been established. It is not known whether the use of topical corticosteroids can lead to such systemic absorption, as a result of which a measurable amount of the preparation will be detected in breast milk. Dermovate should be used during lactation only if the expected benefit to the mother outweighs the risk to the baby. If Dermovate is prescribed during breastfeeding, the cream should not be applied to the breast to avoid accidental contact of the cream through the baby's mouth.
Influence on the ability to drive vehicles and work with other mechanisms. Studies on the study of such an effect have not been conducted. Taking into account the profile of adverse reactions, the effect on the reaction rate when driving a car or operating other mechanisms is not expected.
Interactions
It has been established that combined use with preparations that can inhibit cyp 3a4 (for example, ritonavir, itraconazole) inhibits the metabolism of corticosteroids, which can provoke a systemic effect. how this interaction is clinically significant depends on the dose of the preparation, the route of administration of corticosteroids and the power of the cyp 3a4 inhibitor.
Overdose
Symptoms and signs. with normal use, dermovate can be absorbed in quantities sufficient to cause a systemic effect. the likelihood of acute overdose is very low, however, in the case of chronic overdose or misuse, signs of hypercortisolism may occur.
Treatment. In case of overdose, Dermovate should be gradually withdrawn by reducing the frequency of application of the cream / ointment or replacing it with a less potent corticosteroid, taking into account the risk of glucocorticosteroid insufficiency. Further treatment is carried out in accordance with the patient's condition or according to national recommendations for the treatment of poisoning.
Storage conditions
At temperatures up to 30 °C.
Information for the professional activities of medical and pharmaceutical workers.
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