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Drug Name
Temeifu
Treatment Indications
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 only of the more resistant inflammatory and pruritic manifestations of steroid-responsive dermatoses that are unresponsive to weaker corticosteroids. These include the following:
-Psoriasis (excluding generalized plaque psoriasis)
-Refractory skin diseases
Lichen planus
-Discoid lupus erythematosus
-Other skin diseases that do not respond satisfactorily to less potent steroids.
Modes and methods of administration
Route of administration: Skin
The cream is particularly suitable for wet or weeping surfaces.
Adults, the elderly, and children over 1 year of age
Apply a thin layer once or twice a day and rub gently over the entire affected area until improvement occurs (in more sensitive cases, this may take a few days), then reduce application frequency or change treatment to a less potent preparation. After each use, allow sufficient time for absorption before applying emollient.
Clobetasol propionate can be used to control disease progression.
In more resistant lesions, especially hyperkeratotic ones, the effect of clobetasol can be enhanced, if necessary, by sealing the treated area with a polyethylene film. Overnight occlusion alone is usually sufficient to produce a satisfactory response. Thereafter, improvement can usually be maintained with non-clogging applications.
If the condition worsens or does not improve within 2-4 weeks, treatment and diagnosis should be re-evaluated.
Treatment should not last longer than 4 weeks. If ongoing treatment is required, less potent preparations should be used.
The maximum weekly dose should not exceed 50 grams/week.
Once control is achieved, clobetasol therapy should be gradually discontinued and emollients should be continued as maintenance therapy.
Sudden discontinuation of clobetasol can lead to rebound of the original skin disease.
Refractory dermatoses: patients with frequent relapses
Once acute exacerbations respond to continuous topical corticosteroid treatment, intermittent dosing (once daily, twice weekly, without blocking) may be considered. This has been shown to help reduce the frequency of relapses.
Should continue to be applied to all previously affected sites or sites of known potential recurrence. This treatment should be combined with daily use of emollients. The condition and the benefits and risks of continued treatment must be periodically reassessed.
Pediatric population
Skin oval is contraindicated in children under one year of age.
Children are more susceptible to local and systemic side effects of topical corticosteroids and generally require shorter courses of treatment and weaker medications than adults.
Clobetasol propionate should be used with caution to ensure that the lowest amount administered is the lowest amount that provides therapeutic benefit.
The duration of treatment in children and infants
should be limited to five days whenever possible and reviewed weekly. Occlusion should not be used.
Face application
If possible, it should be limited to five days and no occlusions should be used.
Elderly
Clinical studies have found no difference in response between older and younger patients. If systemic absorption occurs, elimination may be delayed more frequently in older adults with reduced hepatic or renal function. Therefore, the minimum amount should be used for the shortest duration to achieve the desired clinical benefit.
Contraindications
The following conditions should not be treated with Dermovate:
Untreated skin infection
Rosacea
Acne vulgaris
Pruritic without inflammation
Perianal and genital itching
Perioral dermatitis.
Clobetasol is contraindicated in children under one year of age for skin conditions, including dermatitis and diaper rash.
Pediatric Population
In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided if possible because of the potential for adrenal suppression
Children are more likely to develop atrophic changes after the use of topical corticosteroids.
Duration of treatment in children and infants
Should be limited to five days if possible and reviewed once a week. Occlusion should not be used. Risk of infection with occlusion
Bacterial infections can be encouraged by the warm, moist environment within skin folds, or caused by occlusive dressings. When using occlusive dressings, the skin should be cleaned before applying a new dressing.
For use in psoriasis
Topical corticosteroids should be used with caution in psoriasis because rebound recurrence, development of tolerance, risk of generalized pustular psoriasis, and local or systemic toxicity due to impaired skin barrier function have been reported in some cases. If used for psoriasis, careful patient supervision is important.
Concomitant infection
Appropriate antimicrobial therapy should be used whenever an infected inflammatory lesion is treated. The spread of any infection requires discontinuation of topical corticosteroid therapy and administration of appropriate antimicrobial therapy.
Chronic leg ulcers
Topical corticosteroids are sometimes used to treat dermatitis around chronic leg ulcers. However, this use may be associated with a high incidence of local allergic reactions and an increased risk of local infection.
Applying to the face
It is not advisable to apply it on the face because this area is more likely to shrink and change.
If used on the face, treatment should be limited to 5 days.
Apply to eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eyes, as cataracts and glaucoma can result from repeated exposure. If clobetasol gets into the eyes, the affected eye should be bathed in plenty of water.
Overdose
Symptoms
Topically applied clobetasol may be absorbed in sufficient amounts to produce systemic effects. Acute overdose is unlikely, however, in cases of chronic overdose or misuse, features of hypercortisolism may develop
Mechanism of Action
Topical corticosteroids pass Acts as an anti-inflammatory agent to inhibit late allergic reactions by multiple mechanisms, including reducing mast cell density, reducing eosinophil chemotaxis and activation, reducing cytokine production by lymphocytes, monocytes, mast cells, and eosinophils, and inhibiting arachidonic acid metabolism.
Pharmacological effects
Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.
Pharmacokinetic Properties
Absorption
Topical corticosteroids can be absorbed systemically from intact healthy skin. The extent of transdermal absorption of topical corticosteroids is determined by many factors, including the integrity of the vehicle and epidermal barrier. Obstruction, inflammation, and/or other disease processes in the skin may also increase percutaneous absorption.
The mean peak plasma clobetasol propionate concentration was 0.63 ng/ml, which occurred in a study of normal subjects with healthy skin 8 hours after the second application of 30 grams of 0.05% clobetasol propionate ointment (13 hours after the first application). After the second application of 30 g of clobetasol propionate cream, the average peak plasma concentration was 0.05%, which was slightly higher than that of the ointment and occurred 10 hours after application.
In another study, patients with psoriasis and eczema experienced mean peak plasma concentrations of approximately 2.3 ng/ml and 4.6 ng/ml, respectively, after a single application of 25 g of 0.05% clobetasol propionate ointment for 3 hours.
Distribution
Because circulating levels are well below detection levels, the use of pharmacodynamic endpoints to assess systemic exposure of topical corticosteroids is necessary.
Metabolism
Once absorbed through the skin, topical corticosteroids are processed through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolized mainly in the liver.
Elimination
Topical corticosteroids are excreted via the kidneys. In addition, some corticosteroids and their metabolites are also excreted in bile.
Shelf life
24 months.
Special precautions for storage
Stored below 25°C
Nature and contents of container
Collapsible latex aluminum tube internally painted with epoxy resin base paint, with polypropylene cap.
Packaging specifications:
25g, 30g or 100g.
Not all package sizes are available for sale.
Special Precautions for Handling and Other Handling
Patients should be advised to wash their hands after applying Demovat Cream, unless the hands are being treated.