Clobetasol
Clobetasol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Clobetasol
ATX code: D07AD01
Active ingredient: clobetasol (Clobetazolum)
Manufacturer: JSC Borisov Plant of Medical Products (JSC BZMP) (Republic of Belarus); LLC "Arpimed" (Armenia)
Description and photo update: 2019-09-07
Clobetasol is a glucocorticosteroid for external use.
Release form and composition
Dosage forms of Clobetasol:
- cream for external use: a uniform consistency of almost white or white color, odorless or with a slight specific odor (depending on the manufacturer) (15 or 25 g in an aluminum tube, in a cardboard box 1 tube);
- ointment for external use: white, odorless (15 g in an aluminum tube, in a cardboard box 1 tube).
Each pack also contains instructions for the use of Clobetasol.
1 g of cream contains:
- active substance: clobetasol propionate - 0.5 mg;
- additional components: propylene glycol, cetylstearyl alcohol, purified water; depending on the manufacturer - glyceryl oleate, sodium citrate, chlorocresol, synthetic wax, glycerol monostearate, citric acid monohydrate or ethyl alcohol, ceteareth-20, liquid paraffin, methylparaben, ceteareth-12, dimethicone, propylparaben.
1 g of ointment contains:
- active substance: clobetasol propionate - 0.5 mg;
- additional components: white petroleum jelly, propylparaben, ethyl alcohol, liquid paraffin.
Pharmacological properties
Pharmacodynamics
Clobetasol is a glucocorticosteroid (GCS) for external use with a high degree of activity, which has a local anti-inflammatory, antiallergic, antipruritic and antiexudative effect.
The active ingredient of the drug prevents the regional accumulation of neutrophils, helps to reduce inflammatory exudation and reduce the production of lymphokines, slow down the migration of macrophages, weaken the intensity of granulation and infiltration processes. Thanks to these effects, irritation and redness of the skin is stopped, and its swelling is reduced.
Pharmacokinetics
For external use, there may be systemic absorption of clobetasol from intact (healthy) skin. In this case, the severity of absorption from the skin surface depends on factors such as the basis of the drug and the integrity of the epidermal barrier. Percutaneous absorption can enhance the course of any pathological process in the skin, including inflammation, as well as the use of an occlusive dressing.
The average maximum concentration (C max) of the active substance in the plasma is determined 13 hours after the first application of the drug in the form of a cream and 8 hours after its repeated application in an amount of 30 g, and is 0.63 ng / ml. 10 hours after the second application of the cream at a dose of 30 g, its C max slightly exceeds that of the Clobetasol ointment. According to the research results, after one application of the cream at a dose of 25 g after 3 hours in patients with eczema and psoriasis, C max was 4.6 and 2.3 ng / ml, respectively.
In order to assess the systemic exposure of external corticosteroids, it is necessary to conduct a study of pharmacodynamic endpoints, since the content of active substances circulating in the blood is significantly below the detection limit. After absorption through the skin in GCS for external use, metabolic transformation proceeds along the same pharmacokinetic pathways as in GCS for systemic use, mainly in the liver.
Indications for use
Clobetasol is recommended for short-term therapy of persistent symptoms of inflammation and pruritus in dermatoses sensitive to GCS therapy, in case of insufficient effectiveness of the use of less active GCS, including the following diseases:
- eczema (various forms);
- psoriasis (with the exception of common plaque psoriasis);
- discoid lupus erythematosus;
- lichen planus;
- skin lesions resistant to treatment with less active GCS.
Contraindications
- viral, bacterial and fungal skin lesions (including herpes simplex, skin tuberculosis, chickenpox, actinomycosis);
- skin cancer;
- perioral dermatitis;
- Hyde's nodular prurigo;
- acne;
- rosacea (rosacea);
- widespread plaque psoriasis;
- perianal and genital itching;
- itching in the absence of inflammation;
- children's age up to 1 year;
- lactation period;
- hypersensitivity to any of the constituents of Clobetasol ointment or cream.
Clobetasol, instructions for use: method and dosage
Clobetasol is for external use only.
The cream is especially suitable for the treatment of damp / weeping surfaces.
The cream / ointment should be applied 1 or 2 times a day with a thin layer in the smallest amount necessary to cover the entire problem area, then rub gently into the skin until completely absorbed.
Duration of treatment - until a positive effect is observed or, if necessary, a course of up to 4 weeks. If long-term therapy is required, it is recommended to gradually reduce the frequency of use of the drug or switch to the use of drugs with less glucocorticosteroid activity.
After each application of Clobetasol, there should be sufficient time for it to be absorbed before applying the emollient.
In order to prevent the development of exacerbations of skin diseases, short (intermittent) courses of treatment should be carried out.
Against the background of persistent lesions, especially in the presence of hyperkeratosis, the effect of Clobetasol can be enhanced by applying an occlusive dressing in the form of a plastic film overnight to the treatment area. In the course of further therapy, the achieved improvement, as a rule, can be maintained by applying the product without a bandage.
If within 2-4 weeks there is no improvement in the condition or an aggravation of the symptoms of the lesion is recorded, the diagnosis and treatment should be re-evaluated. The course of therapy should not be more than 4 weeks, and the maximum weekly dose of the drug should not be higher than 50 g.
Once the disease is under control, clobetasol should be withdrawn gradually and an emollient should be continued as a maintenance drug. Abrupt cessation of the use of GCS can cause a relapse of previously existing dermatoses.
Applying Clobetasol cream and ointment to the skin of the face is undesirable, since this area is most at risk of developing atrophic changes. If it is necessary to apply the drug to the face, it is not recommended to use occlusive dressings, and the duration of therapy should be limited, if possible, to five days.
In the treatment of dermatoses that are difficult to treat, in the case of an acute lesion, as soon as the effect of a continuous course of local treatment of GCS is noted, the possibility of intermittent use of the agent should be considered (apply once a day, 2 times a week, without an occlusive dressing). It has been found that this therapy effectively reduces the incidence of relapses. It is recommended to continue applying the drug to all previously affected areas of the skin or to known areas of potential exacerbation. A similar regimen of drug use should be combined with constant daily use of emollients. Clinical status and the benefits / risks of continuing treatment should be regularly assessed.
If the next dose of Clobetasol is missed, it should be used as soon as possible. If the time has already come for the next application, you should not double the dose in order to compensate for the previously missed one.
In patients with impaired renal and / or liver function, when treating extensive skin surfaces for a long time, leading to systemic absorption of the drug, its biotransformation and elimination may slow down, exacerbating the risk of systemic toxicity.
Side effects
The incidence of adverse reactions from systems and organs, determined on the basis of data from clinical studies and post-registration monitoring:
- endocrine system: extremely rarely - brittle hair, alopecia, delayed weight gain and / or stunted growth in children, suppression of the hypothalamic-pituitary-adrenal system, hypertension, cataracts, glaucoma, weight gain or obesity, signs of cushingoid (incl. central obesity, moon-shaped face), glucosuria and / or hyperglycemia, osteoporosis, decreased endogenous cortisol;
- immune system: extremely rare - hypersensitivity;
- skin and subcutaneous fat: often - burning sensation / soreness, itching; infrequently - telangiectasias *, striae *, local skin atrophy *; extremely rare - dry skin *, wrinkling, thinning * skin, changes in pigmentation *, rash, urticaria, worsening of symptoms of the disease, hypertrichosis, pustular psoriasis, allergic contact dermatitis, erythema;
- infectious and parasitic lesions: extremely rarely - an infection excited by opportunistic organisms;
- others: very rarely - irritation and / or soreness at the site of application.
* - skin reactions that are local and / or systemic manifestations of suppression of the hypothalamic-pituitary-adrenal system.
In the case of using Clobetasol on large surfaces of the skin for more than 2 weeks, the following systemic side effects may develop: increased intraocular pressure, gastritis, ulceration of the gastrointestinal tract (GIT) mucosa, symptoms of hypercortisolism.
Overdose
When used topically, clobetasol can be absorbed in quantities sufficient to induce systemic effects. The emergence of an acute overdose is unlikely, however, with the wrong use of the drug or chronic overdose, there is a risk of developing symptoms of hypercortisolism.
In case of suspicion of an overdose, you should gradually stop using the drug, less often apply Clobetasol or replace it with a weaker GCS. The course must be completed under medical supervision due to the threat of adrenal insufficiency. Follow-up treatment should be prescribed depending on the clinical situation or as recommended by poison control centers (if available).
special instructions
Local hypersensitivity reactions to Clobetasol may be similar to symptoms of an ongoing disease.
In some cases, due to increased systemic absorption of GCS for external use, symptoms of hypercortisolism (Itsenko-Cushing syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal system, leading to glucocorticoid insufficiency, may appear.
The risk factors for aggravating systemic reactions include: GCS activity; composition and duration of therapy; application on large areas of the skin or in closed areas of the skin, i.e., in intertriginous zones, under occlusive dressings, including in babies under diapers and diapers that act as an occlusive dressing; application to areas with thin skin (for example, face); increased hydration of the stratum corneum of the skin; use on areas with damaged skin, other conditions that can lead to a violation of the integrity of the skin barrier.
The moist and warm conditions in the folds of the skin, as well as the factors arising from the application of an occlusive dressing, contribute to the appearance of a bacterial infection. As a result, the skin must be thoroughly cleansed before applying a new dressing.
Avoid getting the drug on mucous membranes and wounds.
In the event of an infection at the site of application of the product, appropriate antifungal or antibacterial treatment should be carried out. If you cannot stop the symptoms of infection, you should stop using the drug until they are completely removed.
When prescribing clobetasol treatment for the skin in the eyelid area, it is necessary to beware of its contact with the eyes due to the risk of developing cataracts / glaucoma. If, nevertheless, it was not possible to avoid contact with the eyes, they must be thoroughly rinsed with plenty of water.
Against the background of psoriasis therapy with GCS for external use, cases of the development of drug resistance, the appearance of relapses of the disease, the occurrence of generalized pustular psoriasis and local / systemic toxic reactions as a result of a violation of the barrier function of the skin were recorded. During this period, patients need careful monitoring.
Cetearyl alcohol, which is part of the Clobetasol cream, can cause the development of a local skin reaction (for example, contact dermatitis), and chlorcresol can provoke allergic reactions. Propylene glycol can irritate the skin. propylparaben (methylparaben) can cause the development of allergic reactions, possibly of a delayed type, and very rarely - bronchospasm.
Application during pregnancy and lactation
There are limited data on the use of clobetasol during pregnancy. According to the results of preclinical studies, the drug may have a negative effect on the development of the fetus. For humans, the significance of the data from animal studies has not been established.
It is possible to use Clobetasol for the treatment of pregnant women only in the minimum dose for the shortest period, if the expected benefit to the mother significantly exceeds the possible threat to the health of the fetus.
During lactation, the use of Clobetasol is contraindicated.
Pediatric use
Clobetasol is not prescribed for children under one year of age.
Care must be taken during the period of use of the drug in children, since they may have a higher percentage of absorption of GCS, which aggravates the risk of local and systemic adverse reactions. As a result, the drug is recommended to be applied in minimal doses to provide a therapeutic effect. Since long-term therapy with GCS for external use can lead to inhibition of adrenal function, children under 12 years of age need to avoid long-term drug treatment.
During therapy, children also develop atrophic skin changes more often than adults. If it is necessary to use clobetasol in pediatric patients, the duration of its use should not exceed 5 days. The attending physician is obliged to regularly assess the need for further treatment of patients of this age group.
Children should not apply cream / ointment under occlusive dressings.
With impaired renal function
In the presence of impaired renal function, therapy with Clobetasol is recommended to be carried out in minimal doses for as short a period as possible to achieve the desired therapeutic effect.
For violations of liver function
In the presence of functional disorders of the liver, therapy with Clobetasol should be carried out in the lowest doses for the shortest possible period of time, allowing the desired therapeutic effect to be achieved.
Use in the elderly
In elderly patients, due to the high prevalence of reduced renal / hepatic function, Clobetasol must be used in minimum doses for the shortest course necessary to obtain the desired therapeutic effect.
Drug interactions
With the combined use of Clobetasol with drugs that can inhibit the CYP3A4 isoenzyme (including ritonavir, itraconazole), its metabolism is suppressed, which causes an increase in systemic exposure of clobetasol. The clinical significance of this interaction is influenced by the dose and method of administration of GCS, as well as the degree of activity of the inhibitor of the isoenzyme CYP3A4.
Analogs
Dermovate, Cloveit, Powercourt, Etrivex and others are analogues of Clobetasol.
Terms and conditions of storage
Store at a temperature not exceeding 25 ° C, protected from light, out of reach of children.
The shelf life of the cream, depending on the manufacturer, is 2 or 3 years, the ointment is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Clobetasol
According to reviews, Clobetasol, like its analogues, is a highly active GCS for external use and is used by patients to treat the symptoms of dermatoses, psoriasis, eczema and other skin lesions that are resistant to the effects of less active GCS. Cream and ointment can very quickly eliminate itching, allergic rashes, inflammation and redness of the skin.
At the same time, many note addiction to the action of Clobetasol, since a pronounced improvement in the condition during the period of its use is replaced by a significant aggravation of the newly emerging symptoms after discontinuation of therapy.
The price of Clobetasol in pharmacies
There is no reliable data on the price of Clobetasol, since at the moment the drug is not sold in pharmacies.
The approximate cost of an analogue: Cloveit, a cream for external use, a 25 mg tube, is 340 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
