Composition, form of production and packaging
Cream for external use white or almost white, soft, translucent.
100 g
clobetasol propionate 50 mg *
Auxiliary substances: glyceryl monostearate 11 g, propylene glycol glycerol oleate (arlacel 165) 1.5 g, bee wax 6621 1.25 g, cetostearyl alcohol 8.4 g, propylene glycol 47.5 g, chlorocresol 75 mg, sodium citrate 50 mg, citric acid monohydrate - 50 mg, purified water - up to 100 g.
25 grams - tubes of aluminum (1) - packs of cardboard.
* The nominal amount of clobetasol propionate is 52.5 mg (including 5% excess).
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
GCS for external use. It prevents the accumulation of neutrophils, reduces inflammatory exudation and production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, has local anti-inflammatory, antipruritic, anti-allergic and anti-exsudative effects.
PHARMACOKINETICS
Suction
SCS for external use can be systemically absorbed from intact healthy skin. The degree of percutaneous absorption of GCS for external use is determined by a number of factors, including the basis of the drug and the integrity of the epidermal barrier. Occlusion, inflammation and / or other pathological process on the skin side are also capable of increasing percutaneous absorption.
The mean C max of clobetasol in plasma is achieved 13 hours after the first application and 8 hours after repeated application to the healthy skin of 30 g of clobetasol in the form of 0.05% of the ointment and is 0.63 ng / ml. 10 hours after the application of the second dose (30 g) of clobetasol in the form of cream, its C max 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 C max is 2.3 ng / ml and 4.6 ng / ml, respectively.
Distribution
The use of pharmacodynamic endpoints to assess systemic exposure of GCS for external use is necessary because the concentration of the drug circulating in the blood was well below the detection limit.
Metabolism
After absorption through the skin, GCS for external use is metabolized by the same pharmacokinetic pathways as the GCS for systemic use. They are metabolized, mainly, in the liver.
INDICATIONS
Dermoveit В® is a highly active SCS for external use, which is indicated for use in adults, seniors and children over the age of 1 year to alleviate the symptoms of inflammation and skin pruritus with dermatoses sensitive to GCS therapy.
- psoriasis (excluding common plaque psoriasis);
- Eczema (various forms);
- Red flat lichen;
- discoid lupus erythematosus;
- dermatoses resistant to therapy with less active GCS for external use.
DOSING MODE
Outwardly.
The application of the cream is particularly suitable for wet or wet surfaces.
The cream is applied in a thin layer in an amount sufficient to cover the entire affected area, 1-2 times / day, gently rubbed. Duration of application - before the appearance of the effect or, if necessary, up to 4 weeks. Can not be treated for more than 4 weeks. If prolonged treatment is necessary, gradually reduce the frequency of application or use less active drugs. After each application of the Dermoveit В® preparation, it is necessary to provide sufficient time for absorption before applying the emollient.
To prevent exacerbations of skin diseases, short (intermittent) courses of treatment with Dermoveit В® are carried out.
In particularly resistant cases, especially in the presence of hyperkeratosis, the effect of the cream for external use of DermoveitВ® can be enhanced by overnight application of the drug of the occlusive dressing (polyethylene film), which is usually accompanied by a positive dynamics of symptoms. In the future, the achieved effect can 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.
Atopic dermatitis (eczema)
Treatment with DermoveitВ® should be gradually phased out immediately after the control of the disease is achieved, and treatment with an emollient should be continued as maintenance therapy.
Sudden abolition of Dermoveit В® can lead to a recurrence of previously existing dermatoses.
Eczema (persistent current)
Patients with frequent relapses of the disease
In case of acute disease, once the effect of continuous treatment of GCS for external application is achieved, the possibility of its intermittent application (1 time / day, 2 times a week, without occlusive dressing) can be considered. It is shown that such treatment effectively reduces the frequency of relapse.
Application of the drug should be continued on all previously affected areas of the skin or to known areas of potential exacerbation. Such a scheme of application should be combined with routine daily application of emollients. A regular assessment of the condition, as well as the benefits and risks of continuing treatment, should be carried out.
Special patient groups
Children
Children are more likely to develop local and systemic side effects with topical GCS therapy and generally require shorter courses of treatment with less active agents than adults.
Caution should be exercised when using Dermoveit В® in children to ensure that it is applied in a minimal amount that provides a therapeutic effect.
Elderly patients
Clinical studies have not revealed any differences in the effectiveness of the drug in the elderly and younger patients. The high prevalence of decreased hepatic or renal function in elderly patients can lead to a delay in the excretion of the drug in the event of its systemic absorption. Therefore, it should be used in elderly patients in minimal amounts and for as short a period as possible, while ensuring the achievement of the necessary clinical effect.
Patients with impaired renal and / or liver function
In the case of systemic absorption of the drug (when applied to large areas of the skin for an extended period), its metabolism and excretion may slow down, leading to an increased risk of developing systemic toxicity. Therefore, it should be used in such patients in minimal amounts and for as short a period as possible, while achieving the necessary clinical effect.
SIDE EFFECT
The undesirable phenomena presented below are listed depending on the anatomical and physiological classification and frequency of occurrence. Frequency of occurrence is defined as follows: very often (? 1/10), often (? 1/100 and <1/10), infrequently (? 1/1 000 and <1/100), rarely (? 1/10 000 and <1/1 000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.
Infectious and parasitic diseases: very rarely - an infection caused by opportunistic organisms.
From the immune system: very rarely - hypersensitivity.
From the endocrine system: very rarely - oppression of the hypothalamic-pituitary-adrenal system. Signs of a cushingoid (lunar face, obesity by the central type), delay in weight gain and / or growth retardation in children, osteoporosis, glaucoma, hyperglycemia and / or glucosuria, cataracts, hypertension, weight gain or obesity, decreased endogenous cortisol, alopecia , brittle hair.
From the skin and subcutaneous tissues: often - itching, burning sensation or soreness; infrequently - local atrophy of the skin *, stria *, telangiectasia *; very rarely - thinning *, wrinkled skin, dry skin *, pigmentation change *, hypertrichosis, aggravation of symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria.
* Skin manifestations are secondary to local and / or systemic effects of oppression of the hypothalamic-pituitary-adrenal system.
General disorders and disorders together: very rarely - irritation and / or soreness in the application site.
When applied to large surfaces for a long period of time (eg, more than 2 weeks), the systemic side effects may develop in patients : gastritis, ulceration of the gastrointestinal mucosa, increased intraocular pressure, symptoms of hypercorticism.
CONTRAINDICATIONS
- bacterial, viral and fungal skin diseases (including herpes simplex, chicken pox, skin tuberculosis, actinomycosis);
- pink acne (rosacea);
- Acne;
- skin cancer;
- nodal pruritis of Gaida;
- perioral dermatitis;
- skin itching in the absence of inflammation;
- perianal and genital itching;
- common plaque psoriasis;
- age up to 1 year;
- lactation period;
- Hypersensitivity to the active ingredient and auxiliary components of the drug.
Caution should be used during pregnancy.
PREGNANCY AND LACTATION
There is insufficient data on the use of clobetasol in pregnant women.
According to preclinical studies, clobetasol can adversely affect fetal development.
The significance of this data for man has not been studied.
The drug should be used during pregnancy only if the intended benefit to the mother exceeds the potential risk to the fetus.
In case of prescribing during pregnancy, the minimum amount of cream should be used for a short time.
The use of the drug in the period of breastfeeding is contraindicated.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with impaired renal function: in the case of systemic absorption of the drug (when applied to large areas of the skin for an extended period), its metabolism and excretion may slow down, leading to an increased risk of developing systemic toxicity. Therefore, it should be used in such patients in minimal amounts and for as short a period as possible, while ensuring the achievement of the necessary clinical effect.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Patients with impaired hepatic function: in the case of systemic absorption of the drug (when applied to large areas of the skin for an extended period), its metabolism and excretion may slow down, leading to an increased risk of developing systemic toxicity. Therefore, it should be used in such patients in minimal amounts and for as short a period as possible, while ensuring the achievement of the necessary clinical effect.
APPLICATION FOR CHILDREN
Contraindicated in children under the age of 1 year.
APPLICATION IN ELDERLY PATIENTS
Clinical studies have not revealed any differences in the efficacy of the drug in elderly and younger patients. The high prevalence of decreased hepatic or renal function in elderly patients can lead to a delay in the excretion of the drug if it is systemically absorbed. Therefore, it should be used in elderly patients in minimal amounts and for as short a period as possible, while ensuring the achievement of the necessary clinical effect.
SPECIAL INSTRUCTIONS
Dermoveit В® should be used with caution in patients with a history of local hypersensitivity to GCS or to any auxiliary substance that is part of the drug. Local reactions of hypersensitivity may be similar to the symptoms of the ongoing disease. In some individuals, as a result of increased systemic absorption of GCS for external use, hypercorticism (Isenko-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, it is necessary to cancel the drug, gradually reducing the frequency of its application, or replace it with a less active GCS. A sudden cessation of treatment can lead to the development of glucocorticosteroid insufficiency.
Risk factors for systemic effects include: SCS activity and composition of the drug for external use, duration of application, application of the drug to large areas of the skin, application in closed skin areas (ie, in intertriginous zones or occlusive dressings (diapers and diapers infants can play the role of an occlusive bandage)), increased hydration of the stratum corneum of the skin, use on areas with thin skin such as a face, application to damaged skin or in other conditions can be accompanied by a violation of the integrity of the skin barrier. Compared to adults, children and infants may have a greater percentage of absorbing GCS for external use, and 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 value of the ratio of body surface area to body weight compared to adults.
Use in children
If possible, avoid curing of GCS for external use for extended periods in children under 12 years of age, long-term use of GCS for external use can cause oppression of adrenal function.
In children, atrophic skin changes occur more often than in adults with external application of GCS. In the case of prescribing clobetasol to children, the course of treatment should be limited to several days, and a doctor should be observed at least once a week.
Use in psoriasis
In some cases, the treatment of psoriasis of GCS for external use may be accompanied by the resumption of symptoms of the disease, drug resistance, the development of generalized pustular psoriasis and local or systemic toxicity due to disruption of skin barrier function, so careful monitoring of the patient is particularly important.
Concomitant Infection
When attaching a secondary infection, appropriate antibiotic therapy should be carried out. With any signs of generalization of the infection, it is necessary to stop the external application of GCS and to conduct appropriate treatment with antibacterial drugs.
Risk of infection with occlusion
Warm moist conditions created with the application of an occlusive dressing, contribute to the emergence of a bacterial infection, so it is necessary to thoroughly clean the skin before applying a new bandage.
Chronic ulcers of the shins
GCS for external use is sometimes used to treat dermatitis around chronic ulcers of the shins. However, such use may be accompanied by an increased incidence of local hypersensitivity reactions and an increased risk of developing local infections.
Application on the face skin
Application to the skin is undesirable, because This area is more susceptible to the development of atrophic changes. In case of application to the skin of the face, treatment should be limited to a few days.
Application on the eyelids
When applying the cream on the eyelids, care should be taken to ensure that the product does not get into the eyes, because repeated exposure to the cream can cause cataracts and glaucoma.
Impact on the ability to drive vehicles and manage mechanisms
Studies to study the effect of clobetasol on the ability to drive vehicles or work with mechanisms have not been conducted. Based on the profile of adverse reactions of clobetasol for external use, no adverse effect on such activities is expected.
OVERDOSE
Symptoms: Dermoveit В® can be absorbed in external applications 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 Dermoveit В® , symptoms of hypercorticism may develop.
Treatment: In case of an overdose of Dermoveit В® , the drug should be gradually withdrawn, reducing the frequency of application or replacing the less active SCS, under the supervision of a doctor due to the risk of adrenal insufficiency.
Further treatment should be carried out in the light of the clinical situation or in accordance with the recommendations of the toxicology centers, if available.
DRUG INTERACTION
It has been shown that simultaneous use of drugs capable of inhibiting the isoenzyme CYP3A4 (eg, ritonavir and itraconazole) inhibits the metabolism of GCS, 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 GCS and the activity of the inhibitor of the isoenzyme CYP3A4.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of reach of children at a temperature of no higher than 30 В° C. Shelf life - 2 years.
