Dermoveit - instructions for use, dose, side effects, contraindications

Excipients: Glyceryl monostearate 11.0 g, propylene glycol glyceryl oleate (Arlatsel 165) 1.50 g, bee wax substitute-6621 1.25 g, 8.40 g cetostearyl alcohol, propylene glycol, 47.50 g, hlorokrezol 0.075 g, sodium citrate 0 , 05 g, citric acid monohydrate 0.05 g, water purified to 100 g.

Note: The amount of clobetasol propionate is adjusted in accordance with the quantitative determination of clobetasol propionate in the substance to achieve a nominal amount of pure substance.

Description:

Soft white or almost white translucent cream.

Pharmacotherapeutic group:Glucocorticosteroid for topical application

ATX: & nbsp

D.07.A.D.01 Clobetasol

Pharmacodynamics:

Glucocorticosteroid for external use.It prevents the accumulation of neutrophils boundary, reduces the inflammatory exudation and production of lymphokines inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, has a local anti-inflammatory, antipruritic, anti-allergic and anti-exudative effects.

Pharmacokinetics:

Suction

External glucocorticosteroids can undergo systemic absorption with intact healthy skin. The degree of percutaneous absorption of glucocorticosteroids 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 maximum concentration of clobetasol in plasma (C_mOh) is achieved 13 hours after the first application and 8 hours after repeated application to healthy skin of 30 g of clobetasol in the form of 0.05% 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 C_m_Oh 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 eczema C_mOh is 2.3 ng / ml and 4.6 ng / ml, respectively.

Distribution

Using pharmacodynamic endpoints to assess systemic exposure, corticosteroids for external use is necessary because the concentration of the drug circulating in the blood was significantly lower 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:

The drug is a highly Dermoveyt® glucocorticosteroid for external application, which is indicated for use in adults, elderly and children over the age of 1 year to relieve symptoms inflammation of pruritus at dermatoses sensitive to glucocorticoid therapy.

- Psoriasis (excluding common plaque psoriasis);

- eczema (various forms);

- red flat lichen;

- discoid lupus erythematosus;

- Dermatoses resistant to therapy with less active glucocorticosteroids for external use.

Contraindications:

- Bacterial, viral and fungal skin diseases (including herpes simplex, chicken pox, skin tuberculosis, actinomycosis);

- pink acne (rosacea);

- acne;

- skin cancer;

- gnawing prurigo of Gaida;

- perioral dermatitis;

- itching in the absence of inflammation;

- perianal and genital itching;

- common plaque psoriasis;

- hypersensitivity to the active and auxiliary substances of the drug;

- age up to 1 year;

- lactation period.

Carefully:

Use with caution in pregnancy.

Pregnancy and lactation:

Pregnancy

There is insufficient data on the use of clobetasol in pregnant women.

According to preclinical research clobetasol can adversely affect the development of the fetus.

The significance of this data for man has not been studied.

The drug should be used during pregnancy only if the potential 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.

Breastfeeding period

The use of the drug in the period of breastfeeding is contraindicated.

Dosing and Administration:

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 not larger than what is required to cover the entire affected area, once or twice a 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® preparation, it is necessary to ensure sufficient time for absorption before applying the emollient. To prevent exacerbations of skin diseases, short (intermittent) courses are carried out with Dermoveit®.

In particularly resistant cases, especially in the presence of hyperkeratosis, the effect of the cream for external use of Dermoveit®, if necessary, can be enhanced by overlapping the area of application of the preparation of the occlusive dressing (polyethylene film)which is usually accompanied by a positive dynamics of symptoms. In the future, the effect achieved 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.

Atopic dermatitis (eczema)

Treatment with Dermoveit® should be gradually withdrawn as soon as disease control is achieved, and treatment with an emollient should be continued as maintenance therapy. The sudden withdrawal of Dermoveit® can lead to a relapse of previously existing dermatoses. Eczema (persistent current)

Patients with frequent relapses of the disease

In the case of acute illness, as soon as the effect achieved by continuous rate glucocorticosteroid treatment for external application may be considered its intermittent application (once a day, twice a week, without occlusive dressing). 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 glucocorticosteroid therapy and generally require shorter courses of treatment with less active agents than adults.

Care should be taken when using Dermoveit® 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 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.

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 effects:

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: Often (≥1/10), often (≥1/100 and <1/10); infrequently (≥1/1 000 and <1/100), rarely (≥1/10000 and <1/1000), rarely (<1/10000, including individual cases). Frequency categories were formed on the basis of clinical studies of the drug and post-registration surveillance.

Frequency of occurrence of undesirable phenomena.

Infectious and parasitic diseases

very rarely: infection caused by opportunistic organisms.

Immune system disorders

aboutchen rarely: hypersensitivity.

Disorders 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, weight gain and / or growth retardation in children, osteoporosis, glaucoma, hyperglycemia and / or glucosuria, cataract, hypertension, weight gain or obesity, decreased endogenous cortisol, alopecia , brittle hair.

Disturbances 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.

Common disorders and disorders together

very rarely: irritation and / or soreness in the application site.

* Skin manifestations are secondary to local and / or systemic effects of oppression of the hypothalamic-pituitary-adrenal system.

When applied to large surfaces for a long period of time (for example,more than 2 weeks) in patients can develop systemic side effects: gastritis, ulceration of the gastrointestinal mucosa, increased intraocular pressure, symptoms of hypercorticism.

Overdose:

Symptoms and signs

Dermoveit® can be absorbed when used externally in quantities sufficient to induce the development of systemic effects. The development of acute overdose is unlikely. However, in case of chronic overdose or misuse of Dermoveit®, symptoms of hypercorticoid may develop.

Treatment

In case of an overdose of Dermoveit®, the drug should be gradually withdrawn, reducing the frequency of application or replacing the less active glucocorticosteroid, 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.

Interaction:

It was shown that the simultaneous use of drugs capable of inhibiting the isoenzyme CYP3A4 (eg, ritonavir and itraconazole), depresses 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 administration of glucocorticosteroids and the activity of the inhibitor of isoenzyme CYP3A4.

Special instructions:

Dermoveit® should be used with caution in patients with a history of local hypersensitivity to glucocorticosteroids 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 glucocorticosteroids for external use, hypercorticism (the Itenko-Cushing syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal system may result, leading to the development of glucocorticosteroid insufficiency.

If any of the above is observed, you should cancel the drug, gradually reducing the frequency of its application, or replace it with a less active glucocorticosteroid.A sudden cessation of treatment can lead to the development of glucocorticosteroid insufficiency.

The risk factors for enhancing systemic effects include: glucocorticosteroid activity and the 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 (i.e., in intertriginous zones or under occlusive dressings (diapers and diapers infants can play the role of an occlusive bandage)), increased hydration of the stratum corneum, use on areas with thin skin such as face; application to damaged skin or other conditions that may be accompanied by a violation of the integrity of the skin barrier.

Compared to adults, children and infants may have a higher percentage of glucocorticosteroid absorption for external use, which is why 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, glucocorticosteroids should be avoided for external use for extended periods in children under 12 years of age, as long-term use of glucocorticosteroids for external use can cause oppression of adrenal function.

In children more often than in adults, there are atrophic changes in the skin with external application of glucocorticosteroids. If clobetasol is administered 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 by glucocorticosteroids for external use may be accompanied by the resumption of the symptoms of the disease, drug resistance, the development of generalized pustular psoriasis and local or systemic toxicity due to disruption of the 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 spread of infection, it is necessary to stop the external application of glucocorticosteroids and carry outappropriate 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

Glucocorticosteroids for external use are 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

The application to the skin of the face is undesirable, since 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.

Effect on the ability to drive transp. cf. and fur:

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.

Form release / dosage:

Cream for external use, 0.05%.

Packaging:

For 25 grams in an aluminum tube sealed with a membrane sealed with a screwed polypropylene cap.

1 tube with instructions for use in a cardboard pack.

Storage conditions:

At a temperature of no higher than 30 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date stated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N015790 / 01

Date of registration:15.01.2009 / 01.07.2014

Expiration Date:Unlimited

The owner of the registration certificate:GlaxoSmithKline Pharmaceuticals SAGlaxoSmithKline Pharmaceuticals SA Poland

Manufacturer: & nbsp

GlaxoSmithKline Pharmaceuticals, S.A. Poland

Representation: & nbspGlaxoSmithKline group of companies GlaxoSmithKline group of companies Unknown

Information update date: & nbsp24.03.2017

Illustrated instructions

Instructions

Dermovate® (Dermovate®)