Dermovate cream 0.05% 25gr

Dermovate instruction

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Composition

Ointment Dermovate contains 50 mg of clobetasol - an active substance.
Additional Ingredients:
    500 mg - sorbitan sesquioleate;
    5 g of propylene glycol;
    up to 100 g - white soft paraffin.
Cream Dermovate contains 50 mg of clobetasol - an active substance.
Additional Ingredients:
    11 g of glyceryl monostearate;
    1.5 g of arlacel 165;
    8.4 g of cetostearyl alcohol;
    1.25 g - a substitute for beeswax 6621;
    47.5 g of propylene glycol;
    50 mg sodium citrate;
    75 mg - chlorocresol;
    50 mg - citric acid monohydrate;
    up to 100 g of purified water.

Form of issue

Dermovate is available in the form of a cream or ointment for external use.
One package contains 1 aluminum tube with 25 grams of ointment or cream.

pharmachologic effect

Anti-inflammatory.

Pharmacodynamics and pharmacokinetics

Drug Dermovate belongs to the group of glucocorticosteroids and is used for external (local) use. Application of ointment or cream prevents the marginal position of neutrophils in the vascular bed, reduces the production and inflammatory effusion of lymphokines, prevents the migration of macrophages, reduces the intensity of the processes of granulation and infiltration, thus providing anti-inflammatory, antiexudative, antiallergic and antipruritic effects of local character.
The average Cmax of clobetasol is observed in the plasma 13 hours after the first application of 30 g of the preparation in the form of an ointment to healthy skin (or 8 hours after repeated application) and equal to 0.63 ng / ml.
The average Cmax of clobetasol with the repeated application of 30 g of the drug in the form of cream after 10 hours, slightly exceeds this figure when applying the ointment.
After a single application of 25 g of ointment after 3 hours in patients suffering from eczema and psoriasis, the average Cmax of the drug in the plasma equals, respectively, 4.6 ng / ml and 2.3 ng / ml.
The metabolism of the active substance of the drug Dermovate is not fully understood.

Indications for use

    various forms of eczema;
    psoriasis;
    discoid form of lupus erythematosus;
    red flat lichen;
    pathology of skin, resistant to treatment with less active external glucocorticosteroid drugs.
Dermovate in the form of an ointment is recommended to apply at dermal diseases which are accompanied by its dryness, a thickening and a hyperkeratosis as the basis of ointment allows to keep a moisture in integuments.
Dermovate in the form of a cream is recommended to apply in opposite cases, at pathological processes with the expressed inflammation which are accompanied moknutie.

Contraindications

    cancer of the skin;
    acne vulgar;
    nodular pruritus of Gaida;
    genital and perianal itching;
    perioral dermatitis;
    common pustular and plaque psoriasis;
    period of breastfeeding;
    children under 1 year;
    fungal, viral and bacterial pathologies of the skin (including chickenpox, herpes simplex, actinomycosis, skin tuberculosis);
    hypersensitivity to the constituents of the drug Dermovate.

Side effects

With topical application of the drug Dermovate, very rarely observed increased sensitivity.
Among the local manifestations of hypersensitivity were: rash, erythema, pruritus, local burning sensation of the skin, urticaria and contact dermatitis of allergic etiology that occur at the site of application and are similar to those for therapy of which the drug was prescribed.
If symptoms of hypersensitivity occur, therapy with Dermovate should be discontinued.
On the part of the endocrine system, very rarely observed symptoms of hypercorticism, which are manifested when using a large amount of ointment or cream, as well as when applying the drug to large areas of skin, and are a consequence of significant systemic absorption of the drug. These manifestations are most likely in children and infants, as well as in the use, after application, of a hermetically sealed dressing. It is worth remembering that in infants the use of diapers can play the role of a hermetically sealed bandage.
When adults use doses of the drug not exceeding 50 g per week, oppression of the pituitary or adrenal gland function is temporary, with the return of normal parameters of these organs, after the abolition of a short course of therapy with the use of local glucocorticoid agents.
Rarely, with the appointment of Dermovate, there was an increase in the surface vessels of the circulatory system, especially when the medicinal product is intensively rubbed into the folds of the skin or the use of occlusive dressings.
From the skin and subcutaneous tissues, local atrophy and atrophic bands were not often observed. Very rarely there was an exacerbation of the main symptoms of the disease, a change in pigmentation, thinning of the skin, hypertrichosis and the development of psoriasis in a pustular form. These manifestations also occur most often when rubbing the drug in the folds of the skin or when using occlusive dressings.

Instructions for use (Method and dosage)

Instructions for Dermovate recommend the application of a cream or ointment to the affected areas of the skin with a thin layer, once or twice a day, depending on the severity of the lesion.
Cream Dermovate cream (Dermovate cream) is more suitable for pathologies with severe inflammation and wetting, whereas Dermovate ointment is recommended for use in diseases accompanied by dry skin.
The course of Dermovate therapy is determined individually based on the diagnosed disease and its severity, but should not exceed 4 weeks, without further evaluation of the appropriateness of its continuation.
In case of exacerbation of previously treated skin diseases, it is possible to prescribe repeated short courses of Dermovate therapy.
If necessary, with the partial disappearance of external manifestations of the disease, after finishing the course of treatment with Dermovate, they switch to the use of less aggressive external agents from the group of glucocorticosteroids.
In especially severe cases of skin lesions, especially in the presence of hyperkeratosis, it is possible to enhance the anti-inflammatory effect of ointment and Dermovate cream with a polyethylene film as a dressing for the night. The occlusive dressing is applied to the affected area for a greater positive effect, in the event that the progress of the treatment can be maintained without the application of an occlusive bandage.
The maximum recommended weekly dose of ointment or cream is 50 g per week.

Overdose

Due to the fact that the dosage forms of the drug Dermovate are used exclusively locally, the likelihood of developing the symptoms of acute overdose is minimal.
In cases of chronic overdose, due to prolonged use of the drug or the use of large doses, it is possible to develop a syndrome of hypercorticism, which is an indication for reducing the dose of Dermovate or canceling the therapy with local corticosteroids. The abolition of therapy should be carried out under the constant supervision of the attending physician, because of the risk of possible development of adrenal insufficiency.

Interaction

In connection with the appointment of Dermovate exclusively for topical application, clinically significant interaction with other drugs has not been found.

Storage conditions

Store at a temperature not exceeding 30 ° C.
Shelf life - 24 months.

special instructions

Drug therapy using topical glucocorticosteroids is not recommended for a long period of time, especially when this group of drugs is prescribed for the treatment of younger children, because of the possible suppression of the function of the adrenal cortex.
The use of Dermovate drugs in childhood requires mandatory monitoring by the attending physician for the patient's condition, at least once every 7 days.
As a result of long-term treatment with glucocorticosteroids, atrophic changes in the skin can occur, most often more pronounced on the skin of the face.
If it is necessary to apply ointment or cream on the eyelids, it is necessary to protect the mucous membrane of the eyes from getting the drug, as this can lead to the development of glaucoma.
Therapy of psoriasis with Dermovate may be accompanied by relapses of the underlying disease, the development of generalized pustular pathology, increased tolerance to the drug, systemic and local toxic reactions due to violations of the barrier functions of the skin, which requires constant monitoring of the patient's condition .
If signs of adherence to the underlying disease of secondary infection are found, an appropriate antibiotic treatment is prescribed.
With any symptoms that indicate the generalization of the infection, it is necessary to cancel the current therapy and to prescribe adequate treatment with the use of antibacterial drugs.
It should be remembered that with the use of an occlusive dressing moist warm conditions are created that contribute to the development of a bacterial infection, therefore it is necessary to thoroughly clean the affected areas of the skin before applying another bandage.
Dermovate in the form of a cream is not recommended.

Children

Because of the possible suppression of the function of the adrenal cortex, Dermovate's use in children in large doses or for a long period of time is not recommended. When children undergo treatment using local glucocorticoids, it is necessary to conduct a comprehensive examination of the child at least once a week.

In pregnancy and lactation

Ointment and cream Dermovate during pregnancy can appoint or nominate only the doctor. In any case, during this period, do not use local corticosteroids for a long time or in large doses.
During the lactation period, the safety of Dermovate's application has not been established.

Reviews about Dermovate

Reviews of the Dermovate ointment used to treat various skin diseases, including psoriasis, suggest a high effectiveness of therapy, rapid relief and the subsequent complete disappearance of external manifestations. Cream Dermovate also receives positive reviews.
In user forums, there are references to the fact that with relapses of psoriasis or eczema, previously an effective remedy Dermovate, with repeated use did not have the same strength of therapeutic effect.
It is worth noting that with the frequent use of a cream or ointment, especially in large amounts, resistance of the organism to this medication can be developed. In this regard, use the drug is recommended only on indications and in minimally effective doses, in particular for the treatment of patients of childhood.