Clobetasol ointment 0.05% treatment Psoriasis (Hofvate) - 15g.

Contraindications

• Bacterial, viral and fungal diseases of the skin (including herpes simplex, varicella, tuberculosis skin, actinomycosis).
• acne rosacea (rosacea).
• Acne.
• Cancer of the skin.
• Nodular pruritus Hyde.
• Perioral dermatitis.
• itching in the absence of inflammation.
• Perianal and genital pruritus.
• Common plaque psoriasis.
• the Age of 1 year.
• lactation.
• Hypersensitivity to the active substance and auxiliary components of the drug.

caution: the drug should be used during pregnancy.

pregnancy and breastfeeding

GKS for external use should not be used during pregnancy in high doses for a long period of time. While studies have not shown that the use of the drug during pregnancy has a negative effect on the health of the woman or fetus.

the Drug should be used during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus.

the use of the drug during lactation is contraindicated.

Special instructions

Drug Dermovate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the product. Local hypersensitivity reactions may resemble symptoms of illnesses. Some individuals as a result of increased systemic absorption of corticosteroids for topical use you may experience symptoms of hypercortisolism (Cushing's syndrome) and reversible depression of the hypothalamic-pituitary-adrenal system, leading to glucocorticosteroid insufficiency. If you are experiencing any of the above, you should stop the drug, gradually reducing the frequency of application, or replace it with a less active corticosteroids. Sudden cessation of treatment can lead to the development of glucocorticosteroid insufficiency.

risk factors enhance systemic effects include the following: activity and dosage form of corticosteroids for external use, duration of use, the drug causing vast areas of skin, applying in confined areas of the skin (ie, intertriginous areas or under occlusive dressings (nappies and diapers for infants can play the role of occlusive dressings) increased hydration of the stratum corneum of the skin, use on areas with thin skin such as the face, causing the damaged skin or other conditions that may be accompanied by violation of the integrity of the skin barrier. Compared with adults children and infants may be more the rate of absorption of corticosteroids for external use, in connection with which this category of patients are more at risk of developing systemic side effects. This is because children have an immature skin barrier and a greater value of the ratio of the body surface area to body weight compared to adults.

children

Should be avoided GKS for external use for a long time, especially when treating younger children, because this can should be suppressed by adrenal function. The use of the drug Dermovate® in children requires supervision by a doctor at least 1 time a week. On the face often than other parts of the body, as a result of prolonged use of local corticosteroids may appear atrophic changes in the skin that must be taken into account in the treatment of psoriasis, diskoidna lupus erythematosus and severe eczema with localization of lesions on the face.

psoriasis

psoriasis Treatment corticosteroids for external use may be accompanied by a resumption of symptoms, resistance to the drug, development of generalised pustular psoriasis and local or systemic adverse reactions due to impairment of barrier function of the skin, it is particularly important, careful observation of the patient.

Related infection

Upon accession of secondary infection should be the appropriate antibiotic therapy. At any sign of generalization of infection it is necessary to stop the external application of corticosteroids and to hold appropriate treatment with antibiotics.

the Risk of infection under occlusion

the Warm moist environment created by the imposition of occlusive dressings, contribute to the emergence of bacterial infection, so be sure to clean skin thoroughly before applying new bandages.

Chronic leg ulcers

External corticosteroids are sometimes used to treat the dermatitis around chronic ulcers of the lower legs. However, such application may be accompanied by increased frequency of occurrence of local hypersensitivity reactions and an increased risk of local infections.

Applying to the face

Drawing on the skin is undesirable because the area more susceptible to develop atrophic changes. In the case of applying to the skin the treatment should be restrict a few days.

Drawing on eyelids

When applying the cream on the eyelids, you need to ensure that the drug did not get into the eyes, because repeated exposure of the cream can cause cataracts and glaucoma.

Effects on ability to drive vehicles and management mechanisms

Studies of the effect of clobetasol on the ability to drive vehicles or operate machinery have not been conducted. Based on the profile of adverse reactions of clobetasol is for external use, any adverse effects on such activities is not expected.

Structure

100 g of ointment contain:

Active substance: clobetasol propionate - 50 mg*.

other ingredients: propylene glycol 5 g, sorbitan sesquioleate - 500 mg, white soft paraffin to 100 g. 

* - the nominal number clobetasol propionate - mg of 53.75 (subject to the 7.5% excess).

Method of application and doses

Topically.

Ointment applied in a thin layer in an amount sufficient to cover the entire affected area, 1-2 times/day, gently rubbed. Duration of use — to have an effect, or if necessary to 4 weeks. If you want to continue treatment, it is recommended to gradually reduce the frequency of application, or go PA the use of less active drug. You should allow enough time for the effects after each application of the drug Dermovate before applying the emollient. For the treatment of exacerbations of skin disease repeat courses of the drug Dermovate.

In particularly resistant cases, especially when there is hyperkeratosis, the effect of an ointment for external use Dermovate® can be enhanced by using the overlay at night on the area of application of the preparation of an occlusive bandage that is usually accompanied by a positive effect. In the future, the achieved effect it is possible to maintain without the use of occlusive dressings.

If the condition is aggravated or not improved within 2-4 weeks, you should review diagnosis and treatment.

the Maximum weekly dose should not exceed 50 g per week.

Atopic dermatitis (eczema)

Treatment with clobetasol should be gradually lifted once achieving control of the disease, and the treatment emollient should be continued as maintenance therapy. The sudden removal of the clobetasol may lead to relapse of pre-existing dermatosis.

Eczema (various forms)

Patients with frequent relapses of the disease In case of acute illness, as soon as you reach the effect from a continuous course of topical treatment with glucocorticosteroid, can be considered the possibility of intermittent use (once a day, twice a week, without occluzionna bandages). It is shown that such treatment effectively reduces frequency of recurrence.

the application of the drug should be continued for all previously affected areas of skin or on known areas of potential aggravation. This pattern of use should be combined with routine daily use of emollients. There should be regular evaluation of the condition, and the risks and benefits of continued treatment.

Special patient groups 

Children

the children are more likely to develop local and systemic side effects with topical treatment with glucocorticosteroids and, as a rule, it requires a shorter treatment with less active agents than adults. Use caution when using clobetasol in children, to ensure its application in a minimal amount which provides a therapeutic effect.

elderly Patients

Clinical studies did not reveal any differences in effectively of the drug in older and younger patients. A high prevalence of reduced liver function or kidney patients of advanced age may result in slower excretion of the drug in case of systemic absorption. Therefore, it should be used in elderly patients and a minimal amount for the shorter period, but at the same time ensuring that the necessary clinical effect.

Patients with impaired renal function and/or liver

In the case of systemic absorption of the drug (when applied to a large surface of the skin for an extended period), its metabolism and excretion may be slowed down, leading to an increased risk of systemic toxicity. Therefore, it should be applied in such patients and a minimal amount for the shortest period while ensuring the attainment of necessary clinical effect.