Dermovate, 0.05% ointment, 25g

Composition

Ointment for external use 0,05%.100

g of ointment contain:

Active ingredient:  

clobetazole propionate – 50 mg*.

Auxiliary substances:

propylene glycol-5 g,

sorbitan sesquioleate-500 mg,

soft white paraffin-up to 100 g

. * – nominal amount of clobetasol propionate-53.75 mg (including 7.5% excess).

Pharmacological action

CORTICOSTEROIDS for external use.

It prevents the marginal accumulation of neutrophils, reduces inflammatory exudation and lymphokine production, inhibits macrophage migration, reduces the intensity of infiltration and granulation processes, and has local anti-inflammatory, antipruritic, and anti-allergic antiexudative effects.

Indications

• Dermovate is a highly active topical corticosteroid that is indicated for use in adults, the elderly, and children over 1 year of age to relieve symptoms of inflammation and pruritus in dermatoses that are sensitive to corticosteroid therapy.
• Psoriasis (excluding common plaque psoriasis).
• Eczema (various forms).
• Red lichen planus.
• Discoid lupus erythematosus.
• Dermatoses that are resistant to therapy with less active corticosteroids for external use.
• Since the preparation in the form of an ointment helps to preserve moisture in the skin, it is recommended to use Dermovate ointment for external use in skin lesions accompanied by its dryness, hyperkeratosis and thickening.

Use during pregnancy and lactation

CORTICOSTEROIDS for external use should not be used during pregnancy in large doses for a long time.

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

The use of the drug during lactation is contraindicated.

Contraindications

• Bacterial, viral, and fungal skin diseases (including herpes simplex, chickenpox, skin tuberculosis, and actinomycosis).
• Pink acne (rosacea).
• Aagneh.
• Skin cancer.
• Nodal pruritus of the Guide.
• Perioral dermatitis.
• Itching of the skin in the absence of inflammation.
• Perianal and genital pruritus.
• Common plaque psoriasis.
• Under 1 year of age.
• Lactation period.
• Hypersensitivity to the Active ingredient and auxiliary components of the drug.

With caution:  the drug should be used during pregnancy.

Side effects

The adverse events presented below are listed according to the anatomical and physiological classification and frequency of occurrence. The frequency of occurrence is determined as follows:

• Very often (≥ 1/10).
• Frequently ( ≥ 1/100 and
• Infrequently ( ≥ 1/1,000 and
• Rarely ( ≥ 1/10,000 and
• Very rare (

Frequency categories were formed based on clinical studies of the drug and post-marketing 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 – suppression of the hypothalamic-pituitary-adrenal system. Signs of kushingoid (moon-shaped face, central type of obesity), delayed weight gain and/or growth retardation in children, osteoporosis, glaucoma, hyperglycemia and / or glucosuria, cataracts, hypertension, weight gain or obesity, decreased endogenous cortisol levels, alopecia, brittle hair.

Skin and subcutaneous tissue disorders:  often-itching, burning or soreness; infrequently-local skin atrophy*, striae*, telangiectasia*; very rarely-thinning*, wrinkled skin, dry skin*, pigmentation changes*, hypertrichosis, worsening of symptoms of the disease, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria.

* – skin manifestations are secondary to local and / or systemic effects of hypothalamic-pituitary-adrenal depression.

General disorders and disorders of combined use:  very rarely – irritation and / or soreness at the application site.

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

Interaction

Concomitant use of drugs that can inhibit the CYP3A4 isoenzyme (for example, ritonavir and itraconazole) has been shown to inhibit the metabolism of corticosteroids, leading to an increase in their systemic exposure.

The degree of clinical significance of this interaction depends on the dose and method of use of corticosteroids and the activity of the inhibitor of the CYP3A4 isoenzyme.

How to take, course of use and dosage

Externally.

The ointment is recommended for use in skin lesions accompanied by dryness, hyperkeratosis and thickening.

For adults, the elderly, and children over 1 year of age, the drug should be applied in a thin layer and gently rubbed, applying in minimal amounts sufficient to cover the entire affected area once or twice a day until the condition improves, then reduce the frequency of application or replace the drug with a less strong one. After each application, the product should be left for a sufficient time to absorb before applying the emollient.

To prevent exacerbations of skin diseases, short (intermittent) courses of treatment with Dermovate®are performed.

With more persistent lesions, especially in the presence of hyperkeratosis, the effect of Dermovate ® external ointment can be enhanced if necessary by applying an occlusive dressing made of plastic film to the treatment site.

Usually, applying an occlusal dressing overnight is sufficient to get a satisfactory response. In the future, improvement can usually be maintained by applying the drug without a bandage.

If the condition worsens or does not improve within 2-4 weeks, the diagnosis and treatment should be re-evaluated.

Treatment should not last more than 4 weeks. If continuation of treatment is necessary, a less powerful drug should be used.

The maximum dose should not exceed 50 g of ointment per week.

Treatment with Dermovate® should be gradually discontinued after disease control is achieved, and treatment with an emollient should be continued as maintenance therapy.

Abrupt discontinuation of Dermovate may lead to a relapse of pre – existing dermatoses.

Dermatoses that are difficult to treat: patients with frequent relapses of the disease in the case of acute disease, as soon as the effect of a continuous course of treatment with Dermovate® is achieved, the possibility of intermittent use of the drug (once a day, twice a week, without an occlusive dressing) may be considered.

It has been shown that such treatment effectively reduces the frequency of relapses.

Application of the drug should be continued on all previously affected areas of the skin or on known areas of potential exacerbation. Such a scheme of application should be combined with the routine daily use of emollients. Regular assessment of the patient’s condition, as well as the benefits and risks of continuing treatment, should be carried out.

Overdose

Symptoms:  Dermovate can be absorbed externally in sufficient quantities to cause the development of systemic effects.

The development of an acute overdose is unlikely. However, in case of chronic overdose or improper use of Dermovate, symptoms of hypercorticism may develop.

Treatment:  in case of overdose of Dermovate, the drug should be gradually discontinued, reducing the frequency of application or replacing with less active corticosteroids, under the supervision of a doctor due to the risk of adrenal insufficiency.

Further treatment should be carried out taking into account the clinical situation or in accordance with the recommendations of toxicology centers, if any.

Special instructions

Dermovate should be used with caution in patients with a history of local hypersensitivity to corticosteroids or to any of the excipients in the drug.

Local hypersensitivity reactions may be similar to the symptoms of the current disease. Hypercorticism (Cushing’s syndrome) and reversible suppression of the hypothalamic-pituitary-adrenal system, leading to glucocorticoid insufficiency, may occur in some individuals as a result of increased systemic absorption of corticosteroids for external use.

If any of the above is observed, the drug should be discontinued, gradually reducing the frequency of its application, or replaced with less active corticosteroids. Sudden discontinuation of treatment can lead to the development of corticosteroid insufficiency.

Risk factors for increased systemic effects include the following: : activity and dosage form of corticosteroids for external use, duration of use, application of the drug to large areas of the skin, use in closed areas of the skin (i. e.in intertriginal areas or under occlusive dressings (diapers and diapers in children can play the role of an occlusive dressing), increased hydration of the stratum corneum of the skin, use on areas with thin skin, such as the face, application to damaged skin or in other conditions that may be accompanied by a violation of the integrity of the skin barrier.

Compared to adults, children and children may have a higher percentage of absorption of corticosteroids for external use, and therefore 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 higher ratio of body surface area to body weight compared to adults.

Use in children

Corticosteroids for external use should be avoided for a long time, especially in the treatment of young children, as this may inhibit the function of the adrenal glands. The use of Dermovate in children requires medical supervision at least once a week. On the face more often than on other parts of the body, as a result of prolonged use of local corticosteroids, atrophic skin changes may appear, which must be taken into account in the treatment of psoriasis, discoid lupus erythematosus and severe eczema with the localization of rashes on the face.

Use in psoriasis

Treatment of psoriasis with corticosteroids for external use may be accompanied by the resumption of symptoms of the disease, resistance to the drug, the development of generalized pustular psoriasis and local or systemic adverse reactions due to a violation of the skin barrier function, so careful monitoring of the patient is especially important.

Concomitant infection

When a secondary infection is added, appropriate antibacterial therapy should be carried out. If there are any signs of generalization of infection, it is necessary to stop external use of corticosteroids and conduct appropriate treatment with antibacterial drugs.

Risk of infection with occlusion

The warm, humid conditions created when applying an occlusive dressing contribute to the occurrence of bacterial infection, so you should always thoroughly clean the skin before applying a new dressing.

Chronic leg ulcers

External corticosteroids are sometimes used to treat dermatitis around chronic leg ulcers. However, such use may be associated with an increased incidence of local hypersensitivity reactions and an increased risk of local infections.

Application on the face

Application on the face is undesirable, because this area is more susceptible to the development of atrophic changes. If applied to the face, the treatment should be limited to a few days.

Applying to the eyelids

When applying the cream to the eyelids, care must be taken to ensure that the drug does not get into the eyes, because repeated exposure to the cream can cause cataracts and glaucoma.

Influence on the ability to drive motor vehicles and manage mechanisms

Studies on the effect of clobetasol on the ability to drive vehicles or work with mechanisms have not been conducted. Based on the adverse reaction profile of clobetasol for external use, no adverse effects on these activities are expected.

Form of production

Ointment for external use 0,05%.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

2 years

Active ingredient

Clobetazol

Conditions of release from pharmacies

By prescription

Dosage form

ointment

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Dermatosis, Psoriasis, Dermatitis