Dermovate ointment 0.05% tube 25 g

Pharmacodynamics. The main effect of clobetasol propionate on the skin is an anti-inflammatory effect due to vasoconstriction and a decrease in collagen synthesis in the skin.

Pharmacokinetics. The penetration of clobetasol propionate through the skin has significant individual differences and may increase when using airtight dressings or when applied to inflamed or damaged skin. In one study in individuals with healthy skin, the average C _max of clobetasol in blood plasma was 0.63 ng / ml and was achieved 8 hours after repeated application (13 hours after the first application) of 30 g of 0.05% clobetasol propionate ointment. After applying a second dose of 30 g of 0.05% cream C _max in blood plasma was slightly higher than when applying the ointment, and was achieved after 10 hours. In another clinical study, the average C _max (2.3 and 4.6 ng / ml) in patients with psoriasis and eczema, respectively, was achieved 3 hours after a single application of 25 g of 0.05% clobetasol propionate ointment. After absorption through the skin, the drug is most likely metabolized in the same way as after systemic administration. However, the systemic metabolism of clobetasol has not been fully studied.

Psoriasis (except widespread plaque psoriasis), dermatoses that are poorly amenable to treatment, lichen planus, discoid lupus erythematosus and other diseases that are not amenable to treatment with corticosteroids with less activity.

Ointment or cream is applied in a thin layer to the affected areas of the skin 1 or 2 times a day. When the disease is controlled, the use of clobetasol should be gradually discontinued. In conditions of good response to treatment, control of the disease can be achieved in a few days. Treatment should not last more than 4 weeks. The maximum dose should not exceed 50 g per week. In the absence of improvement within 2-4 weeks, the diagnosis and treatment should be reviewed. Repeated short courses of therapy with Dermovate can be carried out to control exacerbations. If long-term continuous treatment is necessary, less active corticosteroids should be used.

In resistant skin lesions, especially in the case of hyperkeratosis, the anti-inflammatory effect of Dermovate can be enhanced by covering the application site with polyethylene film. To achieve a positive result, apply an airtight bandage overnight. The already achieved effect is maintained by simply applying the drug to the skin without covering it with film.

Hypersensitivity to the components of the drug, untreated skin infections, rosacea, common acne, itching without inflammation, perianal and genital itching, perioral dermatitis. Dermovate is not indicated for the treatment of dermatoses in children under 1 year of age, including dermatitis and diaper rash.

Adverse reactions, classified by organ system and by frequency of occurrence. are divided into the following categories by frequency: very common (≥1/10), common (≥1/100 and 1/10), uncommon (≥1/1000 and 1/100), rare (≥1/10,000 and 1/1000), very rare (1/10,000, including isolated cases).

Infections and infestations: very rarely – opportunistic infections.

Immune system: very rarely – local hypersensitivity.

Endocrine system: very rarely – suppression of the hypothalamic-pituitary-adrenal system: Cushingoid features (e.g. moon-shaped face, central obesity), delayed weight gain/growth in children, osteoporosis, glaucoma, hyperglycemia/glucosuria, cataracts, hypertension, weight gain/obesity, decreased endogenous cortisol levels, alopecia, hair fragility.

Skin and subcutaneous tissue: often – itching, local burning sensation / pain in the skin; infrequently – local skin atrophy *, atrophic skin stripes *, telangiectasias *; very rarely – skin thinning *, skin wrinkling *, skin dryness *, pigmentation changes *, hypertrichosis, exacerbation of the main symptoms, allergic contact dermatitis / dermatitis, pustular psoriasis, erythema, rash, urticaria, acne.

General disorders and administration site conditions: very rare – irritation/pain at the application site.

* Skin disorders secondary to local and/or systemic hypothalamic-pituitary-adrenal axis suppression.

The drug should be used with caution in patients with a history of local hypersensitivity reactions to corticosteroids or other substances. Local hypersensitivity reactions (see adverse reactions) may resemble the symptoms of the disease being treated.

Manifestations of hypercorticism (Cushing’s syndrome) and hypothalamic-pituitary-adrenal (HPA)-adrenal axis suppression with adrenal suppression in some patients may result from increased systemic absorption of topical steroids. If any of the above symptoms occur, the drug should be gradually discontinued by reducing the frequency of application or replacing it with a less potent corticosteroid. Abrupt discontinuation of treatment may precipitate glucocorticosteroid insufficiency (see Adverse Reactions).

Risk factors for systemic effects: potency and composition of the topical steroid; duration of application; application to large areas of skin; application to skin surfaces that are in contact, such as diaper areas or where an occlusive dressing is applied (in newborns, diapers can act as an occlusive dressing); increased hydration of the stratum corneum; application to areas with thin skin, such as the face; application to areas of damaged skin or other conditions where the skin barrier is compromised.

Children may absorb proportionally larger amounts of topical corticosteroids than adults and are therefore more susceptible to systemic adverse reactions. This is because children have an underdeveloped skin barrier and a larger skin surface area relative to body weight than adults.

Children: Prolonged use of topical corticosteroids in neonates and children under 12 years of age should be avoided where possible, as they are more likely to develop adrenal suppression.

Children are more prone to developing atrophic changes when using topical corticosteroids. Treatment of children with Dermovate should, if possible, last no more than 5 days. The feasibility of continuing treatment should be reviewed weekly.

Risk of infection when applying an occlusive dressing. The risk of bacterial infections increases in the warm and humid conditions that can occur under occlusive dressings, so the skin must be carefully treated each time before applying a new dressing.

Treatment of psoriasis. Topical corticosteroids should be used with caution in the treatment of psoriasis, as in some cases relapses, development of tolerance, risk of generalization of pustular psoriasis and development of symptoms of local or systemic toxicity due to impaired skin barrier function have been reported. When used for the treatment of psoriasis, the patient should be under close medical supervision.

Concomitant infections. Appropriate antibacterial agents should be administered whenever inflammatory lesions that have become infected are treated. In the event of widespread infection, topical corticosteroids should be discontinued and appropriate antibacterial therapy should be administered.

Chronic leg ulcers. Topical corticosteroids are sometimes used to treat dermatitis that occurs around chronic leg ulcers. However, this use is associated with an increased incidence of local hypersensitivity reactions and the risk of local infections.

Application to the face. Applying ointments/creams to the skin of the face is undesirable, as this area is most prone to atrophic changes. If necessary, use should be limited to 5 days.

Application to the eyelids. When applying ointments/creams to the eyelids, avoid getting the drug in the eyes, as repeated use may cause cataracts and glaucoma.

Pregnancy and breastfeeding

Pregnancy: Data on the use of Dermovate in pregnant women are limited.

Topical application of corticosteroids to pregnant animals may cause fetal malformations. There are no similar data on humans. Dermovate should be used during pregnancy only if the expected benefit to the mother outweighs the risk to the fetus. The minimum amount of the drug should be used for the minimum duration of treatment.

Breastfeeding. The safety of clobetasol propionate during breastfeeding has not been established. It is not known whether topical corticosteroids can result in systemic absorption that would result in measurable amounts of the drug in breast milk. Dermovate should be used during breastfeeding only if the expected benefit to the mother outweighs the risk to the infant. If Dermovate is prescribed during breastfeeding, the cream should not be applied to the breasts to avoid accidental ingestion of the cream by the infant.

Effects on the ability to drive and use machines. No studies have been conducted to study this effect. Taking into account the adverse reaction profile, no effects on the reaction rate when driving or using machines are expected.

It has been established that combined use with drugs that can inhibit CYP 3A4 (for example, ritonavir, itraconazole) inhibits the metabolism of corticosteroids, which can provoke a systemic effect. The extent to which such an interaction is clinically significant depends on the dose of the drug, the route of administration of the GCS and the potency of the CYP 3A4 inhibitor.

Symptoms and signs. With normal use, Dermovate can be absorbed in quantities sufficient to cause systemic effects. The likelihood of acute overdose is very small, but in case of chronic overdose or improper use, signs of hypercortisolism may occur.

Treatment. In case of overdose, Dermovate should be gradually discontinued by reducing the frequency of application of the cream/ointment or replacing it with a less potent corticosteroid, taking into account the risk of glucocorticosteroid insufficiency. Further treatment is carried out in accordance with the patient’s condition or in accordance with national recommendations for the treatment of poisoning.

At temperatures up to 30 °C.