Dermoveit, 0.05% cream 25 g

GCS for external use.

Prevent marginal accumulation of neutrophils, decrease inflammatory exudation and production of lymphokines, inhibit macrophage migration, decrease the intensity of infiltration and granulation processes, have local anti-inflammatory, antipruritic, anti-allergic anti-exudative effects.

Indications

Dermoveit is a highly active topical GCS indicated for use in adults, the elderly and children over 1 year of age for the relief of symptoms of inflammation and skin itching in dermatoses sensitive to GCS therapy.

Active ingredient

Composition

Cream for external use.

100 g of the cream contain:

Active substance:

clobetasol propionate – 50 mg*.

Associates:

Glyceryl monostearate – 11 g,

Propylene glycol glyceryl oleate (arlacel 165) – 1.5 g,

beeswax substitute 6621 – 1.25 g,

cetostearyl alcohol – 8.4 g,

Interaction

The concomitant use of drugs that can inhibit the CYP3A4 isoenzyme (e.g., ritonavir and itraconazole) has been shown to inhibit GCS metabolism, leading to increased systemic exposure.

The degree of clinical significance of this interaction depends on the dose and route of administration of GCS and the activity of CYP3A4 isoenzyme inhibitor.

Special Instructions

The drug Dermoveit should be used with caution in patients with a history of local hypersensitivity to GCS or to any of the excipients in the drug.

Local hypersensitivity reactions may resemble the symptoms of the underlying disease. In some individuals as a result of increased systemic absorption of GCS for external use there may be signs of hypercorticism (Cushing’s syndrome) and reversible suppression of hypothalamic-pituitary-adrenal system leading to glucocorticosteroid insufficiency.

If any of the above is observed, the drug should be discontinued, gradually reducing the frequency of application, or replaced with a less active GCS. Sudden discontinuation of treatment may lead to glucocorticosteroid failure.

Contraindications

With caution: the drug should be used in pregnancy.

Side effects

The undesirable phenomena presented below are listed according to anatomico-physiological classification and frequency of occurrence. The frequency of occurrence is defined as follows:

The frequency categories were formed based on clinical studies of the drug and post-registration surveillance.

Infectious and parasitic diseases: very rarely, infection caused by opportunistic pathogens.

Immune system disorders: very rare – hypersensitivity.

Endocrine system disorders: very rarely – suppression of hypothalamic-pituitary-adrenal system. Signs of cushingoid (moon-shaped face, central obesity), delayed weight gain and/or stunting in children, osteoporosis, glaucoma, hyperglycemia and/or glucosuria, cataracts, hypertension, weight gain or obesity, decreased endogenous cortisol levels, alopecia, hair breakage.

Skin and subcutaneous tissue disorders: frequent – itching, burning sensation or soreness; infrequent – local skin atrophy*, stretch marks*, telangiectasia*; very rare – thinning*, wrinkled skin, dry skin*, pigmentation changes*, hypertrichosis, aggravation of disease symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria.

* – cutaneous manifestations are secondary to the local and/or systemic effects of suppression of the hypothalamic-pituitary-adrenal system.

General disorders and disorders together with the administration: very rare – irritation and/or soreness at the site of application.

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

Overdose

Symptoms: Dermoveit when applied topically may be absorbed in amounts sufficient to cause systemic effects. The development of an acute overdose is unlikely. However, in case of chronic overdose or inappropriate use of Dermoveit, symptoms of hypercorticism may develop.

Treatment: In case of an overdose of Dermoveit, the drug should be gradually withdrawn by reducing the frequency of application or replaced with a less active GCS, under medical supervision due to the risk of adrenal insufficiency. Further treatment should be based on the clinical situation or as recommended by toxicology centers if available.

Pregnancy use

Over-the-counter GCS should not be used in pregnancy in high doses for long periods of time. Studies have not found adverse effects on the health of the woman or the fetus during pregnancy.

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.

Similarities