Dermoveit, 0.05% 25 g ointment

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

Active ingredient

Composition

The ointment for external use is 0.05%.

100 g of the ointment contain:

The active ingredient:

clobetasol propionate – 50 mg*.

Auxiliary substances:

propylene glycol – 5 g,

sorbitan sesquioleate – 500 mg,

paraffin soft white – up to 100 g.

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

How to take, the dosage

Externally.

The ointment is recommended for skin lesions accompanied by dryness, hyperkeratosis and thickening of the skin.

Adults, seniors and children over 1 year old
The product should be applied in a thin layer and rubbed in gently, using the smallest amount needed to cover the entire area affected once or twice daily until the condition improves, then the frequency of application should be reduced or the product changed to a less strong one. After each application, leave the product long enough to absorb before applying the emollient.

Short (intermittent) courses of treatment with Dermoveit® are used to prevent exacerbations of skin conditions.

In more persistent lesions, especially in the presence of hyperkeratosis, the effect of Dermoveit® Topical Ointment may be enhanced if necessary by applying a polyethylene film occlusion dressing to the treatment site.

The application of an occlusive dressing overnight is usually sufficient to obtain a satisfactory response. Thereafter, improvement can usually be maintained with application of the drug without the dressing.

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

The treatment should not be continued for more than 4 weeks. If continued treatment is necessary, a less potent medication should be used.

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

The treatment with Dermoveit® should be withdrawn gradually after achieving control of the disease, and the emollient treatment should be continued as maintenance therapy.

Abrupt withdrawal of Dermoveit® may lead to a recurrence of pre-existing dermatoses.

Dermatoses that are difficult to treat: patients with frequent relapses
In cases of acute disease, once the effects of continuous treatment with Dermoveit® have been achieved, intermittent use of the drug (once daily, twice weekly, no occlusive dressing) may be considered.

This treatment has been shown to be effective in reducing relapse rates.

Application should be continued to all previously affected skin areas or known areas of potential exacerbation. This regimen should be combined with routine daily application of emollients. The patient’s condition and the benefits and risks of continued treatment should be evaluated regularly.

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 improper use of Dermoveit, symptoms of hypercorticism may develop.

Treatment: If there is an overdose of Dermoveit, the drug should be gradually withdrawn by reducing the frequency of application or replaced with a less active GCS under a physician’s supervision because of the risk of adrenal insufficiency.

The further treatment should be based on the clinical situation or as recommended by toxicology centers if available.

Pregnancy use

Off-the-counter GCS should not be used in high doses in pregnancy for a long time.

The use of the drug during pregnancy has not been found to have adverse effects on the health of the woman or the 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.

Similarities