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

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

Pharmacological effect

GKS for external use.

Prevents the marginal accumulation of neutrophils, reduces inflammatory exudation and the production of lymphokines, inhibits the migration of macrophages, reduces the intensity of infiltration and granulation processes, has local anti-inflammatory, antipruritic, antiallergic antiexudative effects.

Special instructions

Dermovate 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 be similar to the symptoms of an ongoing disease. In some individuals, as a result of increased systemic absorption of GCS for external use, manifestations of hypercorticism (Cushing’s syndrome) and reversible inhibition of the hypothalamic-pituitary-adrenal system, leading to glucocorticosteroid insufficiency, may occur.

If any of the above occurs, the drug should be discontinued, gradually reducing the frequency of its application, or replaced with a less active GCS. Sudden cessation of treatment may lead to the development of glucocorticosteroid deficiency.

Risk factors for increased systemic effects include the following: activity and dosage form of GCS for external use, duration of use, application of the drug to large areas of skin, use in closed areas of the skin (i.e. in intertriginous areas or under occlusive dressings (diapers and nappies in infants can act as 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 for other conditions that may be accompanied by a violation of the integrity of the skin barrier.

Compared to adults, children and infants may experience a greater percentage of absorption of topical corticosteroids, 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 larger body surface area to body weight ratio compared to adults.

Use in children

Prescribing corticosteroids for external use for a long time should be avoided, especially when treating young children, since this may inhibit the functions of the adrenal glands. The use of Dermovate in children requires observation by a doctor at least once a week. On the face more often than on other parts of the body, as a result of long-term use of local corticosteroids, atrophic changes in the skin may appear, which must be taken into account in the treatment of psoriasis, discoid lupus erythematosus and severe eczema with localized rashes on the face.

Use for psoriasis

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

Concomitant infection

If a secondary infection occurs, appropriate antibacterial therapy should be carried out. If there are any signs of generalization of the infection, it is necessary to stop the external use of GCS and carry out appropriate treatment with antibacterial drugs.

Risk of infection due to occlusion

The warm, moist conditions created by applying an occlusive dressing are conducive to bacterial infection, so be sure to thoroughly cleanse the skin before applying a new dressing.

Chronic leg ulcers

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

Application to facial skin

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

Application on eyelids

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

Impact on the ability to drive vehicles and operate machinery

There have been no studies examining the effect of clobetasol on the ability to drive or operate machines. Based on the adverse reaction profile of topical clobetasol, no adverse effects on such activities are expected.

Active ingredient

Clobetasol

Composition

Ointment for external use 0.05%.

100 g ointment contains:

Active substance:

clobetasol propionate – 50 mg*.

Excipients:

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).

Pregnancy

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

Studies have not found that 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.

Contraindications

Bacterial, viral and fungal skin diseases (including herpes simplex, chicken pox, skin tuberculosis, actinomycosis).
Rosacea (rosacea).
Aagne.
Skin cancer.
Nodular prurigo Hyde.
Perioral dermatitis.
Skin itching in the absence of inflammation.
Perianal and genital itching.
Common plaque psoriasis.
Age up to 1 year.
Lactation period.
Hypersensitivity to the active substance and auxiliary components of the drug.

With caution: the drug should be used during pregnancy.

Side Effects

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

Very common (≥ 1/10).
Often (≥ 1/100 and < 1/10). Uncommon (≥ 1/1,000 and < 1/100). Rare (≥ 1/10,000 and < 1/1,000). Very rare (<1/10,000, including isolated cases).

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 organisms.

From the immune system: very rarely – hypersensitivity.

From the endocrine system: very rarely – suppression of the hypothalamic-pituitary-adrenal system. Cushingoid signs (moon face, central obesity), delayed weight gain and/or growth retardation in children, osteoporosis, glaucoma, hyperglycemia and/or glycosuria, cataracts, hypertension, weight gain or obesity, decreased endogenous cortisol levels, alopecia, hair fragility.

From the skin and subcutaneous tissues: often – itching, burning sensation or soreness; uncommon – local skin atrophy*, striae*, telangiectasia*; very rarely – thinning*, skin wrinkling, dry skin*, changes in pigmentation*, hypertrichosis, worsening of disease symptoms, allergic contact dermatitis, pustular psoriasis, erythema, rash, urticaria.

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

General disorders and disorders following administration: very rarely – irritation and/or pain at the site of application.

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 hypercortisolism.

Interaction

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

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

Overdose

Symptoms: When applied topically, Dermovate can be absorbed in quantities sufficient to cause systemic effects.

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

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

Further treatment should be based on the clinical situation or in accordance with the recommendations of poison control centers, if available.

Storage conditions

At a temperature not exceeding 30 °C

Shelf life

2 years

Manufacturer

GlaxoSmithKline Pharmaceuticals S.A., Poland