Dermbin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DERMABIN (DERMABIN)

Composition:

Active substances: betamethasone, salicylic acid;

1 g of ointment contains betamethasone dipropionate 0.64 mg, equivalent to betamethasone 0.5 mg, and salicylic acid 30 mg;

Excipients: vaseline, mineral oil.

Pharmaceutical form. Ointment.

Main physicochemical properties: homogeneous, soft ointment of nearly white color, free from extraneous inclusions.

Pharmacotherapeutic group. Dermatological corticosteroids. Potent corticosteroids in combination with other agents. ATC code D07XC.

Pharmacological properties.

Pharmacodynamics.

Betamethasone dipropionate is a synthetic fluorinated corticosteroid that exerts anti-inflammatory, antipruritic, and vasoconstrictive effects. Local treatment with corticosteroids is not etiotropic therapy; therefore, discontinuation of treatment may result in disease relapse. Salicylic acid, due to its keratolytic and desquamating properties, makes the lower layers of the skin more accessible to the action of betamethasone dipropionate and enhances its absorption.

Pharmacokinetics.

Systemic absorption of betamethasone dipropionate is possible primarily after prolonged application over a large skin surface area.

Clinical characteristics.

Indications.

For local treatment of dermatoses sensitive to corticosteroids, such as chronic, erythematous, or hyperkeratotic psoriasis and other erythematous-squamous dermatoses, including seborrheic dermatitis (eczema), dry eczema in the desquamative phase, and lichenification.

Contraindications.

The drug is contraindicated in patients with hypersensitivity to the active substances or to any other component of the preparation.

The drug is also contraindicated in bacterial and viral infections, such as syphilitic and tuberculous skin lesions; postvaccinal reactions, smallpox, chickenpox, herpes simplex, shingles, perioral dermatitis, perianal pruritus and genital pruritus, generalized plaque psoriasis, varicose veins, diaper dermatitis, molluscum contagiosum, dermatomycoses, rosacea, acne, and fungal infections.

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Interaction with other medicinal products and other forms of interaction.

There is no information about cases of interaction with other medicinal products.

Topical application of salicylic acid should not be combined with oral administration of drugs containing acetylsalicylic acid and other nonsteroidal anti-inflammatory agents. Do not use concomitantly with benzoyl peroxide and topical retinoids. Salicylic acid may increase skin permeability to other topical medicinal products, thereby enhancing their systemic absorption. In addition, salicylic acid may potentiate the adverse effects of methotrexate and the hypoglycemic effect of oral antidiabetic sulfonylurea derivatives. If the patient is taking any other medicinal products, this must be reported to the physician.

Special precautions for use.

The product is not intended for ophthalmic use. Contact of the product with the eyes, mucous membranes, wound surfaces, and ulcers should be avoided.

If skin irritation or signs of hypersensitivity occur, treatment should be discontinued and appropriate therapy should be selected for the patient.

Any adverse effects observed with systemic corticosteroids, including suppression of adrenal cortex function, may also occur with topical application of glucocorticosteroids, especially in children.

Systemic absorption of topical corticosteroids increases with larger treated surface areas or when occlusive dressings are used. In such cases or during prolonged treatment, appropriate precautions should be taken.

High-potency corticosteroids applied over large skin areas should be used under careful and periodic monitoring, as they may suppress the hypothalamic-pituitary-adrenal (HPA) axis. If suppression occurs, the drug should be discontinued, the frequency of application reduced, or the patient should be switched to a corticosteroid with weaker activity.

HPA axis function usually recovers after discontinuation of the drug. In some cases, withdrawal symptoms may develop, requiring supplementation with systemic corticosteroids.

After scaling or hyperkeratosis has resolved, treatment should continue with corticosteroids only. The use of the product under occlusive dressings is not recommended.

If excessive dryness or increased skin irritation occurs, the product should be discontinued.

Topical corticosteroids, for various reasons, may induce psoriasis, including rebound symptoms followed by development of tolerance, risk of pustular psoriasis, and local systemic toxicity due to impaired skin barrier function. Patients with hepatic dysfunction are more susceptible to systemic effects. Close monitoring of the patient is required.

If infection is present, appropriate antifungal or antibacterial agents should be administered. If the desired effect is not rapidly achieved, corticosteroid use should be discontinued until signs of infection have resolved.

Appropriate precautions should be observed to prevent increased absorption when the product is applied to damaged skin areas, atrophic skin, large body surface areas, under occlusive dressings, or in children (due to higher body surface area to body weight ratio). When applied over large body surface areas, absorption of salicylic acid should also be considered.

Topical corticosteroids may alter the clinical picture.

Relapse may occur upon interruption of treatment, and infection may worsen or healing may be delayed.

The product should not be applied to mucous membranes or areas around the eyes due to the keratolytic effect of salicylic acid.

Application of the product to areas with atrophic skin is contraindicated.

Visual disturbances.

Visual disturbances may occur with systemic and topical use of corticosteroids (including intranasal, inhaled, and intraocular administration). If symptoms such as blurred vision or other visual disturbances occur, the patient should undergo an ophthalmological examination to evaluate possible causes, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, which has been reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding.

Data on the use of Dermabin during pregnancy are lacking or limited.

Dermabin should not be used during pregnancy except for short-term treatment of a small, isolated skin area.

It is unknown whether systemic exposure to Dermabin achieved after topical application may be harmful to the embryo/fetus.

It should not be used during the first trimester of pregnancy.

During the third trimester of pregnancy, systemic use of prostaglandin synthetase inhibitors may cause cardiopulmonary and renal toxicity in the fetus. At the end of pregnancy, prolonged bleeding may occur in both mother and child, and labor may be prolonged.

Since the safety of topical corticosteroids in pregnant women has not been established, these drugs should be prescribed only if the expected benefit to the mother clearly outweighs the potential risk to the fetus. Drugs of this class are contraindicated in high doses and for prolonged periods during pregnancy.

It is currently unknown whether topically applied corticosteroids, due to systemic absorption, can pass into breast milk; therefore, a decision should be made whether to discontinue breastfeeding when prescribing this product.

Ability to affect reaction speed while driving or operating machinery.

The product usually does not affect reaction speed while driving or operating machinery.

Dosage and Administration

Apply a thin layer of the ointment twice daily, in the morning and evening, to the affected area and allow it to penetrate the skin, gently massaging the area simultaneously. For some patients, once-daily application may be sufficient to achieve satisfactory results.

The maximum daily dose should be gradually reduced to the lowest possible dose that still controls symptoms.

Children

There are no clinical data on the use of this medicinal product in children; therefore, it should not be used in this age group.

Since children have a higher surface area to body weight ratio compared to adults, systemic absorption of topical medications may be more pronounced. Therefore, children are more susceptible to hypothalamic-pituitary-adrenal (HPA) axis suppression and the development of systemic corticosteroid effects following topical corticosteroid use.

In children treated with topical corticosteroids, adrenal suppression, Cushing's syndrome, growth retardation, inadequate weight gain, and increased intracranial pressure have been reported.

Signs of adrenal cortex suppression include low plasma cortisol levels and lack of response to adrenocorticotropic hormone (ACTH) stimulation tests. Increased intracranial pressure may present as bulging fontanelle, headache, and bilateral optic disc swelling (papilledema).

Since corticosteroids may affect growth hormone production in children, body weight and growth should be closely monitored in pediatric patients.

Overdose

Prolonged or excessive use of topical glucocorticosteroids may lead to suppression of the pituitary-adrenal function, resulting in secondary adrenal insufficiency and symptoms of hypercorticism, including Cushing's syndrome. Excessive or prolonged use of topical products containing salicylic acid may lead to symptoms of salicylism. Application of large amounts of the product may intensify keratolytic effects and increase the risk of allergic reactions.

Treatment: Appropriate symptomatic therapy should be administered. Symptoms of acute hypercorticism are usually reversible. If necessary, correction of electrolyte imbalances should be performed. In cases of chronic toxicity, gradual withdrawal of corticosteroids is recommended.

Treatment of salicylism is symptomatic. Measures to enhance elimination of salicylates from the body should be applied. In case of overgrowth of resistant microorganisms, treatment with the product should be discontinued and appropriate therapy initiated. Orally administer sodium bicarbonate to alkalinize urine and enhance diuresis.

Adverse reactions.

The following adverse reactions may occur with the use of topical corticosteroids: burning sensation, pruritus, irritation, dryness of the skin, skin stinging, skin induration, skin cracking, sensation of warmth, lamellar desquamation, focal desquamation, erythema, telangiectasia, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, and allergic contact dermatitis.

When the drug is applied over a large surface area or under occlusive dressing, particularly for prolonged periods, systemic effects of the drug should be considered as possible.

Hypersensitivity reactions may occur in individuals with known hypersensitivity to any component of the drug.

Cases of blurred vision have been reported (see also section "Special precautions for use") with corticosteroid use (frequency unknown).

Any adverse effects associated with systemic administration of glucocorticoids, including suppression of the adrenal cortex, may also occur with topical application of glucocorticosteroids.

The following adverse reactions may occur more frequently when occlusive dressings are used: skin maceration, secondary infection, skin atrophy, striae, and miliaria.

Striae and vascular dilation, particularly on the face, may result from prolonged continuous application of the drug.

Shelf life. 3 years.

Storage conditions. Store out of reach of children at a temperature not exceeding 25 °C.

Packaging.

15 g in tubes. 1 tube per cardboard box.

Prescription status. Prescription only.

Manufacturer.

LLC "FZ "STADA", Ukraine.

Manufacturer's address and location of business activity.

37, Kyivska Street, Bila Tserkva, Kyiv Oblast, 09100, Ukraine.