Betasalik®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETA SALIC® (BETASALIC®)

Composition:

Active substances: betamethasone, salicylic acid (betamethasone, salicylic acid);

1 g of ointment contains betamethasone dipropionate, calculated as 100% substance, 0.64 mg; salicylic acid, calculated as 100% substance, 30.0 mg;

Excipients: mineral oil, white soft paraffin.

Pharmaceutical form. Ointment.

Main physicochemical characteristics: white-colored ointment.

Pharmacotherapeutic group. Corticosteroids for dermatological use. Potent corticosteroids in combination with other agents. ATC code D07XC01.

Pharmacological Properties

Pharmacodynamics

Betamethasone dipropionate

Betamethasone dipropionate belongs to potent corticosteroids. When applied locally, it exerts a rapid and prolonged anti-inflammatory, antipruritic, and vasoconstrictive effect.

Local treatment with corticosteroids is not an etiological therapy; upon discontinuation of treatment, disease relapse may occur.

Salicylic acid

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 area.

Clinical Characteristics

Indications

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

Contraindications

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

The medicinal product is also contraindicated in bacterial and viral infections, such as syphilitic and tuberculous skin lesions; post-vaccination 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, fungal infections.

Interaction with other medicinal products and other forms of interaction

There are no known 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 enhance skin permeability to other topical medicinal products, thereby increasing their systemic absorption. In addition, salicylic acid may potentiate the adverse effects of methotrexate and the hypoglycemic effect of oral antidiabetic drugs – sulfonylurea derivatives. If you are taking any other medicinal products, you must inform your physician.

Special precautions for use

The medicinal product is not intended for ophthalmic use. Contact with eyes, mucous membranes, wounds, and ulcers should be avoided.

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

Any adverse effects associated 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 body surface areas or when occlusive dressings are used. In such cases or during prolonged use, appropriate precautionary measures should be taken.

High-potency corticosteroids applied over large skin areas should be used with careful monitoring of the patient, as they may cause suppression of the hypothalamic-pituitary-adrenal (HPA) axis. If suppression occurs, the medicinal product should be withdrawn, the frequency of application reduced, or the patient switched to a less potent corticosteroid.

HPA axis function usually recovers after discontinuation of the medicinal product. In some cases, withdrawal symptoms may develop, requiring the addition of systemic corticosteroid therapy.

After scaling or hyperkeratosis has resolved, treatment should continue with corticosteroids only.

Use of the medicinal product under occlusive dressings is not recommended.

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

Topical corticosteroids may induce psoriasis, including rebound of symptoms followed by development of tolerance, risk of pustular psoriasis, and local systemic toxicity due to impaired skin barrier function. Patients with hepatic impairment are more sensitive 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 medicinal product is applied to damaged skin, 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 medicinal product should not be applied to mucous membranes or periorbital areas due to the keratolytic action of salicylic acid.

Application of the medicinal 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 ophthalmologic examination to evaluate possible causes of visual impairment, which may include cataract, glaucoma, or rare conditions such as central serous chorioretinopathy, reported after systemic and topical corticosteroid use.

Use during pregnancy or breastfeeding

Pregnancy

Data on the use of Betasalik® ointment during pregnancy are lacking or limited.

Betasalik® ointment should not be used during pregnancy except for short-term treatment of a small, localized skin area.

It is unknown whether systemic exposure to Betasalik® ointment achieved after topical application could be harmful to the embryo/fetus.

Systemic use of prostaglandin synthetase inhibitors during the third trimester of pregnancy may cause cardiovascular-pulmonary and renal toxicity in the fetus. Prolonged bleeding may occur in both mother and child near term, and labor may be prolonged.

It is currently unclear whether corticosteroids, due to systemic absorption after topical application, can pass into breast milk; therefore, a decision should be made whether to discontinue breastfeeding when prescribing this medicinal product.

Effect on ability to drive and operate machinery

The medicinal product usually does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

Apply a thin layer of the ointment to the affected area twice daily, in the morning and evening, allowing it to penetrate the skin with gentle massage.

For some patients, satisfactory results may be achieved with once-daily application.

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, its use is not recommended in this age group.

Due to a higher surface area to body weight ratio compared to adults, children may absorb the drug more actively. Therefore, children are more susceptible to hypothalamic-pituitary-adrenal (HPA) axis suppression and the development of exogenous corticosteroid effects following corticosteroid use.

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

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.

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 pituitary-adrenal function, resulting in secondary adrenal insufficiency and symptoms of hypercortisolism, including Cushing's disease. Excessive or prolonged use of topical products containing salicylic acid may cause symptoms of salicylism.

Excessive doses of the medicinal product may enhance keratolytic effects and increase the risk of allergic reactions.

Treatment. Appropriate symptomatic therapy should be administered. Symptoms of acute hypercortisolism are usually reversible. If necessary, correct electrolyte imbalances. In cases of chronic toxic effects, gradual withdrawal of corticosteroids is recommended.

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

Side effects

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

When the medicinal product is applied over a large area of skin or under occlusive dressing, especially 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 medicinal product.

Cases of blurred vision have been reported with corticosteroid use (see also section "Special precautions for 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 dilated blood vessels, mainly on the face, may result from prolonged continuous application of the medicinal product.

Shelf life. 3 years.

Storage conditions

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging

15 g in a tube, 1 tube per carton.

Prescription status. Prescription only.

Manufacturer. JSC "Kyivmedpreparat".

Manufacturer's address and place of business

139 Saksaganskogo Street, Kyiv, 01032, Ukraine.