Belosalik, ointment 30 g

Pharmaceutical group:

Glucocorticosteroid+keratolytic agent.

Pharmaceutical action:

The drug for external use. Belosalik® lotion has anti-inflammatory, antipruritic, antiedematous, anti-allergic, antiproliferative, immunosuppressive, keratolytic, antimicrobial, antifungal effects.

Betamethasone dipropionate is a synthetic GKS that has anti-inflammatory, anti-allergic, antipruritic and vasoconstrictive effects.

When applied to the skin surface it narrows vessels, reduces itching, decreases release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2 and gamma-interferon (from lymphocytes and macrophages), inhibits activity of hyaluronidase and decreases vascular wall permeability.

It interacts with specific receptors in cell cytoplasm, stimulating synthesis of mRNA, inducing formation of proteins, including lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to inflammation, allergy and other pathological processes).

Salicylic acid due to its keratolytic action cleanses lesion areas of scales, promotes penetration of betamethasone into the skin and maintains the skin acidic environment, preventing the development of bacterial and fungal infection.

Indications

Subacute and chronic dermatoses, for which therapy with topical corticosteroids is effective, and accompanied by hyperkeratosis and peeling, including:

Psoriasis.
Eczema (dyshidrotic, seborrheic, tylotic).
Neurodermatitis.
Lichen planus.
Lichen asbestos.
Chronic discoid lupus erythematosus.
Ichthyosis and ichthyotic skin lesions.
Seborrhea.
Seborrheic dermatitis (scalp).

The drug in the form of a solution for external use is indicated for use on the scalp, as well as in children 6 months and older.

Pharmacological effect

Pharmaceutical group:

glucocorticosteroid + keratolytic agent.

Pharmaceutical action:

Preparation for external use. Belosalik® lotion has anti-inflammatory, antipruritic, decongestant, antiallergic, antiproliferative, immunosuppressive, keratolytic, antimicrobial, antifungal effects.

Betamethasone dipropionate is a synthetic corticosteroid that has anti-inflammatory, antiallergic, antipruritic and vasoconstrictor effects.

When applied to the surface of the skin, it constricts blood vessels, relieves itching, reduces the release of inflammatory mediators (from eosinophils and mast cells), interleukins 1 and 2, interferon gamma (from lymphocytes and macrophages), inhibits the activity of hyaluronidase and reduces the permeability of the vascular wall.

Interacts with specific receptors in the cytoplasm of the cell, stimulates the synthesis of mRNA, inducing the formation of proteins, including lipocortin, mediating cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukotrienes (promoting the development of inflammation, allergies and other pathological processes).

Salicylic acid, due to its keratolytic action, cleanses affected areas of scales, promotes the penetration of betamethasone into the skin, maintains the acidic environment of the skin, preventing the development of bacterial and fungal infections.

Special instructions

The ointment is intended for external use only on the skin and/or scalp.

Avoid contact of the ointment with the eyes and mucous membranes.

Long-term use of the ointment on the skin of the face is not recommended due to the possible development of dermatitis such as rosacea, perioral dermatitis, skin atrophy and acne.

Avoid using the drug in the anogenital area.

It is not recommended to use the drug under an occlusive dressing, except when necessary. If fungal or bacterial microflora develops on the skin, additional use of an antibacterial or antifungal agent is necessary.

Use in pediatrics

The use of the drug Belosalik in children should be as short as possible, subject to strict precautions, because in children, there is a danger of systemic absorption of a proportionally larger amount of active components due to the predominance of skin area over body weight and insufficient maturity of the epidermis. The drug should not be used in children under bandages and, especially under plasticized diapers, as this may increase the risk of adverse events.

Impact on the ability to drive vehicles and operate machinery

There is no data on the adverse effects of the drug Belosalik on the ability to drive vehicles and machines.

Active ingredient

Betamethasone, Salicylic acid

Composition

1 g ointment contains:

Active substances:

betamethasone dipropionate – 640 mcg, which corresponds to the content of betamethasone – 500 mcg;

salicylic acid 30 mg.

Excipients:

mineral oil,

petrolatum.

Pregnancy

The use of Belosalik (in the form of an ointment and/or solution for external use) in pregnant women is permitted in cases where the expected benefit to the mother outweighs the risk to the fetus.

In such cases, the use of the drug should be short-term and limited to small areas of the skin.

During breastfeeding, the use of Belosalik is possible according to strict indications, but the drug should not be applied to the skin of the mammary gland before feeding.

Contraindications

Lupus.
Skin manifestations of syphilis.
Chicken pox.
Viral skin infections.
Skin post-vaccination reactions.
Open wounds.
Trophic ulcers.
Rosacea.
Acne vulgaris.
Children up to 6 months of age (for ointment).
Hypersensitivity to betamethasone, salicylic acid or any of the auxiliary components of the drug.

Side Effects

Side effects are usually mild.

Dermatological reactions: possible development of hypersensitivity reactions (itching, burning, hyperemia); rarely – acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasia, secondary skin infections.

With long-term continuous use and over large areas of skin: betamethasone can cause systemic adverse reactions associated with suppression of the function of the adrenal cortex.

If a hypersensitivity reaction or adverse reactions develop, the drug should be discontinued.

Interaction

No clinically significant interactions with other drugs were observed.

The simultaneous use of cosmetic and dermatological acne treatment products, products containing ethanol, or medicinal soaps with a pronounced drying effect may, in certain cases, cause skin irritation.

Overdose

Symptoms: with long-term continuous use of a combination of betamethasone and salicylic acid, especially in children, on large surfaces of the skin, when applied to skin with impaired integrity or when used under an occlusive dressing, increased absorption of the active components and the manifestation of systemic effects (secondary adrenal insufficiency, hypercortisolism, Itsenko-Cushing syndrome) cannot be ruled out.

Treatment: drug withdrawal and symptomatic therapy are recommended.

Storage conditions

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

Shelf life

4 years.

Manufacturer

Belupo, medicines and cosmetics d.d., Croatia