Belosalik (Betametazon) 30 g

Belupo, drugs and cosmetics dd, Croatia

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Product Overview

Composition

1 g of 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.

pharmachologic effect

Pharmaceutical group: 

glucocorticosteroid + keratolytic agent.


Pharmaceutical action:

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

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

When applied to the surface of the skin, it narrows 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 hyaluronidase activity 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, which mediate cellular effects. Lipocortin inhibits phospholipase A2, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to the development of inflammation, allergies and other pathological processes).


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

Indications

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

  • Psoriasis.
  • Eczema (dyshidrotic, seborrheic, tylotic).
  • Neurodermatitis.
  • Lichen planus.
  • Asbestos lichen.
  • Chronic discoid lupus erythematosus.
  • Ichthyosis and ichthyosis 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 of age and older.

Application during pregnancy and lactation

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

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

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

Contraindications

  • Lupus.
  • Cutaneous manifestations of syphilis.
  • Chicken pox.
  • Viral skin infections.
  • Post-vaccination skin reactions.
  • Open wounds.
  • Trophic ulcers.
  • Rosacea.
  • Acne vulgaris.
  • Children under 6 months of age (for ointment).
  • Hypersensitivity to betamethasone, salicylic acid, or to 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 on large areas of the skin: betamethasone can cause systemic adverse reactions associated with suppression of the function of the adrenal cortex.

With the development of a hypersensitivity reaction or adverse reactions, the drug should be canceled.

Interaction

There were no clinically significant interactions with other drugs.

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

How to take, course of administration and dosage

The drug is intended for external use.

A small amount of ointment is evenly distributed over the surface of the skin, rubbing lightly. Frequency rate of application - 2 times / day, in mild cases, a single use is sufficient.

The duration of a continuous course of treatment is usually limited to 3-4 weeks. If a longer course of therapy is required, it is recommended to use the drug less often, for example, every other day. In the treatment of chronic diseases, treatment should be continued for some time after the disappearance of all symptoms, under the supervision of a doctor, in order to avoid a relapse of the disease.

Repeated courses of therapy are possible during the year.

Overdose

Symptoms: with long-term continuous use of a combination of betamethasone and salicylic acid, especially in children, on extensive skin surfaces, when applied to the skin with impaired integrity or when used under an occlusive dressing, increased absorption of active ingredients and the manifestation of systemic effects are possible (secondary adrenal insufficiency, hypercortisolism, Itsenko-Cushing's syndrome).

Treatment: drug withdrawal and symptomatic therapy are recommended.

Special instructions

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

Avoid getting the ointment in the eyes and on the mucous membranes.

Long-term use of the ointment on the skin of the face is not recommended due to the possible development of dermatitis like 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. With the development of fungal or bacterial microflora 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. in children, there is a danger of systemic absorption of a proportionally larger amount of active components due to the predominance of the area of ​​the skin over the body weight and insufficient maturity of the epidermis. The drug should not be used in children under bandages and, especially under plasticized diapers, which may increase the risk of adverse events.

Influence on the ability to drive vehicles and use mechanisms

There are no data on the adverse effects of Belosalik on the ability to drive vehicles and mechanisms.

Release form

Ointment for external use.

Storage conditions

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

Shelf life

4 years.

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