Universal reference book for medicines
Product name: BELOSALIK ® (BELOSALIC ® )

Active substance: betamethasone, salicylic acid

Type: Anti-inflammatory and keratolytic drug for external use

Manufacturer: BELUPO, Pharmaceuticals & Cosmetics (Croatia)
Composition, form of production and packaging
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Ointment for external use in white, translucent, homogeneous.
1 g

betamethasone dipropionate 640 μg,

which corresponds to the content of betamethasone 500 μg

salicylic acid 30 mg

Excipients: mineral oil, petroleum jelly.

20 g - aluminum tubes (1) - packs of cardboard.

30 g - aluminum tubes (1) - cardboard packs.

40 g - aluminum tubes (1) - packs of cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

The drug with anti-inflammatory, antipruritic, antiproliferative, antimicrobial and keratolytic action for external use.

Betamethasone has anti-inflammatory, anti-allergic, antiproliferative and antipruritic effect.
When applied to the surface of the skin, betamethasone has a rapid and powerful effect in the inflammatory focus, reducing the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).
Salicylic acid due to keratolytic action cleans lesions from scales, promotes the penetration of betamethasone into the skin, supports the acidic environment of the skin, preventing the development of bacterial and fungal infections.

PHARMACOKINETICS

Data on the pharmacokinetics of the drug Belosalik not available.

INDICATIONS

Subacute and chronic dermatoses, in which effective therapy with topical SCS, and accompanied by hyperkeratosis and peeling, including:

- psoriasis;

- eczema (dysgidrotic, seborrheic, tylotic);

- Neurodermatitis;

- Red flat lichen;

- Asbestine ringworm;

- 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 and older.

DOSING MODE

The drug is intended for external use.

A small amount of ointment is evenly distributed over the surface of the skin, gently rubbing.
Multiplicity of application - 2 times / day, in mild cases it is sufficient to use only once.
The duration of a continuous course of treatment is usually limited to 3-4 weeks.
If a longer course of therapy is required, the drug should be used less frequently, for example, every other day. In the treatment of chronic diseases, treatment should continue for some time after the disappearance of all symptoms, under the supervision of a doctor, in order to avoid relapse of the disease.
During the year, repeated courses of therapy are possible.

SIDE EFFECT

Side effects, as a rule, are mildly expressed.

Dermatological reactions: hypersensitivity reactions may develop (itching, burning, hyperemia);
rarely - acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasia, secondary skin infections.
With prolonged continuous use and in large areas of the skin, betamethasone can cause systemic side effects associated with suppression of adrenal cortex function.

When developing a hypersensitivity reaction or adverse reactions, the drug should be discarded.

CONTRAINDICATIONS

- Tuberculosis of the skin;

- cutaneous manifestations of syphilis;

- chickenpox;

- viral skin infections;

- skin postvaccinal reactions;

- open wounds;

- trophic ulcers;

- rosacea;

- Acne vulgaris;

- Children's age to 6 months (for ointment);

- hypersensitivity to betamethasone, salicylic acid or to any of the auxiliary components of the drug.

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 exceeds the risk to the fetus.
In such cases, the use of the drug should be short and limited to small areas of skin.
In 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.

APPLICATION FOR CHILDREN

Use of the drug Belosalik in children should be as short as possible while observing strict precautions,
in children there is a risk of systemic absorption of a proportionally larger number of active components due to the prevalence of skin area over body weight and insufficient maturity of the epidermis. Do not use the drug in children under the bandages, and especially under plasticized diapers, which can increase the risk of developing unwanted phenomena.
SPECIAL INSTRUCTIONS

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

Avoid contact with eyes and mucous membranes.

It is not recommended to use the ointment on the face skin for a long time due to the possible development of dermatitis by the type of rosacea, perioral dermatitis, atrophy of the skin and acne.

Avoid application of the drug in the anogenital area.

It is not recommended to use the drug under an occlusive dressing, except when it is necessary.
When developing fungal or bacterial microflora on the skin, it is necessary to use an additional antibacterial or antifungal agent.
Use in Pediatrics

Use of the drug Belosalik in children should be as short as possible while observing strict precautions,
in children there is a risk of systemic absorption of a proportionally larger number of active components due to the prevalence of skin area over body weight and insufficient maturity of the epidermis. Do not use the drug in children under the bandages, and especially under plasticized diapers, which can increase the risk of developing unwanted phenomena.
Impact on the ability to drive vehicles and manage mechanisms

Data on the adverse effects of the drug Belosalik on the ability to drive vehicles and mechanisms is not available.

OVERDOSE

With prolonged continuous use of combination 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 components and manifestation of systemic effects (secondary adrenal insufficiency, hypercortisy, Syndrome Itenko-Cushing).

Treatment: it is recommended to cancel the drug and symptomatic therapy.

DRUG INTERACTION

There was no clinically significant interaction with other drugs.

Simultaneous use of cosmetic and dermatological agents for the therapy of acne, products containing ethanol, or medical soap with a pronounced drying effect may, in certain cases, cause skin irritation.

TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC..

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life of the ointment is 4 years.
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