2010/12/16

Belosalic

Release form, composition and packing Belosalic 

Ointment for external use translucent, white, homogeneous. 1 g of betamethasone dipropionate 640 mcg, which corresponds to the contents of betamethasone 500 mcg salicylic acid 30 mg. Other ingredients: mineral oil, petrolatum.

Belosalik ® Lotion

Solution for external application transparent, colorless, viscous, with the smell of isopropanol. 1 g of betamethasone dipropionate 640 mcg, which corresponds to the contents of betamethasone 500 mcg salicylic acid 20 mg. Excipients: disodium edetate, hypromellose 4000 cps, sodium hydroxide, isopropyl alcohol, purified water.

Clinico-pharmacological group: drug with antiinflammatory and keratolytic action for topical use.

Pharmacological action

Drug with anti-inflammatory, antipruritic, antiproliferative, antimicrobial and keratolytic action for topical use. Betamethasone has anti-inflammatory, antiallergic, antipruritic and anti-proliferative effect.

When applied to the skin surface, betamethasone has a rapid and dramatic effect in the inflammation, reducing the severity of objective symptoms (erythema, edema, lihenifikatsiya) and subjective sensations (itching, irritation, pain). Salicylic acid at the expense of keratolytic action clears the lesion on the scales, promotes penetration of betamethasone into the skin, supports the acidic environment of skin, preventing the development of bacterial and fungal infections.

Pharmacokinetics

Data on the pharmacokinetics of the drug Belosalik not given.

Statement

Subacute and chronic dermatoses in which effective therapy is topical corticosteroids, and accompanied by hyperkeratosis and scaling, including:
psoriasis;
eczema (disgidroticheskaya, seborrheic tiloticheskaya);
neurodermatitis;
planus;
asbestovidny zoster;
chronic discoid lupus erythematosus;
ichthyosis and ichthyotic skin lesions;
seborrhea;
seborrheic dermatitis (scalp).

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

Dosing regimen

The drug is intended for outdoor use. A small amount of ointment or a few drops of a solution for outdoor applications spread evenly over the surface of the skin, gently rubbing. Multiplicity of use - 2 times / day in mild cases, enough single use. Duration of continuous treatment is usually limited to 3-4 weeks.

If you need a longer course of therapy is recommended to use the drug less often, for example, through the day.

In the treatment of chronic disease treatment should be continued for some time after the disappearance of all symptoms, a doctor's supervision to avoid relapse. During the year, may conduct repeated courses of therapy.

Side effect

Side effects are generally mild in nature. Dermatological reactions: may develop hypersensitivity reactions (itching, burning, redness), rarely - aknepodobnye changes, hypopigmentation, striae, skin atrophy, hypertrichosis, telangiectasia, secondary skin infections.

With long-term continuous use, and large areas of skin betamethasone can cause systemic side effects associated with the suppression of the adrenal cortex. With the development of hypersensitivity reactions or adverse drug reactions should be abolished.

Contraindications
lupus;
cutaneous manifestations of syphilis;
chickenpox;
Viral infections of the skin;
skin reactions post-vaccination;
open wounds;
trophic ulcers;
rosacea;
acne vulgaris;
Children under the age of 6 months (for ointment);
Hypersensitivity to betamethasone, salicylic acid or any of the supporting components of the drug.

Pregnancy and lactation

Use of the drug Belosalik (in the form of ointments and / or solution for external use) in pregnant women is allowed in cases where the intended benefits to the mother outweigh the risks to the fetus.

In such cases, the use of the drug should be brief and limited to small areas of skin. During the period of breast feeding drug use Belosalik possible under strict indications, but the drug should not be applied to the skin of the breast before feeding.

Cautions

The ointment is for external use on skin and / or scalp. Solution for external application is particularly suitable for use on the scalp. Solution is easily distributed over the surface of the skin, hair does not stick, leaves no visible marks and gives a sense of coolness. Avoid getting ointment or solution for topical use in the eyes and mucous membranes. Not recommended for prolonged use of ointments on the skin of a person in connection with possible development of dermatitis by the type of rosacea, perioral dermatitis, atrophy of skin and acne.

Should avoid use of the drug in the anogenital region. It is not recommended to use the drug under occlusive dressing, except when necessary. With the development of fungal or bacterial flora of the skin, additional use of antibacterial or antifungal agents.

Use in pediatrics

Use of the drug Belosalik children should be as short as possible under strict precautions because in children there is a risk the system suction proportionally larger number of active components due to the dominance area of skin on body weight and lack of maturity of the epidermis.

You should not use the drug in children under the bandages and, particularly under the plasticized diapers, which can increase the risk of adverse events.

Effects on ability to drive vehicles and management mechanisms

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

Overdose

With long-term continuous use of a combination of betamethasone and salicylic acid, especially in children, the vast surface of the skin, when applied to skin with impaired integrity or use under occlusive dressings, it is possible increased absorption of active ingredients and a manifestation of systemic effects (secondary adrenal failure, hypercortisolism, Itsenko syndrome-Cushing).

Treatment: It is recommended repeal of the drug and symptomatic therapy.

Drug Interactions

There were no clinically significant interactions with other drugs. Simultaneous use of cosmetics and dermatological resources for treatment of acne, products containing ethanol, or a medical soap with a strong Dries up oily effect, can in certain cases, cause skin irritation.

Conditions and terms of

The drug should be stored in a place inaccessible to children at or above 25 ° C. Shelf Life ointment - 4 years, solution for external application - 2 years.