Belosalik lotion - instructions for use, dose, side effects, contraindications

active substance: betamethasone in the form of dipropionate 0.64 mg (0.064%), corresponding to 0.500 mg of betamethasone and salicylic acid 20 mg (2%);

Excipients: disodium edetate 0.300 mg, hypromellose 4000 cps 5,000 mg, sodium hydroxide 5,000 mg, isopropanol 392,000 mg, water 577,060 mg.

Description:

Transparent, colorless, viscous solution with the smell of isopropanol.

Pharmacotherapeutic group:Glucocorticosteroid for topical use + keratolytic agent

ATX: & nbsp

D.07.X.C.01 Betamethasone in combination with other drugs

Pharmacodynamics:

Belosalik® lotion has anti-inflammatory, antipruritic, anti-edematous, antiallergic, antiproliferative, immunosuppressive,keratolytic, antimicrobial, antifungal actions.

Betamethasone dipropionate - synthetic glucocorticosteroid (GCS), which has anti-inflammatory, antiallergic, antipruritic and vasoconstrictive effect. When applied to the skin surface, it narrows the 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 depresses phospholipase A₂, blocks the release of arachidonic acid and the biosynthesis of endoperoxides, prostaglandins, leukotrienes (contributing to the development of inflammation, allergy and other pathological processes).

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 infection.

Indications:

Subacute and chronic dermatoses sensitive to corticosteroid therapy, accompanied by hyperkeratosis and peeling: psoriasis, seborrheic dermatitis of the scalp, asbestine lichen, seborrhea, neurodermatitis, lichen planus with localization on the scalp, eczema, ichthyosis, skin dyshidrosis.

Contraindications:

Hypersensitivity to betamethasone, salicylic acid or to any auxiliary component of the drug, viral skin infections, skin post-vaccination reactions, open wounds, trophic ulcers, acne vulgaris, rosacea, chickenpox, skin manifestations of syphilis, skin tuberculosis, children under six months.

Pregnancy and lactation:

Local use of Belosalik® Lotion 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, use of the drug Belosalik® lotion is possible on strict indications, but the drug should not be applied to the skin of the breast before feeding.

Dosing and Administration:

Outwardly.

Bottle with a nozzle-sprayer:

Belosalik® lotion is sprayed twice a day on the affected areas of scalp with hair covering with a convenient extended nozzle-sprayer. In some cases, a single application per day is sufficient.

Prior to spraying, the vial should be shaken, placed in a vertical position, then bring the nozzle tip to the affected area of the skin with the hair covering and press the index finger to the sprayer until it stops. Make the necessary amount of spray on the affected areas of the scalp.

The duration of the course of treatment is individual and conducted, as a rule, until the disappearance of the main symptoms of the disease, but is usually limited to 3-4 weeks. If you need a longer course of therapy, it is recommended to use the drug less often, for example, every other day and consult with a specialist.

Bottle-dropper:

Belosalik® lotion is applied twice a day. A few drops of lotion are evenly distributed with a cotton swab or fingers on the surface of the skin, lightly rubbing. In some cases, a single use is sufficient.Duration of treatment is usually limited to 3-4 weeks. If you need a longer course of therapy, it is recommended to use the drug less often, for example, every other day or consult a specialist.

Belosalik® lotion can be given to children from six months of age, with caution and for as short a time as possible.

Side effects:

Side effects, as a rule, are reversible and bear a weak character.

From the skin: hypersensitivity reaction (itching, burning or redness), acne-like changes, hypopigmentation, striae, skin atrophy, hypertrichosis, secondary skin infections.

With continuous continuous uncontrolled application and when applied to large areas of the skin: telangiectasia, systemic manifestations of side effects of GCS or salicylates.

In case of a hypersensitivity reaction or side effects, therapy should be discontinued and consult a doctor.

Overdose:

Symptoms: manifestation of systemic side effects.

Treatment: withdrawal of the drug and symptomatic therapy.

Interaction:

There were no clinically significant interactions with other drugs.

Simultaneous use of cosmetic and dermatological products for external use containing ethanol, or a medical soap with a pronounced drying effect can cause skin irritation.

Special instructions:

Belosalik® Lotion is for external use only.

Avoid contact with eyes and mucous membranes, as well as use of the drug in the anogenital area.

It is not recommended to use the drug for occlusive dressings, except when it is necessary.

When developing fungal or bacterial microflora on the skin, an additional use of an antibacterial or antifungal agent is necessary.

The preparation Belosalik® lotion in the form of a solution for external use is especially suitable for use on the scalp. The solution is easily distributed over the surface of the skin, does not adhere or dry the hair, leaves no visible traces, has a cooling effect on the skin.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

Solution for external use.

Packaging:

50 ml and 100 ml of the drug in a vial of high-density polyethylene with a dropper, sealed with a screw cap made of low-density polyethylene. The plug has a ring to control the first opening. The bottle is placed in a cardboard box along with the instructions for use.

For 20 ml, 50 ml and 100 ml of the preparation in a vial of high-density polyethylene with a spray pump mechanism and a protective plastic cap. 1 bottle complete with a plastic nozzle-sprayer together with instructions for use are placed in a cardboard box.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N012748 / 01

Date of registration:29.12.2010 / 12.03.2012

Expiration Date:Unlimited

The owner of the registration certificate:Beluga, medicines and cosmetics.Beluga, medicines and cosmetics. Croatia

Manufacturer: & nbsp

BELUPO, Pharmaceuticals & Cosmetics, d.d. Croatia

Representation: & nbspBeluga, medicines and cosmetics. Beluga, medicines and cosmetics. Croatia

Information update date: & nbsp21.01.2017

Illustrated instructions

Instructions

Belosalik® Lotion (Belosalic® lotion)