Description
Release form
Ointment for external use.
Pharmacological action
A drug with anti-inflammatory, antipruritic, antiproliferative, antimicrobial and keratolytic effects for external use.
Betamethasone has anti-inflammatory, anti-allergic, antiproliferative and antipruritic effects.
When applied to the skin surface, betamethasone has a quick and powerful effect in the focus of inflammation, reducing the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).
Due to its keratolytic effect, salicylic acid cleanses the lesions from scales, promotes penetration of betamethasone into the skin, supports 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, tilotic).
Neurodermatitis.
lichen planus.
Asbestos lichen.
Chronic discoid lupus erythematosus.
Ichthyosis and ichthyic 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.
Contraindications
Tuberculosis of the skin.
Cutaneous manifestations of syphilis.
Chicken pox.
Viral skin infections.
Dermal post-vaccination 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.
Use during pregnancy and lactation
The use of 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 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 mammary gland before feeding.
Special instructions
Ointment is for external use only on the skin and / or scalp.
Avoid contact with ointment in the eyes and mucous membranes.
Long-term use of 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.
Use of the drug in the anogenital area should be avoided.
The use of the drug under an occlusive dressing is not recommended, unless 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 under strict precautions, as in children, there is a risk of systemic absorption of a proportionally greater number of active components due to the predominance of the skin area over body weight and insufficient maturity of the epidermis. The drug should not be used in children under dressings and, especially, under plasticized diapers, which can increase the risk of developing adverse events.
Influence on the ability to drive vehicles and control mechanisms
Data on the adverse effects of the drug Belosalik on the ability to drive vehicles and mechanisms are not available.
Composition of
1 g of ointment contains:
Active substances:
betamethasone dipropionate – 640 ?g, which corresponds to the content of betamethasone – 500 ?g
salicylic acid 30 mg.
Excipients:
mineral oil,
petroleum jelly.
Dosage and administration
The drug is intended for external use.
A small amount of ointment is evenly distributed over the surface of the skin, rubbing slightly. Multiplicity of use – 2 times / day, in mild cases, 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 necessary, 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 physician, to avoid relapse of the disease.
Repeated courses of therapy are possible throughout the year.
Side effects
Side effects, as a rule, are mild.
Dermatological reactions: hypersensitivity reactions (itching, burning, hyperemia) are possible 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 adverse reactions associated with suppression of adrenal cortex function.
If a hypersensitivity reaction or adverse reactions develops, the drug should be discontinued.
Drug Interactions
No clinically significant interactions with other drugs have been observed.
The simultaneous use of cosmetic and dermatological products for the treatment of acne, products containing ethanol, or a medical soap with a pronounced drying effect, can in some cases cause skin irritation.
overdose
Symptoms: prolonged continuous use of a combination of betamethasone and salicylic acid, especially in children, on extensive skin surfaces, when applied to skin with impaired integrity, or when used under occlusive dressing, secondary adrenal insufficiency, hypercorticism, Itsenko-Cushing’s syndrome).
Treatment: drug withdrawal and symptomatic therapy are recommended.
Storage conditions
Keep out of the reach and sight of children at temperatures not exceeding 25 ° C.
Shelf life
4 years.
Active ingredient
betamethasone, salicylic acid
Dosage form
ointment
Prescribing
Prescribing
For children prescribed by a doctor, For adults, Pregnant as prescribed by a doctor, Children over 6 months of age, For nursing mothers as prescribed by the doctor
Belupo, medicines and cosmetics d.d, Croatia
