Diprosalik® Lotion (Diprosalic® lotion)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceBetamethasone + Salicylic acidBetamethasone + Salicylic acid
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    • Dosage form: & nbspsolution for external use
    Composition:

    1 g of solution contains;

    active ingredients: betamethasone dipropionate 0.64 mg (equivalent to 0.5 mg betamethasone), salicylic acid 20.0 mg;

    Excipients: edetate disodium 0.3 mg, hypromellose 5.0 mg, sodium hydroxide 5.0 mg, isopropanol 392.0 mg, purified water q.s. up to 1.0 g.
    Description:

    A colorless, translucent, viscous liquid with a characteristic smell of isopropyl alcohol, which does not contain visible particles.

    Pharmacotherapeutic group:glucocorticosteroid for topical use + keratolytic agent
    ATX: & nbsp

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

    Pharmacodynamics:

    Combined drug, the effect of which is due to its constituent components.

    Betamethasone dipropionate - synthetic fluorinated glucocorticosteroid (GCS) - has anti-inflammatory, antipruritic and vasoconstrictive effects.

    Salicylic acid at local application possesses keratolytic, and also bacteriostatic and some fungicidal action.

    Indications:

    - Psoriasis of the scalp or other localization;

    - seborrhea of ​​the scalp or other localization;

    - Other dermatoses that are amenable to GKS therapy.

    Contraindications:

    - Hypersensitivity to any of the components of the drug;

    - children under 2 years;

    - pregnancy;

    - lactation period;

    - pink acne, perioral dermatitis;

    - bacterial, viral or fungal skin infection (pyoderma, syphilis, skin tuberculosis, Herpes simplex, chickenpox, Herpes zoster, actinomycosis, blastomycosis, sporotrichosis);

    - trophic ulcers on the background of chronic venous insufficiency;

    - skin tumors (skin cancer, nevus, atheroma, epithelioma, melanoma, hemangioma, xanthoma, sarcoma);

    - postvaccinal skin reactions.

    Carefully:

    - Children up to 12 years;

    - liver failure;

    - long-term therapy.

    Pregnancy and lactation:

    The safety of the use of local GCS in pregnant women is not established.

    Since it has not been determined to date whether the local GCS penetrates into the mother's milk, the issue of stopping breastfeeding or using the drug should be addressed.

    Dosing and Administration:

    Outwardly.

    Apply a thin layer twice a day - in the morning and at night, completely covering the affected areas of the skin. In some patients, the supporting effect can be achieved by less frequent applica- tions.

    The duration of the course of treatment is determined by its effectiveness, as well as the patient's tolerance, the presence and severity of side effects.

    Side effects:

    Burning, itching, skin irritation, dry skin, folliculitis, hypertrichosis, acne, hypopigmentation, perioral dermatitis, allergic contact dermatitis, skin maceration, secondary infection, skin atrophy, striae, sweating, pain, skin cracks, dermatitis, purpura, telangiectasia , local hirsutism.

    With topical application of GCS for a long period and / or in high doses, especially in children, side effects, characteristic of systemic SCS, may develop (incl.suppression of the hypothalamic-pituitary-adrenal system, development of Cushing's syndrome, growth retardation, insufficient weight gain and increased intracranial pressure).

    Salicylic acid preparations can cause dermatitis.

    Overdose:

    Symptoms: prolonged use of GCS for topical use in increased doses can cause suppression of the pituitary-adrenal system leading to secondary adrenal insufficiency and hypercorticoid phenomena, including Cushing's syndrome.

    Long-term use of salicylic acid preparations for topical administration in elevated doses can cause symptoms of salicylate poisoning (early symptoms - nausea and vomiting).

    Treatment: symptomatic.

    In case of an overdose of GCS: if necessary - correction of electrolyte imbalance.

    When poisoning with salicylic acid it is necessary to take measures to rapidly remove salicylic acid from the body, for example, ingestion of sodium bicarbonate - to alkalinize urine and force diuresis.

    Interaction:

    No interaction of the Diprosalik® Lotion with other drugs has been recorded.

    Special instructions:

    If against the background of the use of Diprosalica® Lotion has developed skin irritation or hypersensitivity to the drug, treatment should be discontinued.

    In case of infection, appropriate therapy should be prescribed.

    Systemic absorption of GCS and salicylic acid in their local application will be the higher the large surface of the body is treated. Appropriate precautions should be taken if prolonged use of the drug is contemplated, especially in children.

    The application of salicylic acid on an open wound or damaged skin is not allowed.

    When applying Diprosalica® Lotion can not use bandages.

    If dryness or irritation of the skin occurs, the drug should be discontinued.

    With prolonged treatment with the drug, it is recommended to cancel it gradually.

    Diprosalik® Lotion is not intended for use in ophthalmology. Avoid contact with eyes and mucous membranes.

    Long-term use on the face is not recommended.

    Avoid application in the anogenital area.

    Pediatric Use

    Children are more at risk of oppression of the function of the hypothalamic-pituitary-adrenal system due to the use of local GCS than adults, because of the greater correlation between their body surface area and weight and, accordingly, increased absorption of the drug.

    Suppression of hypothalamic-pituitary-adrenal system function in children is determined by low plasma cortisol level and lack of response to stimulation of adrenocorticotropic hormone. Increase in intracranial pressure is manifested by protrusion of the fontanel, headaches, bilateral edema of the optic disc.

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

    There is no evidence of any effect of Diprosalik® lotion on the ability to drive vehicles and work with mechanisms.

    Form release / dosage:

    Solution for external use, 0.05% + 2%.

    Packaging:

    To 30 ml in plastic bottles-droppers, closing naviMr.plastic cap.

    One bottle-dropper along with instructions for use in a cardboard bundle.

    Storage conditions:

    Store at a temperature of 2 to 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    18 months.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015953 / 01
    Date of registration:08.07.2008
    The owner of the registration certificate:BAYER, AO BAYER, AO Russia
    Manufacturer: & nbsp
    Representation: & nbspBAYER, AOBAYER, AO
    Information update date: & nbsp20.11.2015
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