Active substanceBetamethasoneBetamethasone
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  • Dosage form: & nbspointment for external use
    Composition:

    1 g of the preparation contains:

    active substance: betamethasone dipropionate - 0.643 mg (in terms of betamethasone - 0.500 mg);

    Excipients: paraffin liquid - 400,000 mg, paraffin white soft - up to 1 g.

    Description:

    White or almost white translucent homogeneous ointment.

    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    H.02.A.B.01   Betamethasone

    Pharmacodynamics:

    Betamethasone is a glucocorticosteroid for external use. Has anti-inflammatory, antipruritic, anti-allergic, vasoconstrictive, antiexudative and antiproliferative action. It inhibits the accumulation of leukocytes, the release of lysosomal enzymes and pro-inflammatory mediators in the focus of inflammation, inhibits phagocytosis, reduces vascular-tissue permeability, prevents the formation of inflammatory edema.

    When applied to the skin surface, it has a quick and strong effect in the inflammatory focus, reducing the severity of objective symptoms (erythema, edema, lichenification) and subjective sensations (itching, irritation, pain).

    Pharmacokinetics:

    When the drug is applied in therapeutic doses, transdermal absorption of the substance into the blood is very small. The use of occlusive dressings, inflammation and skin diseases increase the transdermal absorption of betamethasone, which can lead to an increased risk of systemic side effects.

    Indications:

    Diseases of the skin, amenable to glucocorticosteroid therapy:

    - atopic dermatitis;

    allergic contact dermatitis;

    - Eczema (various forms);

    - contact dermatitis (including professional dermatitis) and other non-allergic dermatitis (including sun and radiation dermatitis);

    - reactions to insect bites;

    - psoriasis;

    - bullous dermatoses;

    - discoid lupus erythematosus;

    - Red flat lichen;

    - exudative erythema multiforme;

    - itchy skin of different etiology.

    Contraindications:

    - Hypersensitivity to betamethasone or to any other components of the drug;

    - bacterial skin diseases (skin tuberculosis, skin manifestations of syphilis);

    - fungal skin diseases;

    - Viral skin diseases (chickenpox, herpes simplex);

    - skin postvaccinal reactions;

    - open wounds;

    trophic ulcers of the lower leg;

    - rosacea, acne vulgaris;

    - skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma;

    - the period of breastfeeding;

    - Children's age up to 1 year.

    Carefully:

    Cataract, diabetes, glaucoma, tuberculosis (with prolonged use or application to large areas of the body).

    Pregnancy and lactation:

    Pregnancy

    The safety of external use of glucocorticosteroids in pregnant women is not established. The prescription of drugs of this group during pregnancy is justified only if the intended benefit to the mother exceeds the possible risk to the fetus. In such cases, the use of the drug should be short and limited to small areas of skin.

    Before using the drug Betamethasone, if you are pregnant, or suspect that you might be pregnant, or plan a pregnancy, you should consult your doctor.

    Breastfeeding period

    When applying the drug, breastfeeding should be discontinued.

    Dosing and Administration:

    Outwardly.

    A drug Betamethasone apply to the affected area of ​​the skin with a thin layer twice a day, lightly rubbing. On sites with denser skin (for example, elbows, palms and feet), as well as places from which the drug is easily erased, the drug can be applied more often. The duration of continuous treatment depends on the effectiveness and tolerability of the therapy and is usually not more than 4 weeks.During the year, repeated therapy is possible.

    In children and patients with skin lesions, treatment should not exceed 5 days. If clinical improvement does not occur within 2 weeks, it is necessary to clarify the diagnosis.

    If there is no improvement after treatment, or the symptoms worsen, or new symptoms appear, it is necessary to consult a doctor. Use the drug only according to the indications, the method of administration and the doses specified in the instructions for use.

    Side effects:

    Side effects, as a rule, are slightly expressed.

    With external use of glucocorticosteroids can occur: skin itching, burning, irritation, dry skin, folliculitis, hypertrichosis, striae, acne-like rashes ("steroid" acne), hypopigmentation, perioral dermatitis, allergic contact dermatitis.

    With prolonged use, as well as the use of occlusive dressings - skin maceration, secondary infection, skin atrophy, local hirsutism, telangiectasia, sweating, purpura.

    When applied to large areas of the body, mainly in children,the occurrence of systemic side effects of glucocorticosteroids (hyperglycemia, glucosuria, reversible oppression of the adrenal cortex, the appearance of the syndrome Itenko-Cushing's).

    If you have side effects indicated in the instructions, or are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms

    Acute overdose is unlikely, however, with excessive or prolonged use of the drug, a chronic overdose is possible, accompanied by signs of hypercorticism: hyperglycemia, glucosuria, reversible suppression of adrenal cortex function, manifestation of Itenko-Cushing syndrome.

    Measures to help with overdose

    It is recommended to gradually phase out the drug and, if necessary, to carry out symptomatic treatment.

    Interaction:

    The interaction of betamethasone in a medicinal form ointment for external use with other drugs is unknown.

    Special instructions:

    It is not recommended long-term external application of the drug on the face skin, since it is possible to develop rosacea, perioral dermatitis and acne.The course of treatment should not exceed 5 days.

    The drug should not be used in the eye area due to the likelihood of getting the drug on the mucous membrane, which can contribute to the development of cataracts, glaucoma, fungal infections of the eye and exacerbation of herpetic infection.

    With long-term treatment, when applying the drug on the vast surface of the body, as well as in the armpits and inguinal folds, when using occlusive dressings, diapers, it is possible to systemically absorb glucocorticosteroids.

    For children from 1 year, the drug is prescribed only under strict indications and under medical supervision, since it is possible to develop systemic side effects associated with betamethasone.

    When using the drug in children from 1 year and older, it is necessary to limit the total duration of treatment and exclude measures leading to increased resorption and absorption (warming, fixing and occlusive dressings, diapers).

    When applying the drug on large areas of the body and / or under the occlusive dressing, it is possible to suppress the function of the hypothalamic-pituitary-adrenal system and the development of symptoms of hypercorticism, there may be a decrease in the excretion of growth hormone,increased intracranial pressure.

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

    A drug Betamethasone in a medicinal form ointment for external use does not affect the ability to drive transport or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Ointment for external use 0,05%.

    Packaging:

    For 15, 30 or 50 g in tubes of aluminum.

    Each tube together with instructions for use in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004607
    Date of registration:21.12.2017
    Expiration Date:21.12.2022
    The owner of the registration certificate:VERTEKS, AO VERTEKS, AO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.01.2018
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