Betamethasone + Fusidic acid (Betamethasonum + Acidum fusidicum)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
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Clinical and pharmacological group: & nbsp

Glucocorticosteroids

Antibiotics

Included in the formulation
  • Fucicort®
    cream externally 
    Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S)     Denmark
    • АТХ:

    D.07.C.C.01   Betamethasone in combination with antibiotics

    Pharmacodynamics:

    The drug is a combination of betamethasone and fusidic acid for external use, containing antibiotic polycyclic structure and glucocorticosteroids.

    Fusidic acid is an antibiotic of the polycyclic structure. It is active mainly against gram-positive bacteria, in particular - Staphylococcm aureus, Propionibacterium acnes and corynebacteria. The mechanism of action is associated with the suppression of bacterial protein synthesis. After 30 years of application, the resistance of bacteria to fusidic acid is rare (1-3%). Most often, bacteria resistant to penicillin and other antibiotics are sensitive to fusidic acid.

    Betamethasone belongs to the group of strong glucocorticosteroids (group III) and has a pharmacological effect, suppressing local immune responses, including vasodilation, swelling and pain.

    Pharmacokinetics:

    Suction

    Systemic absorption of fusidic acid is negligible.

    When applied to the skin, absorption of betamethasone can lead to systemic effects, especially when applied to large areas of inflamed skin or under occlusive dressings.With external application of the drug, absorption of betamethasone through intact skin is less than 2%.

    Metabolism and excretion

    After suction betamethasone metabolized in the liver and excreted by the kidneys.

    Indications:

    Infectious inflammatory skin diseases caused by microorganisms sensitive to fusidic acid: dermatitis; infected allergic eczema; toxemia.

    ICD-10

    XII.L20-L30.L20.8   Other atopic dermatitis

    XII.L20-L30.L21   Seborrheic dermatitis

    XII.L20-L30.L23   Allergic contact dermatitis

    XII.L20-L30.L24   Simple irritant contact dermatitis

    XII.L20-L30.L28.0   Simple chronic lichen

    XII.L20-L30.L30.3   Infectious dermatitis

    XII.L80-L99.L93.0   Discoid lupus erythematosus

    Contraindications:

    Rosacea; perioral dermatitis; youthful acne; primary bacterial, viral and fungal skin diseases; lupus; cutaneous manifestations of syphilis; children under 1 year; hypersensitivity to the components of the drug.

    Carefully:

    Caution should be applied to the preparation with perianal or genital itching; on extensive areas of the skin, under occlusive dressings, face, areas of diaper rash; in the periorbital region, since glaucoma can develop in this case.

    Pregnancy and lactation:

    Clinical data regarding the use of the drug in pregnancy and lactation are absent.

    AT experimental research on animals teratogenic action of fusidic acid was not observed, but was noted with the use of glucocorticosteroids.

    Safety of external use of corticosteroids in pregnancy is not established. The use of corticosteroids during pregnancy is only possible if the expected benefit of therapy for the mother exceeds any potential risks to the fetus. In this category of patients, corticosteroids should not be used in high doses or for a long time.

    It is possible to use the drug during lactation only on the advice of a doctor.

    Glucocorticosteroids are excreted in breast milk, but the likelihood of their effect on an infant is very small when applied externally to a limited area of ​​the skin. If prolonged treatment or use of the drug in high doses is indicated, breastfeeding should be discontinued. During the lactation period, do not apply the cream to the mammary glands.

    Dosing and Administration:

    HAn arugal tool.

    Adults and children apply a thin layer of the cream on the affected area 2-3 times a day. The course of treatment - no more than 2 weeks.

    Side effects:

    From the skin and appendages of the skin: infrequent - rash, exacerbation of eczema, skin irritation, itching, burning sensation or tingling of the skin; frequency unknown - skin atrophy, contact dermatitis, erythema, dry skin.

    Although these reactions were not observed in the clinical studies of the drug, external use of glucocorticosteroids can lead to telangiectasia and striae, especially with prolonged use.

    As with the use of other glucocorticosteroids, folliculitis (steroid acne), hypertrichosis, perioral dermatitis, depigmentation, hemorrhagic rash, rosacea, sweating, maceration of the skin, systemic effects of glucocorticosteroids are possible.

    Allergic reactions: frequency unknown - hives.

    Overdose:

    Symptoms: due to excessive, prolonged external application of glucocorticosteroids, it is possible to suppress the function of the pituitary and adrenal glands, which can lead to a secondary (usually reversible) insufficiency of adrenal function.

    Treatment: symptomatic therapy.

    Interaction:

    Clinically significant interactions with other drugs have not been identified.

    Special instructions:

    Bacterial resistance associated with the use of fusidic acid is noted.

    As with the use of other antibiotics, excessive or repeated use of the drug may increase the risk of developing resistance to antibiotics.

    Do not apply the drug to open wounds and mucous membranes.

    If the product causes irritation or excessive skin sensitivity, stop using it and start another appropriate treatment.

    In case of discontinuation of treatment, there may be a withdrawal syndrome, manifested as redness, burning sensation or tingling of the skin, or exacerbation of psoriasis. These phenomena can be prevented with the gradual withdrawal of the drug.

    After prolonged external treatment with potent corticosteroids, atrophic changes occur most often on the face, external genitalia, the inner side of the upper and lower extremities, compared to other areas.

    The drug contains chlorocresol, which can cause allergic reactions, as well as cetostearyl alcohol,which can cause local skin rashes (eg, contact dermatitis).

    Use in Pediatrics

    Due to the fact that the ratio of surface area and body weight is greater in children than in adults, children are at greater risk of suppressing the function of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome with any glucocorticosteroids for external use. Long-term treatment of children glucocorticosteroids can lead to disruption of growth and development of the body.

    In the treatment of children, the drug should be used at the lowest effective dose.

    Impact on the ability to drive vehicles and manage mechanisms

    The drug does not affect the ability to drive vehicles and control mechanisms.

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