Fucicort, cream for external use 15g

Composition

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of 1 g of cream for external use contains:

Active ingredients:  

betamethasone valerate 1,214 mg (equivalent to 1 mg of betamethasone),

fusidic acid hemihydrate 20,4 mg (equivalent to 20 mg of anhydrous fusidic acid),

Auxiliary substances:

macrogol cetostearyl — 18 mg;

cetostearyl alcohol (cetyl alcohol — 60%, stearyl alcohol — 40%) — 72 mg;

chlorocresol — 1 mg;

sodium dihydrogen phosphate dihydrate — 3 mg;

paraffin liquid (contains about 10 ppm alpha-tocopherol) 60 mg;

paraffin soft white (contains about 10 ppm alpha-tocopherol) 150 mg;

sodium hydroxide q. s. ;

purified water — up to 1 g

of Pharmacological action

Pharmacodynamics

Case it is a combined preparation containing corticosteroids betamethasone and guideway acid, which have antibacterial action.

Betamethasone has a pharmacological effect by suppressing local immune responses, including vasodilation, swelling and pain.

Fusidic acid is an antibiotic with a predominant activity against gram-positive bacteria. In particular, fusidic acid is active against Staphylococcus aureus, Propionibacterium acnes and Corynebacteria, and suppresses protein synthesis in bacteria. After 30 years of use, bacterial resistance to fusidic acid is rare (1-3%). Most often, bacteria that are resistant to penicillin and other antibiotics are sensitive to fusidic acid.

Pharmacokinetics

When applied to the skin, the 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 Fucicort, the absorption of betamethasone through intact skin is less than 2%. Absorbed betamethasone is metabolized in the liver and excreted through the kidneys. Systemic absorption of fusidic acid is negligible.

Indications

Dermatitis, allergic eczema and toxiderma infected with microorganisms sensitive to fusidic acid.

Use during pregnancy and lactation

There are no clinical data on the use of Fucicort during pregnancy and lactation. Animal experiments do not show a teratogenic effect of fusidic acid, but they do show such an effect when using corticosteroids.

The safety of using external corticosteroid therapy during pregnancy has not been established, this group of drugs should be used only if the benefits of their use for the mother outweigh any potential risks to the fetus. Pregnant women should not use this group of drugs in large doses or for a long time.

It is possible to use the drug Fucicort during lactation. Women during lactation should use Fucicort only on the recommendation of a doctor. CORTICOSTEROIDS are excreted in breast milk, but the likelihood of their impact on a breastfed child is very small when applied externally to a limited area of the skin. If long-term treatment or the use of high doses of the drug is indicated, breastfeeding should be discontinued. During lactation, the cream should not be applied to the mammary glands.

Contraindications

Hypersensitivity to the components of the drug.

Given the presence of corticosteroids in the composition of the drug Fucicort, the following conditions and diseases:

• rosacea;
• perioral dermatitis;
• juvenile acne;
• primary bacterial, viral and fungal skin diseases;
• skin tuberculosis, syphilis (skin manifestations);
• children under 1 year of age.

Side effects

Side effects are classified according to the frequency of occurrence: very common – ≥1/10; often – ≥1/100,

Immune system disorders: frequency unknown-allergic reactions.

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

Although these reactions have not been reported in clinical studies of Fucicort, external use of corticosteroids can lead to telangiectasia and striae, especially with prolonged use.

As with other corticosteroids, it is possible to develop folliculitis (steroid acne), hypertrichosis, perioral dermatitis, depigmentation, hemorrhagic rash, rosacea, sweating, maceration of the skin and systemic effects of corticosteroids.

How to take, course of use and dosage

Externally.

Adults and children.

Apply the cream in a thin layer 2-3 times a day.

The course of treatment is no more than 2 weeks.

Overdose

Symptoms: Excessive long-term external treatment with corticosteroids can inhibit pituitary and adrenal function, which can lead to secondary (usually reversible) adrenal insufficiency.

Treatment: symptomatic.

Special instructions

Bacterial resistance associated with the use of fusidic acid is noted. As with all antibiotics, excessive or repeated use can increase the risk of developing antibiotic resistance.

The drug should be taken with caution in case of perianal or genital itching.

Fucicort should be used with caution on large areas of the skin, under occlusive dressings, on the face and areas of diaper rash.

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

The drug should be used with caution in the periorbital area, since glaucoma may develop.

If the use of Fucicort cream causes irritation or excessive sensitivity of the skin, you should stop using it and start other appropriate treatment.

If treatment is discontinued, withdrawal symptoms may occur, which may include redness, burning or tingling of the skin, or an exacerbation of psoriasis. These phenomena can be prevented by gradual discontinuation of the drug.

Due to the fact that the ratio of surface area to body weight is higher in children than in adults, children are at greater risk of hypothalamic-pituitary-adrenal suppression and the development of Cushing’s syndrome when using any topical corticosteroids. Long-term treatment of children with corticosteroids can lead to disorders of their growth and development.

Children should receive a minimum dose of the drug sufficient to achieve the effect.

After prolonged external treatment with strong corticosteroids, atrophic changes are more common on the face, external genitalia, and the inner surface 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 (for example, contact dermatitis).

Influence on the ability to drive vehicles and work with mechanisms. It doesn’t affect you.

Form of production

Cream for external use

Storage conditions

At a temperature not exceeding 25 °C.

Shelf

life is 3 years.

Active ingredient

Betamethasone, Fusidic acid

Conditions of release from pharmacies

By prescription

Dosage form

cream

Description

Children over 1 year old, For adults

Indications

Urticaria, Eczema, Dermatitis