Fucicort, cream 15 g

Pharmacodynamics

Fucicort is a combination drug containing GKS betamethasone and fusidic acid with antibacterial effect.

Betamethasone has pharmacological effects by inhibiting local immune responses, including vasodilation, swelling and soreness.

Fusidic acid is an antibiotic with predominant activity against Gram-positive bacteria. In particular, fusidic acid has activity against the bacteria Staphylococcus aureus, Propionibacterium acnes and Corynebacterium, inhibits protein synthesis in bacteria. After 30 years of use, resistance of bacteria to fusidic acid is rare (1-3%). Most often, bacteria resistant to penicillin and other antibiotics are sensitive to fusidic acid.

Pharmacokinetics

When applied to the skin, absorption of betamethasone may lead to systemic effects, especially when applied to large areas of inflamed skin or under occlusive dressings. When Fucicort is applied externally, 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.

Active ingredient

Composition

1 g of cream for external use contains:

The 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),

Excipients:

macrogoal cetostearate, 18 mg;

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

Chlorocresol – 1 mg;

Sodium dihydrophosphate dihydrate – 3 mg;

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

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

sodium hydroxide – q.s.;

Purified water – up to 1 g

How to take, the dosage

Externally.

Adults and children.

The cream is applied in a thin layer 2-3 times a day.

The course of treatment is not more than 2 weeks.

Special Instructions

Bacterial resistance associated with the use of fusidic acid has been noted. As with all antibiotics, overuse or repeated use may increase the risk of antibiotic resistance.

The drug should be used with caution in cases of perianal or genital itching.

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

The drug should not be used on open wounds and mucous membranes.

The product should be used with caution in the periorbital area because it can cause glaucoma.

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

If treatment is discontinued, withdrawal syndrome may occur, manifested by redness, burning or tingling of the skin or exacerbation of psoriasis. These effects can be prevented by gradual withdrawal of the drug.

Because children have a greater surface area to body weight ratio than adults, children have a greater risk of hypothalamic-pituitary-adrenal suppression and Cushing’s syndrome with any topical GCS. Prolonged treatment of children with GCS may cause abnormalities in their growth and development.

Children should receive the minimum dose of medication sufficient to have an effect.

After long-term external treatment with potent corticosteroids, atrophic changes are more common on the face, external genitalia, and inner surface of the upper and lower extremities compared to other areas.

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

Impact on the ability to drive vehicles and operate machinery. No effect.

Contraindications

Hypersensitivity to the components of the drug.

Preferring to the presence of Fucicort GKS, the following conditions and diseases:

Side effects

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

Immune system disorders: frequency unknown – allergic reactions.

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

While these reactions have not been noted in clinical studies of Fucicort, external use of GKS may cause telangiectasia and stretch marks, especially with long-term use.

As with other GKS, folliculitis (steroid acne), hypertrichosis, perioral dermatitis, depigmentation, hemorrhagic rash, pink acne, sweating, skin maceration, and systemic GKS effects may occur.

Overdose

Symptoms: excessive long-term external GCS treatment can suppress pituitary and adrenal function, which can lead to secondary (usually reversible) adrenal insufficiency.

Treatment: symptomatic.

Pregnancy use

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

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

The use of Fucicort during lactation is possible. Women during lactation should use Fucicort only if recommended by their doctor. GKS is excreted with breast milk, but the chance of exposure to the breastfed child is very small if applied externally to a limited area of skin. If prolonged treatment or high doses of the drug are indicated, breastfeeding should be stopped. During lactation, the cream should not be applied to the mammary glands.