Fucicort cream, 15 g

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

For external use.
Adults and children: apply the cream in a thin layer 2-3 times a day.
Treatment course: no more than 2 weeks.

1 g of cream contains:
Active ingredients: Betamethasone valerate (equivalent to betamethasone - 1 mg) - 1.214 mg, Fusidic acid hemihydrate (equivalent to anhydrous fusidic acid - 20 mg) - 20.4 mg
Excipients: macrogol cetostearate 18 mg, cetostearyl alcohol [ cetyl alcohol 60%, stearyl alcohol 40%] 72 mg, chlorocresol 1 mg, sodium dihydrogen phosphate dihydrate 3 mg, liquid paraffin (contains about 10 ppm alpha-tocopherol) 60 mg, soft white paraffin (contains about 10 ppm alpha-tocopherol) 150 mg, sodium hydroxide qs, purified water up to 1 g.

• Hypersensitivity to the components of the drug.

Given the presence of a glucocorticosteroid in the composition of the drug Fucicort, the drug is contraindicated in:

• Rosacea

• Perioral dermatitis

• Acne

• Primary bacterial, viral and fungal skin diseases

• Skin tuberculosis, syphilis (skin manifestations)

• Children under one year of age

Trade name : FucicortЃ (FucicortЃ)

International Non-Proprietary Name (INN) or Group Name :
Betamethasone + Fusidic Acid

Dosage form : cream for external use.
Composition in 1 g of cream contains:
Active ingredients: Betamethasone valerate (equivalent to betamethasone - 1 mg) - 1.214 mg, Fusidic acid hemihydrate (equivalent to anhydrous fusidic acid - 20 mg) - 20.4 mg
Excipients: macrogol cetostearate 18 mg, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] 72 mg, chlorocresol 1 mg, sodium dihydrogen phosphate dihydrate 3 mg, liquid paraffin (contains about 10 ppm alpha-tocopherol) 60 mg, soft white paraffin (contains about 10 ppm alpha-tocopherol) 150 mg, sodium hydroxide qs, purified water up to 1 g.

Description
Homogeneous white cream.

Pharmacotherapeutic group : Topical glucocorticosteroid + polycyclic antibiotic

ATX code : D07CC01

Pharmacological action
FucicortЃ is a combined preparation containing the glucocorticosteroid betamethasone and fusidic acid, which has an antibacterial effect. Betamethasone belongs to the group of strong glucocorticosteroids (group III) and exerts its pharmacological effect by suppressing local immune reactions, including vasodilation, swelling and painful sensations.
Fusidic acid is an antibiotic with predominant activity against gram-positive bacteria. In particular, fusidic acid is active against the bacteria Staphylococcus aureus, Propionibacterium acnes and corynebacteria, and also inhibits protein synthesis in bacteria. After 30 years of use, bacteria resistance 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 can lead to systemic effects, especially when applied to large areas of inflamed skin or under occlusive dressings. With external application of the drug FucicortЃ, the absorption of betamethasone through intact skin is less than 2%. The amount of absorbed betamethasone is metabolized in the liver and excreted through the kidneys.
Systemic absorption of fusidic acid is negligible.

Indications for use
Dermatitis, allergic eczema and toxidermia, infected with microorganisms sensitive to fusidic acid.

Contraindications

• Hypersensitivity to the components of the drug.

Given the presence of a glucocorticosteroid in the composition of the drug Fucicort, the drug is contraindicated in:

• Rosacea

• Perioral dermatitis

• Acne

• Primary bacterial, viral and fungal skin diseases

• Skin tuberculosis, syphilis (skin manifestations)

• Children under one year of age

Application during pregnancy and lactation
During pregnancy: There are no
clinical data regarding the use of Fucicort during pregnancy and lactation. Experiments on animals do not show the teratogenic effect of fusidic acid, but show such an effect when using glucocorticosteroids.
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 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.
During lactation:
It is possible to use FucicortЃ during lactation. Women during lactation should use FucicortЃ only on the recommendation of a doctor.
Glucocorticosteroids are excreted in breast milk, but the likelihood of their effect on a nursing baby is very small when applied topically 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.

Method of administration and dosage
For external use.
Adults and children: apply the cream in a thin layer 2-3 times a day.
Treatment course: no more than 2 weeks.

Side effects
Side effects are classified according to the frequency of occurrence:
most frequent> 1/10
frequent> 1/100 and <1/10
infrequent> 1/1000 and <1/100
rare> 1/10000 and <1/1000
very rare < 1/10000
Immune system disorders:
Frequency unknown: allergic reactions
Skin and appendages of the skin:
Infrequent: 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 were not observed in clinical studies of FucicortЃ, the external use of glucocortico steroids can lead to telangiectasias and striae, especially with prolonged use.
As with other glucocorticosteroids, it is possible to develop folliculitis (steroid acne), hypertrichosis, perioral dermatitis, depigmentation, hemorrhagic rash, rosacea, prickly heat, skin maceration and systemic effects of glucocorticosteroids.

Overdose
Excessive long-term external treatment with glucocorticosteroids can suppress the function of the pituitary and adrenal glands, which can lead to secondary (usually reversible) adrenal insufficiency. In this case, symptomatic therapy may be indicated.

Interaction with other medicinal substances
Not known.

Special instructions
There is a bacterial resistance associated with the use of fusidic acid.
As with all antibiotics, overuse 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, face, areas of diaper skin. Do not apply the drug to open wounds and mucous membranes. The drug should be used with caution in the periorbital region, as this may lead to the development of glaucoma.
If the use of FucicortЃ cream causes irritation or excessive skin sensitivity, discontinue use and start another appropriate treatment.
If treatment is discontinued, a withdrawal syndrome may appear, manifested in the form of redness, a burning or tingling sensation of the skin, or exacerbation of psoriasis.
These phenomena can be prevented by gradual withdrawal of the drug.
Due to the fact that in children the value of the ratio of surface area and body weight is greater than in adults, children are at greater risk of suppression of the function of the hypothalamic-pituitary-adrenal system and the development of Cushing's syndrome with the use of any topical glucocorticosteroids. Long-term treatment of children with GCS can lead to impaired growth and development.
Children should receive the minimum dose of the drug sufficient to achieve the effect.
After long-term external treatment with potent corticosteroids, atrophic changes are most common on the face, external genitals, the inner side of the upper and lower extremities, in comparison with other areas.
The drug contains chlorocresol, which can cause allergic reactions, and cetostearyl alcohol, which can cause local skin rashes (eg contact dermatitis).

Influence on the ability to drive vehicles and mechanisms
Does not affect.

Release form
Cream for external use.
15, 30 60 g of cream in an aluminum tube, sealed with an aluminum foil membrane and sealed with a plastic screw cap; 1 tube with instructions for use in a cardboard box.

Storage conditions
At a temperature not exceeding 25 ? C. Keep out of the reach of children.

Shelf life is
3 years. Do not use after the expiration date.

Terms of dispensing from pharmacies
On prescription.