Fucidin G, cream, 15g

Composition

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of 1 g of cream for external use contains:

Active ingredients:

fusidic acid hemihydrate (in terms of anhydrous acid) 20 mg,

hydrocortisone acetate 10 mg,

Auxiliary substances:

butylhydroxyanisole — 0.04 mg;

cetyl alcohol — 111 mg;

glycerol 85% — 111 mg;

paraffin liquid (contains about 10 ppm alpha-tocopherol) — 111 mg;

potassium sorbate — 2.7 mg;

Polysorbate 60 — 56 mg;

paraffin soft white (contains about 10 ppm alpha-tocopherol) — 56 mg;

hydrochloric acid (3 M maximum) — 3 mg;

purified water — 519,6 mg

Pharmacological action

Pharmacodynamics

Futsidin G – a combined preparation for external use. Combines the anti-inflammatory and antipruritic effects of hydrocortisone with the antibacterial effect of fusidic acid. Highly active against Staphylococcus spp., especially Staphylococcus aureus and Staphylococcus epidermidis (including methicillin-resistant strains), Streptococcus spp., Neisseria spp., Clostridium spp., Nocardia asteroides, Enterococcus spp., Bacteroides spp., Mycobacterium tuberculosis, Mycobacterium leprae and Corynebacterium minutissimum. The antibacterial activity of fusidic acid is not reduced in the presence of hydrocortisone.

Pharmacokinetics

2% of the active ingredients of the applied amount of the drug penetrates the skin. When applied topically, systemic absorption is low.

Fusidic acid. It is mainly excreted in the bile, and only a small amount is excreted in the urine.

Hydrocortisone. Absorbed hydrocortisone is rapidly metabolized and excreted in the urine.

Indications

Treatment of atopic dermatitis with infectious complications caused by pathogens sensitive to fusidic acid.

Use during pregnancy and lactation

Preclinical studies and long-term clinical experience indicate the absence of embryotoxic and teratogenic effects of fusidic acid. Topical corticosteroid use in pregnant animals has led to fetal malformations, although the significance of this phenomenon in humans is unclear.

Data obtained during pregnancy show that there are no serious adverse effects on the fetus and newborn. However, it is not recommended to use Fucidin G cream excessively during pregnancy (that is, for a long time or in volumes exceeding 100 g per week) due to the presence of hydrocortisone in the composition.

With external use of fusidic acid and hydrocortisone acetate, penetration into breast milk is unlikely due to low systemic adsorption and no effect is expected on children who are breastfed. Cream Fucidin G can be prescribed during breastfeeding, however, when applied externally on the skin of the nipple, before feeding, the surface of the nipple should be thoroughly cleaned of any traces of cream.

Contraindications

Hypersensitivity to fusidic acid / sodium fusidate, hydrocortisone acetate or other components of the drug Fucidin G.

Due to the content of corticosteroids, the following conditions and diseases:

• primary skin infections caused by bacteria, fungi, or viruses (such as herpes virus or chickenpox);
• skin manifestations of tuberculosis or syphilis;
• perioral dermatitis and rosacea;
• children under 2 years of age.

Side effects

Data on adverse side effects are given below, depending on the frequency of their occurrence: very often – ≥1/10; often – ≥1/100,

Immune system disorders: very rare — systemic allergic reactions.

From the skin and subcutaneous tissues: infrequently-skin irritation, burning sensation, tingling sensation at the site of application of the drug; frequency unknown-rash, allergic contact dermatitis, depigmentation.

Associated with the presence of corticosteroids: skin atrophy, telangiectasia and striae (especially with prolonged use), folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and suppression of the adrenal cortex.

How to take, course of use and dosage

Externally. Adults and children over 2 years old.

Apply to the affected area of the skin in a thin layer 3 times a day. The course of treatment is 2 weeks.

Special instructions

It is necessary to avoid contact of Fucidin G cream with open wounds and mucous membranes. Apply with caution near the eyes, as contact with the drug can lead to glaucoma.

Prolonged external use of corticosteroids should be avoided, as this may lead to suppression of adrenal function even with low systemic absorption. After prolonged topical treatment with corticosteroids, atrophic changes may occur on the face and, to a lesser extent, on other parts of the body.

Fucidin G cream contains butylhydroxyanisole and cetyl alcohol, which can cause local skin reactions (such as contact dermatitis). Butylhydroxyanisole can also cause eye and mucosal irritation.

Fusidic acid, like all antibiotics, can increase the risk of developing antibiotic resistance with prolonged or repeated use. The use of fixed combinations of corticosteroids with an antibiotic should not exceed 2 weeks, since CORTICOSTEROIDS can mask the symptoms of infection or hypersensitivity reactions. If the bacterial infection persists, treatment with systemic medications should be initiated.

Influence on the ability to drive vehicles and work with mechanisms. The effect on the ability to drive vehicles and mechanisms was not revealed.

Form of production

Cream for external use

Storage conditions

At a temperature not exceeding 25 °C.

Shelf

life is 3 years.

Active ingredient

Hydrocortisone, Fusidic acid

Conditions of release from pharmacies

By prescription

Dosage form

cream

Description

Children as prescribed by a doctor, Adults as prescribed by a doctor, Children over 2 years of age

Indications

Allergy, Dermatitis