Fucidin G cream, 15 g

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

For adults and children over 2 years of age, FucidinЃ G cream is applied to the affected area of ??the skin with a thin layer 3 times a day. The course of treatment is 2 weeks.

1 g of cream contains:
Active substance:

Fusidic acid hemihydrate (in terms of anhydrous acid) - 20 mg;

Hydrocortisone acetate - 10 mg;

Excipients: butylhydroxyanisole - 0.04 mg; cetyl alcohol - 111.00 mg; glycerol 85% - 111.00 mg; liquid paraffin * - 111.00 mg; potassium sorbate - 2.70 mg; polysorbate 60 - 56.00 mg; soft white paraffin * - 56.00 mg; hydrochloric acid 3M (maximum amount) - 3.00 mg; purified water - 519.60 mg.
* contains about 10 ppm alpha-tocopherol

Hypersensitivity to fusidic acid / sodium fusidate, hydrocortisone acetate or other components of the drug.
Due to the glucocorticosteroid content, FucidinЃ G cream is contraindicated in the following conditions:

• primary skin infections caused by bacteria, fungi, or viruses (such as herpes virus or chickenpox virus);

• cutaneous manifestations of tuberculosis or syphilis;

• perioral dermatitis and rosacea.

Children up to age 2 years.

Trade name : FucidinЃ G

INN or Group Name : Hydrocortisone + Fusidic Acid

Dosage form : cream for external use

Composition
1 g of cream contains:
Active substance: fusidic acid hemihydrate (in terms of anhydrous acid) - 20 mg; Hydrocortisone acetate - 10 mg;
Excipients: butylhydroxyanisole - 0.04 mg; cetyl alcohol - 111.00 mg; glycerol 85% - 111.00 mg; liquid paraffin - 111.00 mg; potassium sorbate - 2.70 mg; polysorbate 60 - 56.00 mg; soft white paraffin - 56.00 mg; hydrochloric acid 3M (maximum amount) - 3.00 mg; purified water - 519.60 mg.
* contains about 10 ppm alpha-tocopherol

Description : homogeneous white cream.

Pharmacotherapeutic group : topical glucocorticosteroid + polycyclic antibiotic.

ATX code : D007CA01

Pharmacological properties
Pharmacodynamics . Combined preparation for external use. Combines the anti-inflammatory and antipruritic action of hydrocortisone with the antibacterial action 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 penetrate into the skin. When applied externally, systemic absorption is low.
Fusidic acid. Fusidic acid is excreted mainly 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 sensitive to fusidic acid.

Contraindications
Hypersensitivity to fusidic acid / sodium fusidate, hydrocortisone acetate or other components of the drug.
Due to the glucocorticosteroid content, FucidinЃ G cream is contraindicated in the following conditions:

• primary skin infections caused by bacteria, fungi, or viruses (such as herpes virus or chickenpox virus);

• cutaneous manifestations of tuberculosis or syphilis;

• perioral dermatitis and rosacea.

Children up to age 2 years.

Application during pregnancy and during breastfeeding
Pregnancy
Preclinical studies and long-term clinical experience indicate the absence of embryotoxic and teratogenic effects of fusidic acid. Topical administration of corticosteroids in pregnant animals has resulted in fetal abnormalities, although the significance of this phenomenon in humans is unclear.
Data obtained during pregnancy show no serious adverse effects on the fetus and newborn. However, it is not recommended to use FucidinЃ G cream excessively (that is, for a long time or in volumes more than 100 g per week) during pregnancy due to the presence of hydrocortisone in the composition.
Breastfeeding period
With external use of fusidic acid and hydrocortisone acetate, penetration into breast milk is unlikely due to low systemic absorption and any effect on breastfed babies is not expected. FucidinЃ G cream can be prescribed during breastfeeding, however, when applied externally to the skin of the nipple, the surface of the nipple must be thoroughly cleaned of any traces of cream before feeding.

Dosage and administration For adults and children over 2 years of age, FucidinЃ G cream is applied to the affected area of ??the skin with a thin layer 3 times a day. The course of treatment is 2 weeks.

Side effects
The following are data on adverse side effects, depending on the frequency of their occurrence.
Very often> 1/10
Often? 1/100 and Uncommon?
1/1000 and <1/100 Rarely? 1/10000 and <1/1000
Very rarely <1/10 000
Immune system disorders:
Very rare:
Systemic allergic reactions
Skin and subcutaneous tissue disorders:
Uncommon:
Skin irritation, burning sensation, tingling sensation at the site of application of the drug.
Frequency not known:
Rash, allergic contact dermatitis, depigmentation
Adverse reactions associated with the presence of a glucocorticosteroid in the composition:
Cutaneous atrophy, telangiectasia and striae (especially with prolonged use), folliculitis, hypertrichosis, perioral dermatitis, allergic contact dermatitis, depigmentation and suppression of the adrenal cortex.

Overdose
Overdose is unlikely.

Interaction with other medicinal products
Not identified.

Special instructions
It is necessary to avoid contact of FucidinЃ G cream with open wounds and mucous membranes. Apply with caution near the eyes, as contact with the eyes can lead to glaucoma.
Prolonged external use of glucocorticosteroids should be avoided, as this can lead to suppression of adrenal function even with low systemic absorption. After prolonged local treatment with glucocorticosteroids, atrophic changes can occur on the face and, to a lesser extent, on other parts of the body.
The composition of FucidinЃ G cream contains butylhydroxyanisole and cetyl alcohol, which can cause local skin reactions (such as contact dermatitis). Butylhydroxyanisole can also irritate the eyes and mucous membranes.
Fusidic acid, like all antibiotics, with prolonged or repeated use, may increase the risk of developing antibiotic resistance.
The use of fixed combinations of a glucocorticosteroid with an antibiotic should not exceed 2 weeks, since glucocorticosteroids can mask the symptoms of infection or hypersensitivity reactions. If the bacterial infection persists, treatment with systemic drugs should be initiated.

Influence on the management of vehicles
and mechanisms No influence on the ability to drive vehicles and mechanisms has been identified.

Release form
Cream for external use.
15 g of the drug in an aluminum tube sealed with an aluminum foil membrane, with a plastic screw cap.
1 tube, together with instructions for use, are placed in a cardboard box.

Storage
conditions Store at a temperature not exceeding 25 ? C.
Store the medicinal product 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.