Fucidine® G (Fucidin® H)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceHydrocortisone + Fusidic acidHydrocortisone + Fusidic acid
Dosage form: & nbspcream for external use
Composition:

In 1 g of cream contains:

Active substance: fusidic acid hemihydrate (in terms of acid anhydrous) - 20 mg;

Hydrocortisone acetate - 10 mg; Excipients: butylhydroxyanisole-0.04 mg; cetyl alcohol-111.00 mg; glycerol 85% -111.00 mg; paraffin liquid * -111.00 mg; potassium sorbate - 2.70 mg; polysorbate 60-56.00 mg; paraffin soft white * -56.00 mg; hydrochloric acid ZM (maximum amount) -3.00 mg; purified water-519,60 mg.
* contains about 10 ppm alpha-tocopherol
Description:

homogeneous cream of white color.

Pharmacotherapeutic group:glucocorticosteroid for topical application + antibiotic polycyclic structure.
ATX: & nbsp

D.07.C.A   Low-active corticosteroids in combination with antibiotics

D.07.C.A.01   Hydrocortisone in combination with antibiotics

Pharmacodynamics:

Combination drug for external use. Unites
anti-inflammatory and antipruritic effect of hydrocortisone with antibacterial action of fusidic acid. Highly active in relation to Staphylococcus spp., special 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. Antibacterial activity of fusidic acid does not decrease in the presence of hydrocortisone.

Pharmacokinetics:

The skin gets 2% of the active substances from the applied amount of the drug. At external application system absorption is low.

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

Hydrocortisone. Absorbed hydrocortisone quickly 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.

Because of the glucocorticoid content, Fucidine® G cream is contraindicated under the following conditions:

primary infections of the skin caused by bacteria, fungi, or viruses (such as the herpes virus or varicella zoster virus);

- skin manifestations of tuberculosis or syphilis;

- perioral dermatitis and rosacea.

Children up to 2 years.
Carefully:not described
Pregnancy and lactation:

Pregnancy

Preclinical studies and long-term clinical experience indicate the absence of embryotoxic and teratogenic effects of fusidic acid. Local application of corticosteroids in pregnant animals led to the appearance of fetal anomalies, although the significance of this phenomenon in relation to humans is unclear.

Data obtained during pregnancy show no serious adverse effects on the fetus and the newborn. However, it is not recommended during pregnancy to use excessive cream (that is, for a long time or in volumes more than 100 g per week) because of the presence of hydrocortisone in the composition of Fucidine® G.

Breastfeeding period

With external application of fusidic acid and hydrocortisone acetate, penetration into breast milk is unlikely due to low systemic adsorption and no impact on children breastfed is expected. Cream Fucidin® G may be given during breastfeeding, however, when applied externally to the skin of the nipple, the nipple surface must be thoroughly cleaned from any traces of cream before feeding.

Dosing and Administration:

Adults and children over 2 years of cream Fucidin® G are 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 adverse reactions, depending on the frequency of their occurrence.

Often >1/10

Often > 1/100 and <1/10

Infrequently > 1/1 000 and <1/100

Rarely > 1/10 000 and <1/1 000
Rarely <1/10000

Immune system disorders:

Rarely:

Systemic allergic reactions

Disturbances from the skin and subcutaneous tissues:

Infrequently:

Skin irritation, burning sensation, tingling sensation at the site of application.

Frequency unknown:

Rash, allergic contact dermatitis, depigmentation

Adverse Reactions, associated with the presence of glucocorticosteroid:

Skin 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:Not identified.
Special instructions:

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

Long-term 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 on the face and, to a lesser extent, on other parts of the body can occur.

Fucidin® G cream contains butyl hydroxy anisole and cetyl alcohol, which can cause local skin reactions (such as contact dermatitis). Butylhydroxyanisole can also cause eye and mucous membrane irritation.

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, as glucocorticosteroids can mask symptoms of infection or hypersensitivity reactions. With persistence of bacterial infection, treatment with systemic drugs should be started.
Effect on the ability to drive transp. cf.and fur:

Influences on ability to operate vehicles and mechanisms are not revealed.

Form release / dosage:

Cream for external use.

For 15 g of the drug in an aluminum tube, sealed with a membrane of aluminum foil, with a screwed polyethylene lid.

One tube together with the instruction for use is placed in a cardboard box.

Packaging:Cardboard tutu
Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep the medicinal product out of the reach of children.
Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription
Registration number:П N011629 / 01
Date of registration:21.09.2011
The owner of the registration certificate:Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Leo Pharmaceutical Products Co., Ltd. A / S (Leo Pharma A / S) Denmark
Manufacturer: & nbsp
Representation: & nbspLEO Pharmaceutical Products Ltd.LEO Pharmaceutical Products Ltd.
Information update date: & nbsp14.04.2014
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