Fucidin, 2% cream 15 g

Fucidin has an antibacterial effect.

Fusidic acid belongs to the group of fusidines, antimicrobial compounds whose mechanism of action is related to disruption of protein synthesis in the bacterial cell.

Fusidic acid is susceptible to Gram-positive bacteria and Gram-negative cocci such as Staphylococcus aureus, Staphylococcus epidermidis (including methicillin-resistant strains), Nocardia asteroides, Corynebacterium minutissimum, Streptococcus pyogenes, Pseudomonas spp, Clostridium spp., Neisseria meningitidis, Neisseria gonorrhoeae.

It is inactive against Escherichia coli, Salmonella spp., Proteus spp. and other gram-negative bacteria as well as protozoa and fungi.

Pharmacokinetics

Permeability of fusidic acid through intact skin is low. It does not enter the systemic bloodstream.

Indications

Skin infections caused by bacteria sensitive to fusidic acid.

Active ingredient

Composition

1 g of cream for external use contains:

Active substance:

Fusidic acid hemihydrate (in terms of acid anhydrous) 20.4 mg (equivalent to 20 mg of fusidic acid anhydrous),

Associates:

Cetyl alcohol, 111 mg;

Glycerol 85%, 111 mg;

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

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Paraffin soft white (contains about 10 ppm alpha-tocopherol) – 56 mg;

Polysorbate 60 – 56 mg;

Hydrochloric acid – q.s. to pH 5;

Potassium sorbate – 2.7 mg;

butyl hydroxyanisole – 0.04 mg;

water – about 531 mg

How to take, the dosage

The cream is used topically.

In adults and children from birth to 18 years of age the cream is applied to the affected areas of the skin in a thin layer 3-4 times a day.

If gauze bandages are used, the frequency of application can be reduced to 1-2 times a day.

The duration of treatment depends on the form and severity of the disease and on average is 7-14 days.

Special Instructions

Fucidin should not be applied to the skin in the eye area because fusidic acid will irritate the conjunctiva if it gets into the eye.

Fucidin cream contains butyl hydroxyanisole, cetyl alcohol and potassium sorbate, which may cause localized allergic skin reactions (such as contact dermatitis). Butylhydroxyanisole may also cause eye and mucous membrane irritation.

Bacterial resistance can develop when using fusidic acid. As with other antibiotics, prolonged or intermittent use may increase the risk of developing antibiotic resistance.

Impact on the ability to drive vehicles and operate machinery. No effect on the ability to drive vehicles and operate complex mechanisms has been identified.

Contraindications

Hypersensitivity to the components of the drug Fucidin.

With caution: pregnancy, lactation.

Side effects

Side effects are very rare and can be expected in about 5% of patients.

Frequency definition of adverse reactions: very frequently (> 1/10), frequently (> 1/100 and < 1/10), infrequently (> 1/1000 and < 1/100), rarely (> 1/10 000 and < 1/1000), very rarely (< 1/10 000).

Dermatological reactions: infrequent – rash (erythematous, maculopapular, pustular), skin irritation, including pain, burning sensation, tingling sensation on skin, itching, dry skin, contact dermatitis; rarely – eczema, periorbital edema, erythema.

Allergic reactions: rare – urticaria, angioedema, eczema.

Organ of vision: rarely – irritation of conjunctiva.

The patient should inform the physician about the occurrence of any side effects specified or not specified above.