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.

Pharmacological effect

Fucidin has an antibacterial effect.

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

Gram-positive bacteria and gram-negative cocci are sensitive to fusidic acid, for example Staphylococcus aureus, Staphylococcus epidermidis (including methicillin-resistant strains), Nocardia asteroides, Corynebacterium minutissimum, Streptococcus pyogenes, Pseudomonas spp., Clostridium spp., Neisseria meningitidis, Neisseria gonorrhoeae.

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

Pharmacokinetics

The permeability of fusidic acid through intact skin is low. Does not enter the systemic circulation.

Special instructions

Fucidin should not be applied to the skin in the eye area, since fusidic acid, if it comes into contact with the eyes, causes irritation of the conjunctiva.

Fucidin cream contains butylated hydroxyanisole, cetyl alcohol and potassium sorbate, which may cause local allergic skin reactions (for example, contact dermatitis). Butylated hydroxyanisole can also cause irritation to the eyes and mucous membranes.

Bacterial resistance may develop when using fusidic acid. As with other antibiotics, long-term or repeated 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 complex machinery has been identified.

Active ingredient

Fusidic acid

Composition

1 g of cream for external use contains:

Active ingredient:

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

Excipients:

cetyl alcohol – 111 mg;

glycerol 85% – 111 mg;

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

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

polysorbate 60 – 56 mg;

hydrochloric acid – q.s. up to pH 5;

potassium sorbate – 2.7 mg;

butylated hydroxyanisole – 0.04 mg;

water – about 531 mg

Contraindications

Hypersensitivity to the components of the drug Fucidin.

With caution: pregnancy, lactation period.

Side Effects

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

Determination of the frequency of adverse reactions: very often (> 1/10), often (> 1/100 and 1/1000 and 1/10,000 and <1/1000), very rarely (< 1/10,000).

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

Allergic reactions: rarely – urticaria, angioedema, eczema.

From the organ of vision: rarely – irritation of the conjunctiva.

The patient should inform the doctor about the occurrence of any side effects listed or not listed above.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf life

3 years.

Manufacturer

LEO Laboratories Limited, Ireland