Fusikutan®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FUSICUTAN® (FUSICUTAN)

Composition:

Active substance: fusidic acid;

1 g of cream contains 20 mg of fusidic acid (as fusidic acid hemihydrate);

Excipients: butylhydroxyanisole (E 320), potassium sorbate, white soft paraffin, cetyl alcohol, mineral oil, polysorbate 60, glycerol 85 %, hydrochloric acid diluted, alpha-tocopherol, purified water.

Pharmaceutical form. Cream.

Main physicochemical characteristics: white, shiny, homogeneous, soft cream with a weak specific odor.

Pharmacotherapeutic group. Other antibiotics for topical use.

ATC code D06AX01.

Pharmacological Properties.

Pharmacodynamics.

Fusidic acid is an antibiotic produced during the growth of Fusidium coccineum. It disrupts protein synthesis in microbial cells and, depending on the dose, exerts either bacteriostatic or bactericidal effects. The drug has potent antibacterial activity against a broad range of gram-positive microorganisms – Staphylococcus spp., Streptococcus spp., Corynebacterium minutissimum, and Propionibacterium acnes – including strains resistant to penicillin, streptomycin, chloramphenicol, erythromycin, and other antibiotics. Fucikutan® has the ability to act through intact skin. When applied topically, fusidic acid is active against Corynebacteria spp., Neisseria spp., Clostridia spp., Bacteroides spp.

Pharmacokinetics.

With topical application, systemic absorption is negligible.

Clinical characteristics.

Indications.

Fusikutan® cream is indicated for topical treatment of bacterial skin infections caused by microorganisms sensitive to fusidic acid (see section "Pharmacodynamics"). The cream should be used to treat weeping skin conditions.

Contraindications.

Hypersensitivity to fusidic acid or to any of the excipients. Do not apply Fusikutan® cream to the area around the eyes.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted. Interaction with systemically administered medicinal products is considered to be minimal due to the negligible systemic absorption of fusidic acid.

Special precautions for use

Resistance development in Staphylococcus aureus has been reported during topical application of fusidic acid. As with any antibiotic, prolonged or repeated use of fusidic acid may increase the risk of developing antibiotic resistance.

Butylhydroxyanisole may cause local skin reactions (e.g., contact dermatitis) or irritation of the eyes and mucous membranes. Cetyl alcohol and potassium sorbate may also lead to local skin reactions (e.g., contact dermatitis).

When using latex condoms during treatment with Fucicutan® cream applied to the anal area or genital region, the stability of condoms may be reduced due to the excipients white soft paraffin and liquid paraffin, potentially increasing the risk of condom breakage. This may adversely affect the reliability of this contraceptive method.

Use during pregnancy or breastfeeding

Fucicutan® cream should be used during pregnancy or breastfeeding only if the expected benefit to the mother outweighs the potential risk to the fetus/infant. During breastfeeding, avoid applying the product to the skin of the mammary glands.

Ability to affect reaction speed when driving vehicles or operating machinery

Fusidic acid has no effect or has negligible effect on the ability to drive vehicles or operate machinery.

Dosage and Administration.

For adults and children aged 2 years and older, apply the cream to affected skin areas 2–3 times daily for 7 days. If necrotic debris is present, it should be removed before applying the medication.

Children.

There is no clinical experience with the use of Fusikutan® cream in patients under 2 years of age.

Overdose.

Not reported.

Adverse Reactions

The assessment of the frequency of adverse reactions was based on pooled data from clinical trials and spontaneous reports.

The most commonly reported adverse reactions during treatment were various skin reactions such as itching and rashes; less frequently reported were application site reactions such as pain and irritation, observed in less than 1% of patients.

Cases of hypersensitivity and angioneurotic edema have been reported.

Adverse reactions are listed by MedDRA system organ classes, with individual adverse reactions presented starting with the most frequent. Within each frequency group, adverse reactions are listed in decreasing order of severity.

The corresponding frequency categories of adverse reactions were defined according to the following criteria:

Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100)
Rare (≥1/10,000 to <1/1000)
Very rare (<1/10,000)
Frequency not known (frequency cannot be estimated from available data)

Immune system disorders
Rare: Hypersensitivity.

Eye disorders
Rare: Conjunctivitis.

Skin and subcutaneous tissue disorders
Uncommon: Dermatitis (including contact dermatitis, eczema), rash*, pruritus, erythema.
*Various types of rashes were reported, including erythematous, pustular, vesicular, maculopapular, and papular. Cases of generalized rashes were also observed.
Rare: Angioneurotic edema, urticaria, bullae.

General disorders and administration site conditions
Uncommon: Application site pain (including skin burning sensation), application site irritation.

Paediatric population
The frequency, type, and severity of adverse reactions in children are expected to be no different from those observed in adults.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after medicine authorization is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

Shelf life. 2 years.
After opening the tube – 6 months.

Storage conditions.
Keep out of reach and sight of children. Store below 30°C.

Packaging.
5 g, 10 g, 15 g, or 30 g in a tube in a cardboard box.

Prescription status.
Prescription only.

Manufacturer.
mibe GmbH Arzneimittel.

Manufacturer's address and place of business.
Muenchener Strasse 15, Brehna, Saxony-Anhalt, 06796, Germany.