Fusiderm®

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT FUSIDERM®

Composition:

Active substance: fusidic acid;

1 g of gel contains 20 mg of fusidic acid;

Excipients: carbomer, triethanolamine, isopropyl myristate, polysorbate 20, disodium edetate, methylparaben (E 218), purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: soft white-colored gel.

Pharmacotherapeutic group.

Antibiotics and chemotherapeutic agents for dermatological use.

ATC code D06AX01.

Pharmacological Properties.

Pharmacodynamics.

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

Pharmacokinetics.

With topical application, systemic absorption is negligible.

Clinical characteristics.

Indications.

As monotherapy or in combination with systemic therapy, for the treatment of primary or secondary skin and soft tissue infections caused by susceptible strains of microorganisms (Staphylococcus aureus, Streptococcus spp., and Corynebacterium minutissimum), including: impetigo, folliculitis, paronychia, sycosis of beard area skin, erythrasma, acne vulgaris, infected wounds and burns, infected contact dermatitis, infected eczematous dermatitis.

Contraindications.

Hypersensitivity to fusidic acid or to any of the excipients of the product; skin and soft tissue infections resistant to the drug, e.g., Pseudomonas aeruginosa.

Interaction with other medicinal products and other forms of interaction.

Interaction studies have not been conducted. Interaction with systemically administered drugs is considered minimal, since systemic absorption following topical application of Fusiderm® gel is negligible.

Special precautions for use

Bacterial resistance, including to Staphylococcus aureus, has been reported during the topical use of fusidic acid. As with all topical antibiotics, prolonged and repeated use of the gel may increase the risk of contact sensitization and the development of microbial resistance to antibiotics.

The product should be applied around the eyes with caution, avoiding contact with the eyes, as this may cause irritation of the conjunctiva.

The product contains methylparaben (E 218), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding

Fucidin® gel should be used during pregnancy or breastfeeding only when the expected benefit to the mother outweighs the potential risk to the fetus/infant.

Breastfeeding period

During breastfeeding, avoid applying the product on the skin of the breasts.

Ability to affect reaction rate while driving or operating machinery

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

Method of Administration and Dosage.

The gel should be applied to affected areas of skin in adults and children from 1 month of age as a thin layer 2–3 times daily for 7 days. Treatment of acne should continue for 14 days. Fusiderm® gel may be used under an occlusive dressing; in this case, the medicinal product Fusiderm® can be applied less frequently (1–2 times daily). If necrotic material is present, it should be removed before applying the medication.

Children.

The product can be used in children from 1 month of age.

Overdose.

Overdose is unlikely.

In the absence of hypersensitivity to fusidic acid or any of the excipients, accidental ingestion of Fusiderm® gel is unlikely to cause harm. The total amount of fusidic acid (15 g of Fusiderm® gel contains 300 mg fusidic acid) generally does not exceed the approved total daily dose for oral fusidic acid-containing products, except in children under 1 year of age weighing ≤10 kg. Although even in this case, a child in this specific age group is unlikely to ingest an entire tube of Fusiderm® gel. The concentration of excipients is too low to pose safety risks.

Adverse Reactions

Immune system disorders – hypersensitivity reactions.

Eye disorders – conjunctivitis.

Skin and subcutaneous tissue disorders – dermatitis (including contact dermatitis, eczema), rash*, pruritus, erythema, angioneurotic edema, periorbital edema, urticaria, vesicles.

*Various types of rashes have been reported, including: erythematous, pustular, vesicular, maculopapular, and papular rashes. Generalized rash has also been observed.

General disorders and administration site conditions – application site pain (including sensation of burning), application site reactions, pruritus, sensation of tingling.

The frequency, type, and severity of adverse reactions in children are expected to be the same as in adults.

Reporting of adverse reactions following marketing authorization of the medicinal product is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives should report all suspected adverse reactions and lack of efficacy through the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 ºC.

Keep out of the reach of children.

Packaging.

15 g in an aluminum tube; 1 tube in a cardboard box.

Prescription status. Prescription only.

Manufacturer/Applicant.

Pharma International Company.

Manufacturer's address and location of operations.

Al Kastal area, Airport road, P.O. Box 334 Jubaiha 11941, Amman – Jordan.

Applicant's address.

P.O. Box 334 Al-Jubaiha 11941 Amman, Jordan.

Contact details of the manufacturer's/applicant's representative in Ukraine – Megakom LLC: 195 Klochkivska Street, Kharkiv, 61145, Ukraine; phone: +38 (057) 701 37 55.