Fusiderm (Cream) Instructions for Use

Marketing Authorization Holder

Biosintez, PJSC (Russia)

ATC Code

D06AX01 (Fusidic acid)

Active Substance

Fusidic acid (Rec.INN WHO registered)

Dosage Form

Fusiderm

Cream for external use 2%: tube 15 g

Dosage Form, Packaging, and Composition

Cream for external use from white to white with a yellowish tint.

Excipients: Emulsifier No. 1 – 7 g, Glycerol (distilled glycerin) – 12 g, Liquid paraffin (vaseline oil) – 3 g, Potassium sorbate (E202) – 0.15 g, Butylhydroxyanisole (E320) – 0.001 g, Polysorbate 80 (Tween 80) – 0.7 g, White soft paraffin – 11 g, Purified water – up to 100 g.

15 g – aluminum tubes (1) – cardboard packs.

Clinical-Pharmacological Group

Antibiotic for external use

Pharmacotherapeutic Group

Polycyclic structure antibiotic

Pharmacological Action

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

Fusidic acid is active against gram-positive bacteria and gram-negative cocci, for example, Staphylococcus aureus, Staphylococcus epidermidis (including methicillin-resistant strains), Nocardia asteroides, Corynebacterium minutissimum, Streptococcus pyogenes, Pseudomonas spp., Clostridium spp., Neisseria meningitidis, Neisseria gonorrhoeae.

It is not active against Escherichia coli, Salmonella spp., Proteus spp., as well as protozoa and fungi.

Pharmacokinetics

In vitro studies show that Fusidic acid and its salts can penetrate intact human skin in concentrations sufficient to effectively suppress susceptible microorganisms. The degree of penetration depends on factors such as the duration of exposure to fusidic acid (or its salts) and the condition of the skin. Fusidic acid and its salts are excreted mainly in bile; a small amount is excreted in the urine.

Indications

Skin infections caused by bacteria sensitive to fusidic acid, including impetigo, carbuncles, boils, infected wounds, hidradenitis, folliculitis, paronychia, sycosis barbae, erythrasma, acne vulgaris.

ICD codes

Dosage Regimen

Apply the cream externally only.

Administer a thin layer to the affected skin areas three to four times daily.

Gently rub the cream into the skin until fully absorbed.

When utilizing occlusive dressings or gauze, reduce the application frequency to one or two times per day.

The standard treatment duration is 7 to 14 days.

Do not extend the course of therapy beyond 14 days without medical reevaluation.

Discontinue treatment once the infection has resolved.

If no clinical improvement is observed after several days of use, consult a physician for reassessment.

Avoid contact with the eyes and mucous membranes.

Wash hands thoroughly before and after each application.

Adverse Reactions

Skin and subcutaneous tissue disorders uncommon – rash (erythematous, maculopapular, pustular), skin irritation, including pain, burning sensation, tingling sensation on the skin, itching, dry skin, contact dermatitis; rare – eczema, periorbital edema, erythema.

Allergic reactions: rare – urticaria, angioedema, eczema.

Eye disorders rare – conjunctival irritation.

Contraindications

• Hypersensitivity to fusidic acid.

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation (breastfeeding).

In experimental studies, it was found that Fusidic acid does not have embryotoxic or teratogenic effects.

Pediatric Use

Can be used in children according to indications.

Geriatric Use

The drug is approved for use in elderly patients.

Special Precautions

Do not apply to the skin in the eye area, since Fusidic acid, if it gets into the eyes, causes conjunctival irritation.

The development of bacterial resistance is possible with the use of fusidic acid. As with other antibiotics, long-term or intermittent repeated use may increase the risk of developing antibiotic resistance.

It should be taken into account that the excipients included in the drug used may cause local allergic skin reactions (for example, contact dermatitis).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.