Fucidin^® (Ointment, Cream) Instructions for Use

Instructions
Dosage forms

ATC Code

D06AX01 (Fusidic acid)

Active Substance

Fusidic acid (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Antibiotic for external use

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antibiotics for topical use; other antibiotics for topical use

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 a concentration 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 the bile; a small amount is excreted in the urine.

Indications

Skin infections caused by bacteria sensitive to fusidic acid.
These include impetigo, carbuncles, boils, and infected wounds.
Also indicated for hidradenitis, folliculitis, paronychia, and sycosis barbae.
Use for erythrasma and acne vulgaris.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
L08.0	Pyoderma
L30.3	Infectious dermatitis (infectious eczema)

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

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

When using gauze dressings, reduce the application frequency to once or twice daily.

The typical treatment duration is seven to fourteen days, depending on the form and severity of the disease.

Adverse Reactions

Uncommon skin reactions include rash, irritation, pain, burning, tingling, itching, dry skin, and contact dermatitis. Rarely, eczema, periorbital edema, and erythema may occur.

Rare allergic reactions include urticaria and angioedema. Conjunctival irritation is a rare eye disorder.

Contraindications

Hypersensitivity to fusidic acid or any component of the formulation.
Do not use in patients with a known history of such hypersensitivity reactions.

Drug Interactions

No specific drug interactions are reported for topical application. Concurrent use with other topical products may cause skin irritation.

Avoid applying other topical preparations, especially those containing corticosteroids, to the same area unless directed by a physician.

Overdose

Overdose from topical application is unlikely due to minimal systemic absorption. In case of accidental ingestion, seek medical attention.

Symptoms of oral overdose may include gastrointestinal irritation. Provide symptomatic and supportive care as there is no specific antidote.

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, as 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 be the cause of local allergic skin reactions (for example, contact dermatitis).

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Fucidin^® [Leo Pharma, A/S (Denmark)]
Cream for external use 2%: tube 15 g

Marketing Authorization Holder

Leo Pharma, A/S (Denmark)

Manufactured By

LEO Laboratories, Limited (Ireland)

Dosage Form

Fucidin^®

Cream for external use 2%: tube 15 g

Dosage Form, Packaging, and Composition

Cream for external use homogeneous, from white to almost white.

	1 g
Fusidic acid hemihydrate	20.4 mg,
Equivalent to the content of anhydrous fusidic acid	20 mg

Excipients : cetyl alcohol – 111 mg, glycerol 85% – 111 mg, liquid paraffin* – 111 mg, white soft paraffin* – 56 mg, polysorbate 60 – 56 mg, hydrochloric acid – 3M q.s. to pH 5, potassium sorbate – 2.7 mg, butylated hydroxyanisole – 0.04 mg, purified water – up to 1000 mg.

* contains about 10 ppm of racemic alpha-tocopherol.

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

Fucidin^® [Leo Pharma, A/S (Denmark)]
Ointment for external use 2%: tube 15 g