Fusidic acid (FUCIDIN)

1. Health Canada Product Monograph — Fusidic acid

• Fusidic acid is used to treat skin infections caused by susceptible bacteria, including impetigo (a crusty, weeping skin infection).
• Fusidic acid is used to treat erythrasma, a bacterial skin condition causing brown, scaly patches, often in skin folds.
• Fusidic acid is used to treat infected wounds and infected burns caused by susceptible bacteria.

• The safety of fusidic acid for treating infections during pregnancy has not been established.
• Fusidic acid can cross the placenta after it enters the bloodstream, though absorption from the skin is expected to be minimal.
• Animal studies have not shown evidence that fusidic acid causes birth defects.
• If treatment during pregnancy is necessary, the potential benefits should be weighed against any possible risk to the baby.
• No effects on fertility are expected with topical use, since systemic absorption after applying fusidic acid to the skin is negligible.

• The safety of fusidic acid during breastfeeding has not been established.
• Fusidic acid has been detected in breast milk after the medication reaches the bloodstream.
• Applying fusidic acid directly to the breast area should be avoided to prevent the nursing infant from accidentally swallowing the medication.

• Specific dosing information for elderly patients has not been established, but no unique precautions beyond those for adults are described.

• Health Canada has not authorized an indication for pediatric use, as no data on fusidic acid in children have been submitted for review.

• A small amount of fusidic acid cream or ointment is applied to the affected skin two to three times daily for 7 to 14 days.
• When the treated area is covered with a gauze dressing, less frequent application (once or twice daily) may be used instead.
• Treatment should not continue beyond 14 days at a time, to help reduce the risk of bacteria becoming resistant.
• It is not necessary to remove crusts from impetigo before applying fusidic acid.
• When needed, any collection of pus should be drained by a healthcare professional before starting treatment.

If overdose is suspected, seek emergency medical attention immediately or contact your regional Poison Control Centre without delay.

• No information is available on symptoms from an overdose of topically applied fusidic acid.
• Because the amount of fusidic acid in a single tube does not exceed the systemic daily dose used for oral treatment, serious effects from accidentally swallowing the contents of a tube are unlikely.

• Mild burning or stinging sensation where applied may occur.
• Itching (pruritus) at the application site may occur.
• Mild redness (erythema) of the skin may occur.
• Irritation at the application site may occur.
• Pain at the application site may occur, particularly when used on deep wounds such as leg ulcers.

Serious side effects require immediate discussion with the prescriber or emergency care.

• Contact dermatitis, an allergic-type skin reaction, can develop from the medication or its ingredients.
• Eczema-like skin changes can occur.
• Rash can occur, including erythematous, pustular, vesicular, maculopapular, papular, or widespread (generalized) forms.
• Blistering of the skin can occur.
• Hives (urticaria) can occur.
• Conjunctivitis (eye redness, itching, watering, or discharge) can occur if the product contacts the eyes.
• Angioedema, with swelling of the mouth, throat, lips, or hands, can occur rarely.
• Hypersensitivity reactions, which may include dizziness and difficulty breathing, can occur rarely.
• Seek urgent medical attention for facial or throat swelling, difficulty breathing, or a severe skin reaction.

• Use with caution near the eyes, since the excipients in both the cream and ointment can cause eye or mucous membrane irritation.
• Use with caution in patients sensitive to the FUCIDIN Cream excipients butylhydroxyanisole, cetyl alcohol, or potassium sorbate, which can cause contact dermatitis.
• Use with caution in patients sensitive to the FUCIDIN Ointment excipients cetyl alcohol, lanolin (wool fat), or butylhydroxytoluene, which can cause contact dermatitis or eye and mucous membrane irritation.
• Use with caution beyond 14 days of continuous treatment, as extended use increases the risk of bacterial resistance.
• Prescribing fusidic acid without a proven or strongly suspected bacterial infection is discouraged, as unnecessary use raises the risk of bacteria becoming drug-resistant.
• If a new infection with different, non-susceptible organisms develops during treatment (overgrowth), treatment should be stopped and appropriate alternative therapy started.
• Use with caution if signs of a new or worsening skin infection appear during treatment.
• Severe or refractory skin infections may need an additional systemic (oral or injectable) antibiotic, since topical fusidic acid alone may not be sufficient.

• Contraindicated in patients with known hypersensitivity to fusidic acid, sodium fusidate, or any ingredient in the cream or ointment, including its container components.

• No formal drug-drug interaction studies have been conducted with fusidic acid cream or ointment.
• Because systemic absorption from topical use is minimal, interactions with medications taken by mouth or injection are considered unlikely.
• Interactions with individual behavioural factors such as smoking, cannabis use, or alcohol consumption have not been studied.
• Interactions with herbal products have not been established.

• FUCIDIN cream and ointment are applied to the skin, not swallowed, so food does not need to be taken into account when using this medication.

• FUCIDIN can be applied at any time of day, spaced two to three times daily (or once or twice daily under a dressing); it is not affected by meals.

• Store FUCIDIN Cream below 30°C.
• Store FUCIDIN Ointment below 30°C, and discard it 3 months after first opening the tube.
• Keep out of the reach and sight of children.

• Apply FUCIDIN exactly as directed, and complete the full course even if the skin looks better before treatment ends.
• Do not use FUCIDIN for longer than 14 days without checking with a healthcare professional.
• Avoid contact with the eyes; rinse with water if accidental contact occurs.
• Do not share this medication with others, and seek medical advice if the infection does not improve or gets worse.