Fusidic Acid Cream 2% 30g

Fusidic Acid

Prescription-only topical antibiotic

Dermatology \u2013 topical antibiotic cream for skin infections

UK Licensed medicinal product containing fusidic acid 20 mg/g cream listed in the MHRA database.
Classified as an antibacterial for topical use; ATC code D06AX01 for fusidic acid.
Available on prescription in the UK and subject to MHRA pharmacovigilance, including Yellow Card reporting.

UK Licensed medicinal product containing fusidic acid 20 mg/g cream listed in the MHRA database.
Classified as an antibacterial for topical use; ATC code D06AX01 for fusidic acid.
Available on prescription in the UK and subject to MHRA pharmacovigilance, including Yellow Card reporting.

Dermatology \u2013 topical antibiotic cream for skin infections

Description

Fusidic Acid Cream 2% is a prescription-only topical antibiotic cream used to treat superficial bacterial skin infections, particularly those caused by staphylococci. Each gram of cream contains 20 mg fusidic acid (2% w/w). It is applied directly to the affected area of skin as directed by a healthcare professional for a short course to clear infections such as impetigo, infected dermatitis and minor infected cuts and wounds.

Bnefits

Topical antibiotic treatment for superficial bacterial skin infections caused by fusidic acid–susceptible organisms.
Effective against Staphylococcus aureus and some other Gram-positive bacteria implicated in skin infections.
Local application to the skin minimises systemic exposure compared with oral antibiotics.
Can be used on small areas of infected skin such as impetigo lesions, infected eczema or minor wounds.
Short treatment courses when used appropriately, helping to reduce the risk of antibiotic resistance.
Cream formulation spreads easily and is suitable for use under dressings when advised.

Indications

Non-severe, superficial, non-extensive primary skin infections caused by fusidic acid–sensitive organisms.
Impetigo (including impetigo contagiosa).
Infected dermatitis and infected eczema.
Infected minor cuts, abrasions or wounds.
Boils, folliculitis and similar localised staphylococcal skin infections, where appropriate and as directed by a prescriber.

Composition

Active ingredient: Fusidic acid 20 mg per 1 g cream (2% w/w).
Butylhydroxyanisole (E320).
Cetyl alcohol.
Glycerol 85% (E422).
Liquid paraffin.
Potassium sorbate (E202).
Polysorbate 60 (E435).
White soft paraffin.
Hydrochloric acid (for pH adjustment).
Purified water.

Formulation

Topical cream for cutaneous use only.
Strength: 2% w/w fusidic acid (20 mg/g).
White, homogeneous cream.

Packaging

30 g of cream in an aluminium tube with HDPE screw cap.
Tube supplied in an outer carton; a patient information leaflet may be included depending on supplier.
Other pack sizes such as 15 g exist for fusidic acid cream generally, but this specific product is 30 g.

Usage

For external use on the skin only.
Wash and dry hands and the affected area before application.
Apply a thin layer of cream to the affected skin, usually 2 to 3 times daily, or as directed by the prescribing healthcare professional.
Covering with a dressing may be advised in some cases; follow prescriber or pharmacist instructions.
Avoid contact with the eyes, mouth, mucous membranes and deep or large open wounds.
Wash hands after applying the cream unless hands are the area being treated.
Use for the full course prescribed, even if the skin appears better sooner, to reduce the risk of recurrence and antibiotic resistance.
Do not use for longer than recommended (usually no more than 1 to 2 weeks) unless specifically directed by a prescriber.
Do not apply to large areas of damaged skin or under occlusive dressings for prolonged periods unless advised by a specialist.
If irritation, severe rash or signs of allergy occur, stop using the cream and seek medical advice.

Contraindications

Known hypersensitivity or allergy to fusidic acid or any of the excipients in the cream (e.g. butylhydroxyanisole, cetyl alcohol, potassium sorbate).
Not suitable for infections caused by organisms known to be resistant or not susceptible to fusidic acid, particularly Pseudomonas aeruginosa.
Not for use in or around the eyes; eye preparations should be used instead where indicated.
Do not apply to severe, deep, extensive or systemic skin infections that require systemic antibiotic therapy unless under specialist supervision.
Use with caution in patients with a history of contact dermatitis or sensitivity to topical preparations; discontinue if significant irritation or allergic reaction occurs.

Adverse Effects

Application-site irritation (including pain, burning or stinging sensation, and redness/erythema).
Itching (pruritus).
Rash (including erythematous, pustular, vesicular, maculopapular and generalised rash).
Eczema or dermatitis, including contact dermatitis at or near the application site.
Urticaria (hives).
Blistering and swelling (oedema) of the skin.
Conjunctivitis if accidental eye contact occurs.
Hypersensitivity reactions including angioedema and, rarely, severe allergic reactions.
Very prolonged or repeated use may increase the risk of local sensitisation and antibiotic resistance.

Storage Conditions

Keep out of the sight and reach of children.
Do not store above 25°C.
Keep the tube tightly closed when not in use.
Do not use after the expiry date shown on the carton and tube (EXP).
Discard the tube 4 weeks after first opening, even if some cream remains, in line with patient information leaflet guidance for fusidic acid cream.
Do not dispose of unused medicine via wastewater or household waste; return to a pharmacy for safe disposal.

Duration

Typically used for short courses: often around 5\u20137 days for impetigo and up to 7\u201314 days for other superficial skin infections, as directed by a prescriber and local treatment guidelines.

Onset

Local symptoms such as redness, oozing or crusting often begin to improve within a few days of starting regular application; the full course should still be completed as prescribed.