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Fusidic Acid Cream 2% 30g

Fusidic Acid Cream 2% 30g

Fusidic Acid

Prescription-only topical antibiotic
  • 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.

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