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Fucidic Acid Cream 20mg/g (Fusidic acid 20 mg/g cream, 15 g)

Fucidic Acid Cream 20mg/g (Fusidic acid 20 mg/g cream, 15 g)

Fusidic acid 20 mg/g cream

Medicinal product
  • UK Marketing Authorisation: PL 20046/0256 (Fusidic acid 20 mg/g cream, Focus Pharmaceuticals Ltd / ADVANZ Pharma).
  • Prescription Only Medicine (POM) in the UK.
  • Manufactured and released in accordance with EU/UK GMP and MHRA regulatory requirements for licensed medicinal products.
Topical antibiotic cream for bacterial skin infections

Description

Fucidic Acid Cream 20mg/g is a prescription-only topical antibiotic cream containing fusidic acid 20 mg per gram (2% w/w). It is used for the local treatment of non-severe, superficial, non-extensive skin infections caused by fusidic-acid–susceptible bacteria, particularly Staphylococcus species. Indications include impetigo, superficial folliculitis, sycosis barbae, paronychia and erythrasma. The cream is applied directly to the affected skin and provides high local antibiotic concentrations with negligible systemic exposure. Each aluminium tube (commonly 15 g) is supplied in a carton; the specific listing referenced includes stock with an expiry date of 08/2025.

Bnefits

  • Topical antibiotic treatment for superficial bacterial skin infections caused by fusidic-acid–susceptible organisms, especially Staphylococcus species.
  • Effective in common primary skin infections such as impetigo, folliculitis, sycosis barbae, paronychia and erythrasma.
  • Local cutaneous administration results in negligible systemic exposure compared to oral therapy.
  • Suitable for adults and children, with use permitted in pregnancy and breastfeeding (avoiding application to the breast).
  • Convenient aluminium tube presentation (e.g. 15 g) suitable for short treatment courses of 1–2 weeks.

Indications

  • Topical treatment of non-severe, superficial, non-extensive primary skin infections caused by fusidic-acid–susceptible organisms.
  • Impetigo contagiosa (weeping, crusty, swollen patches of skin).
  • Superficial folliculitis (inflammation/infection of hair follicles).
  • Sycosis barbae (infection of bearded skin).
  • Paronychia (infection of tissue around fingernails or toenails).
  • Erythrasma (brown, scaly patches, particularly in skin folds).

Composition

  • Active ingredient: fusidic acid 20 mg per gram of cream (2% w/w).
  • Excipients: 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

  • White, homogeneous topical cream containing fusidic acid 20 mg/g (2% w/w).
  • Cutaneous use only (for application to the skin).

Packaging

  • Aluminium tube with HDPE screw cap, supplied in a carton.
  • Authorised pack sizes: 15 g and 30 g tubes (not all pack sizes may be marketed).
  • The referenced retail listing relates to 15 g tubes with stated expiry 08/2025.

Usage

  • For cutaneous use only; do not swallow.
  • Wash hands before applying the cream.
  • Apply a small amount of cream gently to the affected area of skin three to four times daily, or as directed by the prescriber.
  • For covered (dressed) lesions, your prescriber may advise less frequent applications.
  • Avoid application in or near the eyes; if accidental eye contact occurs, rinse immediately with cold water and seek medical advice if irritation persists.
  • Wash hands after application unless the hands themselves are being treated.
  • Use for the full duration prescribed by the clinician, even if symptoms improve earlier.
  • Do not use for longer than directed to minimise the risk of antibiotic resistance and contact sensitisation.

Contraindications

  • Known hypersensitivity to fusidic acid.
  • Known hypersensitivity to any excipients in the formulation (including butylhydroxyanisole, cetyl alcohol or potassium sorbate).
  • Use in infections caused by non-susceptible organisms, particularly Pseudomonas aeruginosa.
  • Application directly into or immediately around the eyes.

Adverse Effects

  • Uncommon (may affect up to 1 in 100 people): dermatitis (including contact dermatitis and eczema), rash (various types such as erythematous, pustular, vesicular, maculo-papular or papular), pruritus (itching), erythema (redness).
  • Uncommon: application-site pain (including burning sensation) and application-site irritation.
  • Rare (may affect up to 1 in 1,000 people): hypersensitivity reactions, angioedema, urticaria (hives), blistering, conjunctivitis (usually related to accidental ocular exposure).
  • Excipient-related reactions: butylhydroxyanisole, cetyl alcohol and potassium sorbate may cause local skin reactions such as contact dermatitis; butylhydroxyanisole may also irritate eyes and mucous membranes.

Storage Conditions

  • Do not store above 25°C.
  • Keep the tube tightly closed when not in use.
  • Keep out of the sight and reach of children.
  • Shelf life of unopened tube: 2 years (refer to pack expiry date).
  • After first opening, the cream should be used within 4 weeks.
  • Do not use after the expiry date printed on the tube and carton.

Duration

Usually 1\u20132 weeks; the exact duration is determined by the prescriber based on infection type and clinical response.

Onset

Not specifically stated in the SmPC or PIL; clinical improvement is generally expected over several days of consistent use as directed.

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