Fucidin 20 mg/g Cream 30 g

Fucidin 20 mg/g Cream 30 g

Fucidin

Medicinal product (prescription only medicine)
  • UK Marketing Authorisation: PL 00043/0065 (Fucidin 20 mg/g cream)
  • Prescription Only Medicine (POM) in the UK
  • Classified under ATC code D06AX01 (other topical antibiotics)
  • Product information and leaflet approved and published on the electronic medicines compendium (emc) and regulated by the MHRA
Topical antibiotic cream for bacterial skin infections

Description

Fucidin 20 mg/g Cream is a topical antibiotic cream containing fusidic acid 20 mg per gram, supplied in a 30 g aluminium tube. It is used on the skin to treat primary and secondary bacterial skin infections caused by organisms such as Staphylococcus aureus and Streptococcus spp., including impetigo, infected dermatitis and eczema, folliculitis, sycosis barbae, paronychia, erythrasma, and infected cuts, grazes and abrasions. The cream is white to off-white and is intended for cutaneous use only under medical supervision as a prescription-only medicine.

Bnefits

  • Effective topical treatment for a wide range of primary and secondary bacterial skin infections
  • Contains fusidic acid, a potent antibiotic active against most Staphylococcus aureus strains and other susceptible bacteria
  • Cream formulation suitable for use on larger or exudative infected skin areas
  • Helps reduce infection, inflammation, and associated symptoms such as redness, weeping and crusting
  • Low systemic absorption when used as directed, minimising systemic side effects
  • Multiple tube sizes exist in the product range; this presentation provides 30 g for repeated applications
  • Prescription-only status ensures use under appropriate medical supervision

Indications

  • Primary bacterial skin infections caused by fusidic-acid–susceptible organisms, including impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma
  • Secondary bacterial infections of pre-existing skin conditions such as infected eczematoid dermatitis and infected contact dermatitis
  • Infected cuts, grazes, wounds and abrasions, when caused by susceptible bacteria as judged by the prescriber

Composition

  • Active ingredient: Fusidic acid Ph.Eur. 20 mg per gram of cream
  • Excipients: Butylhydroxyanisole (E320), cetanol (cetyl alcohol), glycerol, liquid paraffin, potassium sorbate, polysorbate 60, purified water, all-rac-α-tocopherol, white soft paraffin, hydrochloric acid

Formulation

  • Topical cream for cutaneous administration
  • Strength: 20 mg/g fusidic acid (2% w/w)
  • Appearance: white to off-white cream

Packaging

  • Aluminium tube containing 30 g of cream with screw cap (also available in other tube sizes such as 3.5 g, 5 g, 10 g, 15 g and 25 g – not all pack sizes may be marketed)
  • Packaged in a carton with patient information leaflet

Usage

  • For external use on the skin only; do not swallow or apply inside the body
  • Wash hands before application; open the tube by piercing the seal with the spike in the cap (first use)
  • Apply a thin layer of cream gently to the affected area three to four times daily, or as directed by the prescriber
  • For covered lesions or when dressings/bandages or nappies are used, less frequent applications may be sufficient as advised by the prescriber
  • Avoid contact with the eyes; if accidental contact occurs, rinse thoroughly with cold water and seek medical advice if irritation persists
  • Always wash hands after applying the cream, unless the hands are the area being treated
  • Use for the full duration prescribed by the healthcare professional; do not stop early without advice even if symptoms improve
  • Do not share the cream with other people and do not use it for other conditions without medical advice

Contraindications

  • Known hypersensitivity or allergic reaction to fusidic acid or to any of the excipients in the cream (including butylhydroxyanisole, cetyl alcohol or potassium sorbate)
  • Not for use in the eyes or for ophthalmic administration
  • Use on large areas, under occlusion, or for prolonged periods should be avoided unless specifically directed by a doctor due to risk of sensitisation and antibiotic resistance

Adverse Effects

  • Uncommon: local irritation at the site of application including pain, burning, stinging, skin redness and application-site discomfort
  • Uncommon: pruritus (itching), rash, eczema or dermatitis (including contact dermatitis)
  • Rare: hypersensitivity reactions including angioedema and urticaria (hives)
  • Rare: conjunctivitis, particularly if used near the eyes
  • Rare: blistering or swelling of the skin
  • Potential for contact sensitisation or allergic contact dermatitis with prolonged or repeated use
  • Very rare risk of severe allergic reaction with breathing difficulty, facial or throat swelling or severe skin rash requiring urgent medical attention
  • Fabric fire risk: product residue on clothing, bedding or dressings may increase flammability and pose a burn hazard if exposed to naked flames or sources of ignition

Storage Conditions

  • Keep out of the sight and reach of children
  • Do not use after the expiry date printed on the tube and carton (EXP; last day of the stated month)
  • No special temperature storage conditions are specified in the SmPC; store in the original tube with cap tightly closed and protect from excessive heat and open flames
  • Do not dispose of unused medicine via wastewater or household waste; return any unused or expired cream to a pharmacy in accordance with local requirements

Duration

Typically applied three to four times daily for around 7\u201310 days or as directed by the prescribing clinician; duration should be the minimum necessary to control the infection and is determined by clinical response.

Onset

Local improvement in signs and symptoms of infection is often observed within a few days of regular use; full response depends on infection severity, site and patient factors.

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