FUSIDIC ACID Cream Ref.[6873] Active ingredients: Fusidic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Therapeutic indications

Treatment of non-severe, superficial, non-extensive, primary skin infections caused by microorganisms that are sensitive to fusidic acid, especially of infections caused by Staphylococcus (see section 5.1).

Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma.

Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Posology and method of administration

Posology

Adults and children

Uncovered lesions: apply gently three or four times daily.

Covered lesions: less frequent applications may be adequate.

Method of administration

Cutaneous use.

Overdose

Overdose is unlikely.

Unless hypersensitivity to fusidic acid or any of the excipients exist, accidental ingestion of Fusidic acid 20mg/g cream is unlikely to cause any harm. The total quantity of fusidic acid (30g Fusidic acid 20mg/g cream contains 600mg fusidic acid) will usually not exceed the approved total daily oral dose of fusidic acid containing products except in children aged less than 1 year and weighing ≤10kg.

Although in this instance a child of this particular age group is unlikely to ingest a whole tube of Fusidic acid 20mg/g cream. The concentration of the excipients is too low to constitute a safety risk.

Shelf life

Unopened tube: 2 years.

After opening of the tube: 4 weeks.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

Aluminium tube with HDPE screw cap.

Pack sizes: 15 gram and 30 gram.

Not all pack sizes may be marketed.

Special precautions for disposal and other handling

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

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