FUCIDIN Oral Suspension Ref.[6872] Active ingredients: Fusidic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Therapeutic indications

Fucidin is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis, cutaneous infections.

Fucidin should be administered intravenously whenever oral therapy is inappropriate, which includes cases where absorption from the gastro-intestinal tract is unpredictable.

Posology and method of administration

Posology

Each 5 ml of Fucidin Suspension is therapeutically equivalent to 175 mg of sodium fusidate owing to its lower oral bioavailability. Therefore the following dosages are recommended:

Adults: 15 ml three times daily.

Children:

0-1 year: 1 ml/kg bodyweight daily, divided into 3 equal doses.
1-5 years: 5 ml 3 times daily.
5-12 years: 10 ml 3 times daily.

Elderly: No dosage alterations are necessary in the elderly.

Since Fucidin is excreted in the bile, no dosage modifications are needed in renal impairment.

The dosage in patients undergoing haemodialysis needs no adjustment as Fucidin is not significantly dialysed.

Method of administration

For oral administration. The Suspension should be shaken well before use and dilution is not recommended.

Overdose

Acute symptoms of overdose include gastrointestinal disturbances. Management should be directed towards alleviation of symptoms. Dialysis will not increase the clearance of fusidic acid.

An overdose of 4 g/day for a duration of ten days in an adult has been reported without any adverse events.

An overdose of 1,250 mg/day for a duration of seven days in a child (three years old) has been reported without any adverse events.

Shelf life

Shelf life: 3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Bottles of 50 ml.

Special precautions for disposal and other handling

No special requirements for disposal.

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

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