If additional antibacterial therapy is to be employed, it is recommended that for parenteral administration, separate infusion fluids be used.
4.3 Contraindications
Hypersensitivity to fusidic acid and its salts, or any of the excipients.

This product should not be infused with amino acid solutions or in whole blood.

Due to local tissue injury, this product should not be administered intramuscularly or subcutaneously.
4.4 Special warnings and precautions for use
Fucidin® must not be co-administered with statins. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination (see section 4.5). In patients where the use of systemic Fucidin® is considered essential, statin treatment should be discontinued throughout the duration of Fucidin® treatment. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of Fucidin®. In exceptional circumstances, where prolonged systemic Fucidin® is needed e.g for the treatment of severe infections, the need for co-administration of statin and Fucidin® should only be considered on a case by case basis and under close medical supervision.

Sodium fusidate is metabolised in the liver and excreted in the bile. Caution should be exercised with other antibiotics which have similar biliary excretion pathways e.g. lincomycin and rifampicin. Elevated liver enzymes and jaundice have occurred during systemic therapy but are usually reversible on discontinuation of the drug (see section 4.8).

Periodic liver function tests should be carried out when the product is given:

• in high oral doses

• for prolonged periods

• to patients with liver dysfunction

• to patients taking potentially hepatotoxic medication

• to patients with biliary tract obstruction

• to patients taking concurrent medication with a similar excretion pathway.

Sodium fusidate displaces bilirubin from its albumin binding site in vitro. Caution is necessary if this product is administered to patients with impaired transport and metabolism of bilirubin.

The use of this product in combination with drugs that are CYP-3A4 biotransformed should be avoided. See Section 4.5

Bacterial resistance has been reported to occur with the use of sodium fusidate. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

This medicinal product contains 3.2 mmol (73 mg) sodium per 500 mg dose. This should be taken into consideration by patients on a controlled sodium diet.
4.5 Interaction with other medicinal products and other forms of interaction
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic Fucidin® with statins. Co-administration of this combination may cause increased plasma concentrations of both agents. The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. If treatment with Fucidin® is necessary, statin treatment should be discontinued throughout the duration of the Fucidin® treatment. Also see section 4.4.

In vitro compatib