The results showed that sodium fusidate reconstituted at 50 mg/ml in buffer solution is physically and chemically compatible for at least 24 hours at room temperature with the following infusion solutions (the figure in parenthesis shows the concentration of sodium fusidate in the final admixture):

Sodium Chloride Intravenous Infusion BP 0.9% (1-2 mg/ml).

Dextrose Intravenous Infusion BP 5% (1-2 mg/ml).

Compound Sodium Lactate Intravenous Infusion (“Ringer-Lactate Solution”) (1 mg/ml).

Sodium Lactate Intravenous Infusion BP (1 mg/ml).

Sodium Chloride (0.18%) and Dextrose (4%) Intravenous Infusion BP (1 mg/ml).

Potassium Chloride (0.3%) and Dextrose (5%) Intravenous Infusion BP (1 mg/ml).

Specific pathways of metabolism of this product in the liver are not known, however, an interaction between this product and drugs being CYP-3A4 biotransformed can be suspected. The mechanism of this interaction is presumed to be a mutual inhibition of metabolism. There is insufficient data to characterise the effect of fusidic acid on CYPs in-vitro. The use of this product systemically should be avoided in patients treated with CYP-3A4 biotransformed drugs.

When this product is administered systemically and concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions, the plasma concentration of these agents may increase enhancing the anticoagulant effect. Anticoagulation should be closely monitored and a decrease of the oral anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation. Similarly, discontinuation of this product may require the maintenance dose of anticoagulant to be re-assessed. The mechanism of this suspected interaction remains unknown.

Co-administration of this product and HIV protease inhibitors such as ritonavir and saquinavir causes increased plasma concentrations of both agents which may result in hepatotoxicity.

Co-administration of this product systemically with ciclosporin has been reported to cause increased plasma concentration of ciclosporin.
4.6 Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Animal studies and many years of clinical experience suggest that fusidic acid is devoid of teratogenic effects. There is evidence to suggest that when given systemically, fusidic acid can cross the placental barrier. If the administration of the product to pregnant patients is considered essential, its use requires that the potential benefits be weighed against the possible hazards to the foetus.

Safety in nursing mothers has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in the breast milk. Caution is therefore required when the product is used in mothers who wish to breast feed.

4.7 Effects on ability to drive and use machines
None known.

4.8 Undesirable effects
Based on clinical trial data on sodium fusidate administered intravenously, in high doses and concomitantly with other antibiotics in critically ill patients, it is estimated that approximately 30% of the patients may experience an undesirable effect. This number is reduced when the product is administered through a central vein.

Venous intolerance such as venous sp