Interactions : אינטראקציות

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 Leo 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 Leo is necessary, statin treatment should be discontinued throughout the duration of the Fucidin Leo treatment. Also see section 4.4.


Specific pathways of Fucidin metabolism in the liver are not known, however, an interaction between Fucidin 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 Fucidin systemically should be avoided in patients treated with CYP-3A4 biotransformed drugs.


Oral anticoagulants
Systemic Fucidin Leo administered concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions may increase the plasma concentration of these agents 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 Fucidin may require the maintenance dose of anticoagulant to be re-assessed. The mechanism of this suspected interaction remains unknown.
HIV protease inhibitors
Co-administration of systemic Fucidin Leo and HIV protease inhibitors such as ritonavir and saquinavir may cause increased plasma concentrations of both agents which may result in hepatotoxicity.
Concomitant use is not recommended. (See section 4.4.)