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
Pharmacotherapeutic group: other antibiotics for topical use
ATC code: D06AX01
Fusidic acid belongs to a unique group of antibiotics, the fusidanes, which act to inhibit bacterial protein synthesis by blocking the lengthening of factor G. This is to prevent it from associating with ribosomes and GTP, thus preventing energy supply to the synthesis process.
As it is the only type of drug available in this family of drugs, there have been no reports of cross resistance to fusidic acid.
Resistance for fusidic acid can vary geographically and information about local resistance patterns should be obtained through a local microbiology laboratory. In general, resistance occurs in 1-10% of Staphylococcus aureus and 10-20% of coagulase negative staphylococci. Cross-resistance between Fusidic acid 20mg/g cream and other antibiotics has not been reported.
The sensitivity of organisms to fusidic acid is based on the in vitro sensitivity and plasma concentrations that are achieved after systemic therapy. Local treatment causes higher peak concentrations as compared to plasma. However, it is not known how the kinetics of the cream after local application may change the effectiveness of the cream.
The following MIC values are recommended to distinguish sensitive and non-sensitive germs: S≤1 µg/ml and R>1 µg/ml. This breakpoint should be used for the systemic use of fusidic acid. In general, no breakpoints are established for the topical use of antibiotics.
Commonly susceptible species: Staphylococcus aureus and Staphylococcus epidermis (including methycillin resistant and beta lactamase producing strains); Corynebacterium minutissimum; Clostridium spp.; Peptococcus spp.; Peptostreptococcus spp.; Neiseria spp.; Bacteroides fragilis.
Inherently resistant organisms: Streptococcus pyogenes; Streptococcus pneumoniae; Streptococci viridans; most gram negative bacilli including Haemophilus influenza; Enterobactericeae; Pseudomonas spp.; Escherichia coli and Klebsiella pneumoniae.
In Vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin.
Fusidic acid is excreted mainly in the bile with little excreted in the urine.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
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