Chemical formula: C₃₁H₄₈O₆ Molecular mass: 516.709 g/mol PubChem compound: 3000226
Fusidic acid interacts in the following cases:
Specific pathways of fusidic acid metabolism in the liver are not known, however, an interaction between fusidic acid 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 fusidic acid systemically should be avoided in patients treated with CYP-3A4 biotransformed drugs.
Fusidic acid is metabolised in the liver and excreted in the bile. Elevated liver enzymes and jaundice have occurred during systemic fusidic acid therapy but are usually reversible on discontinuation of the drug.
Systemic fusidic acid should be given with caution and liver function should be monitored if used in patients with hepatic dysfunction or in patients taking potentially hepatotoxic drugs. Caution is required in patients with biliary disease and biliary tract obstruction. Caution is required in patients treated with HIV-protease inhibitors.
Fusidic acid competitively inhibits binding of bilirubin to albumin. Caution is necessary if systemic fusidic acid is administered to patients with impaired transport and metabolism of bilirubin. Particular care is advised in neonates due to the theoretical risk of kernicterus.
Systemic fusidic acid 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 fusidic acid may require the maintenance dose of anticoagulant to be re-assessed. The mechanism of this suspected interaction remains unknown.
Co-administration of systemic fusidic acid 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.
Systemic co-administration of fusic acid and cyclosporin has been reported to cause increased plasma concentrations of cyclosporin.
In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell’s syndrome) and Stevens-Johnson syndrome have been reported with systemic fusidic acid. Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic fusidic acid, treatment with systemic fusidic acid should be stopped and it is recommended not to reintroduce the therapy.
There are no or limited data (less than 300 pregnancy outcomes) from the use of fusidic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of systemic fusidic acid during pregnancy.
No effects during pregnancy are anticipated, since systemic exposure to topically applied fusidic acid/sodium fusidate is negligible. Topical fusidic acid 20mg/g cream can be used during pregnancy.
No effects during pregnancy are anticipated, since systemic exposure to fusidic acid eye drops is negligible. Fusidic acid eye drops can be used during pregnancy.
Physico-chemical data suggest excretion of fusidic acid in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from systemic Fucidin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
No effects on the breastfed new-born/infant are anticipated since the systemic exposure of the breast-feeding woman is negligible. Topical Fusidic acid 20mg/g cream can be used during breast-feeding but it is recommended to avoid applying topical fusidic acid 20mg/g cream on the breast.
No effects on the breast-fed new-born/infant are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid is negligible. Fusidic acid eye drops can be used during breast-feeding.
There are no clinical studies with systemic Fucidin regarding fertility. Pre-clinical studies did not show any effect of sodium fusidate on the fertility in rats.
Fusidic acid has no or negligible influence on the ability to drive or to use machines.
Fusidic acid eye drops has no or negligible influence on the ability to drive or use machines. Fusidic acid eye drops may, however, cause a blurring of vision following application and patient should take this into account.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
The most frequently reported undesirable effects of fusidic acid administered orally are gastrointestinal disorders like abdominal discomfort and pain, diarrhoea, dyspepsia, nausea and vomiting. Anaphylactic shock has been reported.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency group, adverse reactions are presented in the order of decreasing seriousness.
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from available data)
Uncommon: Pancytopenia, Leukopeniaa, Thrombocytopenia, Anaemia
Uncommon: Anaphylactic shock/anaphylactic reaction
Rare: Hypersensitivity
Uncommon: Headache, Somnolence
Common: Vomiting, Diarrhoea, Abdominal pain, Dyspepsia, Nausea, Abdominal discomfort
Uncommon: Hepatic failure, Cholestasis, Hepatitisb, Jaundicec, Hyperbilirubinaemia, Liver function test abnormald
Rare: Hepatic function abnormal
Uncommon: Acute generalized exanthematous pustulosis, Urticaria, Pruritus, Rashe, Erythema
Rare: Angioedema
Not known:__ Toxic epidermal necrolysis (Lyell’s syndrome)f, Stevens-Johnson syndromef, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndromef
Uncommon: Rhabdomyolysisg
Uncommon: Renal failureh
Common: Lethargy/Fatigue/Asthenia
a Haematological disorders affecting the white cell line (neutropenia, granulocytopenia and agranulocytosis) have been reported.
b Hepatitis also includes Hepatitis cholestatic/Cytolytic hepatitis
c Jaundice also includes Jaundice cholestatic.
d Including alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased and gamma-glutamyltransferase increased.
e Rash includes various types of rash reactions such as drug eruption, erythematous and maculo-papular rash.
f These adverse reactions were identified through post-marketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.
g Rhabdomyolysis may be fatal.
h Renal failure also includes renal failure acute.
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, based on limited data.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
Based on pooled data from clinical studies including 4754 patients who received Fusidic acid 20mg/g cream or fusidic acid ointment, the frequency of undesirable effects is 2.3%.
The most frequently reported adverse reactions during treatment are various skin reactions such as pruritus and rash, followed by application site conditions such as pain and irritation, which all occurred in less than 1% of patients.
Hypersensitivity and angioedema have been reported.
Undesirable effects are listed by MedDRA System Organ Class (SOC) and the individual undesirable effects are listed starting with the most frequently reported according to the following frequency convention:
Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data)
Rare: Hypersensitivity
Rare: Conjunctivitis
Uncommon: Dermatitis (incl. contact dermatitis, eczema) Rash*
Pruritus, Erythema
Rare: Angioedema, Urticaria, Blister
Uncommon: Application site pain (incl. skin burning sensation), Application site irritation
* Various types of rash reactions such as erythematous, pustular, vesicular, maculo-papular and papular have been reported. Rash generalised has also occurred.
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and spontaneous reporting.
Based on pooled data from clinical studies, including 2,499 patients with eye infections including acute conjunctivitis, who received Fucithalmic eye drops, the frequency of undesirable effects was 11.3%.
The most frequently reported adverse reactions during treatment are various application site reactions such as pain, pruritus and irritation/discomfort in/around the eyes, which occurred in approximately 8.5% of patients, followed by blurring of vision, which occurred in approximately 1.2% of patients. Angioedema has been reported in a few patients post marketing.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Very common (≥1/10), Common (≥1/100 and <1/10), Uncommon (≥1/1,000 and <1/100), Rare (≥1/10,000 and <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data)
Uncommon: Hypersensitivity
Common: Vision blurred (transient)
Uncommon: Eyelid oedema, Lacrimation increased
Rare: Conjunctivitis aggravated
Uncommon: Rash, Angioedema
Rare: Urticaria
Common: Application site pain (including eye burning and eye stinging), Application site pruritus, Application site discomfort/irritation
The observed safety profile is similar in children and adults.
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