Fucibet® (fusidic acid and betamethasone valerate) is indicated for the topical treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection caused by Staphylococcus aureus (S. aureus) is confirmed or suspected.
Fucibet® demonstrated efficacy in Eczematous Dermatoses with 2° bacterial infection caused by S. aureus
Results observed after 2 weeks of twice-daily treatment1*:
How was the primary endpoint defined?
The primary endpoint for overall clinical response was the percentage reduction/change in TSS from baseline to end of treatment. TSS was calculated based on the severity of erythema, edema, oozing/crusting and excoriation, each assessed at a 4-point scale. In addition, for overall treatment efficacy patients with marked improvement or complete clearance were defined as responders.
A randomized, double-blind, three-arm, comparative trial of 629 patients with clinically-infected atopic dermatitis. Patients were treated with either twice-daily Fucibet® (n=275), fusidic acid/betamethasone valerate cream (n=264), or lipid cream vehicle (n=90) for two weeks.
See Clinical Trial Cases
Swipe to reveal cases of patients with infected dermatitis at baseline who were treated with Fucibet®
twice-daily for two weeks. Please note these are real patient cases and individual results may vary.
Results observed at Week 2: 37-year-old female patient with infected dermatitis
Results observed at Week 2: 73-year-old female patient with infected dermatitis
Rate of Adverse Events (AEs) observed in a clinical trial of Fucibet®:
Most common AEs were pruritus and skin burning sensation
A low rate of S. aureus resistance to Fucibet® has been observed (less than 3%)1*
Fusidic acid is predominantly active against Gram-positive bacteria, and highly effective against Staphylococcus aureus, including methicillin-resistant S. aureus (MRSA) strains.
In a sensitivity study of 2,302
S. aureus strains isolated over a 6-year period:
*Clinical significance has not been established.
Mechanism of Action*
Dual inhibition of inflammation + bacterial protein synthesis*
†Betamethasone valerate: The mechanism of anti-inflammatory activity of topical coricosteroids is unclear. It is thought to induce lipocortins, which are postulated to control the biosynthesis of potent mediators of inflammation.
‡Fusidic acid: Interferes with amino acid transfer to ribosomes and primarily active against Gram-positive bacteria, in particular S. aureus including MRSA, Streptococcus spp., C. minutissimum, some Neisseria spp., and certain Clostridium spp.; mainly bacteriostatic but may be bactericidal at higher concentrations.
The penetration of fusidic acid*
Please note the dermal absorption of fusidic acid and betamethasone is difficult to quantify.
- 2.5% of topically applied fusidic acid could cross intact human skin within 30 minutes
- Up to 10% of the applied dose could penetrate down into the stratum corneum of the skin, reaching levels well above the minimum inhibitory concentration required for sensitive S. aureus strains*
*Clinical significance has not been established.
Fucibet® Safety Information
Indication and Clinical Use:
Fucibet® (fusidic acid and betamethasone valerate) is indicated for the topical treatment of eczematous dermatoses including atopic eczema, discoid eczema, stasis eczema and seborrhoeic eczema when secondary bacterial infection caused by Staphylococcus aureus is confirmed or suspected.
Fucibet® is suitable in cases where treatment with a potent corticosteroid is appropriate to manage the pruritus and inflammation associated with eczematous dermatoses, and is intended for use during flare-ups for short-term (up to 2 weeks) treatment against bacteria susceptible to fusidic acid.
To reduce the development of drug-resistant bacteria, Fucibet® should only be used to treat infections that are proven or strongly suspected to be caused by bacteria.
Safety and efficacy have been established in patients ≥6 years old. Use with caution in pediatric patients.
● Systemic fungal infections
● Primary skin infections caused by fungi, virus or bacteria
● Skin eruptions associated with tuberculosis or syphilis
● Perioral dermatitis and rosacea
● Eruptions following vaccinations
Relevant warnings and precautions:
● Avoid long-term continuous use
● Risk of systemic absorption
● Should not be used under occlusive dressing, over extensive areas, or on the face, scalp, axillae or scrotum
● Risk of HPA-axis suppression; Cushing’s syndrome, hyperglycemia, and glycosuria
● Susceptibility to infections
● Use with care near eyes
● Risk of bacterial resistance or microbial overgrowth
● Skin atrophy
● Safety during pregnancy or lactation has not been established
For more information:
Please consult the Product Monograph at https://health-products.canada.ca/dpd-bdpp/index-eng.jsp for important information relating to adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling LEO Pharma Medical Information at 1-800-263-4218.
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® Registered trademark of LEO Pharma A/S used under license
and distributed by LEO Pharma Inc.
- Current Fucibet® Product Monograph, LEO Pharma Inc.