Look again at how you treat bacterial conjunctivitis or blepharitis.
Fucithalmic (fusidic acid) is indicated for the topical treatment of bacterial conjunctivitis and blepharitis where the microbiological organism/pathogen is known to be sensitive to the antibiotic1.
Please click the link below for prescribing information and adverse event reporting box.
Figure 1. Adapted from a multicentre, investigator-blind, parallel group study of the clinical and microbiologic efficacy, safety and acceptability of 1% fusidic acid viscous drops (Fucithalmic) with 0.3% tobramycin ophthalmic solution in the treatment of suspected bacterial conjunctivitis 11
Figure 2. Adapted from a study of a single-blind, randomised comparison of 1% fusidic acid and 0.5% chloramphenicol viscous eye drops in the treatment of patients with acute purulent conjunctivitis12
Figure 3. Adapted from a multicentre, investigator-blind, parallel group study of the comparison of the effectiveness, safety and acceptability of 1% fusidic acid viscous drops with 0.3% norfloxacin ophthalmic solution in the treatment of the symptoms of acute bacterial conjunctivitis8
Figure 4. Adapted from a prospective, randomised, double blind, partial crossover, placebo controlled trial comparing the performance of topical fusidic acid gel 1% (Fucithalmic®) and oral oxytetracycline (250 mg) as treatment for symptomatic chronic blepharitis by DV Seal, et al. 7
75% of patients with rosacea improved with fusidic acid alone (p<0.01); 50% with oxytetracycline, but only 35% with the combination In patients without rosacea: 90% were worse with fusidic acid alone but 25% improved with oxytetracycline
Fucithalmic® offers a convenient twice-daily dosing regimen as it contains a unique carbomer gel formulation that prolongs contact time with the eye for over 12 hours. 1,13
Figure 5. The same market research across age groups indicates that ‘dosage’ is the most important product feature when considering bacterial conjunctivitis treatment. 14
Fucithalmic is well tolerated with mild and transient adverse events. Based on clinical studies, it is considered to have a more favourable adverse effect profile than chloramphenicol and
norfloxacin.1,8 - 10, 12
Contact lenses should not be worn/used when fusidic acid eye drops are used. The microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Fusidic acid eye drops contain benzalkonium chloride which may cause eye irritation and is also known to discolour soft contact lenses. Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Hypersensitivity to fusidic acid, sodium fusidate, or any of the excipients.
Application site reactions, including pain, itching and irritation/discomfort inside or outside the eyes were most frequently reported undesirable effects during treatment occurring in 8.5% of the patients based on pooled data from clinical studies and spontaneous reports. The next common undesirable effect was blurred vision in 1.2% of the patients. Post-marketing reports have shown angio-oedema in a few patients.
None known.
Fucithalmic drops do not have an effect on the ability to drive and use machines, or said effect is negligible. The patients should be aware that Fucithalmic may cause transient blurring of vision following application of the drops.
Can be administered during pregnancy if considered necessary and can be used during breastfeeding.
The prescribing information below is applicable to Finland as a reference market. However, the product indication for Fucithalmic in your own country of medical practice may vary.We highly recommend that you check your country specific Summary of Product Characteristics (SPC) and Patient Information Leaflet (PIL) for Fucithalmic for further information, if applicable.
Each gram of eye drops contains 10 mg fusidic acid.
Eye infections, including keratitis, conjunctivitis, meibomitis, blepharitis, caused by bacteria susceptible to fusidic acid.
1 drop twice a day. Initially, more frequent dosage may be used. The eye should be cleaned frequently. For prevention of recurrence, treatment should be continued for at least 2 days after the symptoms have subsided.
Hypersensitivity to the active substance or to any of the excipients.
Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance. Contact lenses should not be worn/used when Fucithalmic is used. Microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Contact lenses may be worn 15 minutes after discontinuation of treatment. Fucithalmic contains benzalkonium chloride which may cause eye irritation and discolour soft contact lenses.
No interaction studies have been conducted. Systemic infections are unlikely.
Can be used during pregnancy and lactation.
Serious: Hypersensitivity, angioedema, aggravated conjunctivitis.
Common: Transient blurring of vision, administration site pain (including burning sensation and stinging in the eye), itching and irritation.
(Please refer to the Summary of Product Characteristics for detailed information)
Total quantity of fusidic acid in one 5g tube of Fucithalmic (50mg) will not exceed the approved total daily oral dose of fusidic acid. Overdosing is unlikely to occur as the concentration of the excipients is too low to constitute a safety risk.
POM
Tube of 5 grams
9996
Amdipharm Limited (a member of the ADVANZ PHARMA group of companies),
Temple Chambers,
3 Burlington Road,
Dublin 4,
Ireland
May 2017
November 2018 [Con/FUT/PI/0013]
Adverse events should be reported to the local regulatory authority. Reporting forms and information can be found at http://www.fimea/fi/. Adverse events should also be reported to ADVANZ PHARMA Medical Information via telephone on +44 (0) 8700 70 30 33 or via e-mail at medicalinformation@advanzpharma.com
References