Ask Your Question - Bacterial eye infections
1. To which class in the ATC (anatomical therapeutic chemical) classification system does Fucithalmic® belong?
Fucithalmic® belongs to....
2. May Fucithalmic® be used in patients suffering from glucose-6-phosphate dehydrogenase (G-6-PD) deficiency?
There is no evidence of risk of haemolytic anaemia in patients with G-6-PD deficiency treated with Fucithalmic® or other fusidic acid products.
3. Is Fucithalmic® contraindicated in patients after corneal transplantation?
4. What are the weaknesses of quinolones compared with Fucithalmic®?
The most important weakness of the fluoroquinolones for ophthalmic use is the concern about resistance development.
5. Are there any references warning against the use of chloramphenicol?
It is well-known that systemic use of chloramphenicol can cause serious and fatal complications such as aplastic anaemia and "gray baby" syndrome.
6. How many hours after application of Fucithalmic® should the patient wait until contact lenses are put on?
Contact lenses should not be used during treatment with Fucithalmic®.
7. How should Fucithalmic® be administered as prophylaxis in cataract surgery?
Prophylaxis in cataract surgery is not an approved indication for Fucithalmic®.
8. Can a fusidic acid solution be used for irrigation of the eye during cataract surgery?
We do not have any experience in this use of Fucidin®.
9. Can Fucithalmic® be used by people wearing daily disposable contact lenses?
It is good clinical practice not to use contact lenses when the eye is infected, due to risk of spread of infection and worsening of inflammation (purulent secretion is not being removed as it otherwise would by the tear fluid).
10. What is the recommended treatment length for Fucithalmic®?
The treatment recommendations vary from country to country.
11. What are the package sizes and packaging material of Fucithalmic®?
Fucithalmic® comes in 3 g and 5g tubes.
12. What is the formulation of Fucithalmic® in the tube?
Active ingredient: fusidic acid 10mg/g (as fusidic acid hemihydrate).
13. What is the formulation of Fucithalmic® Unit Dose?
Active ingredient: fusidic acid 10mg/g (as fusidic acid hemihydrate).
14. What is the pH-value of Fucithalmic®?
The pH-value of Fucithalmic® is approximately 5.6.
15. What is the clinical efficacy of Fucithalmic® in meibomitis?
No clinical studies have been performed specifically in the indication meibomitis/hordeolum.
16. Is Fucithalmic® effective against Acanthamoebae infections?
There are no clinical data available.
17. Is Fucithalmic® effective as prophylaxis in cataract surgery?
Prophylaxis in cataract surgery is not an approved indication for Fucithalmic®.
18. Is Fucithalmic® as effective as chloramphenicol in acute bacterial conjunctivitis?
Several studies document that Fucithalmic® is as effective as chloramphenicol in treating acute bacterial conjunctivitis, but superior with regard to patient compliance and convenience (Carr, 1998, Normann, 2002, Hoerven, 1993, Sinclair, 1988).
19. Is Fucithalmic® effective in conjunctivitis caused by Haemophilus influenzae?
H. influenzae are moderately susceptible to fusidic acid with MIC90 8 mg/Ll (Moore, 1992).
20. Is Fucithalmic® effective in endophthalmitis?
There are no clinical studies with Fucithalmic® in endophthalmitis.
21. Is Fucithalmic® effective in Neisseria conjunctivitis?
The MIC-value for fusidic acid against Neisseria gonorrhoeae is 0.4 mg/L (data on file), but no clinical studies have been performed specifically in Neisseria conjunctivitis.
22. Is Fucithalmic® effective in the treatment of chlamydia conjunctivitis in neonates?
Fucithalmic® has a MIC of 4 mg/L and a MBC of 64 mg/L against Chlamydia trachomatis (Ridgway, 1979) but the limited clinical data shows that it is not clinically effective (Stenberg, 1990).
23. Is Fucithalmic® effective in conjunctivitis caused by S. pneumoniae?
Clinical studies have shown that Fucithalmic® is an effective treatment of acute conjunctivitis caused by S. pneumoniae (Jackson, 2001, Jackson, 2002).
24. Is Fucithalmic® effective in prophylaxis after foreign body removal?
Fucithalmic® is as effective as chloramphenicol in preventing secondary infection after removal of foreign body and can therefore be recommended for this indication.
25. How long does a bacterial conjunctivitis remain contagious after commencing treatment with Fucithalmic®?
It is generally accepted that bacterial conjunctivitis is no longer contagious after approximately 24 hours of treatment, despite presence of pus.
26. Can Fucithalmic® be used in people with intraocular lens (IOL)?
Can Fucithalmic® be used in people with intraocular lens (IOL)? ANSWER There are no specific clinical studies on the use of Fucithalmic® in people who have IOL, but there are generally no restrictions on the use of ophthalmological preparations in patients with IOL. There are no published studies on Fucithalmic used as postoperative prophylaxis after cataract surgery. BACKGROUND In cataract surgery the patient's own lens is replaced by an artificial IOL. A common postoperative prophylaxis is two weeks topical treatment with antibiotic/steroid combination.
27. Can Fucithalmic® be used in children?
Yes, except for a few countries there are no restrictions with regard to age in the indication for Fucithalmic®.
28. Can Fucithalmic® be used to treat bacterial conjunctivitis in neonates?
Yes, except for a few countries there are no restrictions with regard to age in the indication for Fucithalmic®.
29. Is Fucithalmic® effective in the treatment of chlamydia conjunctivitis in neonates?
Fucithalmic® has a MIC of 4 mg/L and a MBC of 64 mg/L against Chlamydia trachomatis (Ridgway, 1979) but the limited clinical data shows that it is not clinically effective (Stenberg, 1990).
30. How long does a bacterial conjunctivitis remain contagious after commencing treatment with Fucithalmic®?
It is generally accepted that bacterial conjunctivitis is no longer contagious after approximately 24 hours of treatment, despite presence of pus.
31. Can Fucithalmic® be used for the treatment of otitis externa?
No, Fucithalmic® should not be used for the treatment of otitis externa as this is not an approved indication.
32. Can Fucithalmic® be used in combination with Zovirax (aciclovir)?
It cannot be recommended to give any other ophthalmic preparations simoultaneously with Fucithalmic® primarily because this could interfere with the mucoadhesive properties of the Fucithalmic® carbomer gel.
33. Can Fucithalmic® be used together with a corticosteroid eye drop?
It cannot be recommended to give any other ophthalmic preparation simoultaneously with Fucithalmic® primarily because this could interfere with the mucoadhesive properties of the Fucithalmic® carbomer gel.
34. What is the registered brand name of Fucithalmic®?
Worldwide the registered brand name is Fucithalmic®, with the exception of Greece where the registered brand name is Fucidin® (viscous eye drops).
35. Can contact lenses be worn during treatment with Fucithalmic®?
Contact lenses must not be worn during treatment with Fucithalmic®.
36. Can Fucithalmic® be used in pregnancy and lactation?
Yes, Fucithalmic® can be used during pregnancy and lactation.
37. What is the concentration of fusidic acid in the vitreous body after administration of Fucithalmic®?
In a study by Taylor (1987) rabbits were treated with one drop of Fucithalmic® every one minute for five minutes followed by one drop every hour for ten hours.
38. What are the MIC values of fusidic acid for eye pathogens?
The MIC90 (mg/L) values are....
39. Does fusidic acid have any anti-inflammatory effect?
In vitro and in vivo animal studies have shown certain immunosuppressive effects of fusidic acid (Bendtzen, 1990).
40. Does Fucithalmic® contain mercury?
Fucithalmic® does not contain mercury.
41. Why does Fucithalmic® occasionally cause stinging?
Fucithalmic® can cause temporary stinging or irritation, tearing or a burning sensation in up to 10% of the patients.
42. Is it documented that Fucithalmic® does not cause blurring of vision?
Fucithalmic® can cause some initial blurring of vision, normally lasting for a few seconds.
43. Has urticaria been reported as a side effect of Fucidin®?
Urticaria has been reported in very rare cases.
44. Has Quincke's edema been reported as a side effect of Fucithalmic®?
Quinke's edema has been reported in a very few cases.
45. Why should Fucithalmic® be discarded 4 weeks after opening of the tube?
4 weeks are the maximum shelf-life for all sterile products for human use after first opening (EU guidelines).
46. Why should unused droppers be discarded 4 weeks after opening of Fucithalmic® unit dose foil pack?
After opening of the foil the droppers are no longer protected against evaporation.
47. Is Fucithalmic® stable when stored at very low or high temperatures?
Fucithalmic® should be stored at room temperature. Fucithalmic® is stable for 12 months at 30°C.
QUESTION
1. To which class in the ATC (anatomical therapeutic chemical) classification system does Fucithalmic® belong?
ANSWER
Fucithalmic® belongs to:
S01 = Ophthalmologicals
S01A = Ophthalmologicals, antii-nfectives
S01AA = Ophthalmologicals, anti-infectives, antibiotics
REFERENCES
WHO Collaborating Centre for Drug Statistics Methodology. Guidelines for ATC classification and DDD asignment. 4th edition, 2000.
www.whocc.nmd.no
QUESTION
2. May Fucithalmic® be used in patients suffering from glucose-6-phosphate dehydrogenase (G-6-PD) deficiency?
ANSWER
There is no evidence of risk of haemolytic anaemia in patients with G-6-PD deficiency treated with Fucithalmic® or other fusidic acid products. So G-6-PD is neither a contraindication, warning or precausion for Fucithalmic®.
BACKGROUND
Systemic concentrations of fusidic acid have not been detected after application of Fucithalmic®. Excessive literature search does not reveal any information on risk of haemolysis in G-6-PD deficient patients by treatment with fusidic acid.
Haemolysis in G-6-PD deficiency occurs as the result of oxidative stress on the red cell. Drugs that are known to induce haemolysis comprise a variety of oxidant drugs, including anti-malarials, sulfonamides, nitrofurantoin, chloramphenicol and phenacetin, and it is the oxidant activity of these compounds that induces haemolysis. Fusidic acid is not described in lists of drugs that have been associated with haemolytic anaemia in patients with G-6-PD deficiency.
QUESTION
3. Is Fucithalmic® contraindicated in patients after corneal transplantation?
ANSWER
Corneal transplantation is not a contra-indication for Fucithalmic® but is on the other hand not included in our product license.
BACKGROUND
In general, surgery prophylaxis is outside the product license and it can be argued whether the antibacterial spectrum of fusidic acid is broad enough in these cases. We have, though, one study where Fucithalmic® unit dose (preservative free) has been used as prophylaxis in patients with corneal abrasion (Boberg-Ans, 1998). This study showed that Fucithalmic® unit dose and chloramphenicol ointment were equally effective with regard to corneal healing, incidence of infection and local side effects. We have furthermore a few studies in cataract surgery prophylaxis.
REFERENCES
Boberg-Ans G, Nissen KR. Comparison of Fucithalmic® viscous eye drops and chloramphenicol eye ointment as a single treatment in corneal abrasion. Acta Ophthalmol Scand 1998; 76: 108-111.
QUESTION
4. What are the weaknesses of quinolones compared with Fucithalmic®?
ANSWER
The most important weakness of the fluoroquinolones for ophthalmic use is the concern about resistance development. Furthermore, ophthalmic fluoroquinolones are generally not recommended used in children under 1 year and they have to be given more than 2 times daily.
BACKGROUND
Fluoroquinolones are broadspectrum antibiotics, covering a.o. Pseudomonas. They have fairly recently been introduced in ophthalmology but are rapidly gaining market shares in most countries. The considerable use of all fluoroquinolones and the increasing resistance to this group of antibiotics have caused concern among microbiologists and infectious disease specialists. General recommendation is now that in order to prevent resistance, the fluoroquinolones should not be used for uncomplicated infections where other alternatives are available.
Systemic use of Fluorouinolones have shown to cause arthropathy in immature animals and their use in children or children below 1 year is contraindicated. The specific age limit for topical use varies in different countries.
REFERENCES
Goldstein MH, Kowlaski RP, Gordon YJ. Emerging fluoroquinolone resistance in bacterial keratitis: a five-year review. Ophthalmology 1999; 106: 1313-1318.
Chaudhry NA, Flynn HW, Murray TG et al. Emerging ciprofloxacin-resistant Pseudomonas aerugunosa. Am J Ophthalmol 1999; 128: 509-510.
Piddock LJV. Fluoroquinolone resistance. Overuse of fluoroquinolones in human and veterinary medicine can breed resistance. B Med J 1998; 317: 1029-1030.
QUESTION
5. Are there any references warning against the use of chloramphenicol?
ANSWER
It is well-known that systemic use of chloramphenicol can cause serious and fatal complications such as aplastic anaemia and "gray baby" syndrome. Based on this the safety of topical chloramphenicol is being debated.
Although there is no consensus regarding the safety risk of the ocular use of topical chloramphenicol, there are several papers warning against this use (Doona, 1995, Fraunfelder, 1993). In USA topical chloramphenicol has a general warning that it should not be used unless there is no alternative treatment available.
To date 23 cases of blood dyscrasia possibly related to the use of topical ocular chloramphenicol have been reported, 7 of these are publiched. A review of these cases concludes that the risk of aplastic anaemia and "grey baby" syndrome is extremely low although it cannot be neglected in patients with a predisposition to haematological disorders, those needing prolonged treatment and in conjunction with other bone marrow suppressive agents (Lam, 2002).
BACKGROUND
Aplastic anaemia accounts for approx. 70% of cases of blood dyscrasias due to chloramphenicol. It can be an idiosyncratic effect which is not dose-related and most often fatal and a reversible toxic, dose-dependant bone marrow suppression which may progress to fatal aplasia.
"Gray baby" syndrome is a toxic effect of chloramphenicol which may develop in neonates and especially in premature babies and which is fatal. This syndrome can be due to either failure of chloramphenicol to conjugate with glucoronic acid or inadequate excretion of unconjugated drug.
REFERENCES
Fraunfelder FT, Morgan RL, Yunis AA
Blood dyscrasias and topical ophthalmic chloramphenicol
Am J Ophthalmol, 1993, 115(6): 812-813
Doona M, Walsh JB
Use of chloramphenicol as topical eye medication: time to cry halt?
B Med J 1995, 310: 1217-1218
Lam RF, Law, RWK, Lam DSC, Lai JSM, Ng JSK, Rao SK.
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