Data Sheet
Fucithalmic®
Fusidic Acid Eye Drops
Qualitative and Quantitative Composition
Each gram contains fusidic acid anhydrous 10 mg as fusidic acid hemihydrate Ph.Eur.
Pharmaceutical Form
Sterile viscous eye drops of 1% aqueous sustained release formulation of fusidic acid (microcrystalline suspension) in a carbomer gel. Fucithalmic® liquefies and becomes clear on contact with the electrolytes of the tear fluid, and therefore causes less blurring of vision than eye ointment. The viscosity of the carbomer allows easy administration and gives rise to prolonged concentrations of fusidic acid in the tear fluid.
Clinical Particulars
USES
Actions
Fucithalmic® is an antimicrobial agent that inhibits bacterial protein synthesis. Fucithalmic® kills a wide range of gram-positive organisms. It is used to treat bacterial eye infections.
Indications
Fucithalmic® is indicated for the topical treatment of bacterial eye infections where the organism is sensitive to the antibiotic. These may include: bacterial conjunctivitis, blepharitis, sty, and keratitis.
Dosage and Administration
For all ages: One Fucithalmic® drop to be instilled into the eye twice daily. Treatment should be continued for at least 48 hours after the eye returns to normal.
Contraindications
Hypersensitivity to any of its components.
Special Warnings and Precautions for Use
Contact lenses should not be worn/used when Fucithalmic® is used. The microcrystalline fusidic acid may cause scratches in the contact lens or cornea. Fucithalmic® eye drops contain benzalkonium chloride, which is known to discolour soft contact lenses.
Fucithalmic® eye drops are preserved with benzalkonium chloride. Benzalkonium chloride may cause eye irritation.
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.
Interactions with Other Medicaments and Other Forms of Interaction
Not applicable
Pregnancy and Lactation
Pregnancy
There are no clinical data on exposed pregnancies available, but animal studies and many years of clinical experience with systemic and topical fusidic acid suggest that fusidic acid is devoid of teratogenic effect. Consequently any risk to the foetus is unlikely using the very low doses of fusidic acid applied topically in Fucithalmic®.
Lactation
No effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to fusidic acid is negligible. Fucithalmic® eye gel can be used during breastfeeding.
Effects on Ability to Drive and Use Machines
Presumed to be safe or unlikely to produce an effect on the ability to drive or use machinery.
Adverse Effects
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
Pooled data from clinical studies, including more than 1,500 patients with acute conjunctivitis, showed that undesirable effects occurred in approximately 10% of the patients; primarily short lasting local discomfort in the form of stinging and burning sensation.
The most frequently reported adverse drug reactions are various application site reactions such as transient stinging and burning sensation or transient blurring of vision. Urticaria, rash and allergic reactions have been reported.
Immune System Disorders:
Uncommon:
Allergic reaction
Eye Disorders:
Common:
Eye burning
Eye stinging
Uncommon:
Eyes tearing
Transient blurring of vision
Rare:
Conjunctivitis aggravated
Skin and Subcutaneous Tissue Disorders:
Uncommon:
Pruritus
Periorbital oedema
Rare:
Rash
Urticaria
Angiooedema
General Disorders and Administration Site Reactions:
Common:
Application site reaction
Overdosage
Not applicable.
Pharmacological properties
Pharmacodynamic Properties
Fusidic acid exerts its antimicrobial action by inhibition of bacterial protein synthesis. Fucithalmic® is active against a wide range of gram-positive organisms, particularly Staphylococcus aureus. Other species against which Fucithalmic® has been shown to have in vitro activity include Streptococcus, Neisseria, Haemophilus, Moraxella and Corynebacteria. Psueudomonas and Enterobacteriaceae spp. are not sensitive to fusidic acid. In vivo fusidic acid is not active against Chlamydia trachomatis.
Pharmacokinetic Properties
The sustained release formulation of Fucithalmic® ensures a prolonged contact with the conjunctival sac. Twice daily application provides sufficient fusidic acid concentrations in all relevant tissues of the eye. Fusidic acid penetrates well into the aqueous humour.
The biological half-life of Fucithalmic® is 7.3 hours and mean antibiotic concentrations after a single dose of one drop 12 hours after administration are 6.0 mcg/mL.
Pharmaceutical Particulars
List of Excipients
Benzalkonium chloride, disodium edetate, mannitol, carbomer, sodium hydroxide and water for injections.
Pharmaceutical Precautions
Incompatibilities
None known.
Shelf Life
3 years.
Special Precautions for Storage
Store below 30°C. Keep the tube tightly closed. The tube should be discarded one month after opening.
Presentation
Package Quantities
5g tubes
Instructions for Use/Handling
None
Medicine Classification
Prescription Medicine
FURTHER INFORMATION
Not Applicable
Name and Address
Under Licence from:
LEO Pharmaceutical Products Ltd. A/S
Industriparken 55
Ballerup
Denmark
Distributed in New Zealand by:
CSL Biotherapies (NZ) Ltd
666 Great South Road
Penrose Auckland 1544
New Zealand
Telephone number: 0800 502 757
Date of Preparation
24 November 2008
Fucithalmic® is a registered trademark of LEO Pharmaceutical Products Ltd. A/S