COMPOSITION:
Each 1g eye gel contains 10.2 mg fusidic acid hemihydrate, (equivalent to 10mg fusidic acid).
Preservative: Benzalkonium Chloride.
MECHANISM OF ACTION:
Fuci-Ophthalmic is active against a wide range of gram-positive organisms, particularly Staphylococcus aureus. Other species against which Fuci-Ophthalmic has been shown to have in vitro activity include Streptococcus, Neisseria, Haemophilus, Moraxella and Corynebacteria.
INDICATIONS:
Fuci-Ophthalmic is indicated for the topical treatment of bacterial conjunctivitis where the organism is known to be sensitive to the antibiotic.
DOSAGE AND ADMINISTRATION:
For all ages: One Fuci-Ophthalmic 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 the active substance or to any of the excipients
SIDE EFFECTS:
Common: Vision blurred, application site pain (including eye burning and eye stinging), pruritus and discomfort/irritation
Uncommon: hypersensitivity ,eyelid oedema ,lacrimation increased ,rash , angioedema
Special warnings and precautions for use:
- Contact lenses should not be used when Fusidic acid viscous eye gel is used. The microcrystalline fusidic acid may
cause scratches in the contact lens or cornea. Contact lenses are kept out until all symptoms of the infection have gone.
- 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.
- Fusidic acid viscous eye gel contains benzalkonium chloride, which may cause eye irritation and discolor soft contact lenses.
Drug interactions:
No interaction studies have been performed
USE IN PREGNANCY AND LACTATION:
Fuci-ophthalmic can be used. No effects during pregnancy and lactation are anticipated.
Effects on ability to drive and use machines:
Fusidic acid viscous eye gel has no or negligible influence on the ability to drive or use machines. Fusidic acid viscous eye gel may ,however, cause a blurring of vision following application and patient should take this into account.
PHARMACOKINETIC PROPERTIES:
The sustained release formulation 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 humor.
Overdose:
The total quantity of fusidic acid in one 5 g tube of Fuci-Ophthalmic viscous eye gel (50 mg) does not exceed the approved total daily oral dose of fusidic acid containing products. The concentration of the excipients is too low to constitute a safety risk. Therefore, overdose is unlikely to occur
DIRECTIONS FOR USE:
1. As with any eye preparation, wash your hands before you administer Fuci-Ophthalmic viscous eye gel.
2. Remove the cap from the tube. To administer Fuci-Ophthalmic viscous eye gel, stand or sit comfortably and tilt your head backwards.
3. Gently pull down your lower eyelid and squeeze one drop from the tube into your lower eyelid, you may find a mirror useful when administering the viscous eye gel.
4. Be careful not to touch the tip of the tube to your eye or other surface, so as to avoid contamination of tube contents.
5. Fuci-Ophthalmic viscous eye gel comes out of the tube as a single viscous drop, which quickly turns to liquid in your
eye.