Fucithalmic Viscous Eye Drops

/ Dexcel

One drop of Fucithalmic should be applied to the conjunctival sac every 12 hours. Treatment should be continued for 2 days after the eye appears normal.

Treatment of external eye infections caused by microorganisms sensitive to the preparation.

Hypersensitivity to fusidic acid/sodium fusidate or to any of the excipients.

Contact lenses should not be worn/used when Fucithalmic 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.
Excipient warning: Fucithalmic contains benzalkonium chloride, which may cause eye irritation and discolour soft contact lenses.

The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and spontaneous reporting.
Based on pooled data from clinical studies, including 2,499 patients with eye infections including acute conjunctivitis, who received Fucithalmic eye drops, the frequency of undesirable effects was 11.3%.
The most frequently reported adverse reactions during treatment are various application site reactions such as pain, pruritus and irritation/discomfort in/around the eyes, which occurred in approximately 8.5% of patients, followed by blurring of vision, which occurred in approximately 1.2% of patients. Angioedema has been reported in a few patients post marketing.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. 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); Not known (cannot be estimated from the available data)
Immune system disorders Uncommon: Hypersensitivity.
Eye disorders Common: Vision blurred (transient), Uncommon: Eyelid oedema, Lacrimation increased, Rare: Conjuctivitis aggravated.
Skin and subcutaneous tissue disorders Uncommon: Rash, Angioedema, Rare: Urticaria
General disorders and administration site conditions Common: Application site pain (including eye burning and eye stinging), Application site pruritis, Application site discomfort/irritation.
Paediatric population: The observed safety profile is similar in children and adults.

No interaction studies have been performed. Systemic interactions are unlikely since systemic exposure after application of Fucithalmic is negligible.

Pregnancy: No effects during pregnancy are anticipated, since systemic exposure to Fusidic acid eye drops is negligible. Fucithalmic can be used during pregnancy.
Lactation: No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to fusidic acid is negligible. Fucithalmic can be used during breast-feeding.
Fertility: There are no clinical studies with Fusidic acid eye drops regarding fertility. No effects on women of childbearing potential are anticipated, since systemic exposure to Fusidic acid eye drops is negligible.

The total quantity of fusidic acid in one 5 g tube of Fucithalmic eye drops (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.