EXOCIN.

Ofloxacin 0.3% w/v.

Eye drops.

Exocin is indicated for the topical treatment of external ocular infections (such as conjunctivitis and keratoconjunctivitis) in adults and children caused by ofloxacin - sensitive organisms. Safety and efficacy in the treatment of ophthalmia neonatorum has not been established.

Topical ocular instillation.

For all ages: one to two drops in the affected eye(s) every two to four hours for the first two days and then four times daily. The length of treatment should not exceed ten days.

Exocin is contra-indicated in patients sensitive to ofloxacin or any of its other components.

When using Exocin eye drops the risk of rhinopharyngeal passage which can contribute to the occurrence and the diffusion of bacterial resistance should be considered. As with other anti-infectives, prolonged use may result in overgrowth of non-susceptible organisms.

If worsening infection occurs, or if clinical improvement is not noted within a reasonable period, discontinue use and institute alternative therapy.

Use Exocin with caution in patients who have exhibited sensitivities to other quinolone antibacterial agents.

Data are very limited to establish efficacy and safety of ofloxacin eye drops 0.3% in the treatment of conjunctivitis in neonates.

The use of ofloxacin eye drops in neonates with ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis is not recommended as it has not been evaluated in such patients. Neonates with ophthalmia neonatorum should receive appropriate treatment for their condition, e.g. systemic treatment in cases caused by Chlamydia trachomatis or Neisseria gonorrhoeae.

Use in elderly: No comparative data are available with topical dosing in elderly versus other age groups.

Clinical and non-clinical publications have reported the occurrence of corneal perforation in patients with pre-existing corneal epithelial defect or corneal ulcer, when treated with topical fluoroquinolone antibiotics. However, significant confounding factors were involved in many of these reports, including advanced age, presence of large ulcers, concomitant ocular conditions (e.g. severe dry eye), systemic inflammatory diseases (e.g. rheumatoid arthritis), and concomitant use of ocular steroids or non-steroidal anti-inflammatory drugs. Nevertheless, it is necessary to advise caution regarding the risk of corneal perforation when using product to treat patients with corneal epithelial defects or corneal ulcers.

The multidose eye drop presentation contains the preservative benzalkonium chloride, which may cause eye irritation. Exocin contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses and discolour them. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

None known

Use in pregnancy: There have been no adequate and well-controlled studies performed in pregnant women. Since systemic quinolones have been shown to cause arthropathy in immature animals, it is recommended that Exocin be used in pregnant women only if the potential benefit justifies the potential risk to the foetus.

Use during lactation: Because ofloxacin and other quinolones taken systemically are excreted in breast milk, and there is potential for harm to nursing infants, a decision should be made whether to temporarily discontinue nursing or not to administer the drug, taking into account the importance of the drug to the mother.

None known.

Adverse reactions: Transient ocular irritation (burning, stinging, redness, itching or photophobia) has been reported. Extremely low incidence of dizziness, with numbness and nausea and of headache were reported from clinical trials. Since ofloxacin is systemically absorbed after topical administration, side-effects reported with systemic use could possibly occur.

In the event of a topical overdosage, flush the eye with water.

Ofloxacin is a synthetic fluorinated 4-quinolone antibacterial agent with activity against a broad spectrum of Gram negative and to a lesser degree Gram positive organisms.

Ofloxacin has been shown to be active against most strains of the following organisms both in vitro and clinically in ophthalmic infections. Clinical trial evidence of the efficacy of Exocin against S. pneumoniae was based on a limited number of isolates.

Gram-negative bacteria: Acinetobacter calcoaceticus var. anitratum, and A. calcoaceticus var. iwoffi; Enterobacter Sp. including E. cloacae; Haemophilis Sp, including H. influenza and H. aegyptius; Klebsiella Sp., including K. Pneumoniae; Moraxella Sp., Morganella morganii; Proteus Sp., including P. Mirabilis; Pseudomonas Sp.; including P. Aeruginosa, P. cepacia, and P. fluoroscens; and Serratia Sp., including S. marcescens.

Gram-positive bacteria: Bacillus Sp.; Corynebacterium Sp.; Micrococcus Sp.; Staphylococcus Sp., including S. aureus and S. epidermidis; Streptococcus Sp., including S. Pneumoniae (see above), S. viridans and Beta-haemolytic.

The primary mechanisms of action is through inhibition of bacterial DNA gyrase, the enzyme responsible for maintaining the structure of DNA.

Ofloxacin is not subject to degradation by beta-lactamase enzymes nor is it modified by enzymes such as aminoglycoside adenylases or phosphorylases, or chloramphenicol acetyltransferase.

After ophthalmic instillation, ofloxacin is well maintained in the tear-film.

In a healthy volunteer study, mean tear film concentrations of ofloxacin measured four hours after topical dosing (9.2 µg/g) were higher than the 2µg/ml minimum concentration of ofloxacin necessary to inhibit 90% of most ocular bacterial strains (MIC₉₀) in-vitro.

Maximum serum ofloxacin concentrations after ten days of topical dosing were about 1000 times lower than those reported after standard oral doses of ofloxacin, and no systemic side-effects attributable to topical ofloxacin were observed.

There are no toxicological safety issues with this product in man as the level of systemic absorption from topical ocular administration of ofloxacin is minimal.

Animal studies in the dog have found cases of arthropathy in weight bearing joints of juvenile animals after high oral doses of certain quinolones. However, these findings have not been seen in clinical studies and their relevance to man is unknown.

Benzalkonium chloride (EP) 0.005% w/v

Sodium chloride (EP) 0.9% w/v

Purified water (EP)

None known.

24 months.

Do not store above 25°C.

5 ml or 10 ml low density polyethylene (LDPE) bottles with LDPE tip and medium or high impact polystyrene cap.

Discard bottle 28 days after opening.

Allergan Ltd

Marlow International

The Parkway

Marlow

Bucks SL7 1YL

United Kingdom

PL 00426/0070

26^th October 1992 / 8^th November 2004

4^th August 2008