Ofloxacin Eye Drops 0.3% (3 mg/mL) 0.4 mL

● US reference: bacterial conjunctivitis and bacterial corneal ulcers caused by susceptible strains such as S. aureus, S. epidermidis, Streptococcus pneumoniae, Enterobacter cloacae, Haemophilus influenzae, Proteus mirabilis and Pseudomonas aeruginosa, plus Serratia marcescens and Propionibacterium acnes for corneal ulcers [1] ● UK reference: topical treatment of external ocular infections, such as conjunctivitis and keratoconjunctivitis, in adults and children caused by ofloxacin-sensitive organisms [2] ● Safety and efficacy in the treatment of ophthalmia neonatorum have not been established [2]

● Topical ocular instillation only; instil into the affected eye(s) as prescribed [1][2][3] ● Not for injection: do not inject subconjunctivally or into the anterior chamber of the eye [1][2] ● Wash hands before use; do not allow the dropper tip to touch the eye, fingers or any other surface [1][3] ● After instillation, close the eye for 2–3 minutes and press gently on the tear duct [3] ● Wait at least 5 minutes between drops in the same eye [3]; give other topical ophthalmic medicines at least 10 minutes before or after (US reference) [1] ● Contact lenses: not recommended during treatment of an eye infection; remove before application and wait at least 15 minutes before reinsertion (UK, as benzalkonium chloride can discolour soft lenses) [2]; MedlinePlus: remove before instillation, reinsert after 10 minutes [3] ● Single-dose units: use one 0.4 mL unit per instillation and discard the remainder; the UK multi-dose bottle is discarded 28 days after first opening [2] ● Storage: US reference — store at 20–25 °C [1]; UK reference — do not store above 25 °C, shelf life 2 years unopened [2]

The schedules below refer to registered ofloxacin 0.3% products; for the single-dose presentation, follow the approved label of the product concerned [1][2]

● Contraindicated in hypersensitivity to ofloxacin, any excipient, or other quinolones [1][2] ● Serious, occasionally fatal anaphylactic/anaphylactoid reactions have been reported with systemic quinolones, including ofloxacin, some after the first dose; discontinue at the first sign of rash or allergy and institute emergency treatment [1][2] ● Prolonged use may cause overgrowth of non-susceptible organisms, including fungi; if superinfection or no improvement occurs, discontinue use and institute alternative therapy [1][2] ● Photosensitivity: sun or UV exposure should be avoided during use [2] ● Corneal perforation has been reported with topical fluoroquinolones in patients with pre-existing corneal epithelial defects or ulcers; caution is needed [2] ● Caution in patients with QT-prolongation risk factors (congenital long QT syndrome, QT-prolonging drugs, electrolyte imbalance, cardiac disease); elderly patients and women may be more sensitive to QTc-prolonging medications [2] ● Paediatrics: safety in infants below 1 year of age has not been established (US) [1]; not recommended for ophthalmia neonatorum caused by Neisseria gonorrhoeae or Chlamydia trachomatis (UK) [2] ● Pregnancy: use only if benefit justifies risk (US) [1]; not recommended in pregnant women (UK) [2]. Breast-feeding: decide whether to discontinue nursing or the drug [1][2] ● Transient blurred vision may occur after instillation; do not drive or operate machinery unless vision is clear [2] ● Drug interactions: no studies with the ophthalmic solution; systemic quinolones may raise theophylline, affect caffeine metabolism, enhance warfarin and cause creatinine elevations with cyclosporine; caution with QT-prolonging drugs [1][2][3] ● Adverse reactions: most frequently transient ocular burning or discomfort, plus stinging, redness, itching, chemical conjunctivitis/keratitis, oedema, foreign body sensation, photophobia, blurred vision, tearing, dryness and eye pain, with rare dizziness and nausea (US) [1]; the UK SmPC lists eye irritation and ocular discomfort as common and keratitis, conjunctivitis, blurred vision, photophobia, eye oedema, increased lacrimation, dry eye, eye pain, ocular hyperaemia and periorbital oedema of unknown frequency, with reports of dizziness, nausea, QT prolongation or ventricular arrhythmia and Stevens–Johnson syndrome/toxic epidermal necrolysis [2] ● Storage: US — 20–25 °C [1]; UK — not above 25 °C, discard 28 days after opening [2]; MedlinePlus — original container, tightly closed, room temperature, out of children’s reach [3] For full prescribing information, refer to the approved product label / Summary of Product Characteristics of the product concerned [1][2][3].