Gentamicin Sulfate Eye Drops 0.3% (3 mg/mL) 0.4 mL

● US reference: topical treatment of ocular bacterial infections caused by susceptible strains, including conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis and dacryocystitis (e.g. Staphylococcus aureus, S. epidermidis, Streptococcus pyogenes, S. pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, Serratia marcescens) [1] ● UK reference: treatment of superficial eye infections caused by gentamicin-sensitive organisms in adults and children, and prophylaxis against infection in trauma of the eye [2]

● For ophthalmic use only; instil one or two drops into the affected eye(s) [1][2][3] ● Not for injection: never inject subconjunctivally and never introduce the solution directly into the anterior chamber of the eye [1] ● Wash hands before use; do not allow the dropper tip to touch the eye, eyelid or any other surface [1][3] ● After instillation, close the eye for 2–3 minutes and press gently on the tear duct; wait at least 5 minutes between drops in the same eye [3] ● Contact lenses: remove before using the drops and wait at least 15 minutes before reinsertion (UK, as benzalkonium chloride can discolour soft lenses) [2]; do not wear contact lenses while there is an eye infection [3] ● Storage: UK reference — store below 25 °C, do not freeze, shelf life 3 years, discard 4 weeks after first opening [2]; US reference — 2–25 °C, avoid excessive heat [1]

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

● Contraindicated in patients with known hypersensitivity to any component (US) [1]; the UK reference also contraindicates myasthenia gravis and known or suspected perforation of the ear drum (for ear use) [2] ● Not for injection into the eye; never inject subconjunctivally or directly into the anterior chamber [1] ● Prolonged use of topical antibiotics may result in overgrowth of non-susceptible organisms, including fungi, and bacterial resistance to gentamicin may develop; long-term continuous topical therapy should be avoided, and treatment should be discontinued if irritation, sensitisation or super-infection occurs [1][2] ● Cross-sensitivity with other aminoglycoside antibiotics may occur [2] ● Gentamicin may cause irreversible partial or total deafness when given systemically or when applied topically to open wounds or damaged skin; the effect is dose-related, enhanced by renal and/or hepatic impairment and more likely in the elderly; caution is advised when topical gentamicin is used together with systemic aminoglycosides [2] ● Interactions: potent diuretics (ethacrynic acid, furosemide) may enhance ototoxicity; amphotericin B, cisplatin, cyclosporine and cephalosporins may enhance nephrotoxicity; neuromuscular blockade has been reported with curare-type muscle relaxants during anaesthesia [2] ● Pregnancy: use only if the potential benefit justifies the potential risk to the fetus (US) [1]; use only when considered essential by the physician after careful assessment (UK) [2]. Breast-feeding: use only when considered essential (UK) [2] ● Transient blurring of vision may occur after instillation; do not drive or operate machinery until vision has cleared [2][3] ● Benzalkonium chloride may cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface; use with caution in dry-eye patients and in patients with a compromised cornea [2] ● Adverse reactions: the most frequently reported are ocular burning and irritation upon instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperaemia; rare reactions include allergic reactions, thrombocytopenic purpura and hallucinations, and bacterial and fungal corneal ulcers have developed during treatment (US) [1]; the UK SmPC lists vision blurred, eye irritation, burning, stinging and itching as eye reactions of unknown frequency, and, for systemic gentamicin, ototoxicity, vestibular disorders, hearing loss, toxic nephropathy and acute renal failure (not expected from topical use) [2]; MedlinePlus reports eye irritation, burning or stinging and swelling of the eye [3] ● Storage: US reference — 2–25 °C, avoid excessive heat [1]; UK reference — below 25 °C, do not freeze, discard 4 weeks after opening [2]; MedlinePlus — original container, tightly closed, room temperature, out of the reach of children [3] For full prescribing information, refer to the approved product label / Summary of Product Characteristics of the product concerned [1][2][3].