Gentamicin Eye/Ear Drops 0.3% (10 ml)

Genticin

Pharmaceutical – Antibiotic Eye & Ear Drops

Topical ophthalmic/otic solution

Regulated prescription Only medicinal product licensed for ophthalmic and otic use under UK prescribing regulations.
Manufactured in compliance with Good Manufacturing Practice (GMP) and relevant pharmaceutical standards for sterile solutions.

Regulated prescription Only medicinal product licensed for ophthalmic and otic use under UK prescribing regulations.
Manufactured in compliance with Good Manufacturing Practice (GMP) and relevant pharmaceutical standards for sterile solutions.

Topical ophthalmic/otic solution

Description

Gentamicin Eye/Ear Drops 0.3% w/v is a sterile isotonic solution containing gentamicin sulphate (equivalent to 30 mg gentamicin base per 10 ml) for topical use in the eye or ear. It is indicated for treatment of bacterial infections of the external structures of the eye (conjunctivitis, keratitis, blepharitis, dacryocystitis, corneal ulcer etc.) and for otitis externa, as well as for prophylactic use after ocular or ear injury. The product is prescription-only (POM) and supplied in a 10 ml dropper bottle.

Bnefits

Broad-spectrum aminoglycoside antibiotic active against many gram-positive and gram-negative bacteria, including Staphylococcus aureus, E. coli, Pseudomonas and others.
Dual ophthalmic and otic formulation – can be used in eyes or ears depending on indication.
Sterile, isotonic aqueous solution with preservative benzalkonium chloride for stability and safety.
Efficacious for a variety of superficial eye infections (conjunctivitis, keratitis, ulcers) and external ear canal infections (otitis externa).
Can be used prophylactically after minor eye/ear trauma or removal of foreign bodies to prevent infection.

Indications

Bacterial conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis and dacryocystitis.
Post-traumatic or post-surgical prophylaxis of ocular infection (after foreign body removal, burns, lacerations, chemical or physical damage).
Otitis externa (external ear canal infections) when tympanic membrane integrity is intact.

Composition

Gentamicin sulphate, equivalent to 0.3% w/v (i.e. 30 mg gentamicin base per 10 ml).
Preservative: benzalkonium chloride 0.10 mg/ml (or 0.020% w/v depending on specific formulation)
Excipients: isotonic aqueous buffered solution (buffer salts, purified water, pH adjusted) depending on the manufacturer.

Formulation

Sterile, isotonic aqueous solution for ophthalmic and otic use
Concentration: 0.3% w/v gentamicin sulphate
Dropper bottle presentation (10 ml sterile dropper vial)

Packaging

Single 10 ml sterile dropper bottle per pack (prescription only product)
Bottle labelled with batch number, expiry date, storage instructions and Rx-only status
Patient Information Leaflet included as per regulatory requirements (SmPC / PIL).

Usage

For eye infections: instill 1–2 drops into the affected eye(s) up to six times daily; in severe infections, 1–2 drops every 15–20 minutes initially, then taper as infection responds.
For ear infections: cleanse the external ear canal, tilt the head so the affected ear faces upward, instill 2–3 drops into the ear canal 3–4 times daily (including night) or as directed.
Discard bottle after completion of course or after 4 weeks from opening, whichever is sooner.
Do not touch the dropper tip to the eye or ear to avoid contamination.
Remove contact lenses before instillation; avoid reinserting until at least 15 minutes post-instillation (due to benzalkonium chloride preservative).

Contraindications

Hypersensitivity to gentamicin or any component of the formulation (e.g. benzalkonium chloride).
Presence or suspicion of perforated tympanic membrane (for ear use).
Patients with myasthenia gravis or other neuromuscular disorders (risk of neuromuscular blockade).
Avoid prolonged continuous topical therapy due to risk of sensitisation, resistance or ototoxicity / local toxicity.
Do not use for viral, fungal or non-bacterial ocular/aural infections unless secondary bacterial infection is confirmed. (Not effective against non-bacterial pathogens)

Adverse Effects

Local irritation, burning or stinging sensation at the application site (eye or ear).
Transient blurred vision if eye drops applied — avoid driving or operating machinery until vision clears.
Possible allergic reactions or hypersensitivity including redness, itching or swelling in patients with sensitivity to aminoglycosides.
If applied to a perforated eardrum or open wound, there is a risk of ototoxicity (hearing damage) due to gentamicin absorption — special care needed.
Risk of antimicrobial resistance and overgrowth of non-susceptible organisms (fungi) with prolonged or inappropriate use.

Storage Conditions

Store at or below 25°C; avoid excessive heat and freezing.
Keep the bottle tightly closed when not in use to maintain sterility.
Protect from light and do not expose to direct sunlight.
Use or discard within 4 weeks of opening.
Keep out of reach of children.

Duration

Usually 5\u201310 days depending on severity and clinical response; milder infections often resolve in 5\u20137 days.

Onset

Improvement often observed within 24\u201348 hours of starting drops in mild to moderate infections; full course should be completed to prevent recurrence or resistance.