Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Gentamicin Eye/Ear Drops 0.3% w/v
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Gentamicin sulfate may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for Gentamicin is a sterile, preserved, aqueous solution used as eye/ear drops. The active ingredient Gentamicin is an antibiotic. Gentamicin is used in adults and children to kill bacteria which cause infection. It is used for the management of infection in injured eye and ear.
What you need to know before you take it
e Gentamicin Do not use Gentamicin if you are allergic to Gentamicin or any of the other ingredients of this medicine (listed in section 6). you have or suspect you have a burst ear drum, if you are being treated for a problem with your ear. you suffer from myasthenia gravis, a disease causing muscle weakness. Warnings and precautions Talk to your doctor or pharmacist before using Gentamicin if you
have any problems with your kidneys or liver; have open wounds or damaged skin;
are using this medicine for a long period of time. know (or think you have) a mitochondrial disease (mutations in the parts of your cells which help make energy); certain mitochondrial diseases may increase your risk of hearing loss with this product.
The drops must not be used in the ear if the ear drum is damaged in any way. Your doctor will check the condition of the ear drum before prescribing the drops. In severe infections treatment with a systemic antibiotic may be necessary in addition to Gentamicin. If any of these apply to you, or if you are not sure, tell your doctor. Other medicines and Gentamicin Tell your doctor if you are taking, or have recently taken, or might take any other medicines including those obtained without a prescription. In particular:
cephalosporins(antibiotics), amphotericin(used to treat fungal infection), cisplatin (used in anti-cancer therapy) or ciclosporin (used to stop the body rejecting bone marrow or organ transplants) which may increase the risk of kidney damage diuretic medicines such as ethacrynic acid (used in the treatment of high blood pressure and swelling) and furosemide(used in the treatment of congestive heart failure and swelling) which may increase the risk of ear damage curare-type muscle relaxants caution is advised when the drops are used with other aminoglycoside antibiotics given by injection.
Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Gentamicin is not recommended for use in pregnancy or breastfeeding unless considered appropriate by your doctor. Driving and using machines Gentamicin may cause temporary blurred vision when used in the eyes. If you are affected, do not drive or use machinery until the blurring has cleared. Gentamicin contains Benzalkonium Chloride This medicine contains 0.10 mg/ml benzalkonium chloride as a preservative. Benzalkonium chloride may be absorbed by soft contact lenses and may change the colour of the contact lenses.
You should remove contact lenses before using this medicine and put them back 15 minutes afterwards. Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or disorders of the cornea (the clear layer at the front of the eye). If you feel abnormal eye sensation, stinging or pain in the eye after using this medicine, talk to your doctor.
How to take it
Gentamicin Always use Gentamicin exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Eyes: Instill 1-2 drops into the affected eye up to 6 times a day. For more severe infections your doctor may tell you to use the drops more often than this. Contact lenses should be removed when treating an eye infection with these drops. Ear: The area should be cleaned and 2-3 drops instilled 3-4 times a day and at night. Your doctor may tell you to use the drops more often than this. The drops should not be used continuously for a long time as it may irritate your skin and the drops may stop working. If your infection is severe, your doctor may also give you antibiotics by injection. Use in children and adolescents: No dosage adjustment required in children. Instructions for use (Please also refer to pictograms at the end of the leaflet)
First wash your hands Avoid touching the eye (or any other surface) with the tip of the bottle If you wear soft contact lenses, they should be removed before using the eye drops and wait at least 15 minutes before reinserting These drops are supplied as a sealed bottle with a spiked cap. When using the bottle for the first time, screw the cap down tightly in order to pierce the tip of the bottle Tilt your head back and look at the ceiling Pull the lower eyelid gently downwards Hold the bottle upside down above the eye and gently squeeze the bottle to release a drop into your eye Keep the affected eye closed and press your fingertip against the inside corner of the closed eye, and hold for 1 minute Repeat for the other eye if necessary Replace and tighten the cap immediately after use.
As ear drops: The area should be cleaned, tilt head sideways and dispense drops with gentle pressure
Ocular solutions if handled wrongly, can become contaminated by common bacteria and cause eye infections. If you do develop any other eye condition whilst using this product, see your doctor immediately. If you use more Gentamicin than you should In adults an overdose due to the use of the eye / ear drops is unlikely, however, if you use too many drops or if the eye / ear drops are accidentally swallowed, you should contact your doctor. If you swallow Gentamicin If you, or someone else, accidentally swallows some of this medicine, contact your doctor, pharmacist or nearest hospital emergency department immediately. If you forget to use Gentamicin If you forget to use Gentamicin, use your next dose as soon as you remember and continue as before. 4. Possible side effects Like all medicines Gentamicin can cause side effects, although not everybody gets them. If you notice: Itching or skin rashes Swelling of the face, lips or throat Difficulty in breathing or wheeziness Stop using these drops and tell your doctor immediately. These may be signs of allergic reaction.
Possible side effects
which you may experience include
ear damage such as difficulty in keeping your balance or hearing loss kidney problems such as passing less water than usual or signs of blood in urine local sensitivity in the eye, transient eye irritation, blurred vision, burning or stinging sensation, itching local sensitivity in the ear, burning or stinging sensation, itching, skin inflammation super infection (infection occurring after an earlier infection).
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
How to store it
Gentamicin
Keep this medicine out of the sight and reach of children. Do not store above 25oC. Protect from light Discard after 28 days of opening. Do not use this medicine after the expiry date which is stated on the bottle and on the carton the bottle is packed in. The expiry date refers to the last day of that month.
Contents of the pack and other information
What Gentamicin contains The active substance(s) is Gentamicin sulphate 0.3% w/v. The other ingredient(s) are 0.02% v/v benzalkonium chloride solution (as preservative), sodium chloride, disodium edetate, sodium metabisulphite, borax, sodium hydroxide solution, hydrochloric acid and Water for Injection. What Gentamicin looks like and contents of the pack Each bottle contains 10 ml of the clear, colourless to pale straw coloured eye/ear drop solution. Marketing Authorisation Holder and Manufacturer FDC International Ltd, Unit 6, Fulcrum 1, Solent Way, Whiteley, Fareham, Hampshire, PO15 7FE United Kingdom
PL number: 15872/0004 Hard to see or read the leaflet? Call + 44(0) 1489 565222 for help. This leaflet was last revised in: 10/2020.
MODE OF USE
Frequently asked questions about Gentamicin Eye/Ear Drops 0.3% w/v
How do I take Gentamicin Eye/Ear Drops 0.3% w/v?
Gentamicin Eye/Ear Drops 0.3% w/v comes as ear drops. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Gentamicin Eye/Ear Drops 0.3% w/v?
The active substance in Gentamicin Eye/Ear Drops 0.3% w/v is gentamicin sulfate.
Are there equivalent medicines to Gentamicin Eye/Ear Drops 0.3% w/v?
Medicines with the same active substance, strength and form include: Genticin (Gentamicin 0.3% w/v) Eye/Ear Drops. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Gentamicin Eye/Ear Drops 0.3% w/v, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Gentamicin Eye/Ear Drops 0.3% w/v without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: gentamicin sulfate
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis and blepharo-conjunctivitis, acute meibomianitis, episcleritis and dacryocystitis. It may be used for the prevention of ocular infection after: removal of a foreign body, burns or lacerations of the conjunctiva; damage from chemical or physical agents and after ocular surgery.
Also indicated for the treatment of otitis externa.
4.2. Posology and method of administration
Posology
Adults, including the elderly and children
Eyes: Instill 1-2 drops into the affected eye up to six times a day, or more frequently if required. (severe infections may require 1 or 2 drops every fifteen to twenty minutes initially, reducing the frequency of instillation gradually as the infection is controlled).
Ears: The area should be cleansed and 2-3 drops instilled in the affected ear 3-4 times a day and at night or more frequently if required.
4.3. Contraindications
Hypersensitivity to active substance, Gentamicin or to any of the excipient listed in section 6.1.
Should not be administered to patients with a known allergy to gentamicin and other aminoglycosides. Evidence exists that gentamicin may cause neuromuscular blockade and is therefore contra-indicated in myasthenia gravis and related conditions.
Perforated tympanic membrane.
4.4. Special warnings and precautions for use
Avoid prolonged use. Prolonged use may lead to skin sensitisation and the emergence of resistant organisms. Cross-sensitivity with other aminoglycoside antibiotics may occur.
In severe infections, topical use of gentamicin should be supplemented with appropriate systemic antibiotic treatment.
Gentamicin may cause ototoxicity (vestibular damage; irreversible partial or total deafness) when given systemically or when applied topically to open wounds or damaged skin. This effect is dose-related and is enhanced by renal and/or hepatic impairment and is more likely in the elderly.
There have been observed cases of an increased risk of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A>G mutation, including cases where the patient's aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
The condition of the ear drum must always be checked before this medicinal product is prescribed. The medicinal product must not be used if the integrity of the ear drum cannot be guaranteed.
Irreversible toxic effects may result from direct contact of gentamicin with the middle and inner ear. The benefits of gentamicin therapy should be considered against the risk of infection itself causing hearing loss.
This formulation of Gentamicin Eye/Ear Drops contains benzalkonium chloride as a preservative which may be deposited in soft contact lenses. Hence, Gentamicin should not be used while wearing these lenses. The lenses should be removed before instillation of the drops and not reinserted earlier than 15 minutes after use.
Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.
Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic gentamicin therapy. Although these effects have not been reported following topical otic use of gentamicin, caution is advised when used concomitantly with systemic aminoglycosides.
4.5. Interaction with other medicinal products and other forms of interaction
Potent diuretics such as ethacrynic acid and frusemide are believed to enhance any risk of ototoxicity whilst amphotericin B, cisplatin and cyclosporin and cephalosporins are potential enhancers of nephrotoxicity.
Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided unless considered essential by the physician.
Neuromuscular blockade and respiratory paralysis have been reported in patients from the administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.
4.6. Pregnancy and lactation
Safety for use in pregnancy and lactation has not been established. Gentamicin should only be used in pregnancy or lactation when considered essential by the physician, after careful assessment of the potential risks and benefits.
4.7. Effects on ability to drive and use machines
Patients should be advised that the use of gentamicin in the eye may cause transient blurring of vision. If affected, patients should not drive or operate machinery until vision has cleared.
4.8. Undesirable effects
There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. Therefore, all the undesirable effects listed are classed as “frequency unknown”.
Eye Disorders:-
Local sensitivity; blurred vision, eye irritation, burning sensation, stinging sensation, itching (eye pruritus)
Ear & Labyrinth Disorders:-
Local sensitivity; ototoxicity; vestibular disorder; hearing loss
Skin & Subcutaneous tissue Disorders:-
burning sensation, stinging, itching (pruritus); dermatitis.
Renal & Urinary Disorders:-
Gentamicin may cause nephrotoxicity when given systemically. However, it is likely that systemic absorption following topical administration does not constitute a comparable risk.
In the event of irritation, sensitivity or super-infection, treatment should be discontinued and appropriate therapy instituted.
Reporting of suspected adverse reactions:-
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow card scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by gentamicin.
💬 Ask about this leaflet
Ask anything about Gentamicin Eye/Ear Drops 0.3% w/v. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
Medicines containing Gentamicin sulfate
- Cidomycin 80mg/2ml Solution for Injection
- Gentamicin 1 mg/ml solution for infusion
- Gentamicin 10mg/ml Solution for Injection or Infusion
- Gentamicin 3 mg/ml solution for infusion
- Gentamicin 40mg/ml Solution for Injection or Infusion
- Gentamicin 40mg/ml Solution for Injection/Infusion
- Gentamicin Intrathecal 5mg/ml
- Gentamicin Paediatric 20mg/2ml Solution for Injection
- Genticin (Gentamicin 0.3% w/v) Eye/Ear Drops
- Genticin (Gentamicin) 40mg/ml Injectable