GENTAMICIN Eye / Ear drops Ref.[6851] Active ingredients: Gentamicin

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.

Topical application of gentamicin into the middle ear also carries a theoretical risk of ototoxicity in susceptible patients.

Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided unless considered essential by the physician (see section 4.5).

Not for use with contact lenses.

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.

There are no proven cases of intrauterine damage caused by gentamicin. However, in common with most drugs known to cross the placenta, usage in pregnancy should only be considered in life-threatening situations where expected benefits outweigh possible risks. In the absence of gastrointestinal inflammation the amount of gentamicin ingested from the milk is unlikely to result in significant blood levels in breast-fed infants.

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.

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: Nephrotoxicity; acute renal failure.

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.

Pharmaceutically incompatible with amphotericin, cephalosporins, erythromicin, heparin, penicillins, sodium bicarbonate and sulphadiazine sodium.