GENTAMICIN EYE/EAR

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.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

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.

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.