Amdipharm Limited

Genticin^®0.3% w/v Eye/Ear Drops Solution.

Gentamicin Sulphate 0.3% w/v gentamicin base.

For excipients, see section 6.1.

Eye/Ear drops, solution.

A clear, colourless liquid.

Genticin eye/ear drops are indicated:

1. For the treatment of superficial eye and ear infections caused by organisms sensitive to gentamicin.

2. For prophylaxis against infection in trauma of the eye or ear.

Adults, including the elderly and children

Eyes: 1 or 2 drops should be instilled in 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 cleaned and 2 - 3 drops instilled in the affected ear three to four times a day and at night, or more frequently if required.

Hypersensitivity to gentamicin or to any of the ingredients. Known or suspected perforation of the ear drum is a contraindication to use in otitis externa only.

Long-term continuous topical therapy should be avoided. 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 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 aminoglycoside antibiotics into the middle ear carries a theoretical risk of causing hearing loss due to ototoxicity. The benefits of gentamicin therapy should be considered against the risk of infection itself causing hearing loss.

Contact lenses should be removed during the period of treatment of ocular infections.

Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided unless considered essential by the physician.

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.

Patients should be advised that the use of Genticin in the eye may cause transient blurring of vision. If affected, patients should not drive or operate machinery until vision has cleared.

Irritation, burning, stinging, itching and dermatitis may occur. In the event of irritation, sensitisation or super-infection, treatment should be discontinued and appropriate therapy instituted.

Very rarely, cases of dizziness, tinnitus, hypersensitivity and allergic reaction have been reported.

Gentamicin may cause nephrotoxicity when given systemically. However, it is likely that systemic absorption following topical administration does not constitute a comparable risk.

The oral ingestion of the contents of one bottle is unlikely to cause any significant adverse effect.

Gentamicin is a bactericidal antibiotic which acts by inhibiting protein synthesis.

Topical application of gentamicin can result in some systemic absorption. Treatment of large areas can result in plasma concentrations of up to 1µg/ml.

> 90% Gentamicin is excreted in the urine by glomerular filtration.

< 10% is bound to plasma protein.

T_½ = 2 - 3 hours in individuals with normal kidney function, but can be increased in cases of renal insufficiency.

Not relevant.

Benzalkonium chloride

Borax (E285)

Sodium chloride

Water, purified

Not applicable.

3 years. Discard contents 4 weeks after opening.

Do not store above 25°C. Do not freeze.

10ml opaque LDPE bottles with closures comprising polythene plug droppers and HDPE tamper evident caps.

No special requirements.

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

PA 1142/13/2

20^th April 1995/ 20^th April 2005

February 2008

Genticin is a registered trade mark

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