Amdipharm Limited

Gentisone^® HC Ear Drops, Suspension.

Gentamicin sulphate, equivalent to 0.3% w/v gentamicin base and 1.0% w/v hydrocortisone acetate.

For excipients, see section 6.1.

Ear drops, suspension.

White, odourless suspension.

Gentisone HC ear drops are indicated:

1. For the treatment of eczema and infection of the outer ear (otitis externa).

2. For prophylaxis against otitis externa following trauma.

3. For post-operative local use in surgery to infected mastoid cavities.

For all ages

The area should be cleaned and 2 - 4 drops instilled in the affected ear three to four times a day and at night. Alternatively, wicks medicated with Gentisone HC drops may be placed in the external ear or mastoid cavity.

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 Gentisone HC 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.

In infants there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression.

None relevant to topical use.

Safety for use in pregnancy and lactation has not been established. Topical administration of any corticosteroid to pregnant animals can cause abnormalities of foetal development. Gentisone HC drops should only be used in pregnancy or lactation when considered essential by the physician, after careful assessment of the potential risks and benefits.

Not applicable.

Irritation, burning, stinging, itching and dermatitis may occur. In the event of irritation, sensitisation or super-infection, treatment with Gentisone HC 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.

Not applicable.

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

Corticosteroids, such as hydrocortisone acetate, are used in pharmacological doses for their antiinflammatory and immuno-suppressant glucocorticoid properties which suppress the clinical manifestation of disease in a wide range of disorders.

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.

Hydrocortisone acetate is not absorbed through the skin as rapidly as hydrocortisone and therefore has a prolonged action. Some is absorbed systemically, where greater than 90% is protein bound.

> 70% hydrocortisone acetate is metabolised by the liver. The metabolites are excreted in the urine.

Plasma T_½ = 1½ hours.

See Pregnancy and lactation.

Benzalkonium chloride

Povidone (E1201)

Macrogol 4000

Sodium chloride

Borax (E285)

Disodium edetate

Purified water.

Not applicable.

3 years. Discard contents 4 weeks after opening.

Store below 25°C. Do not freeze or mix with other liquids.

10ml opaque LDPE bottles with closures comprising polyethylene plug/droppers and screw on HDPE tamper-evident caps.

No special requirements.

Amdipharm Limited

Temple Chambers

3 Burlington Road

Dublin 4

Ireland

PA 1142/14/1

18^th May 1995/ 18^th May 2005

May 2008

Gentisone is a registered trade mark