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1. Name Of The Medicinal Product
Gentisone HC Ear Drops.
2. Qualitative And Quantitative Composition
Gentisone HC ear drops is a sterile aqueous suspension in 10ml dropper bottles containing gentamicin sulphate, equivalent to 0.3% w/v gentamicin base and 1.0% w/v hydrocortisone acetate.
3. Pharmaceutical Form
Sterile aqueous suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
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.
4.2 Posology And Method Of Administration
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.
4.3 Contraindications
Hypersensitivity to gentamicin or to any of the ingredients. Known or suspected perforation of the ear drum is a contra-indication to use in otitis externa only.
4.4 Special Warnings And Precautions For Use
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.
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.
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.
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.
In infants there is a theoretical risk that sufficient steroid may be absorbed to cause adrenal suppression.
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
None relevant to topical use.
4.6 Pregnancy And Lactation
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.
4.7 Effects On Ability To Drive And Use Machines
Not applicable.
4.8 Undesirable Effects
In the event of irritation, sensitisation or super-infection, treatment with Gentisone HC should be discontinued and appropriate therapy instituted.
4.9 Overdose
Not applicable.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Gentamicin is a bactericidal antibiotic which acts by inhibiting protein synthesis.
Corticosteroids, such as hydrocortisone acetate, are used in pharmacological doses for their anti
5.2 Pharmacokinetic Properties
Topical application of gentamicin can result in some systemic absorption. Treatment of large areas can result in plasma concentrations of up to 1?g/ml.
> 90% gentamicin is excreted in the urine by glomerular filtration.
< 10% is bound to plasma protein.
T? = 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? = 1? hours.
5.3 Preclinical Safety Data
See Pregnancy and lactation.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Benzalkonium chloride (preservative), povidone, polyethylene glycol 4000, sodium chloride, borax, disodium edetate and purified water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
3 years. Discard contents 4 weeks after opening.
6.4 Special Precautions For Storage
Store below 25°C. Do not freeze or mix with other liquids.
6.5 Nature And Contents Of Container
10ml dropper bottles.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
Amdipharm PLC
Regency House
Miles Gray Road
Basildon
Essex
SS14 3AF
United Kingdom
8. Marketing Authorisation Number(S)
PL 20072/0058
9. Date Of First Authorisation/Renewal Of The Authorisation
20 December 1994
10. Date Of Revision Of The Text
December 2010
LEGAL STATUS
POM
Gentisone is a registered trade mark Item Code
Gentisone HC Ear Drops
.
