Gentisone HC Ear Drops

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 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.

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