1. Name Of The Medicinal Product
Gentamicin Eye/Ear Drops 0.3% W/V
2. Qualitative And Quantitative Composition
Active Ingredient
Gentamicin sulphate equivalent to 30mg gentamicin base in 10ml of solution
3. Pharmaceutical Form
Eye/Ear Drops
4. Clinical Particulars
4.1 Therapeutic Indications
Treatment of infections of the external structures of the eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, kerato-conjunctivitis, corneal ulcers, blepharitis and blepharo-conjunctivitis, acute meibomianitis, episcleritis and dacryocystitis. It may be used for the prevention of ocular infection after: removal of a foreign body, burns or lacerations of the conjunctiva; damage from chemical or physical agents and after ocular surgery.
Also indicated for the treatment of otitis externa.
4.2 Posology And Method Of Administration
Eye: Instill 1-2 drops into the affected eye every four hours as required.
Ears: The area should be cleansed and 2-4 drops instilled 3-4 times daily.
4.3 Contraindications
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.
4.4 Special Warnings And Precautions For Use
Avoid prolonged use. Not for use with contact lenses
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Potent diuretics such as ethacrynic acid and frusemide are believed to enhance any risk of ototoxicity whilst amphotericin B, cisplatin and cyclosporin are potential enhancers of nephrotoxicity.
Neuromuscular blockade and respiratory paralysis have been reported in patients from the administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.
4.6 Pregnancy And Lactation
There are no proven cases of intrauterine damage caused by gentamicin. However, in common with most drugs known to cross the placenta, usage in pregnancy should only be considered in life-threatening situations where expected benefits outweigh possible risks.
In the absence of gastrointestinal inflammation the amount of gentamicin ingested from the milk is unlikely to result in significant blood levels in breast-fed infants.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Severe dose-related ototoxicity can occur with gentamicin in susceptible patients, particularly those with renal impairment.
Vestibular damage is more common than hearing loss. Reversible nephrotoxicity may occur and acute renal failure has been reported, often in association with concurrent administration of cephalosporins.
Gentamicin drops may cause transient eye irritation or local sensitivity in the ear.
4.9 Overdose
Haemodialysis and peritoneal dialysis will aid the removal from blood but the former is probably more efficient. Calcium salts given intravenously have been used to counter the neuromuscular blockade caused by gentamicin.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Gentamicin is a mixture of antibiotic substances produced by the growth of micromonospora purpurea. It is bactericidal with greater antibacterial activity than streptomycin, neomycin or kanamycin.
Gentamicin exerts a number of effects on cells of susceptible bacteria. It affects the integrity of the plasma membrane and the metabolism of RNA, but it's most important effect is inhibition of protein synthesis at the level of the 30s ribosomal subunit.
5.2 Pharmacokinetic Properties
Gentamicin is not readily absorbed from the gastro-intestinal tract. Gentamicin is 70-85% bound to plasma albumin following administration and is excreted 90% unchanged in urine. The half-life for its elimination in normal patients is 2 to 3 hours.
Effective plasma concentration is 4 - 8ug/ml
The volume of distribution (VD) is 0.3 l/kg
The elimination rate constant is;
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* Therefore in those with anuria care must be exercised.
5.3 Preclinical Safety Data
Nothing of relevance which is not included in other sections of the SPC.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium Chloride
Disodium Edetate
Sodium Metabisulphite
Borax
Benzalkonium Chloride solution
Purified Water
Sodium Hydroxide soluion (pH adjuster)
Hydrochloric acid (pH adjuster)
6.2 Incompatibilities
Pharmaceutically incompatible with amphotericin, cephalosporins, erythromicin, heparin penicillins, sodium bicarbonate and sulphadiazine sodium.
6.3 Shelf Life
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6.4 Special Precautions For Storage
Protect from light.
Store below 25ºC
6.5 Nature And Contents Of Container
10ml polypropylene dropper bottle fitted with an LDPE nozzle and an HDPE tamper evident cap.
6.6 Special Precautions For Disposal And Other Handling
Not applicable.
7. Marketing Authorisation Holder
FDC International Ltd
Unit 6 Fulcrum 1
Solent Way
Whiteley
Fareham
Hants
PO15 7FE
United Kingdom
8. Marketing Authorisation Number(S)
PL 15872/0004
9. Date Of First Authorisation/Renewal Of The Authorisation
22 January 1998/ 18 March 2003
10. Date Of Revision Of The Text
17 June 2009
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