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. 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 ototoxicity (vestibular damage; 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 gentamicin into the middle ear also carries a theoretical risk of ototoxicity in susceptible patients.

Concurrent use with other potentially nephrotoxic or ototoxic drugs should be avoided unless considered essential by the physician (see section 4.5).

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 and cephalosporins are potential enhancers of nephrotoxicity.

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

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

4.8 Undesirable effects
There are no modern clinical studies available that can be used to determine the frequency of undesirable effects. Therefore, all the undesirable effects listed are classed as “frequency unknown”.

Eye Disorders:-

Local sensitivity; blurred vision, eye irritation, burning sensation, stinging sensation, itching (eye pruritus)

Ear & Labyrinth Disorders:-

Local sensitivity; ototoxicity; vestibular disorder; hearing loss

Skin & Subcutaneous tissue Disorders:-

burning sensation, stinging, itching (pruritus); dermatitis.

Renal & Urinary Disorders:-

Nephrotoxicity; acute renal failure

In the event of irritation, sensitivity or super-infection, treatment should be discontinued and appropriate therapy instituted.

Reporting of suspected adverse reactions:-

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow card scheme at www.mhra.gov.uk/yellowcard.
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 1/kg

The elimination rate constant is;

0.02 Hr-1 for anuric patients*

0.30 Hr-1 normal

* 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
Unopened:
 24 months
 
Opened:
 28 days
 
6.4 Special precautions for storage
Protect from light.

Store below 25°C

6.5 Nature and contents of container
10ml low density polyethylene bottle with polystyrene spiked cap.

6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
FDC International Ltd

Unit 6 Fulcrum 1, Solent Way, Whiteley, Fareham, Hants, PO15 7FE.

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
10 June 2015