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

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.

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

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.

Pregnancy category C
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 lifethreatening
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.

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.

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.
To report any side effects:
National Pharmacovigilance & Drug Safety Centre (NPC)
• Fax: +966-11-205-7662
• Toll free phone: 8002490000
• E-mail: npc.drug@sfda.gov.sa
• Website: www.sfda.gov.sa/npc

United Arab Emirates

 Pharmacovigilance & Medical device Section

 P.O. Box: 1853

 Tel: 80011111

 E-mail: pv@mohap.gov.ae

 Drug Department

 Ministry of Health & Prevention 

Dubai

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.

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.

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 (V
D) 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.

Nothing of relevance which is not included in other sections of the SPC

Eye/Ear drops:
Sodium Chloride
Sodium Phosphate
Disodium Phosphate Dihydrate.
Disodium Edetate
Benzalkonium Chloride solution
Purified Water

Pharmaceutically incompatible with amphotericin, cephalosporins, erythromicin, heparin, penicillins,
sodium bicarbonate and sulphadiazine sodium.

Store below 30°C.
Protect from light.
Do not refrigerate or freeze.
In use instruction: use during one month after first opening.

White plastic bottle with white plastic cap and white pilfer proof contains (Clear colorless to slight
yellow solution free from visible particles).

Not applicable.