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.

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.

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.

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.

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.

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 (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.

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

6.1 List of excipients
sodium chloride
sodium metabisulphite
sodium phosphate dibasic
sodium phosphate monobasic.
Benzalkonium chloride

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

3 years.

Protect from light.
Don’t store above 30 °C
Discard contents four weeks after opening.

Apigen is an Eye /Ear drop in a plastic bottle. Each carton contains 1 plastic bottle with a screw
cap. Each bottle contains 10 ml of the eye/ear drops as written on the front of the carton

None.