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GENTAMICIN EYE/EAR DROPS 0.3%W/V

Active substance(s): GENTAMICIN SULPHATE / GENTAMICIN SULPHATE / GENTAMICIN SULPHATE

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SUMMARY OF PRODUCT CHARACTERISTICS

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 blepharoconjunctivitis, 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 or any of
the ingredients, or other aminoglycosides. Evidence exists that gentamicin may cause
neuromuscular blockade and is therefore contra-indicated in myasthenia gravis and
related conditions.
Perforation of the ear drum.

4.4

Special warnings and precautions for use
The condition of the ear drum must always be checked before this medicinal product
is prescribed.
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.
Irreversible toxic effects may result from direct contact of gentamicin with the middle
and inner ear. This medicinal product must not be used if the integrity of the ear drum
cannot be guaranteed.
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..
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 7085% 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 H-1 normal
* Therefore in those with anuria care must be exercised.

5.3.

Pre-clinical 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 solution (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:
Opened:

6.4.

24 months
28 days

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
Not applicable

7

MARKETING AUTHORISATION HOLDER
FDC International Ltd
Unit 6 Fulcrum 1,
Solent Way,
Whiteley,
Fareham,
Hampshire

PO15 7FE
UK

8.

MARKETING AUTHORISATION NUMBER
PL 15872/0004

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
28/07/2010

10

DATE OF REVISION OF THE TEXT
20/07/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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