Consumer medicine information

GENOPTIC EYE DROPS

Gentamicin

BRAND INFORMATION

Brand name

Genoptic

Active ingredient

Gentamicin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using GENOPTIC EYE DROPS.

What is in this leaflet

This leaflet answers some common questions about GENOPTIC® eye drops, (including how to use the eye drops). It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using GENOPTIC® eye drops against the benefits they expect it will have for you.

If you have any concerns about using/taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What GENOPTIC® eye drops are used for

GENOPTIC® eye drops are used for the treatment of infections of the eye caused by bacteria. These include conjunctivitis (an infection of the transparent skin that covers the inner surface of the eyelid and the surface of the eye which causes the eye to produce discharge, to be itchy and to form crusty eyelids); infection of the cornea (the front layer of the eyeball); corneal ulcers; infection of the edges of the eyelids including hair follicles and glands; infection of the oil producing gland that covers the inner surface of the eyelid and infection of the tear sac.

Mechanism of action:

The active ingredient in GENOPTIC® eye drops, gentamicin sulfate, belongs to a chemical group called the aminoglycosides which have an antibiotic activity against a wide range of bacteria.

Your doctor may have prescribed GENOPTIC® eye drops for another reason. Ask your doctor if you have any questions about why GENOPTIC® eye drops have been prescribed for you.

Before you take GENOPTIC® eye drops

When you must not use it

Do not use GENOPTIC® eye drops if:

  1. you have an allergy to GENOPTIC® eye drops or any of the ingredients listed at the end of this leaflet.

Check with your doctor if:

  • you are pregnant or have the intention of becoming pregnant. Like some medicines, GENOPTIC® eye drops should not be used during pregnancy.
  • you are breastfeeding or planning to start breastfeeding. It is not known whether your baby may absorb this medicine from breast milk and therefore there is a possibility of harm to the baby.

Do not use GENOPTIC® eye drops if:

  • the seal around the cap is broken,
  • the bottle/packaging shows signs of tampering,
  • the expiry date on the bottle or carton has passed.

If you use this medicine after the expiry date has passed, it may not work.

If you are not sure whether you should start using GENOPTIC® eye drops, talk to your doctor.

Before you start to take it

Tell your doctor if you have had an allergy to any other medicines or any other substances, such as foods, preservatives or dyes.

If you have not told your doctor about this, tell them before you use GENOPTIC® eye drops.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

There are no known drug interactions with GENOPTIC® eye drops.

How to use GENOPTIC® eye drops

How much to use

The usual dosage of GENOPTIC® eye drops is one or two drops in the affected eye(s) every four hours. If you have a serious infection, your doctor may increase the dosage to a maximum of two drops once every hour.

Your doctor will tell you how many drops you need to use each day. Use GENOPTIC® eye drops only as prescribed by your doctor.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Use GENOPTIC® eye drops every day, at about the same time each day, unless your doctor tells you otherwise. Using your eye drops at the same time each day will have the best effect on your condition. It will also help you remember when to use the eye drops.

If you are being changed from one eye drop to another, follow your doctor’s instructions carefully as to when to stop the old drops and when to start the new drops.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing soft contact lenses, remove them before putting the drops in your eye.

To open a new bottle of GENOPTIC® eye drops, first tear off the protective seal from the bottle. The seal will break and you can pull it off and then throw it away.

  1. Wash your hands well with soap and water.
  2. Shake the bottle gently.
  3. Remove the cap.
  4. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
  5. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  6. Tilt your head back and look up.
  7. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
  8. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
  9. Close your eye. Do not blink or rub your eye.
  10. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
  11. Replace the cap, sealing it tightly.
  12. Wash your hands again with soap and water to remove any residue.

Wait 15 minutes before replacing your contact lenses.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

Contaminated eye drops may give you an eye infection.

How long to use it

Continue using GENOPTIC® eye drops for as long as your doctor prescribes.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using/taking them as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the amount to make up for the dose that you missed.

If you use too much (overdose)

If you accidentally put several drops in your eye(s), immediately rinse your eye(s) with warm water.

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of GENOPTIC® eye drops, immediately telephone your doctor or Poisons Information Centre (telephone 13 11 26) for advice, or go to casualty at your nearest hospital. In New Zealand call the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766).

Do this even if there are no signs of discomfort or poisoning.

While you are using GENOPTIC® eye drops

Things you must do

Your doctor may tell you to use a new container of GENOPTIC® eye drops because of possible contamination of the old one, or may advise you to stop your treatment with GENOPTIC® eye drops.

If you become pregnant while using GENOPTIC® eye drops tell your doctor immediately.

If you are about to be started on any new medicine tell your doctor and pharmacist that you are using GENOPTIC® eye drops.

Things you must not do

Do not give GENOPTIC® eye drops to anyone else, even if they have the same condition as you.

Do not stop using GENOPTIC® eye drops without first talking to your doctor.

Things to be careful of

Be careful driving or operating machinery until you know how GENOPTIC® eye drops affect you.

GENOPTIC® eye drops generally do not cause any problems with your ability to drive a car or operate machinery. However, you should make sure you know how you react to GENOPTIC® eye drops or that your vision is clear before driving a car or operating machinery.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using GENOPTIC® eye drops. GENOPTIC® eye drops help most people with infections of the eye, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by these possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following and they worry you:

  • Temporary irritation of the eye and eyelid
  • Fungal overgrowth
  • Red eye(s)
  • Eye discharge
  • Eye pain
  • Swelling around the eye.

Other side effects not listed above may also occur in some patients. Tell your doctor if you notice any other effects.

After using GENOPTIC® eye drops

Storage

Keep your eye drops in a cool place where the temperature stays below 25°C. Do not freeze the eye drops.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it in the car or on window sills. Do not carry the eye drops in the pockets of your clothes. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Do not leave the top/lid off the bottle for any length of time to avoid contaminating the eye drops.

Disposal

Write the date on the bottle when you open the eye drops and throw out any remaining solution after four weeks.

Eye drops contain a preservative which helps prevent germs growing in the solution for the first four weeks after opening the bottle. After this time there is a greater risk that the drops may become contaminated and cause an eye infection. A new bottle should be opened.

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining solution.

Product description

What it looks like

The eye drops come in a 5 mL sterile plastic bottle.

Ingredients

Active ingredient:
gentamicin sulfate

Inactive ingredients:
polyvinyl alcohol, disodium edetate, sodium phosphate dibasic, sodium chloride,benzalkonium chloride, and purified water.

Manufacturer/Supplier

Allergan Australia Pty Ltd
810 Pacific Highway,
Gordon, NSW 2072
Allergan New Zealand Ltd,Auckland.

ARTG number: AUST R 23215

Date of preparation:
April 2015.

® Marks owned by Allergan, Inc.

Published by MIMS November 2015

BRAND INFORMATION

Brand name

Genoptic

Active ingredient

Gentamicin

Schedule

S4

 

1 Name of Medicine

Gentamicin sulfate.

2 Qualitative and Quantitative Composition

Each mL of Genoptic eye drops contains gentamicin sulfate (equivalent to 3 mg gentamicin).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Eye drops, solution.
Genoptic eye drops are a sterile, aqueous solution buffered to approximately pH 7.0 for use in the eye.

4 Clinical Particulars

4.1 Therapeutic Indications

Genoptic eye drops are indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute meibomianitis and dacryocystitis.

4.2 Dose and Method of Administration

Instil one or two drops of Genoptic eye drops into the affected eye(s) every four hours. In severe infections, dosage may be increased to a maximum of 2 drops once every hour.
In order to minimise systemic absorption of Genoptic eye drops, apply pressure to the tear duct immediately following administration of the drug.

4.3 Contraindications

Hypersensitivity to gentamicin sulfate, benzalkonium chloride or any of the other constituents.

4.4 Special Warnings and Precautions for Use

Identified precautions.

Genoptic eye drops are not for injection. It should never be injected subconjunctivally nor should it be introduced directly into the anterior chamber of the eye.
Prolonged use of topical antibiotics may give rise to overgrowth of nonsusceptible organisms, such as fungi. Bacterial resistance to gentamicin may also develop. Should this occur, or if irritation or hypersensitivity to any component of the product develops, or purulent discharge, inflammation or pain becomes aggravated, discontinue use of the preparation and institute appropriate therapy.
Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection. Patients wearing soft (hydrophilic) contact lenses should be instructed to remove contact lenses before administration of the drug and wait 10-15 minutes after instilling Genoptic eye drops before reinserting soft contact lenses. Patients should be advised that the preservative in Genoptic eye drops, benzalkonium chloride, may be absorbed by soft contact lenses.
To prevent eye injury or contaminating the dropper tip and solution, patients should be advised not touch the eyelids, the surrounding area or any surface with the dropper tip of the bottle.

Use in the elderly.

Safety and effectiveness of Genoptic eye drops in elderly patients have not been established.

Paediatric use.

Safety and effectiveness of Genoptic eye drops in paediatric patients have not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of gentamicin by the foetal kidney resulting in damage (probably reversible) to immature nephrons. Eighth cranial nerve damage has also been reported following in utero exposure to some of the aminoglycosides. Because of their chemical similarity, all aminoglycosides must be considered potentially nephrotoxic and ototoxic to the foetus. It should also be noted that therapeutic blood levels in the mother do not equate with safety for the foetus.
There are no adequate and well controlled studies of Genoptic eye drops in pregnant women. Gentamicin should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.
Studies on the use of Genoptic eye drops during lactation have not been conducted.
Because many drugs are excreted in human milk, caution should be exercised when Genoptic eye drops is administered to a nursing woman.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Transient irritation has been reported with the use of Genoptic eye drops.

Postmarketing experience.

The following adverse reactions have been identified during postmarketing use of Genoptic eye drops: conjunctival hyperaemia; ocular hyperaemia; eye discharge; eye irritation; eye pain; eye oedema; hypersensitivity including eyelid irritation, eyelid oedema, eye swelling.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration 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 at www.tga.gov.au/reporting-problems.

4.9 Overdose

In case of overdosage, immediately flush the eye(s) with water or normal saline.
If ingested accidently, patients should be advised to drink plenty of liquid to dilute and seek medical direction.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Gentamicin sulfate is a water soluble antibiotic of the aminoglycoside group which has shown activity against a wide variety of pathogenic Gram negative and Gram positive bacteria. The Gram positive bacteria against which gentamicin sulfate is active include coagulase positive and negative Staphylococci.
The Gram negative bacteria against which gentamicin sulfate is active include certain strains of Pseudomonas aeruginosa, indole positive and indole negative Proteus species, Escherichia coli, Klebsiella pneumoniae (Friedlander's bacillus), Haemophilus influenzae and Haemophilus aegyptius (Koch-Weeks bacillus), Aerobacter aerogenes, Moraxella lacunata (diplobacillus of Morax-Axenfeld) and Neisseria species, including Neisseria gonorrhoeae.
At this time there are increasing members of resistant cases being reported for the aminoglycoside class of antibiotics, particularly to Streptococcus pneumoniae. This phenomenon will also reduce the synergy with the β-lactam class of drugs as combination therapy. This should be considered when commencing therapy for all ocular infections and the results of therapy should be closely monitored for signs of inefficiency. Should this occur, more aggressive pharmacotherapeutic options, e.g. a cephalosporin, should be used.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Studies on the pharmacokinetics of ophthalmic preparations of gentamicin sulfate have not been conducted.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each mL contains gentamicin sulfate (equivalent to 3 mg gentamicin) with polyvinyl alcohol (Liquifilm), disodium edetate, sodium phosphate dibasic, sodium chloride, benzalkonium chloride as a preservative and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

2 years.

6.4 Special Precautions for Storage

Store below 25°C.
To avoid contamination of the solution, keep container tightly closed.
Do not touch dropper tip to any surface.
Discard unused contents 4 weeks after opening the bottle.
Contents are sterile if seal is intact.

6.5 Nature and Contents of Container

Genoptic eye drops is stored in a 5 mL dropper bottle. AUST R 23215.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.


Description.

Gentamicin sulfate is a white to buff hygroscopic powder which is freely soluble in water, ethylene glycol and formamide. It is practically insoluble in alcohol, acetone, chloroform and ether. Gentamicin sulfate is a mixture of the sulfates of gentamicin C1, gentamicin C1A and gentamicin C2. When dry, gentamicin sulfate contains not less than 590 units of gentamicin per mg.

Chemical name.

O-3-deoxy-4-C-methyl- 3-(methylamino)- β-L-arabinopyranosyl-(1→6)-O-[2, 6-diamino-2,3,4,6-tetradeoxy- α-D-erythro-hexopyranosyl-(1→4)]- 2-deoxy-D-streptamine.

Empirical formula.

Gentamicin C1: C21H43N5O7.
Gentamicin C1A: C19H39N5O7.
Gentamicin C2: C20H41N5O7.

CAS number.

1405-41-0.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes