Consumer medicine information



Active ingredients: Framycetin sulfate, Gramicidin, Dexamethasone

Consumer Medicine Information (CMI)

This leaflet provides important information about using Otodex. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Otodex.

Where to find information in this leaflet:

1. Why am I using Otodex?
2. What should I know before I use Otodex?
3. What if I am taking other medicines?
4. How do I use Otodex?
5. What should I know while using Otodex?
6. Are there any side effects?
7. Product details

1. Why am I using Otodex?

Otodex contains the active ingredients framycetin sulfate, gramicidin and dexamethasone. Otodex contains antibiotics (framycetin sulfate and gramicidin) to kill germs and a corticosteroid (dexamethasone) to stop inflammation, itching and weeping

Otodex is used to treat infection or inflammation of the ear.

2. What should I know before I use Otodex?


Do not use Otodex if:

  • you are allergic to framycetin sulfate, gramicidin, dexamethasone, or any of the ingredients listed at the end of this leaflet.
    Always check the ingredients to make sure you can use this medicine.
  • you are pregnant or intend to become pregnant
  • you have a hole in your eardrum
  • you have viral or tubercular lesions
  • you have chicken pox (varicella virus)
  • you have vaccinia – a type of virus

Do not use Otodex after the expiry date printed on the pack. If you use this medicine after the expiry date has passed, it may not work as well.

Do not use Otodex if the packaging is torn or shows signs of tampering, or if it doesn’t look quite right.

If you are not sure whether you should start using Otodex, contact your doctor or pharmacist.

Tell your doctor if you:

  • have allergies to framycetin, gramicidin or dexamethasone
  • have allergies to any other medicines, especially antibiotics such as neomycin, paromomycin and kanamycin
  • have allergies to any other substance, such as foods, preservatives or dyes
  • have an ototoxicity or family history of ototoxicity (harmful effects to ear) with signs and symptoms including ringing in ears, imbalance (associated with dizziness, nausea, and blurry vision), decreased hearing, hearing loss
  • know (or think) you have a mitochondrial disease (mutations in the parts of your cells which help make energy). These diseases may increase your risk of hearing loss with this product.

Check with your doctor if you:

  • have any other medical conditions
  • take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or intend to become pregnant.

Do not use Otodex if you are pregnant or intend to become pregnant.

Like most aminoglycosides, Otodex is not recommended for use during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of using it if you are pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Otodex.

4. How do I use Otodex?

How much to use

  • Follow the instructions provided by your doctor when Otodex was prescribed, including the number of days it should be used.
  • Generally, the drops are used 3 or 4 times daily.

How to use Otodex

  • Remove the cap from the bottle immediately before use and place it back on the bottle immediately after use. To use the drops, tilt your head so that the affected ear is uppermost. Position the rubber dropper, which is attached to the bottle, directly above the ear hole. With the bottle tipped upside down, gently squeeze the rubber dropper until 2 or 3 drops fall into the ear. Keep your head tilted for about a minute to allow the drops to penetrate deep into the ear.
  • Do not apply to open wounds or damaged skin.
  • Your doctor may decide to adjust your dosage if necessary or ask you to use Otodex in a different way, according to his or her judgment.

How long to use Otodex

  • Continue using Otodex until your doctor or pharmacist tells you to stop.
  • Do not stop using it unless your doctor or pharmacist tells you to – even if you feel better.

If you forget to use Otodex

Otodex should be used regularly at the same time each day.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, use it as soon as you remember, and then go back to using your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

If you are not sure what to do, ask your doctor or pharmacist.

If you have trouble remembering to use your medicine, ask your pharmacist for some hints.

If you use too much Otodex

If you think that you have used too much Otodex, you may need urgent medical attention.

You should immediately:

  • phone the Poisons Information Centre
    (by calling 13 11 26), or
  • contact your doctor, or
  • go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Otodex?

Things you should do

Use Otodex only in the ear unless your doctor advises differently.

Call your doctor straight away if:

  • your condition worsens during treatment
  • an allergic reaction develops
  • you feel no better after completing the prescribed treatment

Remind any doctor, dentist or pharmacist you visit that you are using Otodex.

If you become pregnant while using Otodex, stop using it and tell your doctor or pharmacist immediately.

Things you should not do

  • Do not stop using this medicine, or lower the dosage, without checking with your doctor or pharmacist.
  • Do not give Otodex to anyone else, even if they have the same condition as you.
  • Do not use Otodex to treat any other complaints unless your doctor or pharmacist tells you to.
  • Do not apply Otodex to open wounds or damaged skin, as this may cause irreversible, partial or total deafness. These effects may be aggravated by kidney or liver problems, or prolonged use. Do not continue treatment after these symptoms have resolved.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Otodex affects you.

Otodex may cause dizziness in some people

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

  • Keep Otodex in a cool dry place where the temperature stays below 25°C. Do not refrigerate.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

  • in the bathroom or near a sink, or
  • in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Common side effects

Common side effects What to do
  • local allergic reaction: pain, itching, stinging, weeping or swelling around the site of application
Speak to your doctor if you have any of these less serious side effects and they worry you.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Otodex contains

Active ingredient
(main ingredient)
framycetin sulfate (5 mg/mL)
gramicidin (0.05 mg/mL)
dexamethasone 0.5 mg/mL)
Other ingredients
(inactive ingredients)
phenethyl alcohol (preservative)
polysorbate 80
industrial methylated spirit
citric acid monohydrate
sodium citrate dihydrate
lithium chloride
sodium hydroxide
hydrochloric acid
purified water

Do not take this medicine if you are allergic to any of these ingredients.

What Otodex looks like

Otodex Ear Drops is supplied as a sterile clear solution in a glass dropper bottle (Aust R 43840).

Who distributes Otodex

Otodex is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113

This leaflet was prepared in June 2022.