Consumer medicine information

Otodex

Dexamethasone; Framycetin sulfate; Gramicidin

BRAND INFORMATION

Brand name

Otodex

Active ingredient

Dexamethasone; Framycetin sulfate; Gramicidin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Otodex.

SUMMARY CMI

Otodex®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using Otodex?

Otodex contains the active ingredients framycetin sulfate, gramicidin and dexamethasone. Otodex is used to treat infection or inflammation of the ear. Otodex contains antibiotics (framycetin sulfate and gramicidin) to kill germs and a corticosteroid (dexamethasone) to stop inflammation, itching and weeping.

For more information, see Section 1. Why am I using Otodex? in the full CMI.

2. What should I know before I use Otodex?

Do not use if you have ever had an allergic reaction to Otodex or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use Otodex? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Otodex and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Otodex?

  • Generally Otodex drops are used 3 or 4 times daily
  • To use, tilt your head so that the affected ear is uppermost. Position the rubber dropper 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.

More instructions can be found in Section 4. How do I use Otodex? in the full CMI.

5. What should I know while using Otodex?

Things you should do
  • Remind any doctor, dentist or pharmacist you visit that you are using Otodex.
  • Use Otodex only in the ear unless your doctor advises differently.
  • 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 use Otodex to treat any other complaints unless your doctor or pharmacist tells you to.
Driving or using machines
  • Be careful before you drive or use any machines or tools until you know how Otodex affects you.
Looking after your medicine
  • Keep Otodex in a cool dry place where the temperature stays below 25°C. Do not refrigerate.
  • Do not store Otodex or any other medicine in the bathroom or near a sink.
  • Do not leave it in the car on hot days or on window sills.

For more information, see Section 5. What should I know while using Otodex? in the full CMI.

6. Are there any side effects?

Side effects include local allergic reaction: pain, itching, stinging, weeping or swelling around the site of application

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Otodex®

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?

Warnings

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 effectsWhat 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 www.tga.gov.au/reporting-problems. 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.

otodex-ccdsv2-cmiv8-d1-02jun22

Published by MIMS August 2022

BRAND INFORMATION

Brand name

Otodex

Active ingredient

Dexamethasone; Framycetin sulfate; Gramicidin

Schedule

S4

 

1 Name of Medicine

Framycetin sulfate, gramicidin and dexamethasone (as sodium metasulfobenzoate).

2 Qualitative and Quantitative Composition

Each mL contains framycetin sulfate 5 mg, gramicidin 50 microgram and dexamethasone (as sodium metasulfobenzoate) 500 microgram.
For full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Otodex is a clear bright colourless aqueous solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Inflammatory and allergic conditions of the ear, e.g. otitis externa. Eczema of the auditory meatus is often present and causes inflammation, exudation and pruritus, which are all rapidly relieved by dexamethasone. Infection, often secondary to scratching, is generally due to staphylococci, E. coli, Pseudomonas and Proteus spp. which respond rapidly to framycetin sulfate.

4.2 Dose and Method of Administration

2 or 3 drops should be instilled into the ear three or four times daily; alternatively, a gauze wick kept saturated with the drops may be inserted into the external auditory meatus.

4.3 Contraindications

Hypersensitivity to the active substances (see Section 2 Qualitative and Quantitative Composition) or to any of the excipients listed in List of Excipients.
Viral and fungal infections.
Tubercular lesions.
Varicella, vaccinia.
Eardrum perforation.
Acute purulent, untreated infections.

4.4 Special Warnings and Precautions for Use

Otodex should be discontinued if there are signs of sensitivity to any of its ingredients.
Treatment with corticosteroid/antibiotic combinations should not be continued in the absence of clinical improvement, since prolonged use may lead to occult extension of infections due to the masking effect of the steroid. Prolonged use may also lead to skin sensitisation and the emergence of resistant organisms.
In patients known to be allergic to Streptomyces-derived antibiotics (neomycin, paromomycin, kanamycin), cross-sensitisation to framycetin sulfate may occur, but not invariably so.
Aminoglycoside antibiotics may cause irreversible, partial or total deafness when applied topically to open wounds or damaged skin. This effect is aggravated by renal or hepatic impairment and by prolonged duration of treatment. The treatment should not be continued after resolution of symptoms.
There have been reported cases of ototoxicity with aminoglycosides administered to patients with mitochondrial mutations, particularly the m.1555A > G mutation, which suggests an increased risk of ototoxicity in these patients, including cases where the patient's aminoglycoside serum levels were within the recommended range. Some cases were associated with a maternal history of deafness and/or mitochondrial mutation. Mitochondrial mutations are rare, and the penetrance of this observed effect is unknown.
Although no cases were identified with topical preparations of neomycin, framycetin or gentamicin, the potential for a similar effect with neomycin and other aminoglycosides administered topically cannot be ruled out.
Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) (see Section 4.8 Adverse Effects (Undesirable Effects)).
Pheochromocytoma crisis, which can be fatal, has been reported after administration of corticosteroids. Corticosteroids should only be administered to patients with suspected or identified pheochromocytoma after an appropriate risk/benefit evaluation.
During therapy with Otodex, a possible increased need for insulin or antidiabetics should be considered in patients with diabetes. The hypoglycaemic reactions can be reduced.

Use in the elderly.

No data available.

Paediatric use.

Although it is unlikely that infants will be treated with Otodex for prolonged periods, there is a risk of adrenal suppression, even without occlusive dressings, after prolonged treatment of these patients with topical steroids.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Co-treatment with CYP3A inhibitors, including cobicistat-containing products, is expected to increase the risk of systemic side-effects. The combination should be avoided unless the benefit outweighs the increased risk of such side-effects, in which case patients should be monitored.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category D)
Otodex should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the foetus.
Gentamicin and other aminoglycosides cross the placenta. There is evidence of selective uptake of aminoglycosides by the fetal 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 concentrations in the mother do not equate with safety for the foetus.
There are no available data on the presence of Otodex in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not Otodex is safe for use during breastfeeding. Otodex should be used during breastfeeding only if the potential benefits to the mother outweigh the potential risks, including those to the breastfed child.

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)

Immune system disorders.

Local allergic reactions of the hypersensitivity type have rarely been reported.
Frequency not known: Hypersensitivity reactions, usually of the delayed type, may occur, leading to irritation, burning, stinging, itching and dermatitis.

Eye disorders.

Not known: glaucoma, cataracts, corneal perforation, blurred vision, chorioretinopathy.

Endocrine disorders.

Frequency not known: Iatrogenic Cushing's syndrome, adrenal atrophy.

Metabolism and nutrition disorders.

Frequency not known: diabetes mellitus, glucose tolerance decreased.

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 (Australia).

4.9 Overdose

Long-term intensive topical use may lead to systemic effects.
For information on the management of overdose, contact the Poisons Information Centre, telephone number 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Framycetin sulfate is a bactericidal antibiotic active against a wide variety of Gram-positive and Gram-negative bacteria commonly found in superficial infections; staphylococci (including strains resistant to other antibiotics), Pseudomonas aeruginosa, coliforms and pneumococci.
Gramicidin reinforces the action of framycetin sulfate against streptococci.
Dexamethasone is a highly potent topical corticosteroid. Its topical superiority is particularly apparent in cases in which other corticosteroids have failed.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

It also contains polysorbate 80, industrial methylated spirit, citric acid monohydrate, sodium citrate dihydrate, lithium chloride, sodium hydroxide, hydrochloric acid, purified water and is preserved with phenethyl alcohol.

6.2 Incompatibilities

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

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.
Discard 4 weeks after opening.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

8 mL bottles.

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.

Framycetin sulfate.


Molecular weight: 712.72.

Gramicidin.

See Table 1.

Dexamethasone sodium metasulfobenzoate.


Molecular weight: 598.6.

CAS number.

Framycetin sulphate - 4146-30-9.
Gramicidin - 1405-97-6.
Dexamethasone sodium metasulfobenzoate - 3936-02-5.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes