Consumer medicine information

Sofradex Ear Drops

Dexamethasone; Framycetin sulfate; Gramicidin

BRAND INFORMATION

Brand name

Sofradex

Active ingredient

Dexamethasone; Framycetin sulfate; Gramicidin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sofradex Ear Drops.

What is in this leaflet

This leaflet answers some common questions about Sofradex.

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 or pharmacist has weighed the risks of you using Sofradex against the benefits they expect it will have for you.

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

Keep this leaflet with the medicine.

You may need to read it again.

What Sofradex is used for

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

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

Before you use it

When you must not use it

Do not use Sofradex if you have an allergy to Sofradex or any of the ingredients listed at the end of this leaflet.

Do not use Sofradex if you are allergic to framycetin, gramicidin or dexamethasone.

Do not use Sofradex if you have:

  • a hole in your eardrum
  • viral or tubercular lesions
  • chicken pox (varicella virus)
  • vaccinia - a type of virus

Do not use Sofradex if you are pregnant or intend to become pregnant. Like most aminoglycosides, Sofradex is not recommended for use during pregnancy.

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

Do not use Sofradex 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 Sofradex, contact your doctor or pharmacist.

Before you start to use it

Tell your doctor or pharmacist if you have allergies to:

  • framycetin, gramicidin or dexamethasone
  • any other medicines, especially antibiotics such as neomycin, paromomycin and kanamycin
  • any other substances, such as foods, preservatives or dyes

Tell your doctor if you are pregnant or intend to become pregnant. Like most medicines of this kind, Sofradex is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of using it if you are pregnant.

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.

How to use it

Use Sofradex only as directed by your doctor. Generally this will be as follows:

The drops are usually used 3 or 4 times daily. 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 Sofradex in a different way, according to his or her judgment.

Ask your pharmacist for advice if you need further instructions on how best to use Sofradex.

How long to use it

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

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.

While you are using it

Things you must do

Use Sofradex only in the ear unless your doctor advises differently. Contact your doctor promptly if:

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

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

Things you must not do

Do not give Sofradex to anyone else, even if they have the same condition as you.

Do not use Sofradex to treat any other complaints unless your doctor or pharmacist tells you to.

Do not stop using Sofradex, or lower the dosage, without checking with your doctor or pharmacist.

Do not apply Sofradex 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Sofradex, even if the problem is not listed below.

Sofradex helps most people with an infection or inflammation of the ear, 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.

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

  • local allergic reaction: pain, itching, stinging, weeping or swelling around the site of application.

These are the more common side effects of Sofradex. Mostly these are mild and short-lived.

Other side effects not listed above may occur in some patients.

After using it

Storage

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

Do not store Sofradex 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. 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.

Disposal

If your doctor or pharmacist tells you to stop using Sofradex or the medicine has passed its expiry date, ask your pharmacist what to do with any that is left over.

Return any unused medicine to your pharmacist.

Product description

What it looks like

Sofradex Ear Drops is supplied as a sterile clear solution in a glass dropper bottle.

Ingredients

Active ingredients:

  • framycetin sulfate (5 mg/mL)
  • gramicidin (0.05 mg/mL )
  • dexamethasone (0.5 mg/mL)

Inactive ingredients:

  • phenethyl alcohol (preservative)
  • polysorbate 80
  • industrial methylated spirit
  • citric acid monohydrate
  • sodium citrate dihydrate
  • lithium chloride
  • sodium hydroxide
  • hydrochloric acid
  • purified water

Supplier

Sofradex is supplied in Australia by:

sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall No: 1800 818 806

This leaflet was prepared April 2020

Australian Registration Number

Sofradex Ear Drops: AUST R 13539

sofradex-ccdsv3-cmiv7-29apr20

Published by MIMS June 2020

BRAND INFORMATION

Brand name

Sofradex

Active ingredient

Dexamethasone; Framycetin sulfate; Gramicidin

Schedule

S4

 

1 Name of Medicine

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

6.7 Physicochemical Properties

Framycetin sulfate.

Molecular Weight: 712.72.

Gramicidin.

See Table 1.

Dexamethasone sodium metasulfobenzoate.

Molecular Weight: 598.6.

Chemical structure.


CAS number.

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

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

Sofradex is a clear bright colourless aqueous solution.

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.

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.

4.3 Contraindications

Hypersensitivity to the active substances (see Section 2 Qualitative and Quantitative Composition) or to any of the excipients listed (see Section 6.1 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

Sofradex 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.
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 Sofradex 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 Sofradex 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)
Sofradex should be used during pregnancy only if the potential benefits to the mother outweigh the potential risks, including those to the fetus.
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 Sofradex in human milk, milk production, or the effects on the breastfed infant. No conclusions can be drawn regarding whether or not Sofradex is safe for use during breastfeeding. Sofradex should be used during breastfeeding only if the potential benefits to the mother outweigh the potential risks, including those to the breastfed child.

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).

4.2 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.

4.7 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.

4.9 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).

7 Medicine Schedule (Poisons Standard)

S4.

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.

Summary Table of Changes