Sofradex Sterile Ear/Eye Drops

Sofradex general information

What is Sofradex used for?

Sofradex Ear/Eye Drops are used to treat otitis externa, which is inflammation of the outer ear and the ear canal (external auditory canal) that is characterised by redness, swelling, scaling and thickening of the canal skin lining.  Otitis externa is usually caused either by infection or a skin condition like dermatitis that can lead to a secondary infection.  Common causes of bacterial overgrowth in the skin of the outer ear include excess moisture, due to swimming, humidity or perspiration, carrying bacteria into the cerumen (ear wax) of the ear canals; or physical trauma that damages the skin of the outer ear, such as use of cotton buds or inserting a finger into the ear.  Sofradex Ear/Eye Drops are also used for short term treatment of superficial bacterial eye infections, such as conjunctivitis, which is inflammation of the conjunctiva (outermost layer of the eye and the inside of the eyelid); blepharitis or inflammation of the eyelid; sty, which is infection of a hair follicle on the eyelid; meibomianitis or inflammation of the oil producing glands on the inner surface of the eyelid; keratitis or inflammation of the cornea (the clear area at the front of the eye over the lens and pupil) and corneal ulcers.  The combination of medications in Sofradex Ear/Eye Drops help reduce inflammation and relieve symptoms of infection of the eye, including sore eyes, redness, inflammation, discharge and crusting around the eyelid; also the ear, including discharge, discomfort, itching and deafness.  

How does Sofradex work?

Sofradex Ear/Eye Drops contain a combination of two antibiotics and a corticosteroid.  Framycetin sulfate is an aminoglycoside bactericidal antibiotic that is effective against staphylococci (including strains resistant to other antibiotics), Pseudomonas aeruginosa, coliform bacteria and pneumococci.  Framycetin sulfate in Sofradex Ear/Eye Drops works by binding to the bacterial RNA and blocking synthesis of essential cell proteins needed for bacterial cell growth.  Gramicidin is a mixture of 3 polypeptide antibiotics obtained from the soil bacteria Bacillis brevis that is used as a topical antibiotic, which in Sofradex Ear/Eye Drops reinforces the action of framycetin sulfate against streptococci.  The components of gramicidin assemble within the membrane of the bacteria forming a pore that increases the permeability of the bacterial cell membrane.  This causes a loss of ions (potassium and sodium) from the bacterial cell and a disruption of normal bacterial cell function, leading to bacterial cell death.  Dexamethasone in Sofradex Ear/Eye Drops is a highly potent corticosteroid and works by reducing the vascular (blood vessels) and cellular inflammatory response that triggers inflammation, primarily by blocking the production of inflammatory chemicals, like prostaglandins and leukotrienes from inflammatory cells and preventing the migration of inflammatory cells into inflamed tissues.  This action of dexamethasone in Sofradex Ear/Eye Drops reduces the swelling, redness and pain associated with inflammation.

What does Sofradex contain?

Sofradex Ear/Eye Drops contain the active ingredient framycetin sulfate 5mg, gramicidin 0.05mg and dexamethasone 0.5mg per ML, used to treat otitis externa and eye infections.  They also contain phenethyl alcohol, methylated spirit - industrial, citric acid monohydrate, sodium citrate, lithium chloride, polysorbate 80 and purified water.

Treating otitis externa with Sofradex

Sofradex Ear/Eye Drops contain a combination of two antibiotics and a corticosteroid and are used to treat otitis externa, inflammation of the outer ear and the ear canal (external auditory canal) that is characterised by redness, swelling, scaling and thickening of the canal skin lining.  Otitis externa is usually caused either by infection or a skin condition like dermatitis that can lead to a secondary infection.  Common causes of bacterial overgrowth in the skin of the outer ear include excess moisture, due to swimming, humidity or perspiration, carrying bacteria into the cerumen (ear wax) of the ear canals; or physical trauma that damages the skin of the outer ear, such as use of cotton buds or inserting a finger into the ear.  The antibiotic framycetin in Sofradex Ear/Eye Drops works by blocking synthesis of essential cell proteins needed for bacterial cell growth and the antibiotic gramicidin increases the permeability of the bacterial cell membrane causing disruption of normal bacterial cell function, leading to bacterial cell death.  Dexamethasone in Sofradex Ear/Eye Drops is a highly potent corticosteroid and works by reducing the vascular (blood vessels) and cellular inflammatory response that triggers inflammation, primarily by blocking the production of inflammatory chemicals, like prostaglandins and leukotrienes from inflammatory cells and preventing the migration of inflammatory cells into inflamed tissues.  This action of dexamethasone in Sofradex Ear/Eye Drops reduces the swelling, redness and pain associated with inflammation.

Sofradex for inflammatory or infectious eye conditions

Sofradex Ear/Eye Drops contain a combination of two antibiotics and a corticosteroid and are used for short term treatment of superficial bacterial eye infections, such as conjunctivitis, which is inflammation of the conjunctiva (outermost layer of the eye and the inside of the eyelid); blepharitis or inflammation of the eyelid; sty, which is infection of a hair follicle on the eyelid; meibomianitis or inflammation of the oil producing glands on the inner surface of the eyelid; keratitis or inflammation of the cornea (the clear area at the front of the eye over the lens and pupil) and corneal ulcers.  The antibiotic framycetin in Sofradex Ear/Eye Drops works by blocking synthesis of essential cell proteins needed for bacterial cell growth and the antibiotic gramicidin increases the permeability of the bacterial cell membrane causing disruption of normal bacterial cell function, leading to bacterial cell death.  Dexamethasone in Sofradex Ear/Eye Drops is a highly potent corticosteroid and works by reducing the vascular (blood vessels) and cellular inflammatory response that triggers inflammation, primarily by blocking the production of inflammatory chemicals, like prostaglandins and leukotrienes from inflammatory cells and preventing the migration of inflammatory cells into inflamed tissues.  The combination of medications in Sofradex Ear/Eye Drops help reduce inflammation and relieve symptoms of infection of the eye, including sore eyes, redness, inflammation, discharge and crusting around the eyelid; also the ear, including discharge, discomfort, itching and deafness.  

What are the side effects of Sofradex?

The most commonly reported side effects when taking Sofradex Ear/Eye Drops include irritation, burning, itching, stinging and dermatitis due to hypersensitivity reaction; blurred vision, raised intraocular pressure, cataract, delayed healing in the eye.

When should Sofradex not be used?

You should not use Sofradex Ear/Eye Drops if you:

• are allergic to framycetin or any other aminoglycoside antibiotic, gramicidin or dexamethasone or any ingredients in Sofradex
• are pregnant or are breastfeeding, without discussion with your doctor
• have a viral or fungal eye infection, or tuberculous or a sticky discharge from the eye
• have herpetic keratitis (herpes infection of the eye), such as dendritic ulcer
• are at risk of developing glaucoma (e.g. family history)
• have undiagnosed red eye (swollen blood vessels in the eye)
• have a perforated ear drum
• if you are taking a systemic aminoglycoside antibiotic

How should Sofradex be used?

You should apply your Sofradex Ear/Eye Drops after shaking the bottle and using the dropper provided.  For the ear, tilt your head and apply 2-3 drops into the ear allowing the drops to penetrate deep into the ear and repeat 3-4 times daily.  For the eye, tilt your head back, pulling the lower eyelid to form a pouch and apply 1-2 drops into this conjunctival sac of each affected eye and repeat up to 6 times daily or more frequently if required.  If you wear contact lenses, these should be removed before adding Sofradex Ear/Eye Drops and although they may cause blurred vision when added, this will clear.  Sofradex Ear/Eye Drops are not intended for long term use and you should see an improvement within 7 days.  You should continue to apply your Sofradex Ear/Eye Drops only for as long as recommended by your doctor.

How long should you use Sofradex?

Sofradex Ear/Eye Drops are not intended for long term use and you should see an improvement within 7 days.  You should continue to apply your Sofradex Ear/Eye Drops only for as long as recommended by your doctor.

Missed dose of Sofradex

If you miss a dose of Sofradex apply it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Sofradex be stored?

You should store your Sofradex below 25°C in a cool dry place.