Sofradex Ear/Eye Drops, Solution contains three medicines called Framycetin sulphate, Gramicidin and Dexamethasone sodium metasulphobenzoate.

  • Framycetin sulphate and Gramicidin belong to a group of medicines called antibiotics. These work by killing the bacteria that is causing the infection.
  • Dexamethasone sodium metasulphobenzoate. This belongs to a group of medicines called steroids. It works by lowering inflammation.

What is Sofradex used for?

  • Inflammation of the outer part of the ear canal (otitis externa).
  • Short-term treatment of eye inflammation when preventing bacterial infection is also required, for example after eye surgery.

How does Sofradex work?

  • Sofradex eye and ear drops contain three active ingredients, dexamethasone, framycetin and gramicidin. Dexamethasone belongs to a group of medicines known as corticosteroids that are used for reducing inflammation. Framycetin and gramicidin are antibiotics that are included in these drops to prevent infections with bacteria.
  • Corticosteroids are hormones produced naturally by the adrenal glands that have many important functions, including control of inflammatory responses.
Dexamethasone is a synthetic corticosteroid that can be administered into the eyes or ears to decrease inflammation.
  • Inflammation can occur as a result of allergies, or from irritation or trauma. It is caused by the release of substances that are important in the immune system. These substances cause blood vessels to widen, resulting in the affected area becoming red, swollen and painful. Corticosteroids work by acting within cells to decrease the release of these substances in a particular area, thereby reducing swelling and redness.
  • Framycetin belongs to a group of antibiotics called aminoglycosides. These antibiotics have the ability to kill a wide variety of bacteria. Framycetin works by affecting the production of certain proteins by bacteria. These proteins are necessary for the bacteria's survival. Framycetin causes the bacteria to produce abnormal and faulty proteins, which ultimately kills the bacteria.
  • Gramicidin is an antibacterial medicine that kills bacteria in a different way. The combination of these two antibiotics kills a wide variety of bacteria that may infect inflamed eye or ear conditions.
  • How do I use Sofradex?

    • This medicine is for use in the eyes or ears only; it must not be taken by mouth.
    • Wash your hands before using the drops.
    • If using the drops for the eye, the usual dose is one or two drops into the affected eye(s) up to six times a day. For use in the ears, the usual dose is two or three drops into the affected ear(s) three to four times a day.
    • You should not use these drops for longer than seven days unless advised to by your doctor. Consult your doctor if after seven days of treatment with this medicine there is little or no improvement in your symptoms, or your sympoms get worse despite treatment.
    • These drops contain a preservative that helps to keep the drops sterile while they are in use. However, the drops should be disposed of four weeks after first opening the bottle, because by this time they may have been contaminated with germs that could cause eye or ear infections. You may find it helpful to write the date of opening on the pack. Dispose of carefully, preferably by returning to your pharmacy.

    Things to know about Sofradex before using it

    • If you are using these drops in your eye(s) your vision may blur temporarily after you have put the drops in. Do not drive or operate machinery until this has worn off.
    • These drops should not be used for longer than instructed by your doctor. Intensive or prolonged application of corticosteroids to the eye may lead to an increase in the pressure inside the eye, glaucoma, damage to the optic nerve or the formation of cataracts. Your eye specialist will want you to have regular eye check-ups to monitor for these types of side effects if you use this medicine for long periods of time.
    • It is recommended that the pressure inside your eyes (intraocular pressure) is regularly checked while you are using this medicine in your eyes.

    Who should not use Sofradex?

    • People with a perforated eardrum.
    • People with a fungal, viral or tuberculosis infection of the eyes.
    • People with an eye condition that is producing pus.
    • People with eye inflammation caused by the herpes simplex virus (herpetic keratitis).
    • People with glaucoma.
    • People with  a red eye that has not been diagnosed by a doctor, as inappropriate use can cause blindness.

    This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

    If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

    Can I use Sofradex while pregnant or breastfeeding

    • Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.
    • The safety of this medicine for use during pregnancy and breastfeeding has not been established. The medicine may be absorbed into the bloodstream after application into the eye or ear and can cross the placenta and pass into breast milk. It is not recommended for use during pregnancy or breastfeeding unless the potential benefits to the mother outweigh any possible risks to the baby. Consult your doctor for further advice.

    What are the side effects of Sofradex?

    Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

    • Irritation, burning, stinging, itching or dermatitis of the skin around the eye (if used in the eye) or the skin in the ear (if used in the ear).
    • Intensive or prolonged application of corticosteroids to the eye may lead to thinning of the cornea (front part of the eyeball), glaucoma, damage to the optic nerve, development of eye infections, or the formation of cataracts. Your eye specialist will want you to have regular eye check-ups to monitor for these types of side effects if you use this medicine for longer than a week.

    The side effects listed above may not include all of the side effects reported by the medicine's manufacturer.

    For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

    How can Sofradex affect other medicines?

    • No specific studies have been performed by the manufacturer to determine if this medicine interacts with any other. It is not known how much, if any, of this medicine is absorbed into the bloodstream after being administered into the eye or ears, which makes it difficult to predict interactions that may occur. You should tell your doctor or pharmacist that you are using this medicine before using any others.

    If you are using more than one type of eye drop you should administer them at least five minutes apart, to prevent the subsequent drops washing away the first. Use eye gels or ointments last.



    Health Reference: Eye Complaints