Prescription Required 
Formulation : 
Description
Indications
This combination medication serves to prevent and treat bacterial infections of the eye and outer ear. It additionally addresses inflammation, including redness, swelling, and itching, in the eye or ear resulting from various causes such as allergy, rosacea, seborrhea, or eczema. Its formulation includes framycetin (neomycin B) and gramicidin, antibiotics that halt bacterial growth. It also contains dexamethasone, an anti-inflammatory corticosteroid that diminishes redness, swelling, and itching.
Uses and Dosage
This medication is intended for use in the eye or ear only and should not be ingested orally.
Before using this product, wash your hands thoroughly. To prevent contamination, avoid contact between the dropper tip and your ear or eye, as well as any other surfaces. Refrain from using the same bottle or dropper for both the eye and the ear.
For ear use-
Typically administer this medication 3 to 4 times daily, or as instructed by your doctor. Begin by cleaning and drying the outer ear. To ensure accurate dosing and prevent ear contact with the dropper, consider having another person administer the drops if possible. To make application more comfortable, warm the solution by holding the container in your hand for a few minutes.
To apply ear drops, start by washing your hands. Avoid contamination by refraining from touching the dropper tip or letting it contact your ear or any other surface. Lie on your side or tilt the affected ear upward. Directly position the dropper over the ear and administer the prescribed number of drops into the ear canal. For adults, assist the drops in entering the ear by holding the earlobe up and back. For children, hold the earlobe down and back. Maintain the head position for about 5 minutes or, if directed, insert a soft cotton plug. Repeat the process for the other ear if directed.
Alternatively, your doctor may advise you to administer the medication differently by placing a cotton wick in the ear canal and moistening it with the prescribed number of drops. Replace the wick at least once daily.
For eye use-
Apply the medication to the affected eye(s), usually 3 to 4 times a day or as directed by your doctor. Your doctor may instruct you to use it more often for the first 2 to 3 days (every 1 to 2 hours). Your dosage is based on your medical condition and response to treatment. Do not use this medication more often than prescribed or for longer than 10 days unless directed by your doctor. Follow your doctor’s instructions carefully.
To administer the eye drops, the following steps should be followed:
- Thoroughly wash hands with soap and water.
- Do not allow the dropper tip to touch the eye or any other surface, and ensure that it is kept clean.
- Tilt the head back and pull down the lower lid of the eye using the index finger to form a pocket.
- Hold the dropper as close to the eye as possible without making contact, and brace the remaining fingers against the face.
- Squeeze the dropper gently to instill a single drop in the pocket created by the lower eyelid while looking upwards.
- Remove the index finger from the lower eyelid and keep the eye closed for 2-3 minutes while tilting the head down.
- Apply gentle pressure to the tear duct using a finger.
- Use a tissue to wipe off any excess liquid from the face.
- Wash hands to remove any residual medication.
Do not rinse the dropper. Always replace the cap after each use.
Your dosage is determined by your medical condition and response to treatment. Do not exceed the prescribed frequency or duration of use, typically 5 to 7 days, unless directed by your doctor.
Administer this medication at consistent intervals throughout the day and night to maximize its effectiveness. To facilitate adherence, use it at the same times daily. Continue using the medication until you’ve completed the full prescribed amount, even if symptoms improve before completion. Ceasing treatment prematurely may allow bacteria to persist, leading to a recurrence of the infection. If the treatment is for allergies or swelling, discontinuing too early may result in symptom recurrence.
Inform your doctor if your condition persists or worsens.
Side Effects
Some side effects may occur that usually do not need medical attention:
- burning, stinging, redness, or watering of the eyes
- stinging of the eye or ear
Inform your healthcare provider immediately if you experience any serious side effects:
- decreased vision
- dizziness
- eye infection
- eye pain
- gradual blurring or loss of vision
- hearing loss
- itching, rash, redness, or other irritation that was not present before treatment began
- ringing in the ears
- unsteadiness or loss of balance
- difficulty breathing
- hives
- itchy skin rash
- swelling of the mouth or throat
Caution
- Before using this medication, inform your doctor or pharmacist if you are allergic to framycetin, gramicidin, dexamethasone, or other aminoglycoside antibiotics (such as gentamicin, neomycin), other corticosteroids (such as hydrocortisone, prednisone), or any other substances. This product may contain inactive ingredients that can trigger allergic reactions or other issues.
- Prior to using this medication, disclose your medical history to your doctor or pharmacist, especially if you have glaucoma or increased pressure inside the eye (if using this drug as eye drops), ear or eye infections caused by fungus or certain viruses (such as herpes) or bacteria (such as tuberculosis, chlamydia), punctured eardrum (if using this drug as ear drops), recent ear/eye surgery or injury, or diabetes.
- If you are using this product in your eye(s), you may experience temporary blurred vision. Avoid driving, operating machinery, or engaging in activities requiring clear vision until your vision has returned to normal.
- During pregnancy, use this medication only if clearly necessary. Discuss the potential risks and benefits with your doctor.
- It is unclear whether this drug passes into breast milk. Consult your doctor before breastfeeding.
Form and Strength
Sofracort is available in the following forms and strengths:
- Sofracort eye/ear drops:
- 0.5 mg / 5 mg / 0.05 mg
FAQ
How quickly does Sofracort work for ear/eye infections?
You should begin to feel better during the first few days of treatment with Sofracort.
Is Sofracort a steroid?
Yes. Part of Sofracort’s formulation is a corticosteroid which will help reduce inflammation in your eye or ear.
Resources
- https://www.medicines.org.uk/emc/product/2253/smpc#gref
- https://myhealth.alberta.ca/Health/medications/pages/conditions.aspx?Hwid=fdb1088#fdb1088-03
- https://www.medsafe.govt.nz/consumers/cmi/s/sofradex.pdf
- https://www.rxhealthmed.ca/medication_search/sofracort/
- https://medbroadcast.com/drug/getdrug/sofracort
- https://www.healthlinkbc.ca/medications/framycetingramicidindexamethasone-solution-ophthalmicotic
