Framycetin/Gramicidin/Dexamethasone Solution - Ophthalmic/Otic

Pronunciation: fram-eye-SEAT-in/gram-ih-SYE-din/dex-uh-METH-uh-sown

Common Brand Name(s): Sofracort

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication is used to prevent and treat bacterial infections of the eye and outer ear. It is also used to treat redness/swelling/itching (inflammation) of the eye/ear from other causes (e.g., allergy, rosacea, seborrhea, eczema). This product contains framycetin (also known as neomycin B) and gramicidin, antibiotics that work by stopping the growth of bacteria. It also contains dexamethasone, an anti-inflammatory corticosteroid that works by reducing redness, swelling, and itching.

This medication treats/prevents only bacterial infections. It will not work for other types of ear/eye infections and may worsen them (such as infections caused by viruses, fungi, mycobacteria). Using any antibiotic when it is not needed can cause it to not work for future infections.

How To Use

This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

This medication is for use in the eye or ear only. Do not take by mouth.

Wash your hands first before using this product. To avoid contamination, do not touch the dropper tip or let it touch your ear/eye or any other surface. Do not use the same bottle/dropper in both the eye and the ear.

EYE: 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.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps if your dose is for more than 1 drop and for your other eye if so directed. Repeat as often as directed by your doctor.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Do not rinse the dropper. Replace the dropper cap after each use.

Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to manufacturer's directions, and check with your doctor before you begin using them again.

EAR: Use this medication usually 3 to 4 times daily or as directed by your doctor. First, clean and dry the outer ear. To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person insert the drops if possible. To make it more comfortable to use, you may hold the container in your hand for a few minutes to warm the solution.

To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your ear or any other surface. Lie on your side or tilt the affected ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal. To help the drops roll into the ear of an adult, hold the earlobe up and back. In children, hold the earlobe down and back. Keep the head tilted for about 5 minutes or insert a soft cotton plug if so directed. Repeat for the other ear if so directed.

Your doctor may direct you to give this medication in another way by placing a cotton wick in the ear canal and moistening it with the prescribed number of drops. The wick should be replaced at least once a day.

Do not rinse the dropper. Replace the cap after each use.

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 5 to 7 days unless directed by your doctor.

Use this medication at evenly spaced intervals throughout the day and night to get the most benefit from it. To help you remember, use it at the same times each day. Continue to use this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, resulting in a return of the infection. If treatment is for allergies/swelling, then stopping too soon may result in a return of symptoms.

Tell your doctor if your condition persists or worsens.

Side Effects

Stinging/burning (more common when used in the eyes) for 1 to 2 minutes may occur when this medication is applied. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged/repeated periods may result in a new fungal eye infection and may increase your risk for other eye problems (e.g., glaucoma, cataracts, delayed wound healing). Do not use this medication for longer than prescribed.

Tell your doctor right away if any of these unlikely but serious side effects occur:

  • new or worsening eye/ear symptoms (e.g., discharge, pus, swelling, redness)
  • dizziness/feeling of spinning
  • vision changes
  • eye pain
  • hearing loss
  • ringing in the ears
  • unsteadiness/loss of balance

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to framycetin, gramicidin, or dexamethasone; or to other aminoglycoside antibiotics (e.g., gentamicin, neomycin); or to other corticosteroids (e.g., hydrocortisone, prednisone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • glaucoma/increased pressure inside the eye (if you are using this drug as eye drops)
  • ear or eye infections due to fungus or certain viruses (herpes) or bacteria (tuberculosis, chlamydia)
  • punctured eardrum (if you are using this drug as ear drops)
  • recent ear/eye surgery or injury (e.g., cataract, ear tubes)
  • diabetes

If you are using this product in your eye(s), your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of:

  • other corticosteroids (e.g., hydrocortisone, prednisone)

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Throw away the unused medication after treatment is completed. Do not use it later for another infection unless your doctor tells you to.

If you use this medication for more than 5 to 10 days, laboratory and/or medical tests (e.g., ear or eye exams) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Discard any unused medication 28 days after opening the bottle.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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