How does this medication work? What will it do for me?

This is a combination product that contains 2 antibiotics (framycetin and gramicidin) and an anti-inflammatory (dexamethasone). The antibiotics help to kill bacteria that may cause certain eye and ear irritations. The anti-inflammatory helps to reduce swelling and inflammation in the eye or ear.

For the ear, this medication is used to treat otitis externa (external ear infection) and other inflammatory conditions of the ear. For the eye, this medication is used to treat inflammation associated with infection in the front portion of the eye, including:

  • blepharitis and infected eczema of the eyelid
  • allergic, infectious, and rosacea conjunctivitis
  • rosacea keratitis
  • scleritis
  • episcleritis
  • iridocycitis

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each mL of sterile drops contains 5 mg of framycetin sulfate BP, 0.05 mg of gramicidin, and 0.5 mg of dexamethasone. Nonmedicinal ingredients: citric acid monohydrate, hydrochloric acid, industrial methylated spirit (IMS 66OP), lithium chloride, polysorbate 80, sodium citrate, sodium hydroxide, 2-phenyl ethanol, and water for injection.

How should I use this medication?

Ear drops: The usual dose is 2 or 3 drops instilled in the ear canal 3 or 4 times daily. Instill the drops by tilting your head to one side and letting the drops fall into the ear canal from above. Do not touch your ear with the dropper. Alternatively, a saturated gauze wick may be inserted by your doctor into your external ear canal.

Eye drops: The usual dose for acute conditions is 1 or 2 drops every 1 or 2 hours. This dose is generally used for 2 to 3 days. Then the dose is reduced to 1 or 2 drops 3 to 4 times daily.

Before using the eye drops, wash your hands thoroughly. Follow your doctor or pharmacist's instructions on how to use the eye drops. Do not allow the eye dropper to touch any surface. This could contaminate the dropper and lead to an eye infection. Keep the bottle tightly closed when you are not using it.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones given here, do not change the way that you are using the medication without consulting your doctor.

This medication must be used for the full duration of treatment, even if you start to feel better. This will reduce the chance of the infection returning and becoming more difficult to get rid of.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not administer a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature. Discard any medication that remains in the dropper bottle 4 weeks after opening it.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not use this medication for the ear if you:

  • are allergic to framycetin sulfate, gramicidin, dexamethasone, or to any of the ingredients of the medication
  • have a perforation of the eardrum
  • have untreated infections with thick secretions
  • have viral or fungal infections of the ear

Do not use this medication for the eye if you:

  • are allergic to framycetin sulfate, gramicidin, dexamethasone, or to any of the ingredients of the medication
  • have glaucoma
  • have herpes simplex or other viral diseases of the cornea and conjunctiva
  • have trachoma
  • have tuberculosis or fungal diseases of the eye
  • have untreated infections of the eye with thick secretions

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • burning, stinging, redness, or watering of the eyes
  • stinging of the eye or ear

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • decreased cortisol production (e.g., weakness, fatigue, loss of appetite, nausea, vomiting, dizziness, low blood sugar)
  • decreased vision
  • dizziness
  • eye infection
  • eye pain
  • gradual blurring or loss of vision
  • hearing loss
  • increased cortisol production (e.g., abnormal weight gain with thinning of the arms and legs, acne, high blood pressure, and rounding of the face)
  • itching, rash, redness, or other irritation that was not present before treatment began
  • ringing in the ears
  • symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
  • symptoms of increased pressure in the eye (e.g., blurred vision, seeing halos of bright colours around lights, red eyes, increased pressure in your eyes, eye pain or discomfort)
  • unsteadiness or loss of balance

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of an allergic reaction (e.g., difficulty breathing, hives, itchy skin rash, or swelling of the mouth or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Allergy: Stop using this medication and call your doctor if you experience any signs of allergy or sensitivity to any of its ingredients. Symptoms of such an allergy may include itching, rash, redness, or irritation that was not present before beginning the use of this medication.

Diabetes: People who have diabetes may experience loss of glucose control, requiring increased doses of medication to treat high blood glucose. If you have diabetes and are using this medication, your doctor may suggest that you increase the frequency that you test your blood sugar levels.

Driving/operating machinery: Using this medication to treat eye infections may cause temporary blurred vision. If you experience this, avoid operating machinery until your vision has cleared.

Eye conditions: Extended use of this medication in the eye may increase eye pressure for some people. People taking this medication for an extended period should have their eye pressure checked regularly. Also, people with conditions causing thinning of the cornea may experience perforation of the cornea brought on by skin-applied steroids such as this medication. Cataracts have also occurred after long-term treatment with skin-applied steroids.

Hearing loss: People using this medication may experience decreased hearing when it is applied to open wounds or damaged skin. Do not use this medication on these areas. If you notice changes in your hearing, talk to your doctor as soon as possible.

Medical treatment: Inform all your health care professionals that that you have been using this medication.

Overgrowth of organisms: Prolonged use of this medication may cause an overgrowth of organisms that this medication does not effectively kill. If your symptoms worsen or do not improve, call your doctor as soon as possible.

Pheochromocytoma: Pheochromocytoma are a specific type of tumour of the adrenal gland. The use of corticosteroids is known to trigger symptoms of pheochromocytoma. If you have a pheochromocytoma, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: The safety of prolonged use of this medication during pregnancy has not been established. This medication should not be used for a lengthy period of time during pregnancy unless the benefits outweigh the risks. If you become pregnant while using this medication, contact your doctor immediately.

Breast-feeding: It is not known if this framycetin sulfate – gramicidin – dexamethasone passes into breast milk. If you are breast-feeding and taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between framycetin sulfate - gramicidin - dexamethasone and any of the following:

  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • ceritinib
  • clarithromycin
  • cobicistat
  • HIV protease inhibitors (e.g., atazanavir, darunavir, lopinavir, ritonavir)
  • idelalisib
  • mifepristone
  • nepafenac
  • nirmatrelvir and ritonavir
  • non-steroidal anti-inflammatory (NSAID) eye drops (e.g., diclofenac, flurbiprofen, ketorolac)
  • tucatinib

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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