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

This medication contains 2 active ingredients: clioquinol and flumethasone. Clioquinol is an anti-infective agent that fights bacteria and fungi. Flumethasone belongs to the family of medications called corticosteroids and is used to reduce inflammation and itching.

This combination of ingredients is used for the relief of external ear inflammation and infections (otitis externa) and fungal infections of the outer ear (otomycosis).

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking 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 take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each bottle of clear solution contains 0.02% flumethasone and 1% clioquinol. Nonmedicinal ingredient: polethylene glycol. This medication does not contain parabens or tartrazine.

How should I use this medication?

The recommended dose is 2 to 3 drops twice daily for the prescribed period of time (usually not longer than 10 days). Before you apply the medication, you should warm the eardrops to body temperature by holding the bottle in the palm of your hands. Do not heat it above body temperature.

The following procedure is recommended for instilling eardrops:

  1. Gently clear excess wax and debris from your ear.
  2. Lie down or tilt your head so that the affected ear faces up.
  3. Gently pull the ear lobe up and back for adults (down and back for children) to straighten the ear canal.
  4. Instill the drops into the ear canal and keep the ear facing up for about 5 minutes to allow the medication to reach the bottom of the ear canal.

To avoid contamination, do not let the applicator tip touch any surface.

Your doctor may instruct you to soak a piece of gauze with the solution and to gently insert it in the ear for the first 24 to 48 hours of therapy. Change the gauze at least once every 24 hours.

Do not apply this medication to your eyes. If it accidentally gets into your eyes, flush them at once with plenty of water.

Do not use leftover eardrops to treat future problems without first checking with your doctor. If used for the wrong kind of infection, it could make it worse.

This medication usually begins to work within the first few doses. Be sure to use the medication for the prescribed amount of time, even if the problem seems to have cleared, so that the infection will not recur.

Store the eardrops away from heat and light. The drops may turn yellow when exposed to air. They may also stain clothing, skin, or nails.

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 listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor. If you miss a dose, use 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 instill 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.

Keep this medication out of the reach of children.

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 if you:

  • are allergic to flumethasone - clioquinol or any ingredients of this medication
  • are allergic to any of the following:
    • corticosteroids
    • hydroxyquinolines or quinolone derivatives
    • iodine
    • pivalate
  • have a punctured eardrum
  • have pre-existing tuberculosis of the skin, fungal, or viral infections of the skin (e.g., chickenpox, skin eruptions following vaccination, herpex simplex, herpes zoster)
  • have to apply it to ulcerated areas

Do not give this medication to children under 2 years of age.

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.

  • bleaching of skin
  • burning, dryness, irritation, itching, or redness of skin (usually mild and temporary) in the area where the eardrops were applied
  • increased redness or scaling of skin sores (usually mild and temporary) in the area where the eardrops were applied
  • skin rash (usually mild and temporary) in the area where the eardrops were applied
  • yellow staining of the skin, nails, hair, or fabrics

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

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

  • blood-containing blisters on skin (in the area where the eardrops were applied)
  • burning and itching of skin (in the area where the eardrops were applied)
  • increased skin sensitivity (in the area where the eardrops were applied)
  • lack of healing of outer ear infection
  • raised, dark-red, wart-like spots on skin (in the area where the eardrops were applied)
  • thinning of skin (in the area where the eardrops were applied)

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.

Effectiveness of medication: If your condition does not improve after one week of using the drops, call your doctor.

Medical treatment: Be sure to tell all health care professionals involved in your care that you are using this medication.

Tests: This medication may interfere with the results of certain thyroid function tests and tests for phenylketonuria.

Thinning of skin: Prolonged use of this medication may produce thinning of the skin and of tissues under it in areas where the eardrops where applied. If you notice this, call your doctor.

Pregnancy: The safety of flumethasone - clioquinol eardrops during pregnancy has not been established. If you are pregnant discuss the benefits and risks of using this medication with your doctor.

Breast-feeding: The safety of flumethasone - clioquinol eardrops during breast-feeding has not been established. If you are breast-feeding, discuss the benefits and risks of using this medication with your doctor.

What other drugs could interact with this medication?

There may be an interaction between flumethasone - clioquinol and any of the following:

  • other eardrops that contain corticosteroids or that have irritating effects

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.