Uses

This medication is used to treat certain types of outer ear infections. It helps to reduce swelling, itching, redness, and discomfort in the ear. This ear drop contains both flumethasone, an anti-inflammatory corticosteroid, and clioquinol, an antibiotic that stops the growth of certain bacteria and fungi.

This medication treats only certain types of bacterial and fungal ear infections. It will not work for other types of ear infections. Unnecessary use or overuse of any antibiotic can lead to its decreased effectiveness.

This medication should not be used by children younger than 2 years.

How To Use

This medication is for use only in the ear. For best results, the ear canal should be clean and dry before using this medication. Ask your doctor for instructions on how to properly clean the ear and how to use an ear syringe with a soft rubber bulb if needed.

Apply this medication into the ear as directed by your doctor, usually twice daily. Do not use this medication more often or for longer than prescribed. The length of treatment is usually not more than 10 days.

To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, have another person give the drops if possible. To lower the risk of dizziness, hold the container in your hand for a few minutes to warm it.

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 2 minutes, or insert a soft cotton plug in the ear if so directed. Repeat for the other ear if so directed. Do not rinse the dropper. Replace the cap after use.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed, even if symptoms disappear after a few days. Stopping this medication too early may allow bacteria and fungi to continue to grow, which may result in a return of the infection.

Do not use in the eye.

Tell your doctor if your condition does not improve within 1 week or if it worsens.

Side Effects

A temporary stinging or burning feeling in the ear may occur for 1 to 2 minutes when this medication is applied. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• 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 flumethasone or other corticosteroids (such as prednisone); or to clioquinol or related antibiotic/anti-fungal drugs (such as iodoquinol); or to iodine; 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:

• a hole/perforation in the eardrum
• skin reactions/infections (for example, those caused by vaccines, tuberculosis, syphilis, viruses such as chickenpox or herpes)

This medication may stain clothes, skin, nails, or hair.

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

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Clioquinol may interfere with certain laboratory tests (such as thyroid tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

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. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. 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. Do not use it later for another infection unless your doctor tells you to.

It is important to keep the infected ear(s) clean and dry. Try not to get the infected ear(s) wet when bathing. Avoid swimming unless your doctor tells you otherwise.

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.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature. Keep the bottle tightly closed. The solution may turn yellow when it is exposed to air, but it is still safe to use. It may stain hair, skin, and clothing. Keep all medications away from children and pets.

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.