Uses

This medication is used to treat bacterial ear infections. It is used to treat middle ear infections in children with ear tubes, as well as outer ear infections (also known as swimmer's ear) in children and adults. This medication contains a combination of ciprofloxacin (a quinolone-type antibiotic) and dexamethasone (an anti-inflammatory corticosteroid). This ear drop works by stopping the growth of bacteria and reducing ear swelling and discomfort.

This medication treats only bacterial 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.

How To Use

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before you start using this medication and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

This medication is usually used twice daily (every 12 hours) or as directed by your doctor. The ear canal should be clean and dry before using this medication.

For accuracy and to avoid contamination, have another person insert the drops if possible. Before using, hold the container in your hand for a few minutes in order to warm it. This will minimize dizziness.

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. Shake the container well before using.

When treating middle ear infections in children with ear tubes, the child should lie down with the treated ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal. Next gently press down 5 times in a pumping motion on the cartilage that partially covers the opening to the ear. This will allow the medicine to pass through the tube in the eardrum and into the middle ear. Keep the head tilted with the treated ear upward for at least 1 minute or insert a soft cotton plug if so directed.

When treating outer ear infections, the patient should lie down with the treated ear upward. Hold the dropper directly over the ear, and place the prescribed number of drops into the ear canal. While placing the drops into the ear of an adult, the earlobe should be gently pulled up and back to allow the drops to flow down into the ear canal. For children, gently pull the earlobe down and back. Keep the head tilted with the treated ear upward for at least 1 minute or insert a soft cotton plug if so directed.

Repeat the above steps 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 to continue to grow, which may result in a relapse of the infection.

Tell your doctor if your condition lasts or gets worse after 7 days of treatment. Report any fluid you find in the ear after treatment is completed.

Do not use in the eye.

Side Effects

Discomfort, pain, or itching in the ear may occur. If any of these effects last or get 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.

Use of this medication for prolonged or repeated periods may result in a new fungal ear infection. Do not use this medication for longer than prescribed. Contact your doctor if you notice new or worsening symptoms.

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 ciprofloxacin or dexamethasone; or to quinolone antibiotics (such as levofloxacin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), 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:

• ear infections caused by a fungus or virus (such as herpes simplex)

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

It is unknown if this medication 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.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. 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. This medicine may be harmful if swallowed.

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.

Contact your doctor if, after treatment with this medication, you develop 2 or more ear infections in a 6-month period. You may require further evaluation and a different kind of treatment.

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.

Storage

Store at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. 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.