Otovel

Read the Patient Information Leaflet if available from the pharmacist before you start giving ciprofloxacin/fluocinolone to your child and each time you get a refill. If you have any questions, ask the doctor or pharmacist.

Use this medication in the infected ear as directed by the doctor, usually twice daily (every 12 hours). Use in the ear only. Do not use in the eyes.

To make sure that the right amount of medication is given, and to avoid touching the ear with the dropper, a parent or caregiver should give the drops if possible. To lower the risk of dizziness, hold the container in your hand for 1 to 2 minutes in order to warm it.

To apply ear drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch the ear or any other surface. Have your child lie on his or her side or tilt the affected ear upward. Hold the dropper directly over the ear, and place all of the solution from one single-dose vial into the ear canal. Gently press on the part of the ear called the tragus 4 times to help the drops roll into the ear. Keep the head tilted for about 1 minute, or insert a soft cotton plug if so directed. If directed to use this medication in both ears, repeat these steps for the other ear using a new single-dose vial. Use a new single-dose vial for each dose.

For the best effect, use this medication at evenly spaced times. To help you remember, use this medication at the same times every day.

Continue giving this medication for the full time prescribed, even if symptoms disappear after a few days. Stopping the medication too early may allow bacteria to continue to grow, which may result in a return of the infection.

Tell the doctor if your child's condition lasts or gets worse after 7 days.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to your child 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 give this medication for longer than prescribed. Contact the 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 the 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.

Before using this medication, tell the doctor or pharmacist if your child is allergic to quinolone antibiotics (such as ciprofloxacin, levofloxacin), or to corticosteroids (such as fluocinolone, prednisone); or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: an ear infection caused by a virus (such as herpes simplex, chickenpox) or fungus.

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.

Store at room temperature in the original pouch to protect from light and moisture. Discard any unused vials 7 days after opening the pouch. Do not open a vial until you are ready to give it. Discard each vial after use. 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 the pharmacist or local waste disposal company.

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

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.

Missed Doses:

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

Notes:

Do not share this medication with others.

This medication has been prescribed for your child's current condition only. Do not use it later for another infection unless the doctor directs you to do so. A different medication may be necessary in that case.

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 the doctor tells you otherwise.