Ciprofloxacin (sip-roe-FLOX-a-sin), Fluocinolone Acetonide (floo-oh-SIN-oh-lone a-SEET-oh-nide)

Treats middle ear infection (acute otitis media with tympanostomy tube, AOMT). This medicine contains a quinolone antibiotic and a corticosteroid.

Brand Name(s):

Otovel

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Drop

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Use this medicine only in your ear.
• Gently clean any fluid (discharge) from the outer ear using a clean cloth or tissue. Do not put a cotton swab or any other object in the ear canal.
• Remove the medicine from the foil pouch. Do not open the foil pouch until you are ready to use it.
• You may warm the drops by holding the unopened bottle in your hands for a few minutes. Cold drops might make you dizzy.
• Lie down or tilt your head to the side. For a child, gently pull the child's earlobe down and back to straighten the child's ear canal. For an adult, gently pull the earlobe up and back to straighten the ear canal.
• Twist off the vial cap to open. Drop the entire contents of one vial into the ear and pump the tragus 4 times.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Keep the bottle closed when you are not using it. Store it at room temperature, away from light and heat. Do not freeze. Upon opening the foil pouch, use the vials within 7 days.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding.
• If you have ear drainage 2 or more times within 6 months after you stop using the drops, tell your doctor.
• Call your doctor if your symptoms do not improve or if they get worse.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

If you notice these less serious side effects, talk with your doctor:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088