Otovel (otic)

Ciprofloxacin is an antibiotic that treats infections caused by bacteria.

Fluocinolone is a steroid that decreases the effects of chemicals in the body that lead to inflammation.

Otovel (for the ear) is a combination medicine used to treat a middle ear infection (also called otitis media). Otovel is for use in children who have ear tubes in place and who are at least 6 months old.

Otovel may also be used for other reasons not mentioned in this medication guide.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are using.

You should not use Otovel if you are allergic to ciprofloxacin or fluocinolone, or if you have:

• a viral infection affecting your ear canal, including herpes or chickenpox;
• an ear infection caused by fungus; or
• an allergy to any antibiotic similar to ciprofloxacin (Cipro), such as gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), norfloxacin (Noroxin), or ofloxacin (Floxin).

To ensure Otovel is safe for you, inform your doctor about all your medical conditions or allergies.

Otovel should not be used on a child younger than 6 months old.

Notify the doctor if the person using this medicine is pregnant or breastfeeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives, rash, itching; dizziness; fast or pounding heartbeat; difficult breathing; swelling of your face, lips, tongue, or throat.

Otovel may cause serious side effects. Call your doctor right away if you have:

• the first sign of any skin rash, no matter how mild;
• new or worsening symptoms of infection; or
• ear drainage that continues for up to 6 months after you have finished all doses of this medicine.

Common side effects of Otovel may include:

• ear pain, swelling, or itching;
• problems with balance; or
• scar tissue on part of the ear.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Otic medicine is for use only in the ears.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Wash your hands before using this medicine. Gently clean any ear drainage from the outer ear, using a clean tissue.

You may warm the medicine before use by holding the vial in your hand for 1 or 2 minutes. Using cold ear drops can cause dizziness, especially in a child who has ear tubes in place.

To use the ear drops:

• Lie down or tilt your head with your ear facing upward. Open the ear canal by gently pulling your ear back, or pulling downward on the earlobe when giving this medicine to a child.
• Hold the dropper upside down over your ear and drop the correct number of drops into the ear.
• Stay lying down or with your head tilted for at least 1 minute. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.
• Do not touch the dropper tip or place it directly in your ear. It may become contaminated. Wipe the tip with a clean tissue but do not wash with water or soap.

Use this medicine only in the affected ear, unless your doctor tells you to use the medicine in both ears.

Rinse with water if this medicine gets in your eyes.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have new symptoms.

Each plastic single-use vial contains enough of this medicine for one entire dose. Throw the vial away after one use, even if there is still some medicine left in it.

Store at room temperature away from moisture, heat, and light.

Keep unopened vials in the foil pouch until ready to use. After opening a vial, use the medicine right away. Once you have opened the foil pouch, you must use the vials within 7 days.

Use the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not use extra medicine to make up for the missed dose.

An overdose of Otovel (otic) is not expected to be harmful. Get emergency medical help or call the Poison Help line at 1-800-222-1222 if someone has accidentally swallowed the medication.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

It is unlikely that other medications you take by mouth or injection will affect Otovel when used in the ears. However, many medications can interact with each other. Inform all your healthcare providers about all the medicines you are using, including prescription and over-the-counter medicines, vitamins, and herbal products.