Ofloxacin is an antibiotic that treats infections caused by bacteria.

Ofloxacin otic (for the ear) is used to treat infections of the ear canal in adults and children who are at least 6 months old. Ofloxacin otic is used in adults and children at least 1 year old to treat an inner ear infection (also called otitis media).

Ofloxacin otic may be used on a long-term basis to treat an infection that causes a hole in the ear drum (ruptured ear drum) in adults and children who are at least 12 years old.

Ofloxacin may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

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

Shake the medicine well just before each use.

You may warm the medicine before use by holding the bottle in your hand for 1 or 2 minutes. Using cold ear drops can cause dizziness.

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 5 minutes. You may use a small piece of cotton to plug the ear and keep the medicine from draining out.

• If the patient being treated has ear tubes, the doctor may recommend gently pressing the tragus (part of the ear in front of the opening of the ear canal) four to five times in a pumping motion after administration of the drops. This may allow the drops to pass through the tubes into the middle ear. Follow the doctor's instructions.

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 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.

Store at room temperature away from moisture, heat, and light. Throw away any unused medicine after your treatment is finished.

You should not use ofloxacin otic if you are allergic to ofloxacin or similar antibiotics, such as ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), moxifloxacin (Avelox), or norfloxacin (Noroxin).

FDA pregnancy category C. It is not known whether ofloxacin otic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

It is not known whether this medicine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medicine to a child without medical advice.

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

An overdose of ofloxacin otic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

This medicine is for use only in the ears. Avoid getting the medicine in your eyes, mouth, and nose, or on your lips. Rinse with water if this medicine gets in or on these areas.

Do not use other ear medications unless your doctor tells you to.

Get emergency medical help if you have any of these signs of an allergic reaction: hives, rash, itching; slow heart rate, weak pulse, fainting; difficult breathing, slow breathing (breathing may stop); swelling of your face, lips, tongue, or throat.

ofloxacin otic may cause serious side effects. Stop using ofloxacin otic and call your doctor at once if you have:

• the first sign of any skin rash, no matter how mild; or

• ear drainage, discharge, or worsening pain.

Common side effects of ofloxacin otic may include:

• headache;

• dizziness; or

• mild ear pain or itching after using the ear drops.

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.