Finafloxacin otic

Finafloxacin otic (for use in the ears) is an antibiotic that treats bacterial infections of the outer ear canal in adults and children who are at least 1 year old.

Finafloxacin otic may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Wash your hands before and after using the ear drops.

To use the ear drops:

• Hold the bottle in your hands for 1 to 2 minutes to warm the medicine before use. Using cold drops may cause dizziness. Shake the bottle well before use.
• Lie down or tilt your head with your ear facing upward. Gently pull the outer ear lobe upward and backward to open the ear canal.
• Put 4 drops into the affected ear(s) twice daily for 7 days.
• Keep your ear upward for at least 60 seconds. If both ears need treatment, repeat these steps for the other ear.
• Do not touch the dropper tip or place it directly in your ear. The tip may become contaminated.
• Wipe the tip with a clean tissue but do not wash it with water or soap.

If you have an otowick, your healthcare provider may use 8 drops when the otowick is first placed. Then use 4 drops in the affected ear twice daily for 7 days.

Keep using finafloxacin otic even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Finafloxacin will not treat a viral infection (flu or a common cold).

Store at room temperature away from moisture and heat. Do not allow the medicine to freeze.

Using finafloxacin otic for a longer time than prescribed may lead to the growth of yeast or fungi. If this happens, stop using finafloxacin otic and contact your doctor.

Tell your doctor if you have or have ever had:

• an allergy to any antibacterial medicine, including fluoroquinolones, or to any ingredient in finafloxacin otic.

It is not known if finafloxacin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known if finafloxacin can pass into breast milk. Talk to your doctor about the best way to feed your baby during treatment with finafloxacin.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Finafloxacin may cause serious side effects. Stop using finafloxacin and call your doctor immediately if you have:

• rash, itching, swelling of your mouth, dizziness, a fast heartbeat or pounding in your chest; or
• growth of yeast or fungi.

Common side effects of finafloxacin otic may include:

• itching in the ear; or
• nausea.

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.

Use the medicine as soon as you can, but if it is almost time for your next dose, skip the missed dose. Do not use two doses at once.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222 if someone has accidentally swallowed the medicine.

Do not get finafloxacin otic in your eyes or mouth.

Rinse with water if this medicine gets in your eyes or mouth.

Other drugs may affect finafloxacin otic, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you are using.