Finafloxacin

Finafloxacin is a prescription medication used to treat acute otitis media, commonly known as “swimmer’s ear.”

Finafloxacin belongs to a group of drugs called fluoroquinolone antibiotics. These work by stopping the growth of bacteria that cause infections.

This medication comes in a suspension form and is instilled into the ear twice daily for 7 days.

Common side effects of finafloxacin include itching of the ear and nausea.

Finafloxacin can also cause dizziness. Do not drive or operate heavy machinery until you know how finafloxacin affects you.

Finafloxacin is a prescription medication used to treat acute otitis media, commonly known as “swimmer’s ear,” caused by Pseudomonas aeruginosa and Staphylococcus aureus.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Finafloxacin may be found in some form under the following brand names:

• Xtoro

Serious side effects have been reported with finafloxacin. See the “Finafloxacin Precautions” section.

Common side effects of finafloxacin include the following:

• Itching of the ear
• Nausea

This is not a complete list of finafloxacin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with finafloxacin including the following:

• Itching of the ear
• Nausea

Finafloxacin can cause dizziness. Do not drive or operate heavy machinery until you know how finafloxacin affects you.

Do not take finafloxacin if you:

• are allergic to finafloxacin or to any of its ingredients

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of finafloxacin, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking finafloxacin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to finafloxacin or to any of its ingredients
• are allergic to other quinolone antibiotics
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Finafloxacin falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if finafloxacin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using finafloxacin.

Take finafloxacin exactly as prescribed.

This medication comes in a suspension form and is instilled into the ear twice daily for 7 days.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of finafloxacin at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated

The recommended dose of finafloxacin for the treatment of acute otitis externa is 4 drops into the affected ear(s) twice daily for 7 days.

If a patient requires the use of an otowick, the initial dose can be doubled to 8 drops, followed by 4 drops twice daily for 7 days.

If you take too much finafloxacin, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If finafloxacin is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Store finafloxacin between 2 and 25°C (36 and 77°F). Do not freeze.

Keep this and all medicines out of the reach of children.