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Xtoro

Generic Name: finafloxacin otic suspension
Date of Approval: December 17, 2014
Company: Alcon Laboratories, Inc.

Treatment for: Acute Otitis Externa

FDA Approves Xtoro

Xtoro contains a new fluoroquinolone antibiotic called finafloxacin.

The U.S. Food and Drug Administration has approved Xtoro (finafloxacin otic suspension), a fluoroquinolone antibiotic ear drop used to treat acute otitis externa, commonly known as swimmer’s ear.

Medication Guide

Read this Medication Guide before you start using this medicine. This guide does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions after reading this information, ask your healthcare provider or pharmacist.

What is Xtoro?

Xtoro (finafloxacin) is an antibiotic that fights bacteria.

It is used to treat ear infections that affect the outer ear canal. This type of ear infection is sometimes called "swimmer's ear."

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

Important information

You should not use this medication if you are allergic to finafloxacin, or any other quinolone antibiotic.

Avoid getting this medication in your mouth or eyes or on the skin. If it does get into any of these areas, rinse with water.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Call your doctor if your infection does not improve after the course of treatment, or if your symptoms get worse.

Before using Xtoro

You should not use this medication if you are allergic to finafloxacin, or any other quinolone antibiotic.

FDA pregnancy category C. It is not known whether finafloxacin ear drops are harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether finafloxacin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Xtoro?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Otic medications are for use only the ear. Do not take this medication by mouth or apply it to the skin.

Wash your hands before using this medication.

Before using the medication, warm the container by holding it in your hands for at least a minute. Using ear drops that are cold may cause dizziness when you place the medicine into your ear.

To use the ear drops, lie down with your ear facing upward. Pull back on your ear gently to open up the ear canal. If giving this medicine to a child, pull down on the earlobe to open the ear canal. Instill the prescribed number of drops into the ear and stay lying down for at least one minute longer.

If you are treating both ears, repeat the instructions above for the second ear.

Xtoro should be used two times daily for 7 days, unless your doctor tells you otherwise. Your doses should be spaced at least 12 hours apart.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Call your doctor if your infection does not improve after the course of treatment, or if your symptoms get worse.

Do not use this medication for longer than the prescribed course duration. Prolonged use of this product may lead to overgrowth of nonsusceptible organisms.

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

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose is not likely to cause life-threatening symptoms.

What should I avoid?

Avoid getting this medication in your mouth or eyes or on the skin. If it does get into any of these areas, rinse with water.

Xtoro side effects

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

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

Less serious side effects may include:

  • itching, pain, or mild irritation after using the ear drops;
  • 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.

See also: Side effects (in more detail)

What other drugs will affect Xtoro?

It is not likely that other drugs you take orally or inject will have an effect on this medication used in the ears. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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