Pronunciation:

fee-na-FLOX-a-sin

Brand Names:

• Xtoro

Classifications:

Chemical—

Fluoroquinolone

Uses of This Medicine:

Finafloxacin ear drops is used to treat otitis externa. Otitis externa, also known as swimmer's ear, is an infection of the outer ear canal caused by bacteria. The ear canal and outer part of the ear may be swollen, red, and painful.

Finafloxacin belongs to the class of medicines known as fluoroquinolone antibiotics. It works by killing the bacteria or preventing their growth.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of finafloxacin ear drops in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of finafloxacin ear drops in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should be used only in the ear. Do not put it in the eyes or nose, and do not take it by mouth. If this medicine is swallowed by accident or gets in your eyes, call your doctor right away.

It is important that the infected ear remain clean and dry. When bathing, avoid getting the infected ear wet. Avoid swimming unless your doctor has instructed you otherwise.

To use the ear drops:

• Wash your hands thoroughly with soap and water.
• Hold the bottle in your hands for 1 or 2 minutes to warm the suspension. Cold drops could cause you to become dizzy.
• Shake the bottle well before using it.
• Lie down on your side with the infected ear facing up.
• Drop the prescribed number of drops into the ear. Keep the ear tilted up for 60 seconds.
• Repeat the above steps if both ears are infected.

Keep using this medicine for the full treatment time, even if you or your child feel better after the first few doses. The infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For otic dosage form (suspension):
  • For ear infections:
    • Adults and children 1 year of age and older—4 drops into the affected ear(s) two times a day for 7 days. For patients who need to use an otowick, use a starting dose of 8 drops followed by 4 drops into the affected ear(s) two times a day for 7 days.
    • Children younger than 1 year of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep the bottle closed when you are not using it. You may store it in the refrigerator or at room temperature, away from light and heat. Do not freeze.

Precautions While Using This Medicine:

If you or your child feel that your symptoms are not improved after 7 days, or if they have become worse, check with your doctor.

This medicine may cause allergic reactions. Call your doctor right away at the first sign of a skin rash or any other allergic reaction.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare

Cough

difficulty with swallowing

dizziness

fast heartbeat

hives, itching, or skin rash

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

shortness of breath

tightness in the chest

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Itching of the ear

nausea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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