Finafloxacin (Otic)

Finafloxacin ear drops are 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 is part of a group of medicines called fluoroquinolone antibiotics. It works by killing the bacteria or stopping them from growing.

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

If you or your child do not see any improvement in symptoms after 7 days, or if symptoms get worse, contact your doctor.

This medicine may cause allergic reactions. Call your doctor immediately if you notice a skin rash or any other signs of an allergic reaction.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, the following points should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For over-the-counter products, carefully read the label or package ingredients.

Pediatric

Current studies have not shown any specific problems in children that would limit the use of finafloxacin ear drops. However, safety and effectiveness have not been established in children younger than 1 year old.

Geriatric

Current studies have not shown any specific problems in the elderly that would limit the use of finafloxacin ear drops.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor might want to adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or over-the-counter (OTC) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used during meals or around the time of eating certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

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

In the U.S.

• Xtoro

Chemical Class: Fluoroquinolone

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.