Ozenoxacin (Topical application)

Ozenoxacin cream is used to treat a bacterial skin infection known as impetigo. This medicine is a topical antibiotic.

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

If your skin infection does not get better in 3 days, or if it gets worse, contact your doctor.

In deciding to use a medicine, you and your doctor need to think about the risks of the medicine compared to the benefits it may provide. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies you may have, like allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how ozenoxacin cream affects children younger than 2 months. Its safety and effectiveness for this age group have not been established.

Geriatric

So far, studies have not shown any specific problems for older adults that would limit the use of ozenoxacin cream in this group.

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 there is a chance of interaction. In these situations, your doctor may need to adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around meal times or with specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may impact how you can use this medicine. Be sure to tell your doctor about any other medical issues you have, especially:

• Skin infections (other than impetigo)—This medicine should not be used for other skin issues.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they might need medical attention.

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:

Incidence not known

• Dry, flaky, scaling skin on the scalp, eyebrows, near the ears, and around the nose
• dry, irritated, or swollen eyes
• enlarged nose
• redness of the face
• swollen red bumps on the face

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.

• Xepi

Available Dosage Forms:

• Cream

Therapeutic Class: Antibacterial

Chemical Class: Non-Fluorinated Quinolone

It is very important that you use this medicine only 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 cause unwanted side effects or skin irritation.

This medicine should only be used on the skin. Do not get it in your eyes, nose, mouth, or vagina. If it does get on these areas, rinse it off right away with water.

Keep using this medicine for the full treatment time, even if your symptoms have improved after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

Wash your hands with soap and water before and after using this medicine.

Apply a thin layer of the medicine to the affected area and rub it in gently.

After applying this medicine, the treated area may be covered with a sterile bandage or gauze dressing, unless your doctor tells you otherwise.

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 topical dosage form (cream):For impetigo: Adults and children 2 months of age and older—Apply to the affected area of the skin 2 times a day for five days. Children younger than 2 months of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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.

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.

• What is Xepi (ozenoxacin) used to treat?