Delafloxacin (dela-FLOX-a-sin)

Treats acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). This medicine is a quinolone antibiotic.

Brand Name(s):

Baxdela

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Take all of the medicine in your prescription to clear up your infection, even if you feel better after the first few doses.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:
  • Less than 8 hours until next dose: Skip the missed dose and go back to your regular dosing schedule.
  • More than 8 hours until next dose: Take it as soon as possible and go back to your regular dosing schedule.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how delafloxacin works. Tell your doctor if you are also using diabetes medicine (including glyburide, insulin) or a steroid medicine.
• Take delafloxacin at least 2 hours before or 6 hours after you take didanosine buffered tablets for oral suspension or the pediatric powder for oral suspension, sucralfate, or antacids, multivitamins, or other products containing aluminum, magnesium, iron, or zinc.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, myasthenia gravis, diabetes, aortic aneurysm (bulge in the wall of the largest artery), or a history of nerve problems, seizures, brain problems, stroke, or mental illness. Tell your doctor if you have had tendon or joint problems, including rheumatoid arthritis, or if you have received a transplant.
• This medicine may cause the following problems:
  • Tendinitis or tendon rupture (which may happen after treatment ends)
  • Nerve damage in the arms or legs, which may become permanent
  • Changes in mood or behavior, seizures, or increased pressure in the head
  • Increased risk of aortic aneurysm
  • Changes in blood sugar levels
• This medicine may make you dizzy or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Diarrhea that may contain blood
• Numbness, tingling, weakness, or burning pain in your hands, arms, legs, or feet
• Pain, stiffness, swelling, or bruises around your ankle, leg, shoulder, or other joints
• Seizures, severe headache, unusual thoughts or behavior, trouble sleeping, feeling anxious, confused, depressed, seeing, hearing, or feeling things that are not there
• Sudden chest, stomach, or back pain, trouble breathing, cough

If you notice these less serious side effects, talk with your doctor:

• Nausea

If you notice other side effects that you think are caused by this medicine, tell your doctor

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