Baxdela is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body.

Baxdela is used to treat different types of bacterial infections of the skin.

Baxdela is also used to treat community-acquired bacterial pneumonia.

Fluoroquinolone antibiotics can cause serious or disabling side effects.

Baxdela should be used only for infections that cannot be treated with a safer antibiotic.

Baxdela can cause serious side effects, including tendon problems, nerve damage, serious mood or behavior changes, or low blood sugar.

Stop using this medicine and call your doctor at once if you have symptoms such as: headache, hunger, irritability, feeling anxious or shaky, numbness, tingling, burning pain, confusion, agitation, paranoia, problems with memory or concentration, thoughts of suicide, or sudden pain or movement problems in any of your joints.

In rare cases, Baxdela may cause damage to your aorta, which could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Before taking this medicine

You should not use Baxdela if you are allergic to any fluoroquinolone antibiotic (ciprofloxacin, delafloxacin, gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin, and others).

Tell your doctor if you have ever had:

• tendon problems, arthritis or other joint problems;

• blood circulation problems, aneurysm, narrowing or hardening of the arteries;

• heart problems, high blood pressure;

• a genetic disease such as Marfan syndrome or Ehler's-Danlos syndrome;

• a muscle or nerve disorder, such as myasthenia gravis;

• seizures or epilepsy;

• a head injury or brain tumor; or

• kidney disease.

Baxdela may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop using Baxdela. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Baxdela is not approved for use by anyone younger than 18 years old.

Use Baxdela exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

You may take the tablet with or without food.

Baxdela injection is given as an infusion into a vein. A healthcare provider will give your first dose and may teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use Baxdela injection if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Prepare your injection only when you are ready to give it. Do not use if the medicine has changed colors or has particles in it. Call your pharmacist for new medicine.

Do not inject Baxdela in the same IV line with other medicines.

The injection must be given slowly, and the infusion can take at least 1 hour to complete.

The usual dose of Baxdela is once every 12 hours for 5 to 14 days for skin and structure infections, and once every 12 hours for 5 to 10 days for community-acquired bacterial pneumonia. Follow your doctor's dosing instructions very carefully.

Use this medicine for the full prescribed length of time, even if your symptoms quickly improve. Skipping doses can increase your risk of infection that is resistant to medication. Delafloxacin will not treat a viral infection such as the flu or a common cold.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store tablets at room temperature away from moisture and heat.

After mixing Baxdela injection, store in the refrigerator or at cool room temperature and use within 24 hours. Do not freeze.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

Usual Adult Dose for Skin and Structure Infection:

IV: 300 mg IV every 12 hours
Oral: 450 mg orally every 12 hours

Total duration of therapy:
-Acute bacterial skin and skin structure infections (ABSSSI): 5 to 14 days
Comments:
-May administer IV formulation OR may administer IV formulation then switch to oral formulation at the physician's discretion OR may administer oral formulation
Uses:
-For the treatment of ABSSSI due to susceptible bacteria.

Usual Adult Dose for Community-Acquired Bacterial Pneumonia:

IV: 300 mg IV every 12 hours
Oral: 450 mg orally every 12 hours

Total duration of therapy:
-Community-acquired bacterial pneumonia (CABP): 5 to 10 days
Comments:
-May administer IV formulation OR may administer IV formulation then switch to oral formulation at the physician's discretion OR may administer oral formulation
Uses:
-For the treatment of CABP due to susceptible bacteria.

You should not use Baxdela if you are allergic to any fluoroquinolone antibiotic (ciprofloxacin, delafloxacin, gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, norfloxacin, and others).

Tell your doctor if you have ever had:

• tendon problems, arthritis or other joint problems;

• blood circulation problems, aneurysm, narrowing or hardening of the arteries;

• heart problems, high blood pressure;

• a genetic disease such as Marfan syndrome or Ehler's-Danlos syndrome;

• a muscle or nerve disorder, such as myasthenia gravis;

• seizures or epilepsy;

• a head injury or brain tumor; or

• kidney disease.

Baxdela may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop using Baxdela. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Baxdela is not approved for use by anyone younger than 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 8 hours away. Do not take extra medicine to make up the missed dose.

Call your doctor for instructions if you miss a dose of Baxdela injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.

Get emergency medical help if you have signs of an allergic reaction to Baxdela: hives, or the first sign of a skin rash; fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Delafloxacin can cause serious side effects, including tendon problems, side effects on your nerves (which may cause permanent nerve damage), serious mood or behavior changes (after just one dose), or low blood sugar (which can lead to coma).

Stop using this medicine and call your doctor at once if you have:

• low blood sugar - headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, or feeling anxious or shaky;

• nerve symptoms in your hands, arms, legs, or feet - numbness, weakness, tingling, burning pain;

• serious mood or behavior changes - nervousness, confusion, agitation, paranoia, hallucinations, memory problems, trouble concentrating, thoughts of suicide; or

• signs of tendon rupture - sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions).

In rare cases, delafloxacin may cause damage to your aorta, the main blood artery of the body. This could lead to dangerous bleeding or death. Get emergency medical help if you have severe and constant pain in your chest, stomach, or back.

Also, stop using this medicine and call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;

• a seizure;

• muscle weakness or trouble breathing;

• a light-headed feeling, like you might pass out;

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

• increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common Baxdela side effects may include:

• nausea, vomiting, diarrhea;

• headache; or

• abnormal liver function tests.

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.

Some medicines can make delafloxacin much less effective when taken at the same time. If you take any of the following medicines, take your Baxdela dose 2 hours before or 6 hours after you take the other medicine.

• antacids that contain magnesium or aluminum (such as Maalox, Mylanta, or Rolaids), or the ulcer medicine sucralfate;

• didanosine (Videx) powder or chewable tablets; or

• vitamin or mineral supplements that contain magnesium, iron, or zinc.

Tell your doctor about all your other medicines, especially:

• insulin or oral diabetes medicine (check your blood sugar regularly); or

• steroid medicine (taken by mouth or injected).

This list is not complete. Other drugs may interact with delafloxacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.