delafloxacin (oral/injection)

Pronunciation: DEL a FLOX a sin

Brand: Baxdela

What is the most important information I should know about delafloxacin?

Delafloxacin 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, 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, delafloxacin 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.

What is delafloxacin?

Delafloxacin is a fluoroquinolone (flor-o-KWIN-o-lone) antibiotic that fights bacteria in the body. Delafloxacin is used to treat different types of bacterial infections of the skin.

Fluoroquinolone antibiotics can cause serious or disabling side effects. Delafloxacin should be used only for infections that cannot be treated with a safer antibiotic.

Delafloxacin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using delafloxacin?

You should not use this medicine 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.

Delafloxacin 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 delafloxacin. 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.

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

How should I use delafloxacin?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take the delafloxacin tablet with or without food.

Delafloxacin 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 delafloxacin 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 delafloxacin 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 delafloxacin is once every 12 hours for 5 to 14 days. 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 delafloxacin 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.

What happens if I miss a dose?

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 delafloxacin injection.

What happens if I overdose?

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

What should I avoid while using delafloxacin?

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.

What are the possible side effects of delafloxacin?

Get emergency medical help if you have signs of an allergic reaction: 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 delafloxacin 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 side effects may include:

  • nausea; or
  • diarrhea.

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.

What other drugs will affect delafloxacin?

Some medicines can make delafloxacin much less effective when taken at the same time. If you take any of the following medicines, take your delafloxacin 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.

Where can I get more information?

Your pharmacist can provide more information about delafloxacin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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delafloxacin (oral/injection)