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Baxdela (oral/injection)

Generic Name: delafloxacin (oral/injection) (DEL a FLOX a sin)
Brand Name: Baxdela

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 is the most important information I should know about delafloxacin?

Delafloxacin can have serious effects on your nerves. Stop using this medicine and call your doctor at once if you have symptoms such as numbness, weakness, tingling, or burning pain.

Delafloxacin may cause swelling or tearing of a tendon, especially the Achilles' tendon of the heel. This may be more likely to occur if you are over 60, if you use steroid medication, or if you have had a kidney, heart, or lung transplant.

Call your doctor at once if you have sudden pain, swelling, bruising, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

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).

To make sure delafloxacin is safe for you, tell your doctor if you have ever had:

  • tendon problems, arthritis or other joint problems;

  • 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 is not known whether delafloxacin passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

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. Do not use this medicine in larger or smaller amounts or for longer than recommended.

You may take the delafloxacin tablet with or without food.

Delafloxacin injection is given into a vein through an IV. You may be shown how to use an IV at home. Do not give yourself this medicine if you do not understand how to use the injection and properly dispose of needles, IV tubing, and other items used.

You may need to mix delafloxacin injection with a liquid (diluent) in an IV bag before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

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

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

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.

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. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. 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.

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.

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?

Delafloxacin may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid taking the following medicines within 6 hours before or 2 hours after you take a delafloxacin tablet. These other medicines can make delafloxacin much less effective when taken at the same time:

  • 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.

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. Do not use anti-diarrhea medicine unless your doctor tells you to.

Delafloxacin side effects

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 may cause swelling or tearing of (rupture) a tendon. Delafloxacin can also have serious effects on your nerves, and may cause permanent nerve damage. Stop using this medicine and call your doctor at once if you have:

  • 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); or

  • nerve symptoms--weakness, numbness, tingling, burning pain, or being more sensitive to temperature, light touch, or the sense of your body position.

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

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

  • a seizure;

  • confusion, hallucinations, nightmares, paranoia, depression, thoughts about hurting yourself;

  • muscle weakness or trouble breathing;

  • ongoing headaches (sometimes with blurred vision);

  • tremors, anxiety, trouble sleeping, feeling restless or nervous;

  • 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.

Side Effects (complete list)

What other drugs will affect delafloxacin?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.01.

Date modified: December 03, 2017
Last reviewed: October 30, 2017

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