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Baxdela

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

Medically reviewed on Sep 5, 2018

What is Baxdela?

Baxdela (delafloxacin) 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.

Fluoroquinolone antibiotics can cause serious or disabling side effects.

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

Important Information

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

Stop taking 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, or thoughts of suicide.

Baxdela may cause swelling or tearing of a tendon. Stop using this medicine and call your doctor at once if you have sudden pain, swelling, bruising, tenderness, stiffness, or movement problems in any of your joints.

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:

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.

How should I use Baxdela?

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. 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.

Baxdela dosing information

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: 5 to 14 days

Comments:
-May administer IV formulation for 5 to 14 days OR may administer IV formulation then switch to oral formulation at the physician's discretion for 5 to 14 days (total) OR may administer oral formulation for 5 to 14 days (total)

Use: For the treatment of acute bacterial skin and skin structure infections due to susceptible isolates of Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates), S haemolyticus, S lugdunensis, Streptococcus agalactiae, S anginosus Group (including S anginosus, S intermedius, S constellatus), S pyogenes, Enterococcus faecalis, Escherichia coli, Enterobacter cloacae, Klebsiella pneumoniae, Pseudomonas aeruginosa

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 Baxdela 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 Baxdela?

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.

Baxdela side effects

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).

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; 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 Baxdela?

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.

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.

Further information

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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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