Baxdela

Generic name: Delafloxacin (oral/injection)
Drug class: Quinolones and fluoroquinolones

Usage of Baxdela

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 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).

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.

Before taking Baxdela

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.

Relate drugs

How to use Baxdela

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.

Warnings

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.

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.

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.

Disclaimer

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