Delafloxacin oral / injection

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.

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.

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.

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)

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.