Delafloxacin (By injection)

Baxdela

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. This medicine must be given slowly, so the needle should stay in place for at least an hour.
• A nurse or other health provider will give you this medicine.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Your doctor may give you a few doses of this medicine until your condition improves. Then you may be switched to an oral medicine that works the same way. Talk to your doctor if you have concerns about this.
• Missed dose: You must use this medicine on a fixed schedule. Call your doctor or pharmacist if you miss a dose.

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how delafloxacin works. Tell your doctor if you are using diabetes medicine (including glyburide, insulin) or a steroid medicine.

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, myasthenia gravis, diabetes, aortic aneurysm (bulge in the wall of the largest artery), or a history of nerve problems, seizures, brain problems, stroke, or mental illness. Tell your doctor if you have had tendon or joint problems, including rheumatoid arthritis, or if you have received a transplant.
• This medicine may cause the following problems:
  • Tendinitis or tendon rupture (which may happen after treatment ends)
  • Nerve damage in the arms or legs, which may become permanent
  • Changes in mood or behavior, seizures, or increased pressure in the head
  • Increased risk of aortic aneurysm
  • Changes in blood sugar levels
• This medicine may make you dizzy or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate
• Diarrhea that may contain blood
• Numbness, tingling, weakness, or burning pain in your hands, arms, legs, or feet
• Pain, stiffness, swelling, or bruises around your ankle, leg, shoulder, or other joints
• Seizures, severe headache, unusual thoughts or behavior, trouble sleeping, feeling anxious, confused, depressed, seeing, hearing, or feeling things that are not there
• Sudden chest, stomach, or back pain, trouble breathing, cough

If you notice these less serious side effects, talk with your doctor:

• Nausea
• Pain, swelling, or redness where the needle was placed

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088