Delafloxacin Injection

pronounced as (del" a flox' a sin)

Brand Name(s): Baxdela®

Why is this medicine prescribed?

Delafloxacin injection is used to treat skin infections and pneumonia (infection of the lungs) caused by bacteria. Delafloxacin is in a class of antibiotics called fluoroquinolones. It works by killing the bacteria that cause infections.

Are there other uses for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

How should this medicine be used?

Delafloxacin injection comes as a powder to mixed with liquid and given intravenously (into a vein). It is given over a period of 60 minutes once every 12 hours.

You may receive delafloxacin injection in a hospital, or you may use the medication at home. If you will be using delafloxacin injection at home, your healthcare provider will show you how to infuse the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems infusing delafloxacin injection.

You should begin to feel better during the first few days of treatment with delafloxacin injection. If your symptoms do not improve or get worse, call your doctor.

Use delafloxacin injection until you finish the prescription, even if you feel better. Do not stop using delafloxacin injection without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING or SIDE EFFECTS sections. If you stop using delafloxacin injection too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

What special precautions should I follow?

Before using delafloxacin injection,

  • tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving delafloxacin injection. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had an aortic aneurysm (swelling of the large artery that carries blood from the heart to the body), high blood pressure, peripheral vascular disease (poor blood flow through blood vessels), Marfan syndrome (a genetic condition that can affect the heart, eyes, blood vessels and bones), Ehlers-Danlos syndrome (a genetic condition that can affect skin, joints, or blood vessels), diabetes, or problems with low blood sugar.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using delafloxacin injection, call your doctor.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget to take a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What should I do in case of overdose?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help . If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What side effects can this medicine cause?

Delafloxacin injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea, vomiting, diarrhea
  • headache
  • irritation, pain, tenderness, redness, warmth, or swelling at the injection spot

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop using delafloxacin injection and call your doctor immediately or get emergency medical treatment:

  • severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
  • rash, itching, hives, shortness of breath, tingling or swelling of the face or throat, or fainting
  • extreme thirst or hunger; pale skin; feeling shaky or trembling; fast or fluttering heartbeat; sweating; frequent urination; trembling; blurred vision; or unusual anxiety
  • sudden pain in the chest, stomach, or back

Delafloxacin injection may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( https://www.fda.gov/Safety/MedWatch ) or by phone ( 1-800-332-1088).

What should I know about storage and disposal of this medication?

Your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach https://www.upandaway.org Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://www.fda.gov/drugs/safe-disposal-medicines/disposal-unused-medicines-what-you-should-know for more information.

What other information should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to delafloxacin injection. If you have diabetes, your doctor may ask you to check your blood sugar more often while using delafloxacin.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the delafloxacin injection, call your doctor.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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