Delafloxacin

pronounced as (del" a flox' a sin)

Brand Name(s): Baxdela®

Why is this medicine prescribed?

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

Antibiotics such as delafloxacin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

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 comes as a tablet to take by mouth. It is usually taken with or without food twice a day (every 12 hours). Take delafloxacin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take delafloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

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

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

What special precautions should I follow?

Before taking delafloxacin,

  • tell your doctor and pharmacist if you are allergic or have had a severe reaction to delafloxacin, any other quinolone or fluoroquinolone antibiotic such as ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin, any other medications, or any of the ingredients in delafloxacin tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
  • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking delafloxacin. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • if you are taking antacids containing aluminum hydroxide or magnesium hydroxide (Maalox, Mylanta, others), or certain medications such as didanosine (Videx) solution, sucralfate (Carafate), or vitamin or mineral supplements that contain iron or zinc, take these medications 6 hours before or 2 hours after you take delafloxacin.
  • 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 circulation in the 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 taking delafloxacin, 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?

Take the missed dose as soon as you remember it. However, if you are supposed to take your next dose in 8 hours or less, skip the missed dose and continue your regular dosing schedule. Do not take 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 may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • nausea
  • vomiting
  • diarrhea
  • headache

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, stop taking delafloxacin 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 may cause other side effects. Call your doctor if you have any unusual problems while taking 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 ( http://www.fda.gov/Safety/MedWatch ) or by phone (1-800-332-1088).

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website ( http://goo.gl/c4Rm4p ) for more information if you do not have access to a take-back program.

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. If you have diabetes, your doctor may ask you to check your blood sugar more often while taking 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, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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