Delafloxacin (Oral)

Delafloxacin is used to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Delafloxacin belongs to a group of medications called quinolone antibiotics. It works by killing bacteria or stopping them from growing. However, this medicine will not work for colds, flu, or other viral infections.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure it is working properly. Blood and urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within a few days, or if they get worse, contact your doctor.

Delafloxacin may cause inflammation (tendinitis) or tearing of a tendon (the cord that connects muscles to bones). This can happen while you are taking the medicine or after you finish using it. The chance of having tendon issues may be higher if you are over 60 years old, are using steroid medicines (e.g., dexamethasone, prednisolone, prednisone, Medrol®), have severe kidney problems, have a history of tendon problems (e.g., rheumatoid arthritis), or if you have received an organ transplant (e.g., heart, kidney, or lung). Contact your doctor right away if you experience sudden pain or swelling in a tendon (e.g., ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or cannot bear weight or move the affected area. Avoid exercise until your doctor advises otherwise.

Inform your doctor immediately if you experience numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be signs of a condition called peripheral neuropathy.

Notify your doctor right away if you have any of the following symptoms while using this medicine: seizures, feeling anxious, confused, or depressed, seeing, hearing, or feeling things that are not there, severe headache, trouble sleeping, or unusual thoughts or behaviors.

Delafloxacin may worsen myasthenia gravis (severe muscle weakness) in people who already have this condition. Discuss any concerns with your doctor.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical help. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may increase your risk for aortic aneurysm (bulge in the wall of the largest artery). Contact your doctor immediately if you have sudden chest, stomach, or back pain, trouble breathing, cough, or hoarseness.

Delafloxacin may cause diarrhea, which can be severe in some cases. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or prolong it. If you have any questions about this, or if mild diarrhea continues or worsens, contact your doctor.

Delafloxacin may make some people feel dizzy or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

If you are a diabetic patient taking diabetes medicine by mouth: Delafloxacin may cause hypoglycemia (low blood sugar) in some patients. Symptoms of low blood sugar must be treated before they lead to unconsciousness. Different people may experience different symptoms. If you have symptoms of low blood sugar, contact your doctor immediately.

• Symptoms of low blood sugar can include: anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool pale skin, difficulty concentrating, drowsiness, excessive hunger, headache, nausea, nervousness, rapid heartbeat, shakiness, or unusual tiredness or weakness.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor should weigh the risks of taking it against the benefits it may provide. For this medicine, please consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine is not recommended for use in children. Its safety and effectiveness have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of delafloxacin. However, older adults are more likely to have age-related kidney issues or may develop aortic aneurysm or severe tendon disorders (including tendon rupture), especially if they are also taking steroid medications, which may require caution when using delafloxacin.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might occur. In these cases, your doctor may want to adjust the dose, or other precautions may be necessary. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both medicines.

• Acarbose
• Albiglutide
• Alogliptin
• Canagliflozin
• Chlorpropamide
• Dapagliflozin
• Dulaglutide
• Empagliflozin
• Ertugliflozin
• Exenatide
• Glimepiride
• Glipizide
• Glyburide
• Insulin
• Insulin Aspart, Recombinant
• Insulin Bovine
• Insulin Degludec
• Insulin Detemir
• Insulin Glulisine
• Insulin Lispro, Recombinant
• Linagliptin
• Liraglutide
• Lixisenatide
• Magnesium Sulfate
• Metformin
• Miglitol
• Nateglinide
• Pioglitazone
• Porfimer
• Pramlintide
• Repaglinide
• Rosiglitazone
• Saxagliptin
• Semaglutide
• Sitagliptin
• Tolazamide
• Tolbutamide
• Voglibose

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you take one or both medicines.

• Aluminum
• Calcium
• Iron
• Magnesium
• Sucralfate
• Zinc

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Aortic aneurysm (bulge in the wall of the largest artery) or
• Diabetes or
• Diarrhea or
• History of mental illness or
• History of peripheral neuropathy (nerve problem) or
• History of seizures (epilepsy)—Use with caution. This medicine may worsen these conditions.

• Brain problems (e.g., hardening of the brain arteries, changes in brain structure) or
• Severe kidney disease or
• History of organ transplant (e.g., heart, kidney, or lung) or
• History of tendon disorder (e.g., rheumatoid arthritis)—Use with caution. This medicine may worsen side effects.

• End-stage kidney disease or
• Myasthenia gravis (severe muscle weakness), or a history of these conditions—This medicine should not be used in patients with these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may require medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Diarrhea

Less common

• Anxiety
• bloody urine
• bluish color of the skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• changes in skin color
• chest pain or discomfort
• chills
• cold sweats
• confusion
• continuing ringing or buzzing or other unexplained noise in the ears
• cool, pale skin
• cough
• decreased frequency or amount of urine
• depression
• difficulty with moving
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• fast, slow, irregular, pounding, or racing heartbeat or pulse
• feeling of constant movement of self or surroundings
• fever
• flushed, dry skin
• fruit-like breath odor
• headache
• hearing loss
• hives, itching, skin rash
• hoarseness
• increased blood pressure
• increased hunger
• increased thirst
• increased urination
• irritation
• joint pain, stiffness, or swelling
• loss of appetite
• loss of consciousness
• loss of taste
• lower back or side pain
• muscle cramps, pains, or stiffness
• nausea
• painful or difficult urination
• pounding in the ears
• redness of the skin
• seizures
• sensation of spinning
• shakiness
• slurred speech
• stomach pain
• swelling of the eyelids, face, lips, hands, fingers, lower legs, or feet
• swollen joints
• tenderness, pain, swelling, warmth, skin discoloration, or prominent superficial veins over the affected area
• tightness in the chest
• troubled breathing or swallowing
• unexplained weight loss
• unusual tiredness or weakness
• vomiting
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also know ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common

• Abnormal dreams
• belching
• feeling of warmth
• heartburn
• indigestion
• redness of the face, neck, arms, and occasionally, the upper chest
• stomach discomfort, upset, or pain
• trouble sleeping

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also know ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

In the U.S.

• Baxdela

Available Dosage Forms:

• Tablet

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You may take this medicine with or without food.

If you are taking didanosine buffered tablets for oral suspension or the pediatric powder for oral suspension, sucralfate, or antacids, multivitamins, or other products containing aluminum, magnesium, iron, or zinc, take them at least 6 hours before or 2 hours after using delafloxacin. These medicines may keep delafloxacin from working properly.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using this medicine too soon.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets): For acute bacterial skin and skin structure infections: Adults—450 milligrams (mg) every 12 hours for 5 to 14 days. Children—Use and dose must be determined by your doctor. For community acquired bacterial pneumonia: Adults—450 milligrams (mg) every 12 hours for 5 to 10 days. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose and it is less than 8 hours until your next dose, skip the missed dose and go back to your regular dosing schedule.

If you miss a dose and it is more than 8 hours until your next dose, take it as soon as possible and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

• What type of antibiotic is Baxdela?