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Baxdela (Oral)

Generic Name: delafloxacin (Oral route)

dela-FLOX-a-sin

Oral route(Tablet)

Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and central nervous system effects. Discontinue delafloxacin immediately and avoid the use of fluoroquinolones, including delafloxacin, in patients who experience any of these serious adverse reactions. Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid delafloxacin in patients with known history of myasthenia gravis .

Commonly used brand name(s)

In the U.S.

  • Baxdela

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Uses For Baxdela

Delafloxacin is used to treat acute bacterial skin and skin structure infections (ABSSSI).

Delafloxacin belongs to the class of drugs, known as quinolone antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

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

Before Using Baxdela

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use in children is not recommended. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of delafloxacin in the elderly. However, elderly patients are more likely to have age-related kidney problems, or develop severe tendon disorders (including tendon rupture), especially in those who also take steroid medicines, which may require caution in patients receiving delafloxacin.

Breast Feeding

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

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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

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

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Brain disease (eg, hardening of the arteries) or
  • Kidney disease, severe or
  • Organ transplant (eg, heart, kidney, or lung), history of or
  • Tendon disorder (eg, rheumatoid arthritis), history of—Use with caution. May cause side effects to become worse.
  • Diarrhea or
  • Peripheral neuropathy (nerve problem), history of or
  • Seizures (epilepsy), history of—Use with caution. May make these conditions worse.
  • Myasthenia gravis (severe muscle weakness), or history of—Should not be used in patients with this condition.

Proper Use of Baxdela

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 taking 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 treatment of infection:
      • Adults—450 milligrams (mg) every 12 hours for 5 to 14 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.

Precautions While Using Baxdela

It is very important that your doctor check your progress while you are using this medicine to make sure it is working properly. Urine tests may be needed to check for unwanted effects.

Delafloxacin may cause inflammation (tendinitis) or tearing of a tendon (the cord that attaches muscles to bones). This can occur while you are using the medicine or after you finish using it. The risk of having tendon problems may be increased if you are over 60 years of age, are using steroid medicines (eg, dexamethasone, prednisolone, prednisone, Medrol®), have severe kidney problems, have a history of tendon problems (eg, rheumatoid arthritis), or if you have received an organ transplant (eg, heart, kidney, or lung). Check with your doctor right away if you have sudden pain or swelling in a tendon (eg, ankle, back of the knee or leg, shoulder, elbow, or wrist), bruise more easily after an injury, or are unable to bear weight or move the affected area. Refrain from exercise until your doctor says otherwise.

Tell your doctor right away if you start having numbness, tingling, or burning pain in your hands, arms, legs, or feet. These may be symptoms of a condition called peripheral neuropathy.

Tell 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. Talk to your doctor if you have concerns.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and require immediate medical attention. 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 you use this medicine.

Delafloxacin may cause diarrhea, and in some cases it can be severe. 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 make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.

Delafloxacin may cause some people to become dizzy or lightheaded than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that can be dangerous if you are dizzy or not alert.

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.

Baxdela Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need 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
  • coma
  • confusion
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cool, pale skin
  • cough or hoarseness
  • decreased frequency or amount of urine
  • depression
  • difficulty in 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 taste
  • lower back or side pain
  • muscle aches or cramps
  • muscle pains or stiffness
  • nausea
  • nervousness
  • 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abnormal dreams
  • belching
  • feeling of warmth
  • heartburn
  • indigestion
  • pain or redness at the injection site
  • 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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