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BAXDELA- delafloxacin meglumine tabletBAXDELA- delafloxacin meglumine injection, powder, lyophilized, for solution


  1. Patient Information
  2. Disabling And Potentially Irreversible Serious Adverse Reactions That May Occur Together:
  3. Tendinitis And Tendon Rupture:
  4. Peripheral Neuropathy:
  5. Central Nervous System Effects: (for Example, Convulsions, Dizziness, Lightheadedness, Increased Intracranial Pressure):
  6. Exacerbation Of Myasthenia Gravis:
  7. Hypersensitivity Reactions:
  8. Diarrhea:
  9. Aortic Aneurysm And Dissection:
  10. Antibacterial Resistance:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide)

Serious Adverse Reactions

Advise patients to stop taking BAXDELA if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.

Disabling And Potentially Irreversible Serious Adverse Reactions That May Occur Together: 

Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of fluoroquinolones and may occur together in the same patient. Inform patients to stop taking BAXDELA immediately if they experience an adverse reaction and to call their healthcare provider.

Tendinitis And Tendon Rupture: 

Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue BAXDELA treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.

Peripheral Neuropathy: 

Inform patients that peripheral neuropathies have been associated with BAXDELA use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue BAXDELA and tell them to contact their physician.

Central Nervous System Effects: (for Example, Convulsions, Dizziness, Lightheadedness, Increased Intracranial Pressure): 

Inform patients that convulsions have been reported in patients receiving fluoroquinolones, Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to BAXDELA before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.

Exacerbation Of Myasthenia Gravis: 

Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.

Hypersensitivity Reactions: 

Inform patients that BAXDELA can cause hypersensitivity reactions, even following a single dose, and to discontinue BAXDELA at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.

Diarrhea: 

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.

Aortic Aneurysm And Dissection: 

Inform patients to seek emergency medical care if they experience sudden chest, stomach, or back pain.

Antibacterial Resistance: 

Inform patients that antibacterial drugs including BAXDELA Tablets and Injection should only be used to treat bacterial infections. They do not treat viral infections (for example, the common cold). When BAXDELA Tablets and BAXDELA Injection are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by BAXDELA Tablets and BAXDELA Injection or other antibacterial drugs in the future.

Administration with Food and Concomitant Medications

  • Inform patients that BAXDELA Tablets may be taken with or without food and without any dietary restrictions[seeDosage and Administration (2.1)andClinical Pharmacology (12.3)].
  • Inform patients that BAXDELA Tablets should be taken at least 2 hours before or 6 hours after antacids containing magnesium, or aluminum, with sucralfate, with metal cations such as iron, or with multivitamin preparations containing zinc or iron, or with didanosine buffered tablets for oral suspension or the pediatric powder for oral solution.



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