Delafloxacin Meglumine (1 brand name, 2 dosage forms, 2 routes)
Available dosage forms: POWDER, TABLET.
Routes of administration: INTRAVENOUS, ORAL.
Brand Names
- BAXDELA
Boxed Warning
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together (5.1), including: Tendinitis and tendon rupture (5.2) Peripheral neuropathy (5.3) Central nervous system effects (5.4) Discontinue BAXDELA immediately and avoid the use of fluoroquinolones, including BAXDELA, in patients who experience any of these serious adverse reactions (5.1) Fluoroquinolones may exacerbate muscle weakness in patients with myasthenia gravis. Avoid BAXDELA in patients with known history of myasthenia gravis. (5.5)
Contraindications
BAXDELA is contraindicated in patients with known hypersensitivity to delafloxacin or any of the fluoroquinolone class of antibacterial drugs, or any of the components of BAXDELA [see Warnings and Precautions (5.6)].
Adverse Reactions
The following serious and otherwise important adverse reactions are discussed in greater detail in other sections of labeling: Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1)] Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)] Peripheral Neuropathy [see Warnings and Precautions (5.3)] Central Nervous System Effects [see Warnings and Precautions (5.4)] Hypersensitivity Reactions [see Warnings and Precautions (5.6)] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.7)] Blood Glucose Disturbances [see Warnings and Precautions (5.10)]
Mechanism of Action
BAXDELA is an antibacterial drug [see Microbiology (12.4)].
Overdosage
Treatment of overdose with BAXDELA should consist of observation and general supportive measures. Hemodialysis removed about 19% of delafloxacin and 56% of SBECD (Sulfobutylether β cyclodextrin) after intravenous administration of BAXDELA [see Clinical Pharmacology (12.3)].