Baxdela Generic Name & Formulations
Delafloxacin 450mg; tabs.
Tabs—20; Blister packs—20 (2x10 tabs); Single-dose vials—10
Susceptible acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Baxdela Dosage and Administration
≥18yrs: 450mg every 12hrs. ABSSSI: treat for 5–14 days. CABP: treat for 5–10 days. ESRD (eGFR <15mL/min/1.73m2) or hemodialysis: not recommended (insufficient data). See full labeling.
<18yrs: not recommended.
Baxdela Boxed Warnings
Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects, and exacerbation of myasthenia gravis.
Increased risk of disabling and potentially irreversible adverse reactions (including tendinitis/tendon rupture [esp. in patients >60yrs, or those with kidney, heart or lung transplants], peripheral neuropathy, or CNS/psychiatric effects); discontinue immediately if signs/symptoms occur. CNS disorders (eg, cerebral arteriosclerosis, epilepsy) that increase seizure risk. History of myasthenia gravis; avoid. Increased risk of aortic aneurysm and dissection (esp. in elderly); reserve use only if no alternatives in patients with history or risk of. Discontinue at 1st sign of skin rash, or any other hypersensitivity. Monitor blood glucose in diabetic patients; discontinue if hypoglycemia occurs. Severe renal impairment receiving IV form: monitor serum creatinine levels, eGFR closely; consider switching to oral form if serum creatinine level increases. Discontinue if eGFR falls <15mL/min/1.73m2. Elderly. Pregnancy. Nursing mothers.
Separate dosing of oral form with magnesium- or aluminum-containing antacids, sucralfate, metal cations, multivitamins containing zinc or iron, or didanosine (buffered forms) by at least 2hrs before or 6hrs after these agents. Increased risk of tendinitis/tendon rupture with corticosteroids. Concomitant antidiabetics may increase blood glucose disturbances. For IV: avoid concomitant solution containing multivalent cations (eg, calcium, magnesium) through same IV line.
Baxdela Adverse Reactions
Nausea, diarrhea, headache, transaminase elevations, vomiting; tendinitis/tendon rupture, peripheral neuropathy, CNS/psychiatric effects, hypersensitivity reactions, C. difficile-associated diarrhea, dysglycemia, aortic aneurysm/dissection.
Baxdela Clinical Trials
Baxdela Patient Counseling