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Baxdela Injection Generic Name & Formulations
Legal Class
Rx
General Description
Delafloxacin 300mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.
Pharmacological Class
Quinolone.
See Also
How Supplied
Tabs—20; Blister packs—20 (2x10 tabs); Single-dose vials—10
Manufacturer
Generic Availability
NO
Baxdela Injection Indications
Indications
Susceptible acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).
Baxdela Injection Dosage and Administration
Adult
Infuse over 60mins. ≥18yrs: 300mg every 12hrs; or, 300mg every 12hrs then switch to oral tabs 450mg every 12hrs as clinically indicated. ABSSSI: treat for 5–14 days. CABP: treat for 5–10 days. Renal impairment (eGFR 15–29mL/min/1.73m2): 200mg every 12hrs; may switch to oral form as clinically indicated. ESRD (eGFR <15mL/min/1.73m2) or hemodialysis: not recommended (insufficient data). See full labeling.
Children
<18yrs: not recommended.
Baxdela Injection Contraindications
Not Applicable
Baxdela Injection Boxed Warnings
Boxed Warning
Serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, CNS effects, and exacerbation of myasthenia gravis.
Baxdela Injection Warnings/Precautions
Warnings/Precautions
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.
Baxdela Injection Pharmacokinetics
See Literature
Baxdela Injection Interactions
Interactions
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 Injection Adverse Reactions
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 Injection Clinical Trials
See Literature
Baxdela Injection Note
Not Applicable
Baxdela Injection Patient Counseling
See Literature
