Classes
DEA Class; Rx
Common Brand Names; Baxdela
- Fluoroquinolones
Description
Oral and intravenous fluoroquinolone antibiotic
Used for treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired pneumonia (CAP)
Associated with disabling and potentially irreversible adverse events, including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects, and aortic aneurysm or dissection
Indications
Indicated for treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible bacteria
Contraindications
Hypersensitivity to delafloxacin or its components or other fluoroquinolones
Adverse Effects
- Nausea (8%)
- Diarrhea (8%)
- Headache (3%)
- Transaminase elevations (3%)
- Vomiting (2%)
- Cardiac disorders: Sinus tachycardia, palpitations, bradycardia
- Ear and labyrinth disorders: Tinnitus, vertigo
- Eye disorders: Vision blurred
- General disorders and administration site conditions: Infusion site extravasation, infusion site bruise, discomfort, edema, erythema, irritation, pain, phlebitis, swelling, thrombosis
- Gastrointestinal disorders: Abdominal pain, dyspepsia
- Immune system disorders: Hypersensitivity
- Infections and infestations: Clostridium difficile infection, fungal infection, oral candidiasis, vulvovaginal candidiasis
- Laboratory Investigations: Blood alkaline phosphatase increased, blood creatinine increased, blood creatine phosphokinase increased
- Metabolism and nutrition disorders: Hyperglycemia, hypoglycemia
- Musculoskeletal and connective tissue disorders: Myalgia
- Nervous system disorders: Dizziness, hypoesthesia, paraesthesia, dysgeusia, presyncope, syncope
- Psychiatric disorders: Anxiety, insomnia, abnormal dreams
- Renal and urinary: Renal impairment, renal failure
- Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis, rash
- Vascular disorders: Flushing, hypotension, hypertension, phlebitis
Warnings
Fluoroquinolones are associated with disabling and potentially irreversible serious adverse reactions from different body systems, including tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and CNS effects (eg, hallucinations, anxiety, depression, insomnia, severe headaches, confusion)
Risk of tendinitis and tendon rupture in all ages; the Achilles tendon is most frequently involved, but rupture has also been reported with the rotator cuff, hand, biceps, thumb, and other tendons
Fluoroquinolones are associated with increased risk of peripheral neuropathy; sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported
Fluoroquinolones elicit neuromuscular blocking activity and may exacerbate muscle weakness with myasthenia gravis
Serious and occasional fatal hypersensitivity reactions (including after first dose) reported
Clostridium difficile-associated diarrhea (CDAD) reported with use of nearly all systemic antibiotics
Prescribing an antibiotic in the absence of proven or strongly suspected bacterial infection is unlikely to provide benefit and increases risk developing drug-resistant bacteria
Increased risk of aortic aneurysm and dissection within 2 months following fluoroquinolone use observed in epidemiologic studies, particularly in elderly patients; etiology has not been identified; reserve use in patients with known or at greater risk for aortic aneurysm only when there are no alternative antibacterial treatments available
Blood glucose disturbances reported with fluoroquinolones, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (eg, glyburide) or with insulin; careful blood glucose monitoring recommended; severe cases of hypoglycemia resulting in coma or death reported with other fluoroquinolones
Pregnancy and Lactation
Data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk of major birth defects and miscarriages
Unknown if distributed in human breast milk
Maximum Dosage
900 mg/day PO or 600 mg/day IV.
900 mg/day PO or 600 mg/day IV.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Delafloxacin
injection, lyophilized powder for reconstitution
- 300mg/vial (equivalent to 433mg delafloxacin meglumine)
tablet
- 450mg (equivalent to 649mg delafloxacin meglumine)