Delafloxacin
Indications
Delafloxacin is used for:
Acute bacterial skin and skin structure infections
Adult Dose
Skin and Skin Structure Infections
Parenteral
300 mg IV q12hr for 5-14 days, OR
300 mg IV q12hr, then switch to a 450-mg tablet PO q12hr for 5-14 days, OR
Oral
450 mg PO q12hr for 5-14 days
Hepatic impairment
No dosage adjustment needed
Child Dose
Safety and efficacy not established
Renal Dose
Renal impairment
IV
CrCl 30-89 mL/min: No dosage adjustment needed
CrCl 15-29 mL/min: 200 mg IV q12hr OR 200 mg IV q12hr, then switch to 450 mg PO q12hr
CrCl <15 mL/min: Not recommended
PO
CrCl 15-89 mL/min: No dosage adjustment needed
CrCl <15mL/min: Not recommended
Administration
IV Preparation
Reconstitute 300-mg vial with10.5 mL D5W or 0.9% NaCl, resulting in 300 mg/12 mL (25 mg/mL)
Shake vial vigorously until contents are completely dissolved; solution should appear clear yellow to amber colored
Further dilute reconstituted solution to a total volume of 250 mL with D5W or 0.9% NaCl to achieve a final concentration of 1.2 mg/mL prior to administration
IV Administration
Infuse IV via volume control set or piggyback container
Infuse IV over 60 minutes
Oral Administration
May take with or without food
Missed dose: Take as soon as possible within 4 hr of missed dose; if >4 hr since missed dose, wait until next scheduled dose
Contra Indications
Documented hypersensitivity to delafloxacin or its components or other fluoroquinolones
Precautions
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 (see Black Box Warnings)
Increased risk of CNS reactions (eg, convulsions and increased intracranial pressure [including pseudotumor cerebri]; toxic psychosis); may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts
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
Lactation
Unknown if distributed in human breast milk
Pregnancy-Lactation
Pregnancy
Data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk of major birth defects and miscarriages
Lactation
Unknown if distributed in human breast milk
Excreted in the breast milk of rats
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Fluoroquinolones form chelates with alkaline earth and transition metal cations
Delafloxacin PO administration with antacids containing aluminum or magnesium, with sucralfate, with metal cations (eg, iron), or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations (eg, didanosine buffered tablets for oral suspension or the pediatric powder for oral solution), may substantially interfere with the absorption and decrease systemic exposure
Adverse Effects
Side effects of Delafloxacin :
1-10%
Nausea (8%)
Diarrhea (8%)
Headache (3%)
Transaminase elevations (3%)
Vomiting (2%)
Cardiac disorders: Sinus tachycardia, palpitations, bradycardia (<2%)
Ear and labyrinth disorders: Tinnitus, vertigo (<2%)
Eye disorders: Vision blurred (<2%)
General disorders and administration site conditions: Infusion site extravasation, infusion site bruise, discomfort, edema, erythema, irritation, pain, phlebitis, swelling, thrombosis (<2%)
Gastrointestinal disorders: Abdominal pain, dyspepsia (<2%)
Immune system disorders: Hypersensitivity (<2%)
Infections and infestations: Clostridium difficile infection, fungal infection, oral candidiasis, vulvovaginal candidiasis (<2%)
Laboratory Investigations: Blood alkaline phosphatase increased, blood creatinine increased, blood creatine phosphokinase increased (<2%)
Metabolism and nutrition disorders: Hyperglycemia, hypoglycemia (<2%)
Musculoskeletal and connective tissue disorders: Myalgia (<2%)
Nervous system disorders: Dizziness, hypoesthesia, paraesthesia, dysgeusia, presyncope, syncope (<2%)
Psychiatric disorders: Anxiety, insomnia, abnormal dreams (<2%)
Renal and urinary: Renal impairment, renal failure (<2%)
Skin and subcutaneous tissue disorders: Pruritus, urticaria, dermatitis, rash (<2%)
Vascular disorders: Flushing, hypotension, hypertension, phlebitis (<2%)
Mechanism of Action
Fluoroquinolone antibiotic; inhibits both bacterial topoisomerase IV and DNA gyrase (topoisomerase II) enzymes, which are required for bacterial DNA replication, transcription, repair, and recombination