Dosing & Uses
Dosage Forms & Strengths
injection, lyophilized powder for reconstitution
- 300mg/vial (equivalent to 433mg delafloxacin meglumine)
tablet
- 450mg (equivalent to 649mg delafloxacin meglumine)
Skin and Skin Structure Infections
Indicated for treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria
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
450 mg PO q12hr for 5-14 days
Community-acquired Bacterial Pneumonia
Indicated for treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible bacteria
300 mg IV q12hr for 5-10 days, OR
300 mg IV q12hr, then switch to a 450-mg tablet PO q12hr for 5-10 days, OR
450 mg PO q12hr for 5-10 days
Dosage Modifications
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
Hepatic impairment
- No dosage adjustment needed
Dosing Considerations
Susceptible bacterial
-
ABSSSI
- Staphylococcus aureus (including methicillin-resistant and methicillin-sensitive strains), S haemolyticus, S lugdunensis, Streptococcus pyogenes, S agalactiae, Escherichia coli, Klebsiella pneumoniae, Enterobacter cloacae, Pseudomonas aeruginosa
-
CABP
- Streptococcus pneumoniae, S aureus (methicillin-susceptible [MSSA] isolates only), K pneumoniae, E coli, P aeruginosa, Haemophilus influenzae, H parainfluenzae, Chlamydia pneumoniae, Legionella pneumophila, Mycoplasma pneumoniae
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- fexinidazole
fexinidazole and delafloxacin both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels and/or prolong QT interval.
- microbiota oral
delafloxacin decreases effects of microbiota oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Microbiota oral contains bacterial spores. Antibacterial agents may decrease efficacy if coadministered. Complete antibiotic regimens 2-4 days before initiating microbiota oral. .
- selinexor
selinexor, delafloxacin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
Monitor Closely (28)
- alfuzosin
delafloxacin and alfuzosin both increase QTc interval. Use Caution/Monitor.
- aluminum hydroxide
aluminum hydroxide will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- amifampridine
delafloxacin increases toxicity of amifampridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Amifampridine can cause seizures. Coadministration with drugs that lower seizure threshold may increase this risk.
- calcium acetate
calcium acetate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- calcium carbonate
calcium carbonate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- calcium chloride
calcium chloride will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- calcium citrate
calcium citrate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- calcium gluconate
calcium gluconate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- calcium/vitamin D
calcium/vitamin D will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- carbonyl iron
carbonyl iron will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- ferric maltol
ferric maltol will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- ferrous fumarate
ferrous fumarate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- ferrous gluconate
ferrous gluconate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- ferrous sulfate
ferrous sulfate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- magnesium chloride
magnesium chloride will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- magnesium gluconate
magnesium gluconate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- magnesium oxide
magnesium oxide will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- magnesium sulfate
magnesium sulfate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- magnesium supplement
magnesium supplement will decrease the level or effect of delafloxacin by Other (see comment). Modify Therapy/Monitor Closely. Formation of an insoluble complex reduces absorption of the drug through intestinal tract; administer magnesium 2hr before the quinolone or 6hr after the quinolone
- manganese
manganese will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- multivitamins
multivitamins will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- multivitamins, vision
multivitamins, vision will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- polysaccharide iron
polysaccharide iron will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- sodium sulfate/?magnesium sulfate/potassium chloride
sodium sulfate/?magnesium sulfate/potassium chloride decreases levels of delafloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer fluoroquinolones at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .
- sodium sulfate/potassium sulfate/magnesium sulfate
sodium sulfate/potassium sulfate/magnesium sulfate decreases levels of delafloxacin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer fluoroquinolones at least 2 hr before and no less than 6 hr after each dose to avoid chelation with magnesium. .
- sucralfate
sucralfate will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
- warfarin
delafloxacin increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
- zinc
zinc will decrease the level or effect of delafloxacin by cation binding in GI tract. Modify Therapy/Monitor Closely. Oral delafloxacin form chelates with alkaline earth and transition metal cations. Administer oral delafloxacin at least 2 hr before or 6 hr after these agents.
Minor (0)
Adverse Effects
1-10%
Nausea (8%)
Diarrhea (8%)
Headache (3%)
Transaminase elevations (3%)
Vomiting (2%)
<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
Black Box Warnings
Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects
Discontinue the drug immediately and avoid use of systemic fluoroquinolones in patients who experience any of these serious adverse reactions
May exacerbate muscle weakness in patients with myasthenia gravis; avoid fluoroquinolones with known history of myasthenia gravis
Serious adverse effects and limitations-of-use
- Both oral and injectable fluoroquinolones are associated with disabling adverse effects involving tendons, muscles, joints, nerves and the central nervous system
- These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
- Because the risk of these serious adverse effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, fluoroquinolones should be reserved for use in patients with these conditions who have no alternative treatment options
- For some serious bacterial infections, including anthrax, plague, and bacterial pneumonia, among others, the benefits of fluoroquinolones outweigh the risks and it is appropriate for them to remain available as a therapeutic option
Contraindications
Hypersensitivity to delafloxacin or its components or other fluoroquinolones
Cautions
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; if hypoglycemic reaction occurs in a patient being treated with this medication, discontinue therapy and initiate appropriate therapy immediately
Disabling and potentially irreversible serious reactions
- 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); patients of any age or without pre-existing risk factors have experienced these adverse reactions
- Discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, including this drug, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones
Tendinitis and tendon rupture
- Risk of tendinitis and tendon rupture in all ages; the Achilles tendon is most frequently involved, but rupture also reported with the rotator cuff, hand, biceps, thumb, and other tendons; tendinitis or tendon rupture can occur, within hours or days of starting a fluoroquinolone, or as long as several months after completion of fluoroquinolone therapy; tendinitis and tendon rupture can occur bilaterally
- This risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients > 60 years of age, in patients taking corticosteroid drugs, and, in patients with kidney, heart, and lung transplant; other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis; tendinitis and tendon rupture have also occurred in patients taking fluoroquinolones who do not have the above risk factors
Peripheral neuropathy
- 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
- Discontinue therapy immediately if patient experiences symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness or other alterations of sensation including light touch, pain, temperature, position sense, and vibratory sensation and/or motor strength in order to minimize the development of an irreversible condition
- Symptoms may occur soon after initiation of fluoroquinolones and may be irreversible in some patients; avoid therapy in patients who have previously experienced peripheral neuropathy
Exacerbation of myasthenia gravis
- Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis; post-marketing serious adverse reactions, including death and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis; avoid therapy in patients with known history of myasthenia gravis
Hypersensitivity reactions
- Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, reported in patients receiving fluoroquinolone therapy; some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching
- Hypersensitivity reactions reported in patients receiving therapy; these reactions may occur after first or subsequent doses of this drug; discontinue therapy at first appearance of a skin rash or any other sign of hypersensitivity
Clostridium difficile-associated diarrhea
- Clostridium difficile-associated diarrhea (CDAD) reported in users of nearly all systemic antibacterial drugs, including this medication, with severity ranging from mild diarrhea to fatal colitis; treatment with antibacterial agents can alter normal flora of colon and may permit overgrowth of C. difficile
- C. difficile produces toxins A and B, which contribute to development of CDAD; hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antibacterial therapy and may require colectomy
- CDAD must be considered in all patients who present with diarrhea following antibacterial use; careful medical history is necessary because CDAD has been reported to occur more than 2 months after administration of antibacterial agents
- If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile should be discontinued, if possible; appropriate measures such as fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
Central nervous effects
- If the following adverse effects occur, discontinue delafloxacin immediately and institute appropriate therapy
-
Psychiatric effects
- Associated with increased risk of psychiatric adverse reactions, including: toxic psychosis, hallucinations, paranoia, depression, suicidal thoughts or acts, delirium, disorientation, confusion, disturbances in attention, anxiety, agitation, nervousness, insomnia, nightmares, or memory impairment; may occur after the first dose
- If reactions occur, discontinue therapy and institute appropriate measures
-
CNS effects
- Associated with increased risk of seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness, and tremors
- Assess benefits and risks of use in patients with known or suspected CNS disorders (eg, severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold
- If reactions occur, discontinue therapy and institute appropriate measures
Drug interaction overview
- Do not coadminister IV delafloxacin in the same IV line with any solution containing multivalent cations (eg, magnesium)
-
Chelation
- 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
- Administer delafloxacin at least 2 hr before or 6 hr after the aforementioned agents
Pregnancy
Pregnancy
Data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk of major birth defects and miscarriages
Animal studies
- When administered PO to rats during organogenesis, no malformation or fetal death were observed at doses up to 7 times the estimated clinical exposure based on AUC
- When rats were dosed with the IV form in late gestation and during lactation, no adverse effects on offspring were observed
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
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
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
Absorption
Peak plasma concentration
- Oral: 7.17 mcg/mL (single 450-mg dose); 7.45 mcg/mL (steady-state)
- IV: 8.94 mcg/mL (single 300-mg dose); 9.29 mcg/mL (steady-state)
Peak plasma time
- Oral: 0.75 hr (single 450-mg dose); 1 hr (steady-state)
- IV: 1 hr (single 300-mg dose); 1 hr (steady-state)
AUC
- Oral: 22.7 mcg·hr/mL (single 450-mg dose); 30.8 mcg·hr/mL (steady-state)
- IV: 21.8 mcg·hr/mL (single 300-mg dose); 23.4 mcg·hr/mL (steady-state)
Distribution
Protein bound: ~84% (primarily albumin)
Vd: 30-48 L
Metabolism
Glucuronidation is the primary metabolic pathway, with oxidative metabolism representing about 1% of an administered dose
Glucuronidation is mediated mainly by UGT1A1, UGT1A3, and UGT2B15
Elimination
Half-life: 3.7 hr (single IV dose); 4.2-8.5 hr (multiple PO doses)
Total clearance: 16.3 L/hr (single IV dose)
Renal clearance: 35-45% of total clearance
Excretion
- IV: 65% urine; 28% feces
- PO: 50% urine; 48% feces
Administration
IV Compatibilities
Solutions: D5W, 0.9% NaCl
Y-site: Line should be flushed before and after IV infusion
IV Preparation
Reconstitute 300-mg vial with 10.5 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
Storage
Tablets and lyophilized powder: Store at controlled room temperature of 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Reconstituted vial: Up to 24 hr refrigerated (2-8ºC [36-46ºF]) or at controlled room temperature until further diluted for IV infusion; do not freeze
Diluted solution: Up to 24 hr refrigerated or at controlled room; do not freeze
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Baxdela intravenous - | 300 mg vial |  | |
| Baxdela oral - | 450 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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