Dosing & Uses
Dosage Forms & Strengths
premix, ready-to-use injection
- 250mg/50mL
- 500mg/100mL
- 750mg/150mL
oral solution
- 25mg/mL
tablet
- 250mg
- 500mg
- 750mg
Community-Acquired Pneumonia
500 mg PO/IV once daily for 7-14 days or 750 mg PO/IV once daily for 5 days
Nosocomial Pneumonia
750 mg PO/IV once daily for 7-14 days
Acute Bacterial Sinusitis
500 mg PO/IV once daily for 10-14 days or 750 mg PO/IV once daily for 5 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute sinusitis
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg PO/IV once daily for ≥7 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for acute bacterial exacerbation of chronic bronchitis
Inhalational Anthrax
Postexposure therapy
500 mg PO once daily for 60 days, beginning as soon as possible after exposure
Skin/Skin Structure Infections
Uncomplicated: 500 mg PO/IV once daily for 7-10 days
Complicated: 750 mg PO/IV once daily for 7-14 days
Chronic Bacterial Prostatitis
500 mg PO/IV once daily for 28 days
Complicated Urinary Tract Infections & Acute Pyelonephritis
250 mg PO/IV once daily for 10 days or 750 mg PO/IV once daily for 5 days
Uncomplicated Urinary Tract Infections
250 mg PO/IV once daily for 3 days
Limitations-of-use: Reserve fluoroquinolones for patients who do not have other available treatment options for uncomplicated urinary tract infections
Plague
Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older
500 mg PO/IV once daily for 10-14 days
Acne Vulgaris (Off-label)
100 mg PO q8hr for 4 weeks
Epididymitis (Off-label)
500 mg PO qDay for 10 days
Pseudomonas aeruginosa Pulmonary Infections (Orphan)
Treatment of pulmonary infections due to Pseudomonas aeruginosa and other bacteria in patients with cystic fibrosis
Orphan indication sponsor
- Mpex Pharmaceuticals, Inc, 11535 Sorrento Valley Road, San Diego, CA 92121
Dosage Modifications
Renal impairment (normal dosage, 750 mg/day)
- CrCl 20-49 mL/min: 750 mg every other day
- CrCl 10-19 mL/min or hemodialysis (HD)/peritoneal dialysis (PD): 750 mg initially, then 500 mg every other day
Renal impairment (normal dosage, 500 mg/day)
- CrCl 20-49 mL/min: 500 mg initially, then 250 mg once daily
- CrCl 10-19 mL/min or HD/PD: 500 mg initially, then 250 mg every other day
Renal impairment (normal dosage, 250 mg/day)
- CrCl 20-49 mL/min: No dosage adjustment required
- CrCl 10-19 mL/min: 250 mg every other day; no dosage adjustment required for uncomplicated urinary tract infection (UTI)
- HD/PD: No data
Dialysis
- Supplemental doses not required following hemodialysis or continuous ambulatory peritoneal dialysis (CAPD)
Dosing Considerations
Susceptible organisms
- Aeromonas hydrophila, Campylobacter jejuni, Citrobacter diversus, Citrobacter freundii, Chlamydia pneumoniae, Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella pneumophila, Morganella morganii, Moraxella catarrhalis, Proteus mirabilis, Providencia spp, Pseudomonas aeruginosa, Serratia spp, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Ureaplasma urealyticum
- First-line therapy: C jejuni, C freundii, Enterobacter spp; no unanimity on others (eg, A hydrophila, L pneumophila, M morganii)
Dosage Forms & Strengths
premix, ready-to-use injection
- 250mg/50mL
- 500mg/100mL
oral solution
- 25mg/mL
tablet
- 250mg
- 500mg
Tablets not for administration to pediatric patients with inhalational anthrax or plague who weigh <30 kg due to limitations of available strengths; alternative formulations of levofloxacin may be considered for pediatric patients who weigh <30 kg
Inhalational Anthrax
Postexposure therapy
≥6 months and <50 kg: 8 mg/kg PO q12hr for 60 days, beginning as soon as possible after exposure; individual dose not to exceed 250 mg
≥6 months and >50 kg: 500 mg PO once daily for 60 days, beginning as soon as possible after exposure
Safety in children for treatment duration >14 days has not been established
Plague
Indicated for treatment and prophylaxis of plague, including pneumonic and septicemic plague, caused by Yersinia pestis in adults and pediatric patients, aged 6 months or older
≥6 months and <50 kg: 8 mg/kg PO/IV q12hr for 10-14 days; individual dose not to exceed 250 mg
≥50 kg: 500 mg PO/IV once daily for 10-14 days
Acute Bacterial Rhinosinusitis (Off-label)
10-20 mg/kg/day PO qDay or divided q12hr
Community Acquired Pneumonia (Off-label)
S. pneumonia
- 6 months - 5 years: 16-20 mg/kg/day PO qDay for 10 days
- 5-16 years: 8-10 mg/kg/day PO qDay for 10 days; not to exceed 750 mg/da
M. pneumoniae, C. trachomatis, C. pneumoniae
- Adolescents with skeletal maturity: 500 mg PO qDay for 10 days; not to exceed 750 mg/day
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
1-10%
Nausea (7%)
Headache (6%)
Diarrhea (5%)
Insomnia (4%)
Constipation (3%)
Dizziness (3%)
Dyspepsia (2%)
Rash (2%)
Vomiting (2%)
Chest pain (1%)
Dyspnea (1%)
Edema (1%)
Fatigue (1%)
Injection-site reaction (1%)
Moniliasis (1%)
Pain (1%)
Pruritus (1%)
Vaginitis (1%)
<1%
Cardiac: Cardiac arrest, palpitation, ventricular tachycardia, arrhythmia
Nervous system: Tremor, convulsions, paresthesia, vertigo, hypertonia, hyperkinesias, abnormal gait, somnolence, syncope
Metabolic: Hypoglycemia, hyperglycemia, hyperkalemia
Blood/lymphatic system: Anemia, thrombocytopenia, granulocytopenia
Musculoskeletal/connective tissue: Arthralgia, tendonitis, myalgia, skeletal pain
Gastrointestinal (GI): Gastritis, stomatitis, pancreatitis, esophagitis, gastroenteritis, glossitis, pseudomembranous/C difficile colitis
Hepatobiliary: Abnormal hepatic function, increased hepatic enzymes, increased alkaline phosphatase
Psychiatric: Anxiety, agitation, confusion, depression, hallucinations, nightmares, sleep disorder, anorexia, abnormal dreaming
Other: Immune hypersensitivity reaction, acute renal failure, urticaria, phlebitis, epistaxis
Postmarketing Reports
Cardiac: Prolonged QT interval, torsades de pointes, tachycardia
Vascular disorders: Aortic aneurysm and dissection
Musculoskeletal/connective tissue: Tendon rupture, muscle injury, rhabdomyolysis
Skin/subcutaneous tissue: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, photosensitivity/phototoxicity, leukocytoclastic vasculitis
Renal and urinary disorders: Interstitial nephritis
Vascular disorders: Vasodilation; increased risk of aortic aneurysm and dissection
Blood/lymphatic system: Pancytopenia, aplastic anemia, leukopenia, hemolytic anemia, eosinophilia
Hepatobiliary: Hepatic failure, hepatitis, jaundice
Psychiatric: Psychosis, paranoia, suicidal ideation, isolated reports of suicide attempts
Nervous system: Exacerbation of myasthenia gravis, anosmia, ageusia, parosmia, dysgeusia, peripheral neuropathy, abnormal electroencephalogram (EEG), dysphonia, isolated reports of encephalopathy, pseudotumor cerebri
Central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion)
Respiratory, thoracic and mediastinal disorders: Isolated reports of allergic pneumonitis
Immune system disorders: Hypersensitivity reactions, sometimes fatal including: anaphylactic/anaphylactoid reactions, anaphylactic shock, angioneurotic edema, serum sickness
Eye disorders: Uveitis, vision disturbance (including diplopia), visual acuity reduced, vision blurred, scotoma
Otologic: Hypoacusis, tinnitus
General disorders and administration site conditions: Multiorgan failure, pyrexia
Warnings
Black Box Warnings
Serious adverse effects and limitations-of-use
- Both oral and injectable fluoroquinolones are associated with disabling side effects involving tendons, muscles, joints, nerves and the central nervous system
- 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
- These side effects can occur hours to weeks after exposure to fluoroquinolones and may potentially be permanent
May exacerbate muscle weakness in patients with myasthenia gravis; fluoroquinolones should be avoided in patients with known history of myasthenia gravis
Because the risk of these serious side effects generally outweighs the benefits for patients with acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated UTIs, that 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
Documented hypersensitivity
Cautions
Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose
Use caution in hematologic and renal toxicities
Hepatotoxicity reported with therapy
Peripheral neuropathy: Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported; peripheral neuropathy may occur rapidly after initiating and may potentially become permanent
Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion); these reactions can occur within hours to weeks after starting therapy, including in patients of any age or without pre-existing risk factors; discontinue therapy immediately at first signs or symptoms of any serious adverse reaction; in addition, avoid use of fluoroquinolones, in patients who have experienced any serious adverse reactions associated with fluoroquinolones
Risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants; other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis (see Black Box Warnings)
Excessive sunlight may result in moderate-to-severe phototoxicity
Fatal hypoglycemia reported in elderly patients with or without diabetes; prompt treatment when symptoms are present is essential
May cause C difficile-associated colitis
Prolonged use may result in fungal or bacterial superinfection
Prolongation of QT interval and isolated cases of torsades de pointes; avoid use in patients with known QT prolongation, those with hypokalemia, and those taking other QT-prolonging drugs
May produce false-positive urine opiate screens
In prolonged therapy, perform periodic evaluations of organ system function (eg, renal, hepatic, hematopoietic); adjust dosage in renal impairment; superinfections may occur with prolonged or repeated antibiotic therapy
Pediatric patients may experience increased incidence of musculoskeletal disorders (eg, arthralgia, arthritis, tendinopathy, gait abnormality)
Acute onset of retinal detachment increased 4.5-fold with oral fluoroquinolones in a single case-controlled study - JAMA 2012;307(13):1414-1419; another study disputes these findings (relative risk, 1.29) - JAMA 2013;310(20):2184-2190
Clostridium difficile-associated diarrhea (CDAD) has been reported; if CDAD suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued; appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated
Prescribing antibiotics in absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to patient and increases risk of development of drug-resistant bacteria
CNS effects
- Fluoroquinolones have been associated with an increased risk of CNS effects, including: convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychosis
- May also cause CNS events including: nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and psychotic reactions have progressed to suicidal ideations/thoughts and self-injurious behavior such as attempted or completed suicide; reactions may occur following the first dose; advise patients to inform their healthcare provider immediately if these reactions occur, discontinue treatment, and institute appropriate care
- Fluoroquinolone are also known to trigger seizures or lower the seizure threshold; use with caution in epileptic patients and patients with known or suspected CNS disorders that may predispose to seizures or lower the seizure threshold (eg, severe cerebral arteriosclerosis, previous history of convulsion, reduced cerebral blood flow, altered brain structure, or stroke), or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold (eg, certain drug therapy, renal dysfunction)
FDA MedWatch Safety Alert
- Issued 12-20-2018
- Increase in rate of aortic aneurysm and dissection reported within two months following use of fluoroquinolones, particularly in elderly patients
- May occur with fluoroquinolones for systemic use (IV or PO)
- Patients who have an aortic aneurysm or are at risk for an aortic aneurysm (eg, patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions [eg, Marfan syndrome, Ehlers-Danlos syndrome], elderly patients)
- Prescribe fluoroquinolones to these patients only when no other treatment options are available
- Advise patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm
- Stop treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection
FDA MedWatch Safety Alert
- Issued July 10, 2018
- The FDA is strengthening the current warnings in the prescribing information for fluoroquinolone antibiotics to inform clinicians of significant decreases in blood glucose and certain mental health adverse effects
- Hypoglycemia, sometimes resulting in coma, occurred more frequently in elderly patients or in diabetic patients taking oral hypoglycemic medicine or insulin
- Alert patients regarding hypoglycemic symptoms and carefully monitor blood glucose levels; instruct patients how to treat themselves if symptoms of hypoglycemia occur
- This safety alert affects only systemic formulations; early signs and symptoms of low blood glucose include confusion, dizziness, feeling shaky, unusual hunger, headaches, irritability, pounding heart or very fast pulse, pale skin, sweating, trembling, weakness, and/or unusual anxiety
- Mental health side effects are to be added to or updated across all the fluoroquinolones are disturbances in attention, disorientation, agitation, nervousness, memory impairment, and delirium
- Inform patients of the potential risk of psychiatric adverse reactions that can occur after just 1 dose
- Immediately discontinue treatment if CNS adverse effects occur, including psychiatric adverse reactions, or blood glucose disturbances occur and switch to a nonfluoroquinolone antibiotic if possible
Pregnancy & Lactation
Pregnancy
Levofloxacin has not been shown to increase risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
Animal data
- Oral administration to pregnant rats and rabbits during organogenesis at doses up to 9.4 times and 1.1 times the maximum recommended human dose (MRHD), respectively, did not result in teratogenicity; fetal toxicity reported in the rat study, but absent at doses up to 1.2 times maximum recommended human dose
Lactation
Drug is present in human milk following intravenous and oral administration; there is no information regarding effects on milk production or breastfed infant; because of potential risks of serious adverse reactions, in breastfed infants, a lactating woman may consider pumping and discarding breast milk during treatment and an additional two days (five half-lives) after last dose
Alternatively, advise a lactating woman that breastfeeding is not recommended during treatment and for an additional two days (five half-lives) after last dose
For inhalation anthrax (post-exposure), during an incident resulting in exposure to anthrax, risk-benefit assessment of continuing breastfeeding while the mother (and potentially the infant) is (are) on this drug may be acceptable
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
L-stereoisomer of parent compound ofloxacin; D-isomer form is inactive
Inhibits DNA gyrase activity, which in turn promotes breakage of DNA strands
Good monotherapy with extended coverage against Pseudomonas spp, as well as excellent activity against pneumococcus
Absorption
Well absorbed
Bioavailability: 99%
Peak serum time: 1-2 hr
Distribution
Cerebrospinal fluid (CSF) concentrations ~15% of serum levels; high concentrations achieved in prostate, gynecologic tissues, sinus, breast milk, saliva
Vd: 74-112 L
Metabolism
Limited metabolism in humans
Elimination
Half-life: 6-8 hr
Excretion: Urine (primarily as unchanged drug); after oral administration, 87% is recovered as unchanged drug in urine within 48 hr, and <4% is recovered in feces in 72 hr
Administration
Oral Administration
Administer without regard to food
Oral solution should be taken 1 hour before or 2 hours after eating
IV Incompatibilities
Y-site: Acyclovir, alprostadil, furosemide, heparin, indomethacin, insulin (at 100 U/mL + 5 mg/mL levofloxacin), nitroglycerin, propofol, sodium nitroprusside
IV Compatibilities
Additive: Linezolid
Y-site: Amikacin, aminophylline, ampicillin, bivalirudin, caffeine, cefotaxime, cimetidine, clindamycin, dexamethasone, dexmedetomidine, dobutamine, dopamine, epinephrine, fenoldopam, fentanyl, gentamicin, lactated hetastarch, insulin (at 1 U/mL + 5 mg/mL levofloxacin), isoproterenol, lidocaine, linezolid, lorazepam, metoclopramide, oxacillin, pancuronium, penicillin G sodium, phenobarbital, phenylephrine, sodium bicarbonate, vancomycin
IV Preparation
Premixed: No further preparation needed
Single-use vials: Dilute in 50-100 mL D5W or NS or D5/NS solution for injection to 5 mg/mL; alternative solutions include sodium lactate, Plasma-Lyte, D5/lactated Ringer, D5/NS and potassium chloride
Reconstituted solution should be clear, slightly yellow, and free of particulate matter
Reconstituted drug is stable for 72 hours at room temperature, 14 days when refrigerated in plastic containers, and 6 months when frozen
Thaw at room temperature or in refrigerator only
IV Administration
Give by IV infusion only, not bolus; rapid or bolus administration has been associated with hypotension and must be avoided
Infuse 250-500 mg over 60 minutes or 750 mg over 90 minutes
Avoid using IV line with solution containing multivalent cations (ie, magnesium, calcium)
Compatible with potassium additives
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Formulary
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