Dosing & Uses
ADULT
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)
ADVERSE EFFECTS
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
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
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
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
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
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