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levofloxacin (Rx)Brand and Other Names:Levaquin, Levofloxacin Systemic

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

premix, ready-to-use injection

  • 250mg/50mL
  • 500mg/100mL
  • 750mg/150mL

oral solution

  • 25mg/mL

tablet

  • 250mg
  • 500mg
  • 750mg
more...

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

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
more...

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
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Interactions

Interaction Checker

levofloxacin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

            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

            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

            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

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            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; fluoroquinolones should be avoided in patients with known history of myasthenia gravis

            Serious adverse effects and limitations-of-use

            • Both oral and injectable fluroquinolones are associated with disabling side 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 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

            Central nervous system (CNS) effects, including toxic psychosis, convulsions, increased intracranial pressure (pseudotumor cerebri), anxiety, confusion, depression, and insomnia reported with therapy

            Use with caution in patients with known or suspected disorders that predispose to seizures or take medications that will lower seizure threshold

            May increase risk of tendon rupture in aptients with rheumatoid arthritis; use caution

            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

            No longer recommended for gonorrhea in United States, because of widespread resistance

            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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Drug excreted in breast milk; not recommended

            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.

            more...
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            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

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            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

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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