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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Medication Safety Issues
Sound-alike/look-alike issues:
Levaquin® may be confused with Levoxyl®, Levsin/SL®, Lovenox®
Levofloxacin may be confused with levetiracetam, levodopa, levothyroxine
Pronunciation
(lee voe FLOKS a sin)
U.S. Brand Names
Generic Available
No
Canadian Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Systemic: Treatment of community-acquired pneumonia, including multidrug resistant strains of S. pneumoniae (MDRSP); nosocomial pneumonia; chronic bronchitis (acute bacterial exacerbation); acute bacterial sinusitis; prostatitis, urinary tract infection (uncomplicated or complicated); acute pyelonephritis; skin or skin structure infections (uncomplicated or complicated); reduce incidence or disease progression of inhalational anthrax (postexposure)
Ophthalmic: Treatment of bacterial conjunctivitis caused by susceptible organisms (Quixin® 0.5% ophthalmic solution); treatment of corneal ulcer caused by susceptible organisms (Iquix® 1.5% ophthalmic solution)
Use: Unlabeled/Investigational
Diverticulitis, enterocolitis (Shigella spp.), epididymitis (nongonococcal), gonococcal infections, Legionnaires' disease, peritonitis, PID
Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of gonococcal disease.
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in some animal studies; therefore, the manufacturer classifies levofloxacin as pregnancy category C. Levofloxacin crosses the placenta. Quinolone exposure during human pregnancy has been reported with other agents (see Ciprofloxacin, Ofloxacin, and Norfloxacin monographs). To date, no specific teratogenic effect or increased pregnancy risk has been identified; however, because of concerns of cartilage damage in immature animals exposed to quinolones and the limited levofloxacin specific data, levofloxacin should only be used during pregnancy if a safer option is not available.
Lactation
Enters breast milk/not recommended
Breast-Feeding Considerations
Based on data from a case report, small amounts of levofloxacin are excreted in breast milk. Breast-feeding is not recommended by the manufacturer. Levofloxacin is the L-isomer of ofloxacin. Ofloxacin has also been shown to have minimal concentrations in human milk and is considered “usually compatible with breastfeeding” by the AAP. Nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to levofloxacin, any component of the formulation, or other quinolones
Warnings/Precautions
Boxed Warnings:
• Tendon inflammation/rupture: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in patients with a history of QTc prolongation, uncorrected hypokalemia, hypomagnesemia, or concurrent administration of other medications known to prolong the QT interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).
• CNS stimulation: Tremor, restlessness, confusion, and very rarely hallucinations or seizures may occur; use with caution in patients with known or suspected CNS disorder. Discontinue in patients who experience significant CNS adverse effects (eg, dizziness, hallucinations, suicidal ideations or actions).
• Glucose regulation: Fluoroquinolones have been associated with the development of serious, and sometimes fatal, hypoglycemia. These events have occurred most often in elderly patients with diabetes, but have also been reported in patients without a prior history of diabetes. Prompt identification and treatment of hypoglycemia is essential. Individual quinolones may differ in their potential to cause this effect. It was most evident with gatifloxacin (no longer marketed as systemic formulation). Hyperglycemia has also been associated with the use of fluoroquinolones. Patients should be monitored closely for signs/symptoms of disordered glucose regulation.
• Hepatotoxicity: Unrelated to hypersensitivity, severe hepatotoxicity (including acute hepatitis and fatalities) has been reported. Elderly patients may be at greater risk. Discontinue therapy immediately if signs and symptoms of hepatitis occur.
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.
• Peripheral neuropathy: The use of quinolones has been linked to peripheral neuropathy (rare); discontinue if symptoms of sensory or sensorimotor neuropathy occur.
• Phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing, sunscreen); may cause moderate-to-severe phototoxicity reactions. Discontinue use if photosensitivity occurs.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
• Tendon inflammation/rupture: [U.S. Boxed Warning]: There have been reports of tendon inflammation and/or rupture with quinolone antibiotics; risk may be increased with concurrent corticosteroids, organ transplant recipients, and in patients >60 years of age. Rupture of the Achilles tendon sometimes requiring surgical repair has been reported most frequently; but other tendon sites (eg, rotator cuff, biceps) have also been reported. Strenuous physical activity may be an independent risk factor for tendonitis. Discontinue at first sign of tendon inflammation or pain. May occur even after discontinuation of therapy.
Disease-related concerns:
• Myasthenia gravis: Some quinolones may exacerbate myasthenia gravis, use with caution (rare, potentially life-threatening weakness of respiratory muscles may occur).
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment required. May increase risk of tendon rupture.
• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase risk of tendon rupture.
• Seizures: Use with caution in individuals at risk of seizures (CNS disorders or concurrent therapy with medications which may lower seizure threshold). Potential for seizures, although very rare, may be increased with concomitant NSAID therapy.
Special populations:
• Elderly: Adverse effects (eg, hepatotoxicity, tendon rupture, QT changes) may be increased in the elderly.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients with latent or actual G6PD deficiency.
• Pediatrics: Safety and efficacy have not been established in children <1 year of age for Quixin® and in children <6 years of age for Iquix®. Systemic use is only recommended in children <18 years of age for the prevention of inhalational anthrax (postexposure); increased incidence of musculoskeletal disorders (eg, arthralgia, tendon rupture) has been observed in children.
Dosage form specific issues:
• Ophthalmic solution: For topical use only. Do not inject subconjunctivally or introduce into anterior chamber of the eye. Contact lenses should not be worn during treatment for bacterial conjunctivitis. Indications for ophthalmic solutions are product concentration-specific and should not be used interchangeably.
Adverse Reactions
1% to 10%:
Cardiovascular: Chest pain (1%), edema (1%)
Central nervous system: Headache (6%), insomnia (4%), dizziness (3%), fatigue (1%), pain (1%)
Dermatologic: Rash (2%), pruritus (1%)
Gastrointestinal: Taste disturbance (8% to 10% [ophthalmic]), nausea (7%), diarrhea (5%), constipation (3%), abdominal pain (2%), dyspepsia (2%), vomiting (2%)
Genitourinary: Vaginitis (1%)
Local: Injection site reaction (1%)
Ocular (with ophthalmic solution use): Decreased vision (transient), foreign body sensation, transient ocular burning, ocular pain or discomfort, photophobia
Respiratory: Pharyngitis (4%), dyspnea (1%)
Miscellaneous: Moniliasis (1%)
<1%, postmarketing, and/or case reports (limited to important or life-threatening):
Systemic: Acute renal failure, agitation, agranulocytosis; allergic reaction (including anaphylaxis, angioedema, pneumonitis rash, pneumonitis, and serum sickness); anaphylactoid reaction, arrhythmia (including atrial/ventricular tachycardia/fibrillation and torsade de pointes), aplastic anemia, arthralgia, ascites, bradycardia, bronchospasm, carcinoma, cardiac failure, cholecystitis, cholelithiasis, confusion, depression, EEG abnormalities, encephalopathy, eosinophilia, erythema multiforme, GI hemorrhage, granulocytopenia, hallucination, heart block, hemolytic anemia, hemoptysis, hepatic failure (some fatal), hepatitis, hyper-/hypoglycemia, hyperkalemia, hyperkinesias, hyper-/hypotension, infection, INR increased, intestinal obstruction, intracranial hypertension, involuntary muscle contractions, jaundice, leukocytosis, leukopenia, leukorrhea, lymphadenopathy, MI, migraine, multiple organ failure, myalgia, nephritis (interstitial), palpitation, pancreatitis, pancytopenia, paralysis, paresthesia, peripheral neuropathy, photosensitivity (<0.1%), pleural effusion, pneumonitis, postural hypotension, prothrombin time increased/decreased, pseudomembraneous colitis, psychosis, pulmonary edema, pulmonary embolism, purpura, QTc prolongation, respiratory depression, rhabdomyolysis, seizure, skin disorder, somnolence, speech disorder, Stevens-Johnson syndrome, stupor, suicide attempt/ideation, syncope, tendonitis, tendon rupture, tongue edema, toxic epidermal necrolysis, transaminases increased, thrombocythemia, thrombocytopenia, tremor, urticaria, WBC abnormality
Ophthalmic solution: Allergic reaction, lid edema, ocular dryness, ocular itching
Drug Interactions
Alfuzosin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Antacids: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Exceptions: Sodium Bicarbonate. Risk D: Consider therapy modification
Artemether: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Calcium Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Exceptions: Calcium Chloride. Risk D: Consider therapy modification
Chloroquine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Ciprofloxacin: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk C: Monitor therapy
Corticosteroids (Systemic): Quinolone Antibiotics may enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk of tendon-related side effects, including tendonitis and rupture, may be enhanced. Risk C: Monitor therapy
Didanosine: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents (excludes enteric coated formulation of didanosine). Risk D: Consider therapy modification
Dronedarone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Dronedarone. Risk X: Avoid combination
Gadobutrol: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk D: Consider therapy modification
Insulin: May enhance the hyperglycemic effect of Quinolone Antibiotics. Insulin may enhance the hypoglycemic effect of Quinolone Antibiotics. Risk C: Monitor therapy
Iron Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk D: Consider therapy modification
Lumefantrine: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Magnesium Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Risk D: Consider therapy modification
Mycophenolate: Quinolone Antibiotics may decrease the serum concentration of Mycophenolate. Specifically, quinolones may decrease concentrations of the active metabolite of mycophenolate. Risk C: Monitor therapy
Nilotinib: May enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Nonsteroidal Anti-Inflammatory Agents: May enhance the neuroexcitatory and/or seizure-potentiating effect of Quinolone Antibiotics. Risk C: Monitor therapy
Pimozide: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Pimozide. Risk X: Avoid combination
Probenecid: May increase the serum concentration of Quinolone Antibiotics. Risk C: Monitor therapy
QTc-Prolonging Agents: May enhance the adverse/toxic effect of other QTc-Prolonging Agents. Their effects can be additive, causing life-threatening ventricular arrhythmias. Risk D: Consider therapy modification
Quinapril: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
QuiNINE: QTc-Prolonging Agents may enhance the QTc-prolonging effect of QuiNINE. QuiNINE may enhance the QTc-prolonging effect of QTc-Prolonging Agents. Risk X: Avoid combination
Sevelamer: May decrease the absorption of Quinolone Antibiotics. Risk D: Consider therapy modification
Sucralfate: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of quinolones. Risk D: Consider therapy modification
Sulfonylureas: Quinolone Antibiotics may enhance the hypoglycemic effect of Sulfonylureas. This appears to be particularly concerning early in the course of combination therapy. Quinolone Antibiotics may diminish the hypoglycemic effect of Sulfonylureas. With longer-term combination, there is a greater risk of hyperglycemia. Risk C: Monitor therapy
Tetrabenazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Tetrabenazine. Risk X: Avoid combination
Thioridazine: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Thioridazine. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Quinolone Antibiotics may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Zinc Salts: May decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Risk D: Consider therapy modification
Ziprasidone: QTc-Prolonging Agents may enhance the QTc-prolonging effect of Ziprasidone. The risk of a severe arrhythmia may be increased. Risk X: Avoid combination
Storage
Solution for injection:
Vial: Store at room temperature. Protect from light. Diluted solution is stable for 72 hours when stored at room temperature; stable for 14 days when stored under refrigeration. When frozen, stable for 6 months; do not refreeze. Do not thaw in microwave or by bath immersion.
Premixed: Store at ?25°C (77°F); do not freeze. Brief exposure to 40°C (104°F) does not affect product. Protect from light.
Tablet, oral solution: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Ophthalmic solution: Store at 15°C to 25°C (59°F to 77°F).
Reconstitution
Solution for injection: Single-use vials must be further diluted in compatible solution to a final concentration of 5 mg/mL prior to infusion.
Compatibility
Stable in D5LR, D5NS, D51/2NS with 0.15% KCl, D5W, NS, Plasma-Lyte® 56/5% dextrose, sodium lactate (M/6); incompatible with mannitol 20%, sodium bicarbonate 5%.
Y-site administration: Compatible: Amikacin, aminophylline, ampicillin, bivalirudin, caffeine citrate, cefotaxime, cimetidine, clindamycin, daptomycin, dexamethasone sodium phosphate, dobutamine, dopamine, epinephrine, fenoldopam, fentanyl, gentamicin, isoproterenol, lidocaine, linezolid, lorazepam, metoclopramide, morphine, oxacillin, pancuronium, penicillin G sodium, phenobarbital, phenylephrine, sodium bicarbonate, vancomycin. Incompatible: Acyclovir, alprostadil, azithromycin, drotrecogin alfa, furosemide, heparin, indomethacin, lansoprazole, nitroglycerin, propofol, sodium nitroprusside. Variable (consult detailed reference): Insulin (regular).
Mechanism of Action
As the S (-) enantiomer of the fluoroquinolone, ofloxacin, levofloxacin, inhibits DNA-gyrase in susceptible organisms thereby inhibits relaxation of supercoiled DNA and promotes breakage of DNA strands. DNA gyrase (topoisomerase II), is an essential bacterial enzyme that maintains the superhelical structure of DNA and is required for DNA replication and transcription, DNA repair, recombination, and transposition.
Pharmacodynamics/Kinetics
Absorption: Rapid and complete
Distribution: Vd: 74-112 L; CSF concentrations ~15% of serum levels; high concentrations are achieved in prostate, lung, and gynecological tissues, sinus, saliva
Protein binding: ~24% to 38%; primarily to albumin
Metabolism: Minimally hepatic
Bioavailability: ~99%
Half-life elimination: ~6-8 hours
Time to peak, serum: Oral: 1-2 hours
Excretion: Urine (~87% as unchanged drug, <5% as metabolites); feces (<4%)
Dosage
Note: Sequential therapy (intravenous to oral) may be instituted based on prescriber's discretion.
Usual dosage range:
Children ?1 year: Ophthalmic: 1-2 drops every 2-6 hours
Adults:
Ophthalmic: 1-2 drops every 2-6 hours
Oral, I.V.: 250-500 mg every 24 hours; severe or complicated infections: 750 mg every 24 hours
Indication-specific dosing:
Children ?1 year and Adults: Ophthalmic:
Conjunctivitis (0.5% ophthalmic solution):
Treatment day 1 and day 2: Instill 1-2 drops into affected eye(s) every 2 hours while awake, up to 8 times/day
Treatment day 3 through day 7: Instill 1-2 drops into affected eye(s) every 4 hours while awake, up to 4 times/day
Children ?6 years and Adults: Ophthalmic:
Corneal ulceration (1.5% ophthalmic solution):
Treatment day 1 through day 3: Instill 1-2 drops into affected eye(s) every 30 minutes to 2 hours while awake and 4-6 hours after retiring
Treatment day 4 through completion: Instill 1-2 drops into affected eye(s) every 1-4 hours while awake
Children ?6 months and Adults: Oral, I.V.:
Anthrax (inhalational, postexposure):
?50 kg: 8 mg/kg every 12 hours for 60 days (do not exceed 250 mg/dose), beginning as soon as possible after exposure
>50 kg and Adults: 500 mg every 24 hours for 60 days, beginning as soon as possible after exposure
Adults: Oral, I.V.:
Chronic bronchitis (acute bacterial exacerbation): 500 mg every 24 hours for at least 7 days
Diverticulitis, peritonitis (unlabeled use): 750 mg every 24 hours for 7-10 days; use adjunctive metronidazole therapy
Dysenteric enterocolitis,
Shigella
spp. (unlabeled use): 500 mg every 24 hours for 3-5 days
Epididymitis, nongonococcal (unlabeled use): 500 mg once daily for 10 days
Gonococcal infection (unlabeled use):
Cervicitis, urethritis: 250 mg for one dose with azithromycin or doxycycline; Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of uncomplicated gonococcal disease.
Disseminated infection: 250 mg I.V. once daily; 24 hours after symptoms improve may change to 500 mg orally every 24 hours to complete total therapy of 7 days; Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for the treatment of more serious gonococcal disease, unless no other options exist and susceptibility can be confirmed via culture.
Pelvic inflammatory disease (unlabeled use): 500 mg once daily for 14 days with or without adjunctive metronidazole; Note: The CDC recommends use only if standard cephalosporin therapy is not feasible and community prevalence of quinolone-resistant gonococcal organisms is low. Culture sensitivity must be confirmed.
Pneumonia:
Community-acquired: 500 mg every 24 hours for 7-14 days or 750 mg every 24 hours for 5 days (efficacy of 5-day regimen for MDRSP not established)
Nosocomial: 750 mg every 24 hours for 7-14 days
Prostatitis (chronic bacterial): 500 mg every 24 hours for 28 days
Sinusitis (acute bacterial): 500 mg every 24 hours for 10-14 days or 750 mg every 24 hours for 5 days
Skin and skin structure infections:
Uncomplicated: 500 mg every 24 hours for 7-10 days
Complicated: 750 mg every 24 hours for 7-14 days
Traveler's diarrhea (unlabeled use): 500 mg for one dose
Urinary tract infections:
Uncomplicated: 250 mg once daily for 3 days
Complicated, including pyelonephritis: 250 mg once daily for 10 days or 750 mg once daily for 5 days
Dosing adjustment in renal impairment:
Normal renal function dosing of 750 mg/day:
Clcr 20-49 mL/minute: Administer 750 mg every 48 hours
Clcr 10-19 mL/minute: Administer 750 mg initial dose, followed by 500 mg every 48 hours
Hemodialysis/CAPD: Administer 750 mg initial dose, followed by 500 mg every 48 hours
Normal renal function dosing of 500 mg/day:
Clcr 20-49 mL/minute: Administer 500 mg initial dose, followed by 250 mg every 24 hours
Clcr 10-19 mL/minute: Administer 500 mg initial dose, followed by 250 mg every 48 hours
Hemodialysis/CAPD: Administer 500 mg initial dose, followed by 250 mg every 48 hours
Normal renal function dosing of 250 mg/day:
Clcr 20-49 mL/minute: No dosage adjustment required
Clcr 10-19 mL/minute: Administer 250 mg every 48 hours (except in uncomplicated UTI, where no dosage adjustment is required)
Hemodialysis/CAPD: No information available
CRRT: Note: Clearance dependent on filter type, flow rates, and other variables.
CVVH/CVVHD/CVVHDF: Alternative recommendations exist:
500 mg every 48 hours or
250 mg every 24 hours (Note: This regimen has been shown to be equivalent to 500 mg/day in normal renal function. Appropriateness of this regimen for target dosing equal to 750 mg/day is not known.)
Administration: Oral
Tablets may be administered without regard to meals. Oral solution should be administered 1 hour before or 2 hours after meals. Maintain adequate hydration of patient to prevent crystalluria.
Administration: I.V.
Infuse 250-500 mg I.V. solution over 60 minutes; infuse 750 mg I.V. solution over 90 minutes. Too rapid of infusion can lead to hypotension. Avoid administration through an intravenous line with a solution containing multivalent cations (eg, magnesium, calcium). Maintain adequate hydration of patient to prevent crystalluria.
Administration: I.V. Detail
pH: 3.8-5.8
Monitoring Parameters
Evaluation of organ system functions (renal, hepatic, ophthalmologic, and hematopoietic) is recommended periodically during therapy; the possibility of crystalluria should be assessed; WBC and signs of infection
Test Interactions
Some quinolones may produce a false-positive urine screening result for opiates using commercially-available immunoassay kits. This has been demonstrated most consistently for levofloxacin and ofloxacin, but other quinolones have shown cross-reactivity in certain assay kits. Confirmation of positive opiate screens by more specific methods should be considered.
Dietary Considerations
Tablets may be taken without regard to meals. Oral solution should be administered on an empty stomach (1 hour before or 2 hours after a meal). Take 2 hours before or 2 hours after multiple vitamins, antacids, or other products containing magnesium, aluminum, iron, or zinc.
Patient Education
Do not take any new prescription or OTC medications or herbal products during therapy without consulting prescriber. If administered by infusion, report immediately any chest or back pain; tightness in chest; difficulty swallowing; swelling of face or mouth; or redness, swelling, or pain at infusion site.
Oral: Take exactly as directed (timing with meals, dairy products, antacids, or products containing calcium, iron, or zinc differs with each formulation). Take entire prescription, even if feeling better. If you have diabetes, monitor glucose levels closely; may cause hypoglycemia. May cause dizziness, lightheadedness, or confusion (use caution when driving or engaging in tasks that require alertness until response to drug is known); nausea or vomiting (small frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or photosensitivity (use sunscreen, wear protective clothing and eyewear, and avoid exposure to direct sunlight or tanning situations). Report chest pain or palpitations; persistent diarrhea, abdominal pain, or constipation; signs of infection (unusual fever or chills, vaginal itching, or foul-smelling vaginal discharge); unusual bruising or bleeding; or other persistent adverse effects. If tendon inflammation or pain occurs or you experience signs of an allergic reaction (eg, itching, skin rash, respiratory difficulty, facial edema, difficulty swallowing, chest pain, palpitations) discontinue use and contact prescriber immediately. Pregnancy/breast-feeding precautions: Inform prescriber if you are or intend to become pregnant. Breast-feeding is not recommended.
Ophthalmic: Wash hands before instilling solution. Sit or lie down to instill. Open eye, look at ceiling, and instill prescribed amount of solution. Close eye, roll eye in all directions, and apply gentle pressure to inner corner of eye. Do not let tip of applicator touch eye; do not contaminate tip of applicator (may cause eye infection, eye damage, or vision loss). Temporary stinging or blurred vision may occur. Report persistent pain, burning, vision changes, swelling, itching, or worsening of condition. Discontinue medication and contact prescriber immediately if you develop a rash or allergic reaction. Do not wear contact lenses.
Geriatric Considerations
The risk of torsade de pointes and tendon inflammation and/or rupture associated with the concomitant use of corticosteroids and quinolones is increased in the elderly population. See Warnings/Precautions regarding tendon rupture in patients >60 years of age. Adjust dose for renal function.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Levofloxacin is one of the drugs confirmed to prolong the QT interval and is accepted as having a risk of causing torsade de pointes. The risk of drug-induced torsade de pointes is extremely low when a single QT interval prolonging drug is prescribed. In terms of epinephrine, it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval. Until more information is obtained, it is suggested that the clinician consult with the physician prior to the use of a vasoconstrictor in suspected patients, and that the vasoconstrictor (epinephrine, mepivacaine and levonordefrin [Carbocaine® 2% with Neo-Cobefrin®]) be used with caution.
Dental Comment
Levofloxacin is known to prolong the QT interval. The QT interval is measured as the time and distance between the Q point of the QRS complex and the end of the T wave in the ECG tracing. After adjustment for heart rate, the QT interval is defined as prolonged if it is more than 450 msec in men and 460 msec in women. A long QT syndrome was first described in the 1950s and 60s as a congenital syndrome involving QT interval prolongation and syncope and sudden death. Some of the congenital long QT syndromes were characterized by a peculiar electrocardiographic appearance of the QRS complex involving a premature atria beat followed by a pause, then a subsequent sinus beat showing marked QT prolongation and deformity. This type of cardiac arrhythmia was originally termed “torsade de pointes” (translated from the French as “twisting of the points”). Levofloxacin is considered as having a risk of causing torsade de pointes. Since it is not known what effect vasoconstrictors in the local anesthetic regimen will have in patients with a known history of congenital prolonged QT interval or in patients taking any medication that prolongs the QT interval, a medical consult is suggested.
Infectious Diseases Comment
Treatment of asymptomatic bacteriuria: Guidelines endorsed by the Infectious Disease Society of America recommend urine culture screening and antimicrobial treatment (3-7 days) of pregnant women presenting with asymptomatic bacteriuria. These patients should also receive periodic screening for recurrence post-treatment. These recommendations were based on the results of prospective, clinical trials data showing that treatment consistently results in a reduced incidence of pyelonephritis and low birth-weight or preterm deliveries.
The guidelines also recommend screening and treatment for patients undergoing urologic procedures in which mucosal bleeding is anticipated. Patients undergoing specific procedures, such as TURP, should be screened for bacteriuria and treatment initiated shortly before the procedure. Antimicrobial therapy should be continued beyond length of procedure only if an indwelling catheter is placed.
A review of studies evaluating several other patient cohorts suggests that treatment of asymptomatic bacteriuria does not reduce the risk of adverse outcomes (eg, progression to symptomatic UTI, increased disease-related complications [eg, diabetic nephropathy], reduced survival, increased rates of reinfection) or may predispose certain patients to recurrence with resistant organisms (elderly and spinal cord injury). As such, the IDSA guidelines recommend no routine screening or antibiotic therapy in any of the following patient groups presenting with asymptomatic bacteriuria:
Premenopausal (nonpregnant) or postmenopausal women
Elderly institutionalized patients
Women with diabetes
Spinal cord injury
Short- or long-term indwelling catheters
Note: Antimicrobial therapy may be considered if catheter-associated bacteriuria persists for ?48 hours after catheter removal)
Mental Health: Effects on Mental Status
May cause agitation, anxiety, confusion, depression, dizziness, hallucinations, insomnia, nervousness, paranoia, and sedation
Mental Health: Effects on Psychiatric Treatment
May cause leukopenia; use caution with clozapine and carbamazepine; inhibits CYP1A2 isoenzyme; caution with clozapine and other psychotropics; monitor for adverse effects
Nursing: Physical Assessment/Monitoring
Assess results of culture and sensitivity tests prior to beginning therapy. Use caution in patients with known or suspected CNS disorder, current or potential for QT prolongation, renal or hepatic impairment, or diabetes. Assess other pharmacological or herbal products patient may be taking for potential interactions. See Administration for infusion specifics. Patient should be monitored closely; if an allergic reaction occurs (itching, urticaria, dyspnea or facial edema, loss of consciousness, tingling, cardiovascular collapse), drug should be discontinued immediately and prescriber notified. Evaluate results of laboratory tests, therapeutic effectiveness (resolution of infection), and adverse reactions (eg, hypersensitivity reactions [severe reactions, including anaphylaxis, have occurred with quinolone therapy], opportunistic infection, tendon rupture, persistent diarrhea [C. difficile-associated colitis can occur up to 2 months post treatment]) regularly during prolonged therapy. Teach patient proper use (according to formulation), possible side effects/appropriate interventions, and adverse symptoms to report.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Infusion, premixed in D5W [preservative free]:
Levaquin®: 250 mg (50 mL); 500 mg (100 mL); 750 mg (150 mL)
Injection, solution [preservative free]
Levaquin®: 25 mg/mL (20 mL, 30 mL)
Solution, ophthalmic [drops]:
Iquix®: 1.5% (5 mL)
Quixin®: 0.5% (5 mL) [contains benzalkonium chloride]
Solution, oral:
Levaquin®: 25 mg/mL (480 mL) [contains benzyl alcohol, propylene glycol]
Tablet, oral:
Levaquin®: 250 mg, 500 mg, 750 mg [DSC]
Levaquin® Leva-Pak: 750 mg (5s) [DSC]
Pricing: U.S. (www.drugstore.com)
Tablets (Levaquin)
250 mg (10): $119.91
750 mg (30): $773.29
Tablets (Levaquin LEVA-pak)
750 mg (5): $130.69
References
American Thoracic Society and Infectious Diseases Society of America, “Guidelines for the Management of Adults With Hospital-Acquired, Ventilator-Associated, and Healthcare-Associated Pneumonia,” Am J Respir Crit Care Med, 2005, 171(4):388-416.
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International Brand Names
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Last full review/revision October 2009
Content last modified October 2009
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