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Levofloxacin (Systemic)


VA CLASSIFICATION
Primary: AM402

Commonly used brand name(s): Levaquin.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antibacterial (systemic) —

Indications

Accepted

Bronchitis, bacterial exacerbations (treatment)— Levofloxacin is indicated in the treatment of bacterial exacerbations of bronchitis caused by Haemophilus influenzae , Haemophilus parainfluenzae , Moraxella catarrhalis , Staphylococcus aureus , or Streptococcus pneumoniae {01}.

Pneumonia, community-acquired (treatment)—Levofloxacin is indicated in the treatment of community-acquired pneumonia caused by Chlamydia pneumoniae , H. influenzae , H. parainfluenzae , Klebsiella pneumoniae , Legionella pneumophila , M. catarrhalis , Mycoplasma pneumoniae , S. aureus , or S. pneumoniae {01}.

Pyelonephritis (treatment)—Levofloxacin is indicated in the treatment of pyelonephritis caused by Escherichia coli {01}.

Sinusitis (treatment)—Levofloxacin is indicated in the treatment of sinusitis caused by H. influenzae , M. catarrhalis , or S. pneumoniae {01}.

Skin and soft tissue infections, uncomplicated (treatment)—Levofloxacin is indicated in the treatment of uncomplicated skin and soft tissue infections caused by S. aureus or Streptococcus pyogenes {01}.

Skin and soft tissue infections, complicated (treatment)—Levofloxacin is indicated in the treatment of complicated skin and soft tissue infections caused by Enterococcus faecalis,Proteus mirabilis,S. aureus, or S. pyogenes.{02}{03}
[Enterobacter cloacae, E.coli,K. pneumoniaeor Pseudomonas aeruginosa{03}]
Urinary tract infections, bacterial, complicated (treatment)—Levofloxacin is indicated in the treatment of complicated bacterial urinary tract infections caused by E. cloacae , E. faecalis , E. coli , K. pneumoniae , P. , or P. aeruginosa {01}.

Urinary tract infections, bacterial, uncomplicated (treatment) —Levofloxacin is indicated in the treatment of uncomplicated bacterial urinary tract infections caused by E.coli,K. pneumoniaeorStaphylococcus saprophyticus {02}{03}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical group—
    Fluoroquinolone; levofloxacin is the L-isomer of the racemic medication, ofloxacin {01}.
Molecular weight—
    370.38 {01}

Mechanism of action/Effect:

Levofloxacin acts by inhibiting DNA gyrase (bacterial topoisomerase II), an enzyme required for DNA replication, transcription, repair, and recombination {01}.

Absorption:

Rapidly and almost completely absorbed after oral administration {01}. Bioavailability is approximately 99% {01}. Levofloxacin may be taken with or without food {01}.

Distribution:

Widely distributed. Levofloxacin penetrates well into blister fluid and lung tissues {01}.

Vol D—89 to 112 L after single and multiple 500-mg doses {01}.

Protein binding:

Moderate (24 to 38%) {01}.

Biotransformation:

Levofloxacin is stereochemically stable and does not invert metabolically to its enantiomer, D-ofloxacin {01}. It undergoes limited metabolism {01}.

Half-life:

Elimination—6 to 8 hours {01}.

Time to peak concentration:

Oral—Approximately 1 to 2 hours {01}. Oral administration with food prolongs the time to peak concentration by approximately 1 hour {01}; however, levofloxacin may be taken without regard to food consumption {01}.

Peak serum concentration:

Oral—Approximately 5.7 mcg per mL after multiple doses of 500 mg {01}. Oral administration with food prolongs the peak concentration by approximately 14% {01}.

Intravenous—Approximately 6.4 mcg per mL {01}. The serum concentration profile of the intravenous infusion is similar and comparable to the extent of exposure (area under the plasma concentration–time curve [AUC]) seen with the tablets when equal doses are administered {01}. Therefore, oral and intravenous routes of administration are considered to be interchangeable {01}.

Elimination:
    Renal—Approximately 87% of an orally administered dose is excreted unchanged in the urine within 48 hours {01}; renal clearance in excess of the glomerular filtration rate suggests that tubular secretion also occurs {01}.
    Fecal—Approximately 4% of an orally administered dose is excreted fecally within 72 hours {01}.


In dialysis—
        Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis {01}.



Precautions to Consider

Cross-sensitivity and/or related problems

Patients allergic to one fluoroquinolone or other chemically related quinolone derivatives (e.g., cinoxacin, nalidixic acid) may be allergic to other fluoroquinolones also {01}.

Carcinogenicity/Tumorigenicity

In a long-term study in rats, levofloxacin did not show carcinogenic or tumorigenic potential after daily dietary administration for 2 years. The highest dose was two times the recommended human dose or 10 times the recommended human dose based on body surface area or body weight, respectively. {01}

Mutagenicity

Levofloxacin was not mutagenic in the Ames test ( Salmonella typhimurium and Escherichia coli ), CHO/HGPRT forward mutation assay, mouse micronucleus test, mouse dominant lethal assay, rat unscheduled DNA synthesis assay, and the mouse sister chromatid exchange assay. It was positive in the in vitro chromosomal aberration (CHL cell line) and sister chromatid exchange (CHL/IU cell line) assays. {01}

Pregnancy/Reproduction
Fertility—
Levofloxacin had no effect on the fertility or reproductive performance of male and female rats at oral doses of up to 360 mg per kg of body weight (mg/kg), or 2124 mg per square meter of body surface area (mg/m 2), per day, corresponding to 18 and 3 times the maximum recommended human dose (MRHD) based on body weight and body surface area, respectively, or at intravenous doses of up to 100 mg/kg, or 590 mg/m 2, per day, corresponding to 5 and 1 times the MRHD based on body weight and body surface area, respectively. {01}

Pregnancy—
Adequate and well-controlled studies in humans have not been done. Since levofloxacin has been shown to cause arthropathy in immature animals, use is recommended in pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. {01}

Levofloxacin was not teratogenic in rats at oral doses of up to 810 mg/kg, or 4779 mg/m 2, per day, corresponding to 82 and 14 times the MRHD based on body weight and body surface area, respectively, or at intravenous doses of up to 160 mg/kg, or 944 mg/m 2, per day, corresponding to 16 and 2.7 times the MRHD based on body weight and body surface area, respectively. Doses equivalent to 81 and 26 times the MRHD of levofloxacin, based on body weight and body surface area, respectively, caused decreased fetal body weight and increased fetal mortality in rats when administered orally at doses of 810 mg/kg, or 8910 mg/m 2, per day. No teratogenicity was observed when rabbits were given oral doses of up to 50 mg/kg, or 550 mg/m 2, per day, corresponding to 5 and 1.6 times the MRHD based on body weight and body surface area, respectively, or at intravenous doses of up to 25 mg/kg, or 275 mg/m 2, per day, corresponding to 2.5 and 0.8 times the MRHD based on body weight and body surface area, respectively. {01}

FDA Pregnancy Category C {01}.

Breast-feeding

It is not known whether levofloxacin is distributed into breast milk {01}; however, based on data for ofloxacin, it is expected that levofloxacin is distributed into human milk {01}. Because of the potential for serious adverse effects in nursing infants, a decision should be made to either stop breast-feeding or discontinue taking levofloxacin {01}.

Pediatrics

Safety and efficacy have not been established in patients up to 18 years of age {01}. Fluoroquinolones have been shown to cause arthropathy and osteochondrosis in immature animals of several species {01}.


Geriatrics


The pharmacokinetics of levofloxacin are not altered in elderly patients with normal renal function {01}. Following a 500-mg oral dose of levofloxacin, the mean elimination half-life was approximately 7.6 hours in healthy elderly subjects, as compared with 6 hours in younger adults {01}. The difference was attributed to variation in renal function and was not believed to be clinically significant {01}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Unlike other fluoroquinolones, levofloxacin does not alter the pharmacokinetics of cyclosporine, digoxin, theophylline, or warfarin {01}.
Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Antacids, aluminum-, calcium-, and/or magnesium-containing {01} or
» Ferrous sulfate {01} or
» Sucralfate {01} or
» Zinc {01}    (antacids, ferrous sulfate, sucralfate, and zinc may reduce absorption of levofloxacin by chelation, resulting in lower serum and urine concentrations {01}; therefore, concurrent use is not recommended {01}; it is recommended that levofloxacin be taken at least 2 hours before or 2 hours after taking any of these agents {01})


» Antiarrhythmic agents, class Ia or class III {04}    (concurrent administration may increase the risk of cardiac arrhythmias through prolongation of the QT interval on the electrocardiogram {04})


» Antidiabetic agents {01}    (concurrent administration has resulted in hyperglycemia or hypoglycemia, usually in diabetic patients who are taking oral hypoglycemic agents or insulin {01}; careful monitoring of blood glucose is recommended {01})


» Anti-inflammatory drugs, nonsteroidal {01}    (concurrent use may increase the risk of central nervous system [CNS] stimulation and seizures {01})


Cimetidine {01} or
Probenecid {01}    (concurrent use of levofloxacin with cimetidine or probenecid increases the area under the plasma concentration–time curve [AUC] by 27 to 38% and 30%, respectively, and decreases the clearance by 21 to 35% {01}; although these differences are statistically significant, the changes are not considered high enough to warrant a change in dose {01})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
» Glucose, blood {01}    (concentrations may be increased or decreased {01})


Lymphocytes {01}    (counts may be decreased {01})


Prothrombin time{04}    (increased International Normalized Ratio (INR) )


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problem exists:
» Previous allergic reaction to fluoroquinolones or other chemically related quinolone derivatives {01}
Risk-benefit should be considered when the following medical problems exist
» Bradycardia, significant {04}    (levofloxacin may cause cardiac arrhythmias and prolongation of the QT interval in the presence of significant bradycardia {04})


CNS disorders, including cerebral arteriosclerosis or epilepsy {01}    (levofloxacin may cause CNS stimulation or toxicity, increasing the risk of seizures in patients with these conditions {01})


» Diabetes mellitus {01}    (levofloxacin has been reported to cause hyperglycemia and hypoglycemia, usually in diabetic patients who are taking oral hypoglycemic agents or insulin {01}; diabetic patients should be carefully monitored {01})


» Hypokalemia {04}    (levofloxacin may cause cardiac arrhythmias and prolongation of the QT interval in the presence of hypokalemia {04})


» Renal function impairment {01}    (levofloxacin is renally excreted {01}; it is recommended that patients with a creatinine clearance of less than 50 mL per minute receive a reduced dosage of levofloxacin {01})




Side/Adverse Effects

Note: There have been reports of ruptures of the Achilles tendon and of tendons in the shoulder and hand that required surgical repair or resulted in prolonged disability in patients taking levofloxacin or other fluoroquinolones. Patients should discontinue levofloxacin if they experience pain, inflammation, or rupture of a tendon. They should rest and refrain from exercise until the diagnosis of tendinitis or tendon rupture has been excluded. Tendon rupture can occur at any time during or after levofloxacin therapy. {01}

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
    
Central nervous system (CNS) stimulation {01} (agitation; confusion; hallucinations ; psychosis, acute; tremors)
    
hypersensitivity reactions {01} (skin rash, itching, or redness)
    
phototoxicity {01} (blisters; itching; rash; redness; sensation of skin burning; swelling)
    
pseudomembranous colitis {01} (abdominal or stomach cramps and pain, severe; abdominal tenderness; diarrhea, watery and severe, which may also be bloody; fever)
    
tendonitis or tendon rupture {01} ( pain, inflammation, or swelling in calves, shoulders, or hands)



Those indicating need for medical attention only if they continue or are bothersome
Incidence less frequent
    
CNS effects {01} (dizziness; drowsiness; headache; lightheadedness; nervousness ; trouble in sleeping)
    
gastrointestinal effects {01} (abdominal or stomach pain or discomfort; constipation; diarrhea; nausea; vomiting)
    
taste perversion {01} ( change in sense of taste)
    
vaginal candidiasis {01} (vaginal itching and discharge)



Those indicating possible pseudomembranous colitis and the need for medical attention if they occur after medication is discontinued
    
Abdominal or stomach cramps and pain, severe {01}
    
abdominal tenderness {01}
    
diarrhea, watery and severe, which may also be bloody {01}
    
fever {01}



Incidence not determined and indicating the need for medical attention
—Observed during clinical practice; estimates of frequency cannot be determined{04}    
allergic pneumonitis (difficult breathing)
    
anaphylactic shock (sharp drop in blood pressure; hives )
    
abnormal electroencephalogram (abnormal brain waves)
    
encephalopathy ( blurred vision; coma; confusion; dizziness)
    
meosinophilia (black, tarry stools; sore throat; swollen glands; unusual bleeding or bruising)
    
erythema multiforme (blistering, peeling, loosening of skin; itching; joint or muscle pain )
    
hemolytic anemia ( bleeding gums; dark urine; fatigue; general body swelling )
    
multi-system organ failure ( failure of the heart, lungs, kidneys and/or liver)
    
increased international normalized ratio/prothrombin time (increased bleeding time)
    
Stevens-Johnson Syndrome (blistering, peeling, loosening of skin; diarrhea itching; red skin)
    
torsades de pointes {04}(fast heartbeat; prolonged QT interval)





Overdose
In the event of an acute levofloxacin overdose, the stomach should be emptied, the patient observed, and hydration maintained {01}. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis {01}.

Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs, and monkeys exhibited the following signs after receiving a single high dose of levofloxacin: ataxia, decreased locomotor activity, dyspnea, prostration, ptosis, seizures, and tremors. Doses greater than 1500 mg per kg of body weight (mg/kg) orally and 250 mg/kg intravenously produced significant morbidity in rodents. {01}

For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Treatment of overdose
Supportive care—Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Levofloxacin (Systemic) .

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergy to fluoroquinolones or other quinolone derivatives

Pregnancy—Levofloxacin is recommended for use during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus, because levofloxacin has been shown to cause arthropathy in immature animals





Breast-feeding—It is not known whether levofloxacin is distributed into breast milk; however, caution should be exercised in making the decision whether to breast-feed, since levofloxacin has been shown to cause arthropathy in immature animals





Use in children—Safety and efficacy have not been established in children up to 18 years of age; levofloxacin has been shown to cause arthropathy in immature animals

Other medications, especially antidiabetic agents; aluminum-, calcium-, and/or magnesium-containing antacids; antiarrhythmic agents; ferrous sulfate; nonsteroidal anti-inflammatory drugs; sucralfate; or zinc
Other medical problems, especially bradycardia, diabetes mellitus, hypokalemia or renal function impairment

Proper use of this medication
» Levofloxacin may be taken with or without food

Importance of maintaining adequate fluid intake

» Importance of not missing doses and taking at evenly spaced times

» Proper dosing
Missed dose: Taking as soon as possible; not taking if almost time for next dose; not doubling doses

» Proper storage

Precautions while using this medication
Checking with physician if no improvement within a few days

» Avoiding concurrent use of antacids, ferrous sulfate, sucralfate, or zinc and levofloxacin; taking these products at least 2 hours before or 2 hours after administration of levofloxacin

Avoid concurrent use of Class IA and Class III antiarrhythmic agents.

» Possible phototoxicity reactions

» Discontinuing levofloxacin at the first sign of skin rash or other allergic reaction

» Caution when driving or doing anything else requiring alertness because of possible dizziness, drowsiness, or lightheadedness

» Discontinuing levofloxacin and notifying physician if pain, inflammation, or rupture of a tendon is experienced; resting and refraining from exercise until the diagnosis of tendinitis or tendon rupture has been excluded

» Discontinuing levofloxacin and contacting physician if patient is a diabetic being treated with insulin or an oral hypoglycemic agent and a hypoglycemic episode occurs
» Discontinuing levofloxacin and contacting physician if patient is hypokalemic and develops a fast, slow or irregular heartbeat
» Discontinuing levofloxacin and contacting physician if patient is bradycardic and develops a fast, slow or irregular heartbeat

Side/adverse effects
Signs of potential side effects, especially allergic pneumonitis, anaphylactic shock, anemia, hemolytic, abnormal electroencephalogram, central nervous system stimulation, encephalopathy, eosinophilia, erythema multiforme, hypersensitivity reactions, increased international normalized ratio/prothrombin time, organ failure, multi-system, phototoxicity, pseudomembranous colitis, Stevens-Johnson Syndrome, tendinitis or tendon rupture, or torsades de pointes


General Dosing Information

For parenteral dosage forms only
Because rapid intravenous injection may result in hypotension, levofloxacin should be administered only by slow intravenous infusion over a period of not less than 60 minutes and up to 90 minutes, depending on the dose. {01}.{02}{03}

Appropriate culture and susceptibility tests should be performed before treatment to isolate and identify the organism that is causing the infection and to determine their susceptibility to levofloxacin. Culture and susceptibility performed periodically during therapy will give information about the continued susceptibility of the pathogens and also about the possible emergence of bacterial resistance.{02}

Levofloxacin concentrate for injection must be diluted prior to parenteral administration {01}.

Diet/Nutrition
Levofloxacin may be taken with or without food {01}.

Bioequivalence information
The profile of serum levofloxacin concentration observed after intravenous administration is comparable to the extent of exposure (area under the plasma concentration–time curve) observed for oral administration of tablets when equal doses are administered (mg/mg) {01}. Therefore, the oral and intravenous routes of administration are considered to be interchangeable {01}.

For treatment of adverse effects


For antibiotic-associated pseudomembranous colitis (AAPMC) {01}:
   • Some patients may develop antibiotic-associated pseudomembranous colitis (AAPMC), caused by Clostridium difficile toxin, during or after administration of levofloxacin. Mild cases may respond to discontinuation of the drug alone. Moderate to severe cases may require fluid, electrolyte, and protein replacement. {01}
   • In cases not responding to the above measures or in more severe cases, oral doses of an antibacterial medication effective against C. difficile should be administered. {01}
   • In addition, AAPMC may result in severe watery diarrhea, which may occur during therapy or up to several weeks after therapy is discontinued. If diarrhea occurs, administration of antiperistaltic antidiarrheals (e.g., diphenoxylate and atropine combination, loperamide, opiates) is not recommended since they may delay the removal of toxins from the colon, thereby prolonging and/or worsening the condition. {01}



Oral Dosage Forms

LEVOFLOXACIN TABLETS

Usual adult dose
Bronchitis, bacterial exacerbations, treatment
Oral, 500 mg every twenty-four hours for seven days. {01}

Pneumonia, community-acquired, treatment
Oral, 500 mg every twenty-four hours for seven to fourteen days. {01}

Note: Canadian manufacturer recommends 10 to 14 days for severe infections.{03}


Pyelonephritis, treatment
Oral, 250 mg every twenty-four hours for ten days. {01}

Sinusitis, treatment
Oral, 500 mg every twenty-four hours for ten to fourteen days. {01}

Skin and soft tissue infections, complicated, treatment
Oral, 750 mg every twenty-four hours for seven to fourteen days.{02}


Note: Canadian manufacturer recommends 500 mg every twelve hours for seven to fourteen days.{03}

Skin and soft tissue infections, uncomplicated, treatment
Oral, 500 mg every twenty-four hours for seven to ten days. {01}

Urinary tract infections, bacterial, complicated, treatment
Oral, 250 mg every twenty-four hours for ten days. {01}

Urinary tract infections, bacterial, uncomplicated, treatment
Oral, 250 mg every twenty-four hours for three days.{02}{03}


Usual pediatric dose
Safety and efficacy have not been established {01}.

Strength(s) usually available
U.S.—


250 mg (Rx) [Levaquin (hydroxypropyl methylcellulose ) (crospovidone) (microcrystalline cellulose) (magnesium stearate) ( polyethylene glycol) (titanium dioxide) (polysorbate 80) (synthetic red iron oxide)]{01}{04}


500 mg (Rx) [Levaquin (hydroxypropyl methylcellulose ) (crospovidone) (microcrystalline cellulose) (magnesium stearate) ( polyethylene glycol) (titanium dioxide) (polysorbate 80) (synthetic red iron oxide) (synthetic yellow iron oxide)]{01}{04}


750 mg (Rx) [Levaquin (hydroxypropyl methylcellulose ) (crospovidone) (microcrystalline cellulose) (magnesium stearate) ( polyethylene glycol) (titanium dioxide) (polysorbate 80)]{01}{04}

Canada—


250 mg (Rx) [Levaquin (hydroxypropyl methylcellulose ) (crospovidone) (microcrystalline cellulose) (magnesium stearate) ( polyethylene glycol) (titanium dioxide) (polysorbate 80) (synthetic red iron oxide)]{01}


500 mg (Rx) [Levaquin (hydroxypropyl methylcellulose ) (crospovidone) (microcrystalline cellulose) (magnesium stearate) ( polyethylene glycol) (titanium dioxide) (polysorbate 80) (synthetic red iron oxide) (synthetic yellow iron oxide)]{03}

Packaging and storage:
Store below 40 ºC (104 ºF), preferably between 15 and 30 ºC (59 and 86 ºF), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Continue medicine for the full time of treatment.
   • Avoid too much sun exposure or use of sunlamp.
   • Take with full glass of water.
   • May cause dizziness, drowsiness, or lightheadedness.



Parenteral Dosage Forms

LEVOFLOXACIN FOR INJECTION

Usual adult dose
Bronchitis, bacterial exacerbations, treatment
Intravenous infusion, 500 mg, administered over a 60-minute period, every twenty-four hours for seven days. {01}

Pneumonia, community-acquired, treatment
Intravenous infusion, 500 mg, administered over a 60-minute period, every twenty-four hours for seven to fourteen days. {01}

Note: Canadian manufacturer recommends 10 to 14 days for severe infections.{03}


Pyelonephritis, treatment
Intravenous infusion, 250 mg, administered over a 60-minute period, every twenty-four hours for ten days. {01}

Sinusitis, treatment
Intravenous infusion, 500 mg, administered over a 60-minute period, every twenty-four hours for ten to fourteen days. {01}

Skin and soft tissue infections, complicated, treatment
Intravenous infusion, 750 mg administered over a 90 minute period, every twenty-four hours for seven to fourteen days.{02}


Note: Canadian manufacturer recommends 500 mg every twelve hours for seven to fourteen days.{03}

Skin and soft tissue infections, uncomplicated, treatment
Intravenous infusion, 500 mg, administered over a 60-minute period, every twenty-four hours for seven to ten days. {01}{02}

Urinary tract infections, bacterial, complicated, treatment
Intravenous infusion, 250 mg, administered over a 60-minute period, every twenty-four hours for ten days. {01}

Urinary tract infections, bacterial, uncomplicated, treatment
Intravenous infusion, 250 mg every twenty-four hours for three days.{02}{03}


Usual pediatric dose
Safety and efficacy have not been established {01}.

Strength(s) usually available
U.S.—


500 mg per 20 mL (Rx) [Levaquin]{01}{04}


750 mg per 30 mL (Rx) [Levaquin]{04}

Canada—


500 mg per 20 mL (Rx) [Levaquin]{03}

Packaging and storage:
Store below 40 ºC (104 ºF), preferably between 15 and 30 ºC (59 and 86 ºF), unless otherwise specified by the manufacturer. Protect from light.

Preparation of dosage form:
Levofloxacin for injection must be further diluted with compatible intravenous fluids prior to intravenous administration. The concentration of the resulting diluted solution must be 5 mg/mL prior to administration.{04}

To prepare a 250-mg dose for intravenous infusion, withdraw 10 mL of levofloxacin concentrate for injection from the vial and dilute with 40 mL of a compatible intravenous solution, for a total volume of 50 mL. To prepare a 500-mg dose, withdraw 20 mL of levofloxacin concentrate for injection from the vial and dilute with 80 mL of a compatible intravenous solution, for a total volume of 100 mL. {01}

To prepare a 750-mg dose for intravenous infusion, withdraw 30 mL of levofloxacin concentrate for injection from the vial and dilute with 120 mL of a compatible intravenous solution, for a total volume of 150 mL.{04}

Stability:
When diluted to a concentration of 5 mg per mL, levofloxacin concentrate for injection is stable for 72 hours when stored at or below 25 ºC (77 ºF) and for 14 days when refrigerated (5 ºC [41 ºF]) in plastic intravenous containers. Diluted solutions that are frozen in glass bottles or plastic containers are stable for 6 months when stored at -20 ºC (-4 ºF). Frozen solutions should be thawed at room temperature or in a refrigerator. They should not be thawed in a microwave or by water bath immersion. Do not refreeze after initial thawing. {01}

Incompatibilities:
Because there is only limited data on the compatibility of other substances with levofloxacin concentrate for injection, additives or other medications should not be added to levofloxacin concentrate for injection in the single-use vials or infused simultaneously through the same intravenous line. {01}

Note: This product should be inspected visually for any particulate matter before administration. Samples with visible particles should be discarded. {01}
Levofloxacin concentrate for injection contains no preservative or bacteriostatic agent. Because of this, the vials are for single use only; any unused portion remaining in the vial should be discarded. {01}



LEVOFLOXACIN INJECTION

Usual adult dose
See Levofloxacin For Injection . {01}

Usual pediatric dose
See Levofloxacin For Injection . {01}

Strength(s) usually available
U.S.—


250 mg per 50 mL (Rx) [Levaquin]{01}{04}


500 mg per 100 mL (Rx) [Levaquin (5% Dextrose )]{01}{04}


750 mg per 150 mL (Rx) [Levaquin (5% Dextrose )]{04}

Canada—


250 mg per 50 mL (Rx) [Levaquin (5% Dextrose )]{01}


500 mg per 100 mL (Rx) [Levaquin (5% Dextrose )]{01}

Packaging and storage:
Store at or below 25 ºC (77 ºF); however, brief exposure up to 40 ºC (104 ºF) does not adversely affect the product. Protect from excessive heat, freezing, and light. {01}

Incompatibilities:
Because there are only limited data on the compatibility of other substances with levofloxacin injection, additives or other medications should not be added to levofloxacin injection in the single-use vials or infused simultaneously through the same intravenous line. {01}

Note: This product should be inspected visually for any particulate matter before administration. Samples with visible particles should be discarded. {01}
Levofloxacin pre-mix injection flexible containers are for single use only; any unused portion should be discarded. {01}{04}
Do not use levofloxacin flexible containers in series connections {04}




Developed: 07/31/1997
Revised: 02/04/2002



References
  1. Levaquin package insert (Ortho—US), New 12/96, Rec 2/97.
  1. Product Information: Levaquin®, levofloxacin. Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey, (PI Issued 09/2000) reviewed 01/2001
  1. Product Information: Levaquin, levofloxacin. Janssen-Ortho Inc., Toronto, Ontario, (PI Revised 6/2000) reviewed 01/2001
  1. Product Information: Levaquin®, levofloxacin. Ortho-McNeil Pharmaceutical, Inc., Raritan, New Jersey, (PI Issued 11/2000) reviewed 02/2002
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