LEVAQUIN Tablets/Injection and Oral Solution are indicated for the treatment of adults with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed below. LEVAQUIN Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

Nosocomial Pneumonia: (adults)

• Indicated in adult patients for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended.

Community-Acquired Pneumonia: 7–14 day Treatment Regimen: (adults)

• Indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.

MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Community-Acquired Pneumonia: 5-day Treatment Regimen: (adults)

• Indicated in adult patients for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae.

Complicated Skin and Skin Structure Infections: (adults)

• Indicated in adult patients for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis.

Uncomplicated Skin and Skin Structure Infections: (adults)

• Indicated in adult patients for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

Chronic Bacterial Prostatitis: (adults)

• Indicated in adult patients for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis.

Inhalational Anthrax (Post-Exposure): (adults and pediatric patients, 6 months of age and older)

• Indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults and pediatric patients, 6 months of age and older. The effectiveness of LEVAQUIN is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit.

LEVAQUIN has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEVAQUIN in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged LEVAQUIN therapy should only be used when the benefit outweighs the risk.

Plague: (adults and pediatric patients, 6 months of age and older)

• Indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older.

Efficacy studies of LEVAQUIN could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals.

Complicated Urinary Tract Infections: 5-day Treatment Regimen: (adults)

• Indicated in adult patients for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis.

Complicated Urinary Tract Infections: 10-day Treatment Regimen: (adults)

• Indicated in adult patients for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.

Acute Pyelonephritis: 5 or 10-day Treatment Regimen: (adults)

• Indicated in adult patients for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia.

Uncomplicated Urinary Tract Infections: (adults)

• Indicated in adult patients for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions and for some patients uncomplicated urinary tract infection is self-limiting, reserve LEVAQUIN for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.

Acute Bacterial Exacerbation of Chronic Bronchitis: (adults)

• Indicated in adult patients for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve LEVAQUIN for treatment of ABECB in patients who have no alternative treatment options.

Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens: (adults)

• Indicated in adult patients for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.

Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions and for some patients ABS is self-limiting, reserve LEVAQUIN for treatment of ABS in patients who have no alternative treatment options.

Fluoroquinolones, including LEVAQUIN, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together including:

• Tendinitis and tendon rupture
• Peripheral neuropathy
• Central nervous system effects

Fluoroquinolones, including LEVAQUIN are associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon And has also been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendon sites. Tendinitis or tendon rupture can occur within hours or days of starting LEVAQUIN or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally..

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis. Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors.

Fluoroquinolones, including LEVAQUIN may exacerbate muscle weakness in persons with myasthenia gravis. Avoid LEVAQUIN in patients with a known history of myasthenia gravis.

An increased incidence of musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) compared to controls has been observed in pediatric patients receiving LEVAQUIN

Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including LEVAQUIN. Symptoms may occur soon after initiation of LEVAQUIN and may be irreversible in some patients.

Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, toxic psychosis, increased intracranial pressure (including pseudotumor cerebri) . Fluoroquinolones may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts. These reactions may occur following the first dose.

Fluoroquinolones, including LEVAQUIN, have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting LEVAQUIN. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.

Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of psychiatric adverse reactions, including: toxic psychosis, hallucinations, or paranoia; depression, or suicidal thoughts; anxiety, agitation, restlessness, or nervousness; confusion, delirium, disorientation, or disturbances in attention; insomnia or nightmares; memory impairment. Attempted or completed suicide have been reported, especially in patients with a medical history of depression, or an underlying risk factor for depression. These reactions may occur following the first dose.

Fluoroquinolones, including LEVAQUIN, have been associated with an increased risk of seizure (convulsions), increased intracranial pressure (including pseudotumor cerebri), tremors, and lightheadedness. As with other fluoroquinolones, LEVAQUIN® should be used with caution in patients with a known or suspected central nervous system (CNS) disorder that may predispose them to seizures or lower the seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose them to seizures or lower the seizure threshold (e.g., certain drug therapy, renal dysfunction).

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including LEVAQUIN, and may range in severity from mild diarrhea to fatal colitis.

Epidemiologic studies report an increased rate of aortic aneurysm and dissection within two months following use of fluoroquinolones, particularly in elderly patients. The cause for the increased risk has not been identified. In patients with a known aortic aneurysm or patients who are at greater risk for aortic aneurysms, reserve LEVAQUIN® for use only when there are no alternative antibacterial treatments available.

Some fluoroquinolones, including LEVAQUIN, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia.

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with fluoroquinolones, including LEVAQUIN.

As with other fluoroquinolones, disturbances of blood glucose, including symptomatic hyper and hypoglycemia, have been reported with LEVAQUIN, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin.

In patients with renal impairment (creatinine clearance less than 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance. No adjustment is necessary for patients with a creatinine clearance greater than or equal to 50 mL/minute.

Post-marketing reports of severe hepatotoxicity (including acute hepatitis and fatal events) have been received for patients treated with LEVAQUIN.

Adequate hydration of patients receiving LEVAQUIN should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones.

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of fluoroquinolones after sun or UV light exposure.

Because fluoroquinolones, including LEVAQUIN, have been associated with serious adverse reactions reserve LEVAQUIN for use in patients who have no alternative treatment options for the following indications:

• Uncomplicated urinary tract infection 
• Acute bacterial exacerbation of chronic bronchitis 
• Acute bacterial sinusitis 

Other serious and sometimes fatal adverse reactions, some due to hypersensitivity, and some due to uncertain etiology, have been reported rarely in patients receiving therapy with fluoroquinolones, including LEVAQUIN. These events may be severe and generally occur following the administration of multiple doses. Clinical manifestations may include one or more of the following:

• fever, rash, or severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson Syndrome)
• vasculitis; arthralgia; myalgia; serum sickness
• allergic pneumonitis
• interstitial nephritis; acute renal insufficiency or failure
• hepatitis; jaundice; acute hepatic necrosis or failure
• anemia, including hemolytic and aplastic; thrombocytopenia, including thrombotic thrombocytopenic purpura; leukopenia; agranulocytosis; pancytopenia; and/or other hematologic abnormalities

Elevations of the prothrombin time in the setting of concurrent warfarin and LEVAQUIN use have been associated with episodes of bleeding.

Some fluoroquinolones, including LEVAQUIN, may produce false-positive urine screening results for opiates using commercially available immunoassay kits.

LEVAQUIN Tablets and Oral Solution should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution.

LEVAQUIN Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line.

The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including LEVAQUIN, may increase the risk of CNS stimulation and convulsive seizures.

Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent.

Theophylline levels should be closely monitored and appropriate dosage adjustments made when LEVAQUIN is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels.

There are, however, no adequate and well-controlled studies in pregnant women. LEVAQUIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Because of the potential for serious adverse reactions from LEVAQUIN in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Pelvic inflammatory disease. GoToSource

• Obstetric and gynecological infections. GoToSource

• Epididymitis. GoToSource

• Legionnaires disease. GoToSource

• Tuberculosis. GoToSource

• Typhoid fever. GoToSource

• Use in patients under the age of 6 months. GoToSource

Tendinitis and tendon ruptures. GoToSource

Clostridium difficile (bacterium causing diarrhea and serious intestinal conditions such as colitis). GoToSource

Peripheral neuropathy (damage to or disease affecting nerves). GoToSource 

Prolongation of the QT interval (heart rhythm condition potentially causing fast, chaotic heartbeats), arrhythmia and torsades de pointes (life-threatening heart rhythm disturbances). GoToSource

Convulsions, confusion, anxiety, depression and insomnia. GoToSource

Aortic aneurysms. GoToSource

Hallucinations, tremor, psychosis and delirium. GoToSource

Severe hepatotoxicity including acute hepatitis (inflammation of the liver) and death. GoToSource

Worsening muscle weakness in patients with myasthenia gravis. GoToSource

Increased intracranial pressure. GoToSource

Stevens-johnson syndrome and toxic epidermal necrolysis (potentially fatal skin reaction). GoToSource 

Kounis syndrome (acute coronary syndrome, symptoms such as chest pain relating to reduced blood flow to the heart caused by an allergic reaction). GoToSource

Hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar). GoToSource

Phototoxicity reaction. GoToSource

Antibiotic resistance. GoToSource 

Development of diabetes. GoToSource

Memory loss. GoToSource

Suicidal ideation. GoToSource

Retinal detachment. GoToSource

Kidney injury including Interstitial nephritis and tubular necrosis. GoToSource

Hypersensitivity reactions. GoToSource

Lawsuits filed for ruptured tendons and stevens-johnson syndrome.