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These highlights do not include all the information needed to use Levofloxacin safely and effectively. See full prescribing information for Levofloxacin. Levofloxacin Tablets'Initial U.S. Approval:' 1996 | LEVOFLOXACIN

04:59 EDT 27th August 2014 | BioPortfolio

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Fluoroquinolones, including levofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants [See Warnings and Precautions (5.1)]. Fluoroquinolones, including levofloxacin tablets, may exacerbate muscle weakness in persons with myasthenia gravis. Avoid levofloxacin tablets in patients with a known history of myasthenia gravis [See Warnings and Precautions (5.2)].

Levofloxacin tablets are indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].

Levofloxacin tablets are indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].

Levofloxacin tablets are indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)].

Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin 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 levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].

Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
Type of Infection* Dosed Every 24 hours Duration (days)
 Nosocomial Pneumonia  750 mg  7–14
 Community Acquired Pneumonia  500 mg  7–14
 Community Acquired Pneumonia§  750 mg  5
 Acute Bacterial Sinusitis  750 mg  5
 500 mg  10–14
 Acute Bacterial Exacerbation of Chronic Bronchitis  500 mg  7
 Complicated Skin and Skin Structure Infections (SSSI)  750 mg  7–14
 Uncomplicated SSSI  500 mg  7–10
 Chronic Bacterial Prostatitis  500 mg  28
 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)  750 mg  5
 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#  250 mg  10
 Uncomplicated Urinary Tract Infection  250 mg  3
 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg and ≥ 6 months of age Þ,ß  500 mg  60ß
 Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß  see Table 2 below (2.2)  60ß
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
Type of Infection* Dose Freq. Once every Duration
 Inhalational Anthrax (post-exposure)‡,§      
 Pediatric patients > 50 kg and ≥ 6 months of age  500 mg  24 hr  60 days§
 Pediatric patients < 50 kg and ≥ 6 months of age  8 mg/kg
(not to exceed 250 mg per dose)
 12 hr  60 days§
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)
Dosage in Normal Renal Function Every 24 hours Creatinine Clearance
20 to 49 mL/min
Creatinine Clearance
10 to 19 mL/min
Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
 750 mg  750 mg every 48 hours  750 mg initial dose, then 500 mg every 48 hours  750 mg initial dose, then 500 mg every 48 hours
 500 mg  500 mg initial dose, then 250 mg every 24 hours  500 mg initial dose, then 250 mg every 48 hours  500 mg initial dose, then 250 mg every 48 hours
 250 mg  No dosage adjustment required  250 mg every 48 hours. If treating uncomplicated UTI, then no dosage adjustment is required  No information on dosing adjustment is available
Table 4: Common (≥1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin
System/Organ Class Adverse Reaction %
(N=7537)
 Infections and Infestations  moniliasis  1
 Psychiatric Disorders  insomnia* [see Warnings and Precautions (5.6)]
 4
 Nervous System Disorders  headache
dizziness [see Warnings and Precautions (5.6)]
 6
3
 Respiratory, Thoracic and Mediastinal Disorders  dyspnea [see Warnings and Precautions (5.3)]  1
 Gastrointestinal Disorders  nausea  7
 diarrhea  5
 constipation  3
 abdominal pain  2
 vomiting   2
 dyspepsia  2
 Skin and Subcutaneous Tissue Disorders  rash [see Warnings and Precautions (5.3)]
pruritus
 2
1
 Reproductive System and Breast Disorders  vaginitis  1
 General Disorders and Administration Site Conditions  edema  1
 injection site reaction  1
 chest pain  1
Table 5: Less Common (0.1 to 1%) Adverse Reactions Reported in Clinical Trials with Levofloxacin (N=7537)
System/Organ Class Adverse Reaction
 Infections and Infestations  genital moniliasis
 Blood and Lymphatic System Disorders  anemia
thrombocytopenia
granulocytopenia
[see Warnings and Precautions (5.4)]
 Immune System Disorders
 allergic reaction [See Warnings and Precautions (5.3, 5.4)]
 Metabolism and Nutrition Disorders  hyperglycemia
hypoglycemia
[see Warnings and Precautions (5.11)]

hyperkalemia
 Psychiatric Disorders  anxiety
agitation
confusion
depression
hallucination
nightmare*
[see Warnings and Precautions (5.6)]

sleep disorder*
anorexia
abnormal dreaming*
 Nervous System Disorders  tremor
convulsions
[see Warnings and Precautions (5.6)]

paresthesia [see Warnings and Precautions (5.8)]
vertigo
hypertonia
hyperkinesias
abnormal gait
somnolence*
syncope
 Respiratory, Thoracic and Mediastinal Disorders  epistaxis
 Cardiac Disorders  cardiac arrest
palpitation
ventricular tachycardia
ventricular arrhythmia
 Vascular Disorders  phlebitis
 Gastrointestinal Disorders  gastritis
stomatitis
pancreatitis
esophagitis
gastroenteritis
glossitis
pseudomembraneous/ C. difficile colitis [see Warnings and Precautions (5.7)]
 Hepatobiliary Disorders  abnormal hepatic function
increased hepatic enzymes
increased alkaline phosphatase
 Skin and Subcutaneous Tissue Disorders  urticaria [see Warnings and Precautions (5.3)]
 Musculoskeletal and Connective Tissue Disorders  arthralgia
tendonitis
[see Warnings and Precautions (5.1)]

myalgia
skeletal pain
 Renal and Urinary Disorders  abnormal renal function
acute renal failure [see Warnings and Precautions (5.4)]
Table 6: Postmarketing Reports Of Adverse Drug Reactions
System/Organ Class Adverse Reaction
 Blood and Lymphatic System Disorders  pancytopenia
aplastic anemia
leukopenia
hemolytic anemia
[see Warnings and Precautions (5.4)]

eosinophilia
 Immune System Disorders  hypersensitivity reactions, sometimes fatal including:
  anaphylactic/anaphylactoid reactions
  anaphylactic shock
  angioneurotic edema
  serum sickness
[see Warnings and Precautions (5.3, 5.4)]
 Psychiatric Disorders  psychosis
paranoia
isolated reports of suicide attempt and suicidal ideation
[see Warnings and Precautions (5.6)]
 Nervous System Disorders
 exacerbation of myasthenia gravis [see Warnings and Precautions (5.2)]
anosmia
ageusia
parosmia
dysgeusia
peripheral neuropathy [see Warnings and Precautions (5.8)]
isolated reports of encephalopathy
abnormal electroencephalogram (EEG)
dysphonia
 Eye Disorders  vision disturbance, including diplopia
visual acuity reduced
vision blurred
scotoma
 Ear and Labyrinth Disorders  hypoacusis
tinnitus
 Cardiac Disorders  isolated reports of torsade de pointes
electrocardiogram QT prolonged
[see Warnings and Precautions (5.9)]
tachycardia
 Vascular Disorders  vasodilatation
 Respiratory, Thoracic and Mediastinal Disorders  isolated reports of allergic pneumonitis [see Warnings and Precautions (5.4)]
 Hepatobiliary Disorders  hepatic failure (including fatal cases)
hepatitis
jaundice
[see Warnings and Precautions (5.4, 5.5)]
 Skin and Subcutaneous Tissue Disorders  bullous eruptions to include:
  Stevens-Johnson Syndrome
  toxic epidermal necrolysis
  erythema multiforme
[see Warnings and Precautions (5.4)]
photosensitivity/phototoxicity reaction [see Warnings and Precautions (5.12)]
leukocytoclastic vasculitis
 Musculoskeletal and Connective Tissue Disorders  tendon rupture [see Warnings and Precautions (5.1)]
muscle injury, including rupture
rhabdomyolysis
 Renal and Urinary Disorders  interstitial nephritis [see Warnings and Precautions (5.4)].
 General Disorders and Administration Site Conditions  multi-organ failure
pyrexia
 Investigations  prothrombin time prolonged
international normalized ratio prolonged
muscle enzymes increased

The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including levofloxacin, may increase the risk of CNS stimulation and convulsive seizures [see Warnings and Precautions (5.6)].

Table 7: Incidence of Musculoskeletal Disorders in Pediatric Clinical Trial
Follow-up Period Levofloxacin
N = 1340
Non-Fluoroquinolone*
N = 893
p-value 
 60 days  28 (2.1%)  8 (0.9%)  p = 0.038
 1 year  46 (3.4%)  16 (1.8%)  p = 0.025
IMAGE levoflxacin-tablets-1.jpgIMAGE levoflxacin-tablets-2.jpgIMAGE levoflxacin-tablets-3.jpg
Table 8: Mean ±SD Levofloxacin PK Parameters
Regimen Cmax Tmax AUC CL/F1 Vd/F2 t1/2 CLR
(mcg/mL) (h) (mcg∙h/mL) (mL/min) (L) (h) (mL/min)
 Single dose
 250 mg oral tablet3  2.8 ± 0.4  1.6 ± 1.0  27.2 ± 3.9  156 ± 20  ND  7.3 ± 0.9  142 ± 21
 500 mg oral tablet3*  5.1 ± 0.8  1.3 ± 0.6  47.9 ± 6.8  178 ± 28  ND  6.3 ± 0.6  103 ± 30
 500 mg oral solution12  5.8 ± 1.8  0.8 ± 0.7  47.8 ± 10.8  183 ± 40  112 ± 37.2  7.0 ± 1.4  ND
 500 mg IV3  6.2 ± 1.0  1.0 ± 0.1  48.3 ± 5.4  175 ± 20  90 ± 11  6.4 ± 0.7  112 ± 25
 750 mg oral tablet5*  9.3 ± 1.6  1.6 ± 0.8  101 ± 20  129 ± 24  83 ± 17  7.5 ± 0.9  ND
 750 mg IV5  11.5 ±4.04  ND  110 ±40  126 ±39  75 ± 13  7.5 ± 1.6  ND
 Multiple dose
 500 mg every 24h oral tablet3  5.7 ± 1.4  1.1 ± 0.4  47.5 ± 6.7  175 ± 25  102 ± 22  7.6 ± 1.6  116 ± 31
 500 mg every 24h IV3  6.4 ± 0.8  ND  54.6 ± 11.1  158 ± 29  91 ± 12  7.0 ± 0.8  99 ± 28
 500 mg or 250 mg every 24h IV, patients with bacterial infection6  8.7± 4.07  ND  72.5 ± 51.27  154 ± 72  111 ± 58  ND  ND
 750 mg every 24h oral tablet5  8.6 ± 1.9  1.4 ± 0.5  90.7 ± 17.6  143 ± 29  100 ± 16  8.8 ± 1.5  116 ± 28
 750 mg every 24h IV5  12.1 ± 4.14  ND  108 ± 34  126 ± 37  80 ± 27  7.9 ± 1.9  ND
 500 mg oral tablet single dose, effects of gender and age:
 Male8  5.5 ± 1.1  1.2 ± 0.4  54.4 ± 18.9  166 ± 44  89 ± 13  7.5 ± 2.1  126 ± 38
 Female9  7.0 ± 1.6  1.7 ± 0.5  67.7 ± 24.2  136 ± 44  62 ± 16  6.1 ± 0.8  106 ± 40
 Young10  5.5 ± 1.0  1.5 ± 0.6  47.5 ± 9.8  182 ± 35  83 ± 18  6.0 ± 0.9  140 ± 33
 Elderly11  7.0 ± 1.6  1.4 ± 0.5  74.7 ± 23.3  121 ± 33  67 ± 19  7.6 ± 2.0  91 ± 29
 500 mg oral single dose tablet, patients with renal insufficiency:
 CLCR 50–80 mL/min  7.5 ± 1.8  1.5 ± 0.5  95.6 ± 11.8  88 ± 10  ND  9.1 ± 0.9  57 ± 8
 CLCR 20–49 mL/min  7.1 ± 3.1  2.1 ± 1.3  182.1 ± 62.6  51 ± 19  ND  27 ± 10  26 ± 13
 CLCR <20 mL/min  8.2 ± 2.6  1.1 ± 1.0  263.5 ± 72.5  33 ± 8  ND  35 ± 5  13 ± 3
 Hemodialysis  5.7 ± 1.0  2.8 ± 2.2  ND  ND  ND  76 ± 42  ND
 CAPD  6.9 ± 2.3  1.4 ± 1.1  ND  ND  ND  51 ± 24  ND

These interpretive standards are applicable only to broth microdilution susceptibility testing with Haemophilus influenzae and Haemophilus parainfluenzae using Haemophilus Test Medium. The current absence of data on resistant strains precludes defining any categories other than "Susceptible." Strains yielding MIC /zone diameter results suggestive of a "nonsusceptible" category should be submitted to a reference laboratory for further testing. These interpretive standards are applicable only to disk diffusion susceptibility testing with Haemophilus influenzae and Haemophilus parainfluenzae using Haemophilus Test Medium. These interpretive standards are applicable only to broth microdilution susceptibility tests using cation-adjusted Mueller-Hinton broth with 2-5% lysed horse blood. These zone diameter standards for Streptococcus spp. including S. pneumoniae apply only to tests performed using Mueller-Hinton agar supplemented with 5% sheep blood and incubated in 5% CO. A report of Susceptible indicates that the pathogen is likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable. A report of Intermediate indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where a high dosage of drug can be used. This category also provides a buffer zone which prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of Resistant indicates that the pathogen is not likely to be inhibited if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.

Standardized susceptibility test procedures require the use of laboratory control microorganisms to control the technical aspects of the laboratory procedures. For dilution technique, standard levofloxacin powder should give the MIC values provided in Table 10. For diffusion technique, the 5 mcg levofloxacin disk should provide zone diameters provided in Table 10.

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Table 9: Susceptibility Interpretive Criteria for Levofloxacin
Minimum Inhibitory
Concentrations (mcg/mL)