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Uses
To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tabletsand other antibacterial drugs, levofloxacin tabletsshould be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Levofloxacin tablets are indicated for the treatment of adults (≥ 18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section.
Culture and susceptibility testing
Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to levofloxacin [see Microbiology (12.4)]. Therapy with levofloxacin tablets may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.
As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with levofloxacin tablets. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.
Levofloxacin tablet is indicated 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 [see Clinical Studies (14.1)].
Levofloxacin tablet is indicated 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 [see Dosage and Administration (2.1) and Clinical Studies (14.2)].
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.
Levofloxacin tablet is indicated 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 [see Dosage and Administration (2.1) and Clinical Studies (14.3)].
Levofloxacin tablet is indicated for the treatment of acute bacterial sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].
Levofloxacin tablet is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.
Levofloxacin tablet is 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 tablet is indicated 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.
Levofloxacin tablet is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)].
Levofloxacin tablet is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)].
Levofloxacin tablet is indicated 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 [see Clinical Studies (14.8)].
Levofloxacin tablet is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)].
Levofloxacin tabletis indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.
Levofloxacin tabletis indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of levofloxacin tablet is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablethas not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tabletsin 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 tabletstherapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].
Levofloxacin tablet is 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 Levofloxacin tablets 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 [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].
History
There is currently no drug history available for this drug.
Other Information
Levofloxacin is a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, levofloxacin, a chiral fluorinated carboxyquinolone, is the pure (-)-(S)-enantiomer of the racemic drug substance ofloxacin. The chemical name is (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic acid hemihydrate.
Figure 1
The Chemical Structure of Levofloxacin
Its molecular formula is C18H20FN3O4 • ½ H2O and the molecular weight is 370.38. Levofloxacin, USP is a light yellowish–white to yellow–white crystals or crystalline powder. The molecule exists as a zwitterion at the pH conditions in the small intestine.
The data demonstrate that from pH 0.6 to 5.8, the solubility of levofloxacin is essentially constant (approximately 100 mg/mL). Levofloxacin is considered soluble to freely soluble in this pH range, as defined by USP nomenclature. Above pH 5.8, the solubility increases rapidly to its maximum at pH 6.7 (272 mg/mL) and is considered freely soluble in this range. Above pH 6.7, the solubility decreases and reaches a minimum value (about 50 mg/mL) at a pH of approximately 6.9.
Levofloxacin has the potential to form stable coordination compounds with many metal ions. This in vitro chelation potential has the following formation order:
Al+3> Cu+2> Zn+2> Mg+2> Ca+2.
Excipients and Description of Dosage Forms
Each levofloxacin tablet intended for oral administration contains levofloxacin hemihydrate equivalent to 250 mg or 500 mg or 750 mg of levofloxacin. In addition, each tablet contains the following inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 6000, talc and titanium dioxide.
Sources
Levofloxacin Manufacturers
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Proficient Rx Lp
Levofloxacin | Proficient Rx Lp
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection*
Dosed Every 24 hours
Duration (days)†
*Due to the designated pathogens [see Indications and Usage (1)]. †Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. §Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized
B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ßThe safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk. a Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablet typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 kgÞ, ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ, ß500 mg
See Table 2 below (2.2)60 ß
60 ßPlague, adult and pediatric patients > 50 kga
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
See Table 2 below (2.2)10 to 14
2.2 Dosage in Pediatric Patients
10 to 14The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2Dosage in Pediatric Patients ≥ 6 months of age Type of Infection*
Dose
Freq. Once every
Duration†
*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. †Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] §The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk. ¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg500 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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tabletswith caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3Dosage 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 hours750 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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Remedyrepack Inc.
Levofloxacin | Remedyrepack Inc.
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 availableAntacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Blenheim Pharmacal, Inc.
Levofloxacin | Laboratoires Clarins S.a.
apply liberally 15 minutes before sun exposure apply to all skin exposed to the sun children under 6 months: Ask a doctor Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a board spectrum SPF value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m. - 2p.m. wear long-sleeved shirts, pants, hats and sunglasses. reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating. -
Proficient Rx Lp
Levofloxacin | Proficient Rx Lp
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14
Community Acquired Pneumonia
500 mg
7 to 14
Community Acquired Pneumonia
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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
Plague, adult and pediatric patients > 50 kg
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of AgeType of Infection
Dose
Freq. Once Every
Duration
Inhalational Anthrax (post-exposure)
Pediatric patients > 50 kg
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
Plague
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose)12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Camber Pharmaceuticals, Inc.
Levofloxacin | Camber Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
Type of Infection*
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
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
Inhalation Anthranx (Post-Exposure), adult and pediatric patients > 50 kg Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500mg
see Table 2 below (2.2)
60ß
60ß
Plague, adult and pediatric patients > 50 kgá
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
*Due to the designated pathogens [see Indications and Usage (1)].
2.2 Dosage in Pediatric Patients
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
ßThe safety of levofloxacin in adults for duration of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions(5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
áDrug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Type of Infection*
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6
months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
2.3 Dosage Adjustment in Adults with Renal Impairment
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
Dosage in Normal Renal Function
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations,Levofloxacin Tablets
2.5 Administration Instructions
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Preferred Pharmaceuticals, Inc.
Levofloxacin | Preferred Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14
Community Acquired Pneumonia ‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß500 mg see Table 2 below (2.2)
60 ß
60 ßPlague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
see Table 2 below (2.2)10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents:Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Akorn, Inc.
Levofloxacin | Akorn, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)1 Due to the designated pathogens [see Indications and Usage (1)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of Levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of Levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Type of Infection1 Dosed Every 24 hours Duration (days)2 Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia3 500 mg 7 to 14 Community Acquired Pneumonia4 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8 Pediatric patients < 50 kg and
≥6 months of age7,8 500 mg
see Table 2 below (2.2) 608
608 Plague, adult and pediatric patients
> 50 kg9
Pediatric patients < 50 kg and
≥6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 14 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
4 The safety of Levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection1 Dose Freq. Once every Duration2 Inhalational Anthrax (post-exposure)3, 4 Pediatric patients
> 50 kg 500 mg 24 hr 60 days4 Pediatric patients
< 50 kg and ≥6 months of age 8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days4 Plague5 Pediatric patients
> 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients
< 50 kg and ≥6 months of age 8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days 2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister Levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].
2.5 Administration InstructionsLevofloxacin Injection
Caution: Rapid or bolus intravenous infusion of Levofloxacin Injection has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Hydration for Patients Receiving Levofloxacin Injection
Adequate hydration of patients receiving intravenous Levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
2.6 Preparation of Intravenous ProductParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection in Single-Use Vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.
LEVOFLOXACIN Injection in Single-Use Vials
Single-use vials require dilution prior to administration.
Levofloxacin Injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin/mL. These Levofloxacin Injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.
Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:
Table 4: Compatible Intravenous Solutions Intravenous Fluids Final pH of Levofloxacin Injection Solution 0.9% Sodium Chloride Injection, USP 4.71 5% Dextrose Injection, USP 4.58 5% Dextrose/0.9% NaCl Injection 4.62 5% Dextrose in Lactated Ringers 4.92 Plasma-Lyte®56/5% Dextrose Injection 5.03 5% Dextrose, 0.45% Sodium Chloride, and 0.15% Potassium Chloride Injection 4.61 Sodium Lactate Injection (M/6) 5.54Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].
Prepare the desired dosage of levofloxacin according to Table 5:
Table 5: Preparation of Levofloxacin Injection Intravenous Solution Desired Dosage Strength From Appropriate Vial, Withdraw Volume Volume of Diluent Infusion Time 250 mg 10 mL (20 mL Vial) 40 mL 60 min 500 mg 20 mL (20 mL Vial) 80 mL 60 min 750 mg 30 mL (30 mL Vial) 120 mL 90 minFor example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.
This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
Stability of Levofloxacin Injection Following Dilution: Levofloxacin Injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.
-
Stat Rx Usa Llc
Levofloxacin | Stat Rx Usa Llc
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. † The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection Dosed Every 24 Hours Duration (Days) Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia 500 mg 7 to 14 Community Acquired Pneumonia 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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*,† 500 mg 60† Pediatric patients < 50 kg and ≥ 6 months of age*,† See Table 2 below (2.2) 60† 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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* 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
H.j. Harkins Company, Inc.
Levofloxacin | H.j. Harkins Company, Inc.
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection* Dosed Every 24 Hours Duration (Days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 ageÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below (2.2) 60ß 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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§ 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Physicians Total Care, Inc.
Levofloxacin | Physicians Total Care, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß1* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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§*Due to Bacillus anthracis [see Indications and Usage (1.13)]
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 availableAntacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Rebel Distributors Corp
Levofloxacin | Rebel Distributors Corp
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection* Dosed Every 24 Hours Duration (Days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 ageÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß See Table 2 below (2.2) 60ß 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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§ 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Unit Dose Services
Levofloxacin | Unit Dose Services
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablet is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see ]. DOSAGE AND ADMINISTRATION ( ) 2.3
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/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 Pediatric patients < 50 kg and ≥6 months of ageInhalational Anthrax (Post-Exposure), adult and pediatric
patients > 50 kg and ≥6 months of age Þ,β
Þ, β see table below (2.2)500 mg
6060 β
βDue to the designated pathogens [see ]. *INDICATIONS AND USAGE ( ) 1
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. †
Due to methicillin-susceptible (including multi-drug-resistant strains [MDRSP]), or [see ]. ‡Staphylococcus aureus, Streptococcus pneumoniaeHaemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila,Mycoplasma pneumoniaeINDICATIONS AND USAGE ( ) 1.2
Due to (excluding multi-drug-resistant strains [MDRSP]), [see ]. §Streptococcus pneumoniaeHaemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniaeINDICATIONS AND USAGE ( ) 1.3
This regimen is indicated for cUTI due to and AP due to including cases with concurrent bacteremia. ¶Escherichia coli, Klebsiella pneumoniae, Proteus mirabilisE. coli,
This regimen is indicated for cUTI due to and for AP due to #Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa;E. coli.
Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see ]. ÞB. anthracis.CLINICAL STUDIES ( ) 14.9)
The safety of levofloxacin tablet in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients see ] Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. β[WARNINGS AND PRECAUTIONS ( ), USE IN SPECIFIC POPULATIONS ( ), AND CLINICAL STUDIES ( ) 5.108.414.9 )
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥6 months of age is described below in Table 2.
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 (not to exceed 250 mg per dose)8 mg/kg
12 hr 60 days §Due to (see ] *Bacillus anthracisINDICATIONS AND USAGE (1.13)
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. †
Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit. [See ] ‡B. anthracis.CLINICAL STUDIES( ) 14.9
The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see ]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. §WARNINGS AND PRECAUTIONS ( ), USE IN SPECIFIC POPULATIONS ( ), AND CLINICAL STUDIES ( ) 5.108.414.9)
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablet with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see ]. USE IN SPECIFIC POPULATIONS ( ) 8.6
shows how to adjust dose based on creatinine clearance. Table 3
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablet 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 suspension. [See ]. DRUG INTERACTIONS ( ) AND PATIENT COUNSELING INFORMATION ( ) 7.117.2
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablet can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ]. ADVERSE REACTIONS ( ) AND PATIENT COUNSELING INFORMATION ( ) 6.117.2
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Mylan Institutional Inc.
Levofloxacin | Mylan Institutional Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. Type of Infection* Dosed Every 24 hours Duration (days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þß
Pediatric patients < 50 kg and ≥ 6 months of ageÞß 500 mg
see Table 2 below (2.2)60ß
60ßThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see Indications and Usage (1.13)] † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4) and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. Type of Infection* Dose Freq. Once Every Duration†Inhalational Anthrax (post-exposure)‡§
Pediatric patients > 50 kg and ≥ 6 months of agePediatric patients < 50 kg and ≥ 6 months of age
500 mg
8 mg/kg
250 mg per dose)
(not to exceed
24 hr
12 hr
60 days§
60 days§
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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/minCreatinine 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 availableLevofloxacin tablets should be administered at least 2 hours before or 2 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions Food and Levofloxacin TabletsLevofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin TabletsAdequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Bryant Ranch Prepack
Levofloxacin | Bryant Ranch Prepack
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection* Dosed Every 24 Hours Duration (Days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
(2.2) 60ß Plague, adult and pediatric patients > 50 kgà 500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection* Dose Freq. Once Every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed 250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Cadila Healthcare Limited
Levofloxacin | Cadila Healthcare Limited
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection*
Dosed Every 24 hours
Duration (days)†
*Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized
B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
aDrug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablet typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mg
see Table 2 below (2.2)
60ß
60ß
Plague, adult and pediatric patients > 50 kga
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
See Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2Dosage in Pediatric Patients ≥ 6 months of age Type of Infection*
Dose
Freq. Once every
Duration†
*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
8 mg/kg
(not to exceed 250 mg per dose)
24 hr
12 hr
60 days§
60 days§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tabletswith caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3Dosage 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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Wockhardt Limited
Levofloxacin | Wockhardt Limited
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)* Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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 Þ, ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ, ß
500 mg
See Table 2 below (2.2)
60 ß
60 ß
Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
See Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Wockhardt Usa Llc.
Levofloxacin | Wockhardt Usa Llc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)* Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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 Þ, ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ, ß
500 mg
See Table 2 below (2.2)
60 ß
60 ß
Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
See Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Sandoz Inc
Levofloxacin | Sandoz Inc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/min) Type of Infection* Dosed Every 24 hours Duration (days)† * Due to the designated pathogens [see Indications and Usage (1)] . † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumonia [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Mycoplasma pneumoniae , or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae , Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis , Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae , Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis . This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis . Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.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 kgÞ,ß
Pediatric patients < 50 kg and ≥ 6 months
of ageÞ,ß500 mg
See Table 2 below (2.2)60ß
60ßPlague, adult and pediatric patients >50 kgà
Pediatric patients <50 kg and ≥6 months
of age500 mg
See Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
Type of Infection*
Dose Freq. Once
every
Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis .Inhalational Anthrax (post-exposure)‡,§
Pediatric Patients > 50 kg
500 mg
24hr
60 days§
Pediatric Patients < 50 kg
and ≥ 6 months of age8 mg/kg
(not to exceed
250 mg per dose)12hr
60 days§
Plague¶
Pediatric Patients >50 kg
500 mg
24hr
10 to 14 days
Pediatric Patients <50 kg
and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)12hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 hours750 mg initial dose, then
500 mg every 48 hours500 mg
500 mg initial dose, then
250 mg every 24 hours500 mg initial dose, then
250 mg every 48 hours500 mg initial dose, then
250 mg every 48 hours250 mg
No dosage adjustment
required250 mg every 48 hours. If
treating uncomplicated
UTI, then no dosage
adjustment is requiredNo information on dosing
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
adjustment is availableLevofloxacin Injection
Levofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].
2.5 Administration InstructionsLevofloxacin Injection
Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Hydration for Patients Receiving Levofloxacin Injection
Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
2.6 Preparation of Intravenous ProductParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix in Single-Use Flexible Containers, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.
Levofloxacin Injection Premix in Single-Use Flexible Containers (5 mg/mL)
Levofloxacin Injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 100 mL premixed flexible containers contain either 250 mg/50 mL or 500 mg/100 mL of levofloxacin solution. The 150 mL flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.
Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers:
1. Tear outer wrap at the notch and remove solution container. 2. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. 3. Do not use if the solution is cloudy or a precipitate is present. 4. Use sterile equipment. 5. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.Preparation for Administration:
1. Close flow control clamp of administration set. 2. Remove cover from port at bottom of container. 3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 4. Suspend container from hanger. 5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. 6. Open flow control clamp to expel air from set. Close clamp. 7. Regulate rate of administration with flow control clamp. -
Bryant Ranch Prepack
Levofloxacin | Bryant Ranch Prepack
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection* Dosed Every 24 Hours Duration (Days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
(2.2) 60ß Plague, adult and pediatric patients > 50 kgà 500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection* Dose Freq. Once Every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed 250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Lake Erie Medical Dba Quality Care Products Llc
Levofloxacin | Lake Erie Medical Dba Quality Care Products Llc
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection1 Dosed Every 24 hours Duration (days)2 1 Due to the designated pathogens [see Indications and Usage (1)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia3
500 mg
7 to 14
Community Acquired Pneumonia4
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
Pediatric patients < 50 kg and ≥ 6 months of age 7,8
500 mg
see Table 2 below (2.2)
608
608
Plague, adult and pediatric patients > 50 kg9
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection1 Dose Freq. Once
every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
4 The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)3, 4
Pediatric patients > 50 kg
500 mg
24 hr
60 days4
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
60 days4
Plague5
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Remedyrepack Inc.
Levofloxacin | Remedyrepack Inc.
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection1 Dosed Every 24 hours Duration (days)2 Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia3
500 mg
7 to 14
Community Acquired Pneumonia4
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
Pediatric patients < 50 kg and ≥ 6 months of age 7,8
500 mg
see Table 2 below (2.2)
608
608
Plague, adult and pediatric patients > 50 kg9
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection1 Dose Freq. Once
every Duration2 Inhalational Anthrax (post-exposure)3, 4
Pediatric patients > 50 kg
500 mg
24 hr
60 days4
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
60 days4
Plague5
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Lake Erie Medical Dba Quality Care Products Llc
Levofloxacin | Lake Erie Medical Dba Quality Care Products Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablet is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION (2.3 )].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50mL/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 3Inhalational Anthrax (Post-Exposure), adult and pediatric
patients > 50 kg and ≥6 months of ageÞ,β
Pediatric patients < 50 kg and ≥6 months of ageÞ, β500 mg
see table below (2.2)60β
60β* Due to the designated pathogens [see INDICATIONS AND USAGE (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see INDICATIONS AND USAGE (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see INDICATIONS AND USAGE (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9))].
β The safety of levofloxacin tablet in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), AND CLINICAL STUDIES (14.9 ))] Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk.
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥6 months of age is described below in Table 2.
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 age8 mg/kg
(not to exceed 250 mg per dose) 12 hr 60 days§* Due to Bacillus anthracis (see INDICATIONS AND USAGE (1.13)]
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit. [See CLINICAL STUDIES(14.9)]
§ The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), AND CLINICAL STUDIES (14.9))]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk.
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablet with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablet 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 suspension. [See DRUG INTERACTIONS (7.1) AND PATIENT COUNSELING INFORMATION (17.2 )].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablet can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) AND PATIENT COUNSELING INFORMATION (17.2)].
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Pd-rx Pharmaceuticals, Inc.
Levofloxacin | Csl Behring Ag
As with all blood products, patients should be observed for at least 20 minutes following administration of Rhophylac.
2.1 Preparation and HandlingRhophylac is a clear or slightly opalescent, colorless to pale yellow solution. Inspect Rhophylac visually for particulate matter and discoloration prior to administration. Do not use if the solution is cloudy or contains particulates.
Prior to intravenous use, ensure that the needle-free intravenous administration system is compatible with the tip of the Rhophylac glass syringe.
Do not freeze.
Bring Rhophylac to room temperature before use.
Rhophylac is for single use only. Dispose of any unused product or waste material in accordance with local requirements.
2.2 Suppression of Rh IsoimmunizationRhophylac should be administered by intravenous or intramuscular injection. If large doses (greater than 5 mL) are required and intramuscular injection is chosen, it is advisable to administer Rhophylac in divided doses at different sites.
Ensure the site of administration will allow the injection to reach the muscle if Rhophylac is administered intramuscularly. Consider intravenous administration if reaching the muscle is of concern [see Postmarketing Experience (6.2)]. Do not administer Rhophylac subcutaneously into the fatty tissue.
Table 1 provides dosing guidelines based on the condition being treated.
Table 1: Dosing Guidelines for Suppression of Rh Isoimmunization Indication Timing of Administration Dose*
(Administer by Intravenous or Intramuscular Injection) IU, international units; mcg, micrograms. * A 1500 IU (300 mcg) dose of Rhophylac will suppress the immunizing potential of ≥15 mL of Rh 0(D)-positive RBCs. 1 † The dose of Rhophylac must be increased if the patient is exposed to >15 mL of Rh 0(D)-positive RBCs; in this case, follow the dosing guidelines for excessive fetomaternal hemorrhage. Rh-incompatible pregnancy Routine antepartum prophylaxis At Week 28-30 of gestation 1500 IU (300 mcg) Postpartum prophylaxis
(required only if the newborn is Rh 0(D)-positive) Within 72 hours of birth 1500 IU (300 mcg)† Obstetric complications
(e.g., miscarriage, abortion, threatened abortion, ectopic pregnancy or hydatidiform mole, transplacental hemorrhage resulting from antepartum hemorrhage) Within 72 hours of complication 1500 IU (300 mcg)† Invasive procedures during pregnancy (e.g., amniocentesis, chorionic biopsy) or obstetric manipulative procedures (e.g., external version, abdominal trauma) Within 72 hours of procedure 1500 IU (300 mcg)† Excessive fetomaternal hemorrhage
(>15 mL) Within 72 hours of complication 1500 IU (300 mcg) plus:
100 IU (20 mcg) per mL fetal RBCs in excess of 15 mL if excess transplacental bleeding is quantified
or An additional 1500 IU (300 mcg) dose if excess transplacental bleeding cannot be quantified Incompatible transfusions Within 72 hours of exposure 100 IU (20 mcg)
per 2 mL transfused blood or per 1 mL erythrocyte concentrate 2.3 ITPFor treatment of ITP, ADMINISTER RHOPHYLAC BY THE INTRAVENOUS ROUTE ONLY [see Preparation and Handling (2.1)]. Do not administer intramuscularly.
A 250 IU (50 mcg) per kg body weight dose of Rhophylac is recommended for patients with ITP. The following formula can be used to calculate the recommended amount of Rhophylac to administer:
Dose (IU) × body weight (kg) = Total IU / 1500 IU per syringe = Number of syringes
Rhophylac should be administered at a rate of 2 mL per 15 to 60 seconds.
-
Pd-rx Pharmaceuticals, Inc.
Levofloxacin | Pd-rx Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia3
500 mg
7 to 14
Community Acquired Pneumonia4
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
Pediatric patients < 50 kg and ≥ 6 months of age 7,8
500 mg
see Table 2 below (2.2)
608
608
Plague, adult and pediatric patients > 50 kg9
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
4 The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)3, 4
Pediatric patients > 50 kg
500 mg
24 hr
60 days4
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
60 days4
Plague5
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)and Patient Counseling Information (17.2)]. -
Pd-rx Pharmaceuticals, Inc.
Levofloxacin | Pd-rx Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. † The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection Dosed Every 24 Hours Duration (Days) Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia 500 mg 7 to 14 Community Acquired Pneumonia 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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*,† 500 mg 60† Pediatric patients < 50 kg and ≥ 6 months of age*,† see Table 2 below
(2.2) 60† Plague, adult and pediatric patients > 50 kg 500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection Dose Freq. Once Every Duration Inhalational Anthrax (post-exposure) ,* Pediatric patients > 50 kg 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* Plague Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed 250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Pd-rx Pharmaceuticals, Inc.
Levofloxacin | Pd-rx Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection* Dosed Every 24 Hours Duration (Days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
(2.2) 60ß Plague, adult and pediatric patients > 50 kgà 500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection* Dose Freq. Once Every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed 250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Avkare, Inc.
Levofloxacin | Avkare, Inc.
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection* Dosed Every 24 Hours Duration (Days)† Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 kgÞ,ß 500 mg 60ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß see Table 2 below
(2.2) 60ß Plague, adult and pediatric patients > 50 kgà 500 mg 10 to 14 Pediatric patients < 50 kg and ≥ 6 months of age see Table 2 below 10 to 14 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage ( 1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection* Dose Freq. Once Every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed 250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Pd-rx Pharmaceuticals, Inc.
Levofloxacin | Pd-rx Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. † The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. Type of Infection Dosed Every 24 Hours Duration (Days) Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia 500 mg 7 to 14 Community Acquired Pneumonia 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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*,† 500 mg 60† Pediatric patients < 50 kg and ≥ 6 months of age*,† See Table 2 below (2.2) 60† 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. 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* 2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
West-ward Pharmaceutical Corp
Levofloxacin | West-ward Pharmaceutical Corp
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
Type of Infection1
Dosed Every 24 hours
Duration
(days)2Nosocomial Pneumonia
750 mg
7–14
Community Acquired Pneumonia3
500 mg
7–14
Community Acquired Pneumonia4
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)5
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg 7,8
Pediatric patients < 50 kg and ≥ 6 months of age 7,8500 mg
see Table 2 below (2.2)60 8
60 8Plague, adult and pediatric patients > 50 kg 9
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
10 to 14
see Table 2 below (2.2)
10 to 141 Due to the designated pathogens [see INDICATIONS AND USAGE (1)].
2.2 Dosage in Pediatric Patients
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see INDICATIONS AND USAGE (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see INDICATIONS AND USAGE (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)].
8 The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10); USE IN SPECIFIC POPULATIONS (8.4); and CLINICAL STUDIES (14.9)] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
Type of Infection 1
Dose
Freq. Once Every
Duration2
Inhalational Anthrax (post-exposure)3,4Pediatric patients > 50 kg
500 mg
24 hr
60 days4
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
60 days4
Plague5 Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days1 Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13) and Yersinia pestis (see INDICATIONS AND USAGE (1.14)]
2.3 Dosage Adjustment in Adults with Renal Impairment
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)]
4 The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10); USE IN SPECIFIC POPULATIONS (8.4); CLINICAL STUDIES (14.9).] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min)
Dosage in Normal Renal Function
Every 24 hoursCreatinine Clearance
20 to 49 mL/minCreatinine Clearance
10 to 19 mL/minHemodialysis 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
Levofloxacin Injection
Levofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see DOSAGE AND ADMINISTRATION (2.6)].Levofloxacin Injection
Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.Hydration for Patients Receiving Levofloxacin Injection
Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1); PATIENT COUNSELING INFORMATION (17.2)].Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix in Single Dose Flexible Containers, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.
Levofloxacin Injection Premix in Single Dose Flexible Containers (5 mg/mL)
Levofloxacin injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single dose. The 50 mL premixed flexible containers contain 250 mg/50 mL, the 100 mL premixed flexible containers contain 500 mg/100 mL, and the 200 mL premixed flexible containers contain 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single dose only, any unused portion should be discarded.Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers:
Tear outer wrap at the notch and remove solution container. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. Do not use if the solution is cloudy or a precipitate is present. Use sterile equipment. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.Preparation for Administration:
Close flow control clamp of administration set. Remove cover from port at bottom of container. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. Suspend container from hanger. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. Open flow control clamp to expel air from set. Close clamp. Regulate rate of administration with flow control clamp. -
Lake Erie Medical Dba Quality Care Products Llc
Levofloxacin | Lake Erie Medical Dba Quality Care Products Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION(2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance > 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus , Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Klebsiella pneumoniae , Moraxella catarrhalis , Chlamydophila pneumoniae , Legionella pneumophila, or Mycoplasma pneumoniae [see INDICATIONS AND USAGE (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae , Haemophilus parainfluenzae , Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see INDICATIONS AND USAGE (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae , Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis , Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae , Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10) , USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspented or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 Hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 kgÞ,ß
500 mg
60ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
see Table 2 below (2.2)
60ß
Plague, adult and pediatric patients > 50 kgà
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients > 6 Months of Age * Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13)] and Yersinia pestis [see INDICATIONS AND USAGE (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tabletswith caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].
2.5 Administration InstructionsFood and LevofloxacinTablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving LevofloxacinTablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].
-
Major Pharmaceuticals
Levofloxacin | Major Pharmaceuticals
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)* Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mg
See Table 2 below (2.2)
60ß
60ß
Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
See Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Dr. Reddy’s Laboratories Limited
Levofloxacin | Dr. Reddy's Laboratories Limited
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 availableAntacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Remedyrepack Inc.
Levofloxacin | Remedyrepack Inc.
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 availableAntacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Remedyrepack Inc.
Levofloxacin | Remedyrepack Inc.
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 availableAntacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
American Health Packaging
Levofloxacin | American Health Packaging
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see INDICATIONS AND USAGE (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see INDICATIONS AND USAGE (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every
24 hoursDuration
(days)†Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 kgÞ,ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß500 mg
see Table 2 below
(2.2)60ß
60ßPlague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
see Table 2 below
(2.2)10 to 14
2.2 Dosage in Pediatric Patients
10 to 14The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see INDICATIONS AND USAGE ( 1.13)] and Yersinia pestis [see INDICATIONS AND USAGE ( 1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES ( 14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once
everyDuration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose)12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)Dosage in Normal Renal Function Every 24 hours
Creatinine Clearance20 to 49 mL/min
Creatinine Clearance10 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 hours750 mg initial dose, then
500 mg every 48 hours500 mg
500 mg initial dose, then
250 mg every 24 hours500 mg initial dose, then
250 mg every 48 hours500 mg initial dose, then
250 mg every 48 hours250 mg
No dosage adjustment required
250 mg every 48 hours.
If treating uncomplicated UTI, then no dosage adjustment is requiredNo information on dosing adjustment is available
2.4 Drug Interaction with Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].
-
Sandoz Inc
Levofloxacin | Renu Laboratories, Inc.
Directions:
clean the affected area and dry thoroughly apply a thin layer over the affected area twice daily (morning and night) supervise children in the use of this product for athlete's foot, pay special attention to the spaces between toes..
Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks. If condition lasts longer, as a doctor to prevent athlete's foot, apply to the feet once or twice daily this product is not effective on the scalp or nails -
Clinical Solutions Wholesale
Levofloxacin | Clinical Solutions Wholesale
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION(2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance > 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae(including multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Moraxella catarrhalis, Chlamydophilapneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see INDICATIONS AND USAGE (1.2)]. § Due to Streptococcus pneumoniae(excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae[see INDICATIONS AND USAGE(1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis, Pseudomonasaeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES(14.9)]. ß The safety of levofloxacin tabletsin adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablettherapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspented or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 Hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 kgÞ,ß
500 mg
60ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
see Table 2 below (2.2)
60ß
Plague, adult and pediatric patients > 50 kgà
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients > 6 Months of Age * Due to Bacillus anthracis[see INDICATIONS AND USAGE (1.13)]and Yersinia pestis[see INDICATIONS AND USAGE (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)]. § The safety of levofloxacin tabletsin pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10),USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tabletswith caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].
2.5 Administration InstructionsFood and LevofloxacinTablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving LevofloxacinTablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].
-
Major Pharmaceuticals
Levofloxacin | Major Pharmaceuticals
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents:Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Fresenius Kabi Usa, Llc
Levofloxacin | Rite Aid Corporation
• do not take more than 6 doses in any 24-hour period • measure only with dosing cup provided • keep dosing cup with product • mL = milliliter • this adult product is not intended for use in children under 12 years of ageage
dose
adults and children 12 years and over
10 mL every 4 hours
children under 12 years
do not use
-
Remedyrepack Inc.
Levofloxacin | Remedyrepack Inc.
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 availableAntacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
New Horizon Rx Group, Llc
Levofloxacin | New Horizon Rx Group, Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function(creatinine clearance ≥ 50 mL/min) Type of Infection* Dosed Every Duration 24 hours (days) † * Due to the designated pathogens [see Indications and Usage (1)]. †Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. 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 > 50kg and ≥ 6 months of ageÞ,ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß 500 mg
see Table 2below (2.2) 60ß
60ß 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection* Dose Freq. Once every Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. Inhalational Anthrax (post-exposure) ‡,§ Pediatric patients > 50 kg and ≥ 6 months of age 500 mg 24 hr 60 days§ 8 mg/kg Pediatric patients < 50 kg and ≥ 6 months of age (not to exceed 250 mg per dose) 2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min) Dosage in Creatinine Creatinine Hemodialysis Normal Clearance Clearance or Chronic Renal Function 20 to 49 mL/min 10 to 19 mL/min Ambulatory Every 24 hours Peritoneal Dialysis (CAPD) 750 mg 750 mg 750 mg initial dose, 750 mg initial dose, every 48 hours then 500 mg then 500 mg every 48 hours every 48 hours 500 mg 500 mg initial dose, 500 mg initial dose, 500 mg initial dose, then 250 mg then 250 mg then 250 mg every 24 hours every 48 hours every 48 hours 250 mg No dosage 250 mg No information adjustment every 48 hours. on dosing required If treating uncomplicated UTI, then no dosage adjustment is required 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Remedyrepack Inc.
Levofloxacin | Remedyrepack Inc.
The usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 to 14 Community Acquired Pneumonia ‡ 500 mg 7 to 14 Community Acquired Pneumonia§ 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß 500 mg see Table 2 below (2.2)
60 ß
60 ß Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 141* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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 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§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 availableAntacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [seeDrugInteractions (7.1) and Patient Counseling Information (17.2)]
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [seeAdverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Aidarex Pharmaceuticals Llc
Levofloxacin | Aidarex Pharmaceuticals Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)* Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mg
See Table 2 below (2.2)
60ß
60ß
Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
See Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Preferred Pharmaceuticals, Inc.
Levofloxacin | Preferred Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersiniapestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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 Þ, ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ, ß500 mg
See Table 2 below (2.2)60 ß
60 ßPlague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
See Table 2 below (2.2)10 to 14
2.2 Dosage in Pediatric Patients
10 to 14The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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/minCreatinine Clearance
10 to 19 mL/minHemodialysis 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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Preferred Pharmaceuticals, Inc
Levofloxacin | Preferred Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. † Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. ‡ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. § This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. ¶ This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. # Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. Þ The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection
Dosed Every 24 Hours
Duration (Days)*
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia†
500 mg
7 to 14
Community Acquired Pneumonia‡
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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#,Þ
Pediatric patients < 50 kg and ≥ 6 months of age#,Þ
500 mg
see Table 2 below
(2.2)
60Þ
60Þ
Plague, adult and pediatric patients > 50 kgß
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once Every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose)12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Preferred Pharmaceuticals, Inc.
Levofloxacin | Preferred Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.
á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß500 mg
see Table 2 below (2.2)60 ß
60 ßPlague, adult and pediatric patients > 50 kgá
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
see Table 2 below (2.2)10 to 14
2.2 Dosage in Pediatric Patients
10 to 14The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection* Dose Freq. Once
every Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
§ The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)‡, §
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 hours750 mg initial dose, then
500 mg every 48 hours500 mg
500 mg initial dose, then
250 mg every 24 hours500 mg initial dose, then
250 mg every 48 hours500 mg initial dose, then
250 mg every 48 hours250 mg
No dosage adjustment
required250 mg every 48 hours.
If treating uncomplicated
UTI, then no dosage
adjustment is requiredNo information on
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
dosing adjustment is availableLevofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Preferred Pharmaceuticals, Inc.
Levofloxacin | Cardinal Health
2.1 Important Dosing and Administration InformationIn selecting a LANOXIN dosing regimen, it is important to consider factors that affect digoxin blood levels (e.g., body weight, age, renal function, concomitant drugs) since toxic levels of digoxin are only slightly higher than therapeutic levels. Dosing can be either initiated with a loading dose followed by maintenance dosing if rapid titration is desired or initiated with maintenance dosing without a loading dose.
Consider interruption or reduction in LANOXIN digoxin dose prior to electrical cardioversion [see Warnings and Precautions (5.4)].
Use digoxin solution to obtain the appropriate dose in infants, young pediatric patients, or patients with very low body weight.
2.2 Loading Dosing Regimen in Adults and Pediatric PatientsFor adults and pediatric patients if a loading dosage is to be given, administer half the total loading dose initially, then ¼ the loading dose every 6-8 hours twice, with careful assessment of clinical response and toxicity before each dose. The recommended loading dose is displayed in Table 1.
Table 1. Recommended LANOXIN Oral Loading Dose mcg = microgramAge
Total Oral Loading Dose (mcg/kg)
Administer half the total loading dose initially,
then ¼ the loading dose every 6 to 8 hours twice5 to 10 years
20-45
Adults and pediatric patients over 10 years
10-15
2.3 Maintenance Dosing in Adults and Pediatric Patients Over 10 Years OldThe maintenance dose is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)].
The recommended starting maintenance dose in adults and pediatric patients over 10 years old with normal renal function is given in Table 2. Doses may be increased every 2 weeks according to clinical response, serum drug levels, and toxicity.
Table 2. Recommended Starting LANOXIN Maintenance Dosage in Adults and Pediatric Patients Over 10 Years Old mcg = microgramAge
Total Oral Maintenance Dose, mcg/kg/day
(given once daily)Adults and pediatric patients over 10 years
3.4-5.1
Table 3 provides the recommended (once daily) maintenance dose for adults and pediatric patients over 10 years old (to be given once daily) according to lean body weight and renal function. The doses are based on studies in adult patients with heart failure. Alternatively, the maintenance dose may be estimated by the following formula (peak body stores lost each day through elimination):
Total Maintenance Dose = Loading Dose (i.e., Peak Body Stores) x % Daily Loss/100
(% Daily Loss = 14 + Creatinine clearance/5)Reduce the dose of LANOXIN in patients whose lean weight is an abnormally small fraction of their total body mass because of obesity or edema.
Table 3. Recommended Maintenance Dose (in micrograms given once daily) of LANOXIN in Pediatric Patients Over 10 Years Old and Adults by Lean Body Weight and by Renal Functiona a Doses are rounded to the nearest dose possible using whole LANOXIN tablets. Recommended doses approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin levels in patients receiving these initial doses and increase dose if needed.
b For adults, creatinine clearance was corrected to 70-kg body weight or 1.73 m2 body surface area. If only serum creatinine concentrations (Scr) are available, a corrected Ccr may be estimated in men as (140 – Age)/Scr. For women, this result should be multiplied by 0.85.
For pediatric patients, the modified Schwartz equation may be used. The formula is based on height in cm and Scr in mg/dL where k is a constant. Ccr is corrected to 1.73 m2 body surface area. During the first year of life, the value of k is 0.33 for pre-term babies and 0.45 for term infants. The k is 0.55 for pediatric patients and adolescent girls and 0.7 for adolescent boys.
GFR (mL/min/1.73 m2) = (k x Height)/Scr
c If no loading dose administered.
d The doses listed assume average body composition.Corrected
Creatinine
ClearancebLean Body Weightd
Number of Days
Before Steady
State Achievedckg
40
50
60
70
80
90
100
10 mL/min 62.5* 125 125 187.5 187.5 187.5 250 19 20 mL/min 125 125 125 187.5 187.5 250 250 16 30 mL/min 125 125 187.5 187.5 250 250 312.5 14 40 mL/min 125 187.5 187.5 250 250 312.5 312.5 13 50 mL/min 125 187.5 187.5 250 250 312.5 312.5 12 60 mL/min 125 187.5 250 250 312.5 312.5 375 11 70 mL/min 187.5 187.5 250 250 312.5 375 375 10 80 mL/min 187.5 187.5 250 312.5 312.5 375 437.5 9 90 mL/min 187.5 250 250 312.5 375 437.5 437.5 8 100 mL/min 187.5 250 312.5 312.5 375 437.5 500 7 2.4 Maintenance Dosing in Pediatric Patients Less Than 10 Years OldThe starting maintenance dose for heart failure in pediatric patients less than 10 years old is based on lean body weight, renal function, age, and concomitant products [see Clinical Pharmacology (12.3)]. The recommended starting maintenance dose for pediatric patients between 5 years and 10 years old is given in Table 4. These recommendations assume the presence of normal renal function.
Table 4. Recommended Starting LANOXIN Oral Maintenance Dosage in Pediatric Patients between 5 and 10 Years OldAge
Oral Maintenance Dose,
mcg/kg/dose5 years to 10 years
3.2-6.4 Twice daily
Table 5 provides average daily maintenance dose requirements for pediatric patients between 5 and 10 years old (to be given twice daily) with heart failure based on age, lean body weight, and renal function.
Table 5. Recommended Maintenance Dose (in micrograms given TWICE daily) of LANOXIN in Pediatric Patients between 5 and 10 Years of Agea Based upon Lean Body Weight and Renal Functiona,b a Recommended are doses to be given twice daily.
b The doses are rounded to the nearest dose possible using whole LANOXIN tablets. Recommended doses approximately 30 percent lower than the calculated dose are designated with an *. Monitor digoxin levels in patients receiving these initial doses and increase dose if needed.
c The modified Schwartz equation may be used to estimate creatinine clearance. See footnote b under Table 3.
d If no loading dose administered.Corrected
Creatinine
ClearancecLean Body Weight
Number of Days
Before Steady
State Achieveddkg
20
30
40
50
60
10 mL/min - 62.5 62.5* 125 125 19 20 mL/min 62.5 62.5 125 125 125 16 30 mL/min 62.5 62.5* 125 125 187.5 14 40 mL/min 62.5 62.5* 125 187.5 187.5 13 50 mL/min 62.5 125 125 187.5 187.5 12 60 mL/min 62.5 125 125 187.5 250 11 70 mL/min 62.5 125 187.5 187.5 250 10 80 mL/min 62.5* 125 187.5 187.5 250 9 90 mL/min 62.5* 125 187.5 250 250 8 100 mL/min 62.5* 125 187.5 250 312.5 7 2.5 Monitoring to Assess Safety, Efficacy, and Therapeutic Blood LevelsMonitor for signs and symptoms of digoxin toxicity and clinical response. Adjust dose based on toxicity, efficacy, and blood levels.
Serum digoxin levels less than 0.5 ng/mL have been associated with diminished efficacy, while levels above 2 ng/mL have been associated with increased toxicity without increased benefit.
Interpret the serum digoxin concentration in the overall clinical context, and do not use an isolated measurement of serum digoxin concentration as the basis for increasing or decreasing the LANOXIN dose. Serum digoxin concentrations may be falsely elevated by endogenous digoxin-like substances [see Drug Interactions (7.4)]. If the assay is sensitive to these substances, consider obtaining a baseline digoxin level before starting LANOXIN and correct post-treatment values by the reported baseline level.
Obtain serum digoxin concentrations just before the next scheduled LANOXIN dose or at least 6 hours after the last dose. The digoxin concentration is likely to be 10-25% lower when sampled right before the next dose (24 hours after dosing) compared to sampling 8 hours after dosing (using once-daily dosing). However, there will be only minor differences in digoxin concentrations using twice daily dosing whether sampling is done at 8 or 12 hours after a dose.
2.6 Switching from Intravenous Digoxin to Oral DigoxinWhen switching from intravenous to oral digoxin formulations, make allowances for differences in bioavailability when calculating maintenance dosages (see Table 6).
Table 6. Comparison of the Systemic Availability and Equivalent Doses of Oral and Intravenous LANOXINAbsolute
BioavailabilityEquivalent Doses (mcg)
LANOXIN Tablets
60-80%
62.5
125
250
500
LANOXIN Intravenous Injection
100%
50
100
200
400
-
Preferred Pharmaceuticals, Inc.
Levofloxacin | Preferred Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)]. †Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Type of Infection*
Dosed
Every 24 hoursDuration
(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),
adultand pediatric patients > 50 kg Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mg
see Table 2 below (2.2)
60ß
60ßPlague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
see Table 2 below (2.2)10 to 14
2.2 Dosage in Pediatric Patients
10 to 14The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage(1.14)]. †Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
500 mg
24 hr
60 days§
Pediatric patients < 50 kg and ≥ 6 months of age8 mg/kg
(not to exceed 250 mg per dose)12 hr
60
days§Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age8 mg/kg
(not to exceed 250 mg per dose)12 hr
10 to 14 daysAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance < 50 mL/min)Dosage in
Normal
Renal Function
Every 24 hoursCreatinine
Clearance
20 to 49 mL/minCreatinine
Clearance
10 to 19 mL/minHemodialysis
or Chronic
Ambulatory
Peritoneal
Dialysis (CAPD)750 mg
750 mg
every 48 hours750 mg initial dose,
then 500 mg
every 48 hours750 mg initial dose,
then 500 mg
every 48 hours500 mg
500 mg initial dose,
then 250 mg
every 24 hours500 mg initial dose,
then 250 mg
every 48 hours500 mg initial dose,
then 250 mg
every 48 hours250 mg
No dosage
adjustment
required250 mg
every 48 hours.
If treating
uncomplicated UTI, then no dosage
adjustment is
requiredNo information
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
on dosing
adjustment is
availableLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Preferred Pharmaceuticals, Inc
Levofloxacin | Amedra Pharmaceuticals Llc
For Treatment of Toxoplasmosis: The dosage of DARAPRIM for the treatment of toxoplasmosis must be carefully adjusted so as to provide maximum therapeutic effect and a minimum of side effects. At the dosage required, there is a marked variation in the tolerance to the drug. Young patients may tolerate higher doses than older individuals. Concurrent administration of folinic acid is strongly recommended in all patients.
The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a sulfonamide of the sulfapyrimidine type, e.g. sulfadoxine. This dosage is ordinarily continued for 1 to 3 weeks, depending on the response of the patient and tolerance to therapy. The dosage may then be reduced to about one half that previously given for each drug and continued for an additional 4 to 5 weeks.
The pediatric dosage of DARAPRIM is 1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage is used in conjunction with DARAPRIM.
For Treatment of Acute Malaria: DARAPRIM is NOT recommended alone in the treatment of acute malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for treatment of acute malaria. However, DARAPRIM at a dosage of 25 mg daily for 2 days with a sulfonamide will initiate transmission control and suppression of non-falciparum malaria. DARAPRIM is only recommended for patients infected in areas where susceptible plasmodia exist. Should circumstances arise wherein DARAPRIM must be used alone in semi-immune persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4 through 10 years old may be given 25 mg daily for 2 days. In any event, clinical cure should be followed by the once-weekly regimen described below for chemoprophylaxis. Regimens which include suppression should be extended through any characteristic periods of early recrudescence and late relapse, i.e., for at least 10 weeks in each case.
For Chemoprophylaxis of Malaria:
Adults and pediatric patients over 10 years – 25 mg (1 tablet) once weekly
Children 4 through 10 years – 12.5 mg (1/2 tablet) once weekly
Infants and children under 4 years – 6.25 mg (1/4 tablet) once weekly. -
Blenheim Pharmacal, Inc.
Levofloxacin | Blenheim Pharmacal, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
* Due to the designated pathogens [see Indications and UsageHYPERLINK l "_RefINDICATIONS_AND_USAGE" (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and UsageHYPERLINK l "_Ref_cd55f535-bc4f-26eb-5f98-c25935287e6" (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and UsageHYPERLINK l "_Ref_10fa1391-4861-375e-e722-fda832a596a" (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical StudiesHYPERLINK l "_Ref_8b0fe90b-f154-e516-63e6-69d9217a8f0" (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and PrecautionsHYPERLINK l "_Ref_9697f448-d255-5ba4-05a0-d00b0688a83" (5.10), Use in Specific PopulationsHYPERLINK l "_RefPEDIATRIC_USE" (8.4), and Clinical StudiesHYPERLINK l "_Ref_8b0fe90b-f154-e516-63e6-69d9217a8f0" (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia ‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß500 mg see Table 2 below (2.2)
60 ß
60 ßPlague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
see Table 2 below (2.2)10 to 14
2.2 Dosage in Pediatric Patients
10 to 14The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
* Due to Bacillus anthracis [see Indications and UsageHYPERLINK l "_Ref_44e8b8b4-7787-1604-7e7b-4abf6e612f3" (1.13)] and Yersinia pestis [see Indications and UsageHYPERLINK l "_Ref_37b72727-96be-cb93-91f4-bc446d623da" (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure toaerosolizedB. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrationsachieved in humans are reasonably likely to predict clinical benefit [see Clinical StudiesHYPERLINK l "_Ref_8b0fe90b-f154-e516-63e6-69d9217a8f0" (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not beenstudied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. # Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure) ‡,§
Pediatric patients > 50 kg
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¶
Plague#
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction with Chelation Agents:Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [see DrugInteractions (7.1) and Patient Counseling Information (17.2)]
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Greenstone Llc
Levofloxacin | Greenstone Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection1
Dosed Every 24 hours
Duration (days)2
1 Due to the designated pathogens [see Indications and Usage (1)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically inidicated.
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia3
500 mg
7 to 14
Community Acquired Pneumonia4
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Inhalational Anthrax (Post-Exposure), adult and pediatric patients > 50 kg7,8
Pediatric patients < 50 kg and ≥ 6 months of age 7,8
500 mg
see Table 2 below (2.2)
608
608
Plague, adult and pediatric patients > 50 kg9
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age 1 Due to Bacillus anthracis [see Indications and Usage (1.13)]and Yersinia pestis [see Indications and Usage (1.14)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
4 The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection1
Dose
Freq. Once every
Duration2
Inhalational Anthrax (post-exposure)3, 4
Pediatric patients > 50 kg
500 mg
24 hr
60 days4
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
60 days4
Plague5
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Direct Rx
Levofloxacin | Direct Rx
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) 1 Due to the designated pathogens [see Indications and Usage (1)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection1 Dosed Every 24 hours Duration
(days)2 Nosocomial Pneumonia 750 mg 7 to 14 Community Acquired Pneumonia3 500 mg 7 to 14 Community Acquired Pneumonia4 750 mg 5 Acute Bacterial Sinusitis 750 mg 5 500 mg 10 to 14 Acute Bacterial Exacerbation of Chronic Bronchitis 500 mg 7 Complicated Skin and Skin Structure Infections (SSSI) 750 mg 7 to 14 Uncomplicated SSSI 500 mg 7 to 10 Chronic Bacterial Prostatitis 500 mg 28 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5 750 mg 5 Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6 250 mg 10 Uncomplicated Urinary Tract Infection 250 mg 3 Plague, adult and pediatric patients > 50 kg9
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 142.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection1 Dose Freq. Once
every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
4 The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Inhalational Anthrax (post-exposure)3, 4 Pediatric patients > 50 kg 500 mg 24 hr 60 days4 Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed
250 mg per dose) 12 hr 60 days4 Plague5 Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed
250 mg per dose) 12 hr 10 to 14 days2.3 Dosage Adjustment in Adults with Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 available2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Direct Rx
Levofloxacin | Direct Rx
2.1 Dosage in Adult Patients With Normal Renal Function
The usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
2.3 Dosage Adjustment in Adults With Renal Impairment
Administer levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Readymeds
Levofloxacin | Readymeds
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) 1 Due to the designated pathogens [see Indications and Usage (1)].
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
4 Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
5 This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
6 This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
7 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
8 The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
9 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Type of Infection1
Dosed Every 24 hours
Duration
(days)2
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia3
500 mg
7 to 14
Community Acquired Pneumonia4
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 10
Chronic Bacterial Prostatitis
500 mg
28
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)5
750 mg
5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)6
250 mg
10
Uncomplicated Urinary Tract Infection
250 mg
3
Plague, adult and pediatric patients > 50 kg9
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection1 Dose Freq. Once
every Duration2 1 Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
2 Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
3 Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
4 The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
5 Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)3, 4
Pediatric patients > 50 kg
500 mg
24 hr
60 days4
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
60 days4
Plague5
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)and Patient Counseling Information (17.2)]. -
Proficient Rx
Levofloxacin | Proficient Rx
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION(2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
* Due to the designated pathogens [see INDICATIONS AND USAGE ( 1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae(including multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Klebsiellapneumoniae, Moraxella catarrhalis, Chlamydophilapneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae[see INDICATIONS AND USAGE (1.2)]. § Due to Streptococcus pneumoniae(excluding multi-drug-resistant isolates [MDRSP]), Haemophilusinfluenzae, Haemophilusparainfluenzae, Mycoplasma pneumoniae, or Chlamydophilapneumoniae [see INDICATIONS AND USAGE(1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiellapneumoniae, Proteus mirabilis, Pseudomonasaeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES(14.9)]. ß The safety of levofloxacin tabletsin adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10), USE IN SPECIFIC POPULATIONS (8.4), and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablettherapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every 24 Hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 kgÞ,ß
500 mg
60ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
see Table 2 below (2.2)
60ß
Plague, adult and pediatric patients > 50 kgà
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2 : Dosage in Pediatric Patients ≥ 6 Months of Age
* Due to Bacillus anthracis [see INDICATIONS AND USAGE (1.13)] and Yersinia pestis[see INDICATIONS AND USAGE (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS (5.10),USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL STUDIES (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tabletswith caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].
2.5 Administration InstructionsFood and LevofloxacinTablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving LevofloxacinTablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].
-
Proficient Rx Lp
-
Northwind Pharmaceuticals
-
Bryant Ranch Prepack
Levofloxacin | Bryant Ranch Prepack
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
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 ageÞ,ß Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mg
see Table 2 below (2.2)
60ß
60ß
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age* Due to Bacillus anthracis [see Indications and Usage (1.13)]
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
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§
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1)and Patient Counseling Information (17.2)].
-
Aurobindo Pharma Limited
Levofloxacin | Aurobindo Pharma Limited
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.
á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mg
see Table 2 below (2.2)
60 ß
60 ß
Plague, adult and pediatric patients > 50 kgá
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection* Dose Freq. Once
every Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
§ The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)‡, §
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Heritage Pharmaceuticals Inc.
Levofloxacin | Heritage Pharmaceuticals Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin injection
is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mg
see Table 2 below (2.2)
60ß
60ß
Plague, adult and pediatric patients > 50 kgà
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14*
Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ßThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
2.2 Dosage in Pediatric Patients
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose) 12 hr
10 to 14 days
*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), andClinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
2.3 Dosage Adjustment in Adults with Renal Impairment
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [seeUse in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin injection
Levofloxacin injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [seeDosage and Administration (2.6)].
2.5 Administration InstructionsLevofloxacin injection
2.6 Preparation of Intravenous Product
Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Hydration for Patients Receiving Levofloxacin Injection
Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to levofloxacin injection Premix in Single-Use Flexible Containers and levofloxacin injection in Single-Use Vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.
Levofloxacin Injection in Single-Use Vials
Single-use vials require dilution prior to administration.
Levofloxacin injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of Levofloxacin USP in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin USP/mL. These levofloxacin injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.
Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:
Table 4: Compatible Intravenous Solutions
Intravenous Fluids
Final pH of Levofloxacin Solution
0.9% Sodium Chloride Injection, USP
4.71
5% Dextrose Injection, USP
4.58
5% Dextrose/0.9% NaCl Injection
4.62
5% Dextrose in Lactated Ringers
4.92
Plasma-Lyte® 56/5% Dextrose Injection
5.03
5% Dextrose, 0.45% Sodium Chloride, and 0.15% Potassium Chloride Injection
4.61
Sodium Lactate Injection (M/6)
5.54
Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].
Prepare the desired dosage of levofloxacin according to Table 5:
Table 5: Preparation of Levofloxacin Intravenous Solution
Desired Dosage Strength
From Appropriate Vial, Withdraw Volume
Volume of Diluent
Infusion Time
500 mg
20 mL (20 mL Vial)
80 mL
60 min
750 mg
30 mL (30 mL Vial)
120 mL
90 min
For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.
This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
Stability of Levofloxacin Injection Following Dilution: Levofloxacin injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing. -
Claris Lifesciences Inc.
Levofloxacin | Meds Direct Rx Of Ny Llc
Clean and dry affected area. Remove patch from backing and apply to affected area. Use only one patch at a time, and maximum of four patches/day. Leave patch on affected area for up to 8 hours. Do not use patches for longer than 5 consecutive days. Children under 12 should consult physician prior to use. -
Cardinal Health
Levofloxacin | Silarx Pharmaceuticals, Inc
The recommended oral dose of Lamivudine in HIV-1-infected adults and adolescents >16 years of age is 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily, in combination with other antiretroviral agents. If lamivudine is administered to a patient infected with HIV-1 and HBV, the dosage indicated for HIV-1 therapy should be used as part of an appropriate combination regimen [see Warnings and Precautions (5.2)].
2.2 Pediatric PatientsThe recommended oral dose of Lamivudine Oral Solution in HIV-1-infected pediatric patients 3 months to 16 years of age is 4 mg/kg twice daily (up to a maximum of 150 mg twice a day), administered in combination with other antiretroviral agents.
2.3 Patients With Renal ImpairmentDosing of lamivudine is adjusted in accordance with renal function. Dosage adjustments are listed in Table 1 [see Clinical Pharmacology (12.3)].
Table 1. Adjustment of Dosage of Lamivudine in Adults and Adolescents (≥30 kg) in accordance With Creatinine Clearance Creatinine Clearance (mL/min) Recommended Dosage of Lamivudine ≥50
150 mg twice daily or 300 mg once daily
30-49
150 mg once daily
15-29
150 mg first dose, then 100 mg once daily
5-14
150 mg first dose, then 50 mg once daily
less than 5
50 mg first dose, then 25 mg once daily
No additional dosing of Lamivudine is required after routine (4-hour) hemodialysis or peritoneal dialysis.
Although there are insufficient data to recommend a specific dose adjustment of Lamivudine in pediatric patients with renal impairment, a reduction in the dose and/or an increase in the dosing interval should be considered. -
Citron Pharma Llc
Levofloxacin | Citron Pharma Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacintablets therapy should only be used when the benefit outweighs the risk.
á Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß
500 mg
see Table 2 below (2.2)
60 ß
60 ß
Plague, adult and pediatric patients > 50 kgá
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection* Dose Freq. Once
every Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
§ The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Inhalational Anthrax (post-exposure)‡, §
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Teva Pharmaceuticals Usa Inc
Levofloxacin | Teva Pharmaceuticals Usa Inc
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. † Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. ‡ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. § This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. ¶ This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. # Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. Þ The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection
Dosed Every 24 Hours
Duration (Days)*
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia†
500 mg
7 to 14
Community Acquired Pneumonia‡
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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#,Þ
Pediatric patients < 50 kg and ≥ 6 months of age#,Þ
500 mg
see Table 2 below
(2.2)
60Þ
60Þ
Plague, adult and pediatric patients > 50 kgß
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below (2.2)
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once Every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose)12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Macleods Pharmaceuticals Limited
Levofloxacin | Macleods Pharmaceuticals Limited
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of Levofloxacin Tablet is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)>
* Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae,Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and
Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli,
Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin therapy in adults should only be used when the benefit outweighs the risk à Drug administration should begin as soon as possible after suspected or confirmed exposure to <em>Yersinia pestis</em>. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. 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 ageÞ,ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mg
see Table 2 below (2.2) 60ß
60ß
Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2) 10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9).] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection* Dose
Table 2: Dosage in Pediatric Patients ≥ 6 months of age
Freq. Once every
Duration† Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose) 12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Dosage in Normal Renal Function Every 24 hours Creatinine Clearance
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)
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
Levofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)] .
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Lupin Pharmaceuticals, Inc.
Levofloxacin | Lupin Pharmaceuticals, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see DOSAGE AND ADMINISTRATION (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) * Due to the designated pathogens [see INDICATIONS AND USAGE ( 1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see INDICATIONS AND USAGE ( 1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see INDICATIONS AND USAGE ( 1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES ( 14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated. Type of Infection*
Dosed Every
24 hours
Duration
(days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of
Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure
Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 kgÞ,ß Pediatric patients < 50 kg and ≥ 6 months
of ageÞ,ß
500 mg see Table 2 below (2.2) 60ß
60ß
Plague, adult and pediatric patients
> 50 kgà Pediatric patients < 50 kg
and ≥ 6 months of age
500 mg see Table 2 below (2.2) 10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age * Due to Bacillus anthracis [see INDICATIONS AND USAGE ( 1.13)] and Yersinia pestis [see INDICATIONS AND USAGE ( 1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see CLINICAL STUDIES ( 14.9)] § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see WARNINGS AND PRECAUTIONS ( 5.10), USE IN SPECIFIC POPULATIONS ( 8.4), and CLINICAL STUDIES ( 14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14
days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed
250 mg per dose)
12 hr
10 to 14
days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see USE IN SPECIFIC POPULATIONS (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction with Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see DRUG INTERACTIONS (7.1) and PATIENT COUNSELING INFORMATION (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see ADVERSE REACTIONS (6.1) and PATIENT COUNSELING INFORMATION (17.2)].
-
Auromedics Pharma Llc
Levofloxacin | Auromedics Pharma Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)
* Due to the designated pathogens [see Indications and Usage (1)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
# This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
Type of Infection*
Dosed Every 24 hours
Duration (days)†
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia‡
500 mg
7 to 14
Community Acquired Pneumonia§
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 kgÞ,ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mg
see Table 2 below (2.2)
60ß
60ß
Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
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
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§
Plague¶
Pediatric patients
> 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients
< 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose)
12 hr
10 to 14 days
* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
† Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin injection with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min) Dosage in
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin injection should not be coadministered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].
2.5 Administration InstructionsCaution: Rapid or bolus intravenous infusion of levofloxacin injection has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
2.6 Preparation of Intravenous Product
Hydration for Patients Receiving Levofloxacin Injection
Adequate hydration of patients receiving intravenous levofloxacin injection should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to levofloxacin injection in single-use vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.
Levofloxacin Injection in Single-Use Vials
Single-use vials require dilution prior to administration.
Levofloxacin injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin/mL. These levofloxacin injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.
Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:
Table 4: Compatible Intravenous Solutions Intravenous Fluids Final pH of
Levofloxacin Solution 0.9% Sodium Chloride Injection, USP
4.71
5% Dextrose Injection, USP
4.58
5% Dextrose/0.9% NaCl Injection
4.62
5% Dextrose in Lactated Ringers
4.92
Plasma-Lyte® 56/5% Dextrose Injection
5.03
5% Dextrose, 0.45% Sodium Chloride, and
0.15% Potassium Chloride Injection
4.61
Sodium Lactate Injection (M/6)
5.54
Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].
Prepare the desired dosage of levofloxacin according to Table 5:
Table 5: Preparation of Levofloxacin Intravenous Solution
Desired Dosage Strength
From Appropriate Vial, Withdraw Volume
Volume of Diluent
Infusion Time
250 mg
10 mL (20 mL Vial)
40 mL
60 min
500 mg
20 mL (20 mL Vial)
80 mL
60 min
750 mg
30 mL (30 mL Vial)
120 mL
90 min
For example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.
This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
Stability of Levofloxacin Injection Following Dilution: Levofloxacin injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C (- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.
-
Torrent Pharmaceuticals Limited
Levofloxacin | Torrent Pharmaceuticals Limited
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance≥ 50 mL/min)* Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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),
adultand pediatric patients > 50 kg Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of ageÞ,ß
500 mg
see Table 2 below (2.2)
60ß
60ß
Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age
500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age* Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage(1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§ The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose)
12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin tablets should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Boca Pharmacal, Llc
Levofloxacin | Boca Pharmacal, Llc
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min) Type of Infection* Dosed Every 24 hours Duration (days)† * Due to the designated pathogens [see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9 )].ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatm
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 Þ, ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ, ß 500 mg
see Table 2 below (2.2)60ß
60ß
Plague, adult and pediatric patients > 50 kg à Pediatric patients < 50 kg and ≥ 6 months of age500 mg
see Table 2 below (2.2)
10 to 14
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age Type of Infection* Dose Freq. Once every Duration† * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]§ The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.<</html>
Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 500 mg 24 hr 60 days§ Pediatric patients < 50 kg and ≥ 6 months of age8 mg/kg
(not to exceed 250 mg
per dose)12 hr
60 days§
Plague¶
Pediatric patients > 50 kg500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg (not to exceed 250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets 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 [see Drug Interactions (7.1)and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.Hydration for Patients Receiving Levofloxacin tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)]. -
Cardinal Health
Levofloxacin | Cardinal Health
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin tablets are 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
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 Þ,ß
Pediatric patients < 50 kg and ≥ 6 months of age Þ,ß500 mg
See Table 2 below (2.2)60ß
60ßPlague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age500 mg
See Table 2 below (2.2)10 to 14
10 to 14The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of ageType of Infection*
Dose
Freq. Once every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients > 50 kg
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§
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg (not to exceed 250 mg per dose)
12 hr
10 to 14 days
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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/minCreatinine Clearance
10 to 19 mL/minHemodialysis 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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
-
Sagent Pharmaceuticals
Levofloxacin | Hospira Worldwide, Inc.
Oxaliplatin should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
2.1 DosageAdminister Oxaliplatin in combination with 5-fluorouracil/leucovorin every 2 weeks. For advanced disease, treatment is recommended until disease progression or unacceptable toxicity. For adjuvant use, treatment is recommended for a total of 6 months (12 cycles):
Day 1: Oxaliplatin 85 mg/m2 intravenous infusion in 250-500 mL 5% Dextrose injection, USP and leucovorin 200 mg/m2 intravenous infusion in 5% Dextrose Injection, USP both given over 120 minutes at the same time in separate bags using a Y-line, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2 to 4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
Day 2: Leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2 to 4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.
The administration of Oxaliplatin does not require prehydration. Premedication with antiemetics, including 5-HT3 blockers with or without dexamethasone, is recommended.
For information on 5-fluorouracil and leucovorin, see the respective package inserts.
2.2 Dose Modification RecommendationsPrior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and recommended laboratory tests [see Warnings and Precautions (5.6)]. Prolongation of infusion time for Oxaliplatin from 2 hours to 6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and leucovorin do not need to be changed.
Adjuvant Therapy in Patients with Stage III Colon Cancer
Neuropathy and other toxicities were graded using the NCI CTC scale version 1 [see Warnings and Precautions (5.2)].
For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 75 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin regimen need not be altered.
A dose reduction of Oxaliplatin to 75 mg/m2 and infusional 5-fluorouracil to 300 mg/m2 bolus and 500 mg/m2 22 hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer
Neuropathy was graded using a study-specific neurotoxicity scale [see Warnings and Precautions (5.2)]. Other toxicities were graded by the NCI CTC, Version 2.0.
For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 65 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The 5-fluorouracil/leucovorin regimen need not be altered.
A dose reduction of Oxaliplatin to 65 mg/m2 and 5-fluorouracil by 20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Dose Modifications in Therapy for Patients with Renal Impairment
In patients with normal renal function or mild to moderate renal impairment, the recommended dose of Oxaliplatin is 85 mg/m2. In patients with severe renal impairment, the initial recommended Oxaliplatin dose should be reduced to 65 mg/m2 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
Reconstitution or final dilution must never be performed with a sodium chloride solution or other chloride containing solutions.
The lyophilized powder is reconstituted by adding 10 mL (for the 50 mg vial) or 20 mL (for the 100 mg vial) of Water for Injection, USP or 5% Dextrose Injection, USP. Do not administer the reconstituted solution without further dilution. The reconstituted solution must be further diluted in an infusion solution of 250-500 mL of 5% Dextrose Injection, USP.
After reconstitution in the original vial, the solution may be stored up to 24 hours under refrigeration [2-8°C (36-46°F)]. After final dilution with 250-500 mL of 5% Dextrose Injection, USP, the shelf life is 6 hours at room temperature [20-25°C (68-77°F)] or up to 24 hours under refrigeration [2-8°C (36-46°F)].
Oxaliplatin for Injection, USP is not light sensitive.
Oxaliplatin Injection, USP is incompatible in solution with alkaline medications or media (such as basic solutions of 5-fluorouracil) and must not be mixed with these or administered simultaneously through the same infusion line. The infusion line should be flushed with 5% Dextrose Injection, USP prior to administration of any concomitant medication.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration and discarded if present.
Needles or intravenous administration sets containing aluminum parts that may come in contact with Oxaliplatin Injection, USP should not be used for the preparation or mixing of the drug. Aluminum has been reported to cause degradation of platinum compounds.
2.2 Dose Modification RecommendationsPrior to subsequent therapy cycles, patients should be evaluated for clinical toxicities and recommended laboratory tests [see Warnings and Precautions (5.6)]. Prolongation of infusion time for Oxaliplatin from 2 hours to 6 hours may mitigate acute toxicities. The infusion times for 5-fluorouracil and leucovorin do not need to be changed.
Adjuvant Therapy in Patients with Stage III Colon Cancer
Neuropathy and other toxicities were graded using the NCI CTC scale version 1 [see Warnings and Precautions (5.2)].
For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 75 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The infusional 5-fluorouracil/leucovorin regimen need not be altered.
A dose reduction of Oxaliplatin to 75 mg/m2 and infusional 5-fluorouracil to 300 mg/m2 bolus and 500 mg/m2 22 hour infusion is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Dose Modifications in Therapy in Previously Untreated and Previously Treated Patients with Advanced Colorectal Cancer
Neuropathy was graded using a study-specific neurotoxicity scale [see Warnings and Precautions (5.2)]. Other toxicities were graded by the NCI CTC, Version 2.0.
For patients who experience persistent Grade 2 neurosensory events that do not resolve, a dose reduction of Oxaliplatin to 65 mg/m2 should be considered. For patients with persistent Grade 3 neurosensory events, discontinuing therapy should be considered. The 5-fluorouracil/leucovorin regimen need not be altered.
A dose reduction of Oxaliplatin to 65 mg/m2 and 5-fluorouracil by 20% (300 mg/m2 bolus and 500 mg/m2 22-hour infusion) is recommended for patients after recovery from grade 3/4 gastrointestinal (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. The next dose should be delayed until: neutrophils ≥ 1.5 x 109/L and platelets ≥ 75 x 109/L.
Dose Modifications in Therapy for Patients with Renal Impairment
In patients with normal renal function or mild to moderate renal impairment, the recommended dose of Oxaliplatin is 85 mg/m2. In patients with severe renal impairment, the initial recommended Oxaliplatin dose should be reduced to 65 mg/m2 [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
-
Sagent Pharmaceuticals
Levofloxacin | Major Pharmaceuticals
do not take more than directed the smallest effective dose should be used adults and children 12 years and over: take 1 tablet every 4 to 6 hours while symptoms persist if pain or fever does not respond to 1 tablet, 2 tablets may be used do not exceed 6 tablets in 24 hours, unless directed by a doctor children under 12 years: ask a doctor -
Sagent Pharmaceuticals
Levofloxacin | Sagent Pharmaceuticals
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)*Due to the designated pathogens [see Indications and Usage (1)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].
¶This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
ÞDrug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
βThe safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
àDrug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.
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 Þ,β
pediatric patients < 50 kg and ≥ 6 months of ageÞ,β 500 mg
see Table 2 below (2.2) 60 β
60 β Plague, adult and pediatric patients > 50 kg à
Pediatric patients < 50 kg and ≥ 6 months of age 500 mg
see Table 2 below (2.2) 10 to 14
10 to 14 2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 months of age*Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Type of Infection* Dose Freq. Once every Duration† Inhalational Anthrax (post-exposure)‡,§ Pediatric patients > 50 kg 500 mg 24hr 60 days§ Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed
250 mg per dose) 12hr 60 days§ Plague¶ Pediatric patients > 50 kg 500 mg 24 hr 10 to 14 days Pediatric patients < 50 kg and ≥ 6 months of age 8 mg/kg
(not to exceed
250 mg per dose) 12 hr 10 to 14 days 2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
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 2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Injection
Levofloxacin injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].
2.5 Administration InstructionsLevofloxacin Injection
Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.
Hydration for Patients Receiving Levofloxacin Injection
Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
2.6 Preparation of Intravenous ProductParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because only limited data are available on the compatibility of levofloxacin injection with other intravenous substances, additives or other medications should not be added to levofloxacin injection in single-use vials, or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of levofloxacin injection with an infusion solution compatible with levofloxacin injection and with any other drug(s) administered via this common line.
Levofloxacin Injection in Single-Use Vials
Single-use vials require dilution prior to administration.
Levofloxacin injection is supplied in single-use vials containing a concentrated levofloxacin solution with the equivalent of 500 mg (20 mL vial) and 750 mg (30 mL vial) of levofloxacin in Water for Injection, USP. The 20 mL and 30 mL vials each contain 25 mg of levofloxacin/mL. These levofloxacin injection single-use vials must be further diluted with an appropriate solution prior to intravenous administration [see Table 4]. The concentration of the resulting diluted solution should be 5 mg/mL prior to administration.
Compatible Intravenous Solutions: Any of the following intravenous solutions may be used to prepare a 5 mg/mL levofloxacin solution with the approximate pH values:
Table 4: Compatible Intravenous Solutions Intravenous Fluids Final pH of Levofloxacin
Solution 0.9% Sodium Chloride Injection, USP 4.71 5% Dextrose Injection, USP 4.58 5% Dextrose/0.9% NaCl Injection 4.62 5% Dextrose in Lactated Ringers 4.92 Plasma-Lyte® 56/5% Dextrose Injection 5.03 5% Dextrose, 0.45% Sodium Chloride,
and 0.15% Potassium Chloride Injection 4.61 Sodium Lactate Injection (M/6) 5.54Since no preservative or bacteriostatic agent is present in this product, aseptic technique must be used in preparation of the final intravenous solution. Since the vials are for single-use only, any unused portion remaining in the vial should be discarded. When used to prepare two 250 mg doses from the 20 mL vial containing 500 mg of levofloxacin, the full content of the vial should be withdrawn at once using a single-entry procedure, and a second dose should be prepared and stored for subsequent use [see Stability of Levofloxacin Injection Following Dilution].
Prepare the desired dosage of levofloxacin according to Table 5:
Table 5: Preparation of Levofloxacin Intravenous Solution Desired Dosage
Strength From Appropriate Vial,
Withdraw Volume Volume of Diluent Infusion Time 500 mg 20 mL (20 mL Vial) 80 mL 60 min 750 mg 30 mL (30 mL Vial) 120 mL 90 minFor example, to prepare a 500 mg dose using the 20 mL vial (25 mg/mL), withdraw 20 mL and dilute with a compatible intravenous solution to a total volume of 100 mL.
This intravenous drug product should be inspected visually for particulate matter prior to administration. Samples containing visible particles should be discarded.
Stability of Levofloxacin Injection Following Dilution: Levofloxacin injection, when diluted in a compatible intravenous fluid to a concentration of 5 mg/mL, is stable for 72 hours when stored at or below 25°C (77°F) and for 14 days when stored under refrigeration at 5°C (41°F) in plastic intravenous containers. Solutions that are diluted in a compatible intravenous solution and frozen in glass bottles or plastic intravenous containers are stable for 6 months when stored at - 20°C(- 4°F). Thaw frozen solutions at room temperature 25°C (77°F) or in a refrigerator 8°C (46°F). Do not force thaw by microwave irradiation or water bath immersion. Do not refreeze after initial thawing.
-
Zydus Pharmaceuticals (Usa) Inc.
Levofloxacin | Sun Pharmaceutical Industries Limited
2.1 Dosing in Mild to Moderate Alzheimer's DiseaseThe recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride in patients with mild to moderate Alzheimer’s disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.
2.2 Dosing inModerate to Severe Alzheimer's DiseaseThe recommended starting dosage of donepezil hydrochloride is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of donepezil hydrochloride in patients with moderate to severe Alzheimer’s disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months.
2.3 Administration InformationDonepezil hydrochloride tablets should be taken in the evening, just prior to retiring. Donepezil hydrochloride tablets can be taken with or without food.
The donepezil hydrochloride 23 mg tablet should not be split, crushed, or chewed. -
Sagent Pharmaceuticals
-
Direct Rx
Levofloxacin | Direct Rx
2.1 Dosage in Adult Patients with Normal Renal Function
The usual dose of Levofloxacin Tablet is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥ 50 mL/min)>
Due to the designated pathogens [see Indications and Usage (1)].
†
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡
Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].
§
Due to Streptococcus pneumoniae (excluding multi-drug-resistant strains [MDRSP]), Haemophilus influenzae,Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and
Usage (1.3)].
¶
This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.
#
This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli,
Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.
Þ
Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].
ß
The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)] Prolonged levofloxacin therapy in adults should only be used when the benefit outweighs the risk
à
Drug administration should begin as soon as possible after suspected or confirmed exposure to <em>Yersinia pestis</em>. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.2.2 Dosage in Pediatric Patients
The dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
†
Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.
‡
Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)]
§
The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9).] Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk.
¶
Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.2.3 Dosage Adjustment in Adults With Renal Impairment
Administer levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
Levofloxacin Tablets
Levofloxacin Tablets 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 [see Drug Interactions (7.1) and Patient Counseling Information (17.2)] .
2.5 Administration Instructions
Food and Levofloxacin Tablets
Levofloxacin Tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].
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Hospira, Inc.
Levofloxacin | Hospira, Inc.
2.1 Dosage in Adult Patients with Normal Renal FunctionThe usual dose of Levofloxacin Injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥50 mL/min. For patients with creatinine clearance <50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].
Table 1: Dosage in Adult Patients with Normal Renal Function (creatinine clearance ≥50 mL/min) * Due to the designated pathogens [ see Indications and Usage (1)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage (1.2)]. § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage (1.3)]. ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. ß The safety of levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection*
Dosed Every
24 hoursDuration
(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 kgÞ,ß
Pediatric patients <50 kg and ≥6 months of ageÞ,ß500 mg
See Table 2 below (2.2)60ß
60ßPlague, adult and pediatric patients >50 kgà
Pediatric patients <50 kg and ≥6 months of age500 mg
See Table 2 below (2.2)10 to 14
2.2 Dosage in Pediatric Patients
10 to 14The dosage in pediatric patients ≥6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥6 months of age * Due to Bacillus anthracis [ see Indications and Usage (1.13)]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies (14.9)]. § The safety of levofloxacin in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions (5.10), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once Every
Duration†
Inhalational Anthrax (post-exposure)‡,§
Pediatric patients >50 kg
500 mg
24 hours
60 days§
Pediatric patients <50 kg and ≥6 months of age
8 mg/kg
(not to exceed
250 mg per dose)12 hours
60 days§
Plague¶
Pediatric patients >50 kg
500 mg
24 hours
10 to 14 days
Pediatric patients <50 kg and ≥6 months of age
8 mg/kg
(not to exceed
250 mg per dose)12 hours
10 to 14 days
2.3 Dosage Adjustment in Adults with Renal ImpairmentAdminister levofloxacin with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥50 mL/min.
In patients with impaired renal function (creatinine clearance <50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)].
Table 3 shows how to adjust dose based on creatinine clearance.
Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (creatinine clearance <50 mL/min)Dosage in
Normal Renal
Function
Every 24 hoursCreatinine Clearance
20 to 49 mL/minCreatinine Clearance
10 to 19 mL/minHemodialysis or
Chronic Ambulatory
Peritoneal Dialysis
(CAPD)750 mg
750 mg every 48 hours
750 mg initial dose, then
500 mg every 48 hours750 mg initial dose, then
500 mg every 48 hours500 mg
500 mg initial dose, then
250 mg every 24 hours500 mg initial dose, then
250 mg every 48 hours500 mg initial dose, then
250 mg every 48 hours250 mg
No dosage adjustment
required250 mg every 48 hours. If treating uncomplicated
UTI, then no dosage adjustment is required
No information on dosing adjustment is
2.4 Drug Interaction with Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins
availableLevofloxacin Injection should not be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.6)].
2.5 Administration InstructionsLevofloxacin Injection
Caution: Rapid or bolus intravenous infusion of levofloxacin has been associated with hypotension and must be avoided. Levofloxacin Injection should be infused intravenously slowly over a period of not less than 60 or 90 minutes, depending on the dosage. Levofloxacin Injection should be administered only by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration.Hydration for Patients Receiving Levofloxacin Injection
2.6 Preparation of Intravenous Product
Adequate hydration of patients receiving intravenous levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17.2)].Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Because only limited data are available on the compatibility of Levofloxacin Injection with other intravenous substances, additives or other medications should not be added to Levofloxacin Injection Premix in Single-Use Flexible Containers or infused simultaneously through the same intravenous line. If the same intravenous line is used for sequential infusion of several different drugs, the line should be flushed before and after infusion of Levofloxacin Injection with an infusion solution compatible with Levofloxacin Injection and with any other drug(s) administered via this common line.
Levofloxacin Injection Premix in Single-Use Flexible Containers (5 mg/mL)
Levofloxacin Injection is supplied in flexible containers within a foil overwrap. These contain a premixed, ready to use levofloxacin solution in 5% dextrose (D5W) for single-use. The 100 mL premixed flexible containers contain either 250 mg/50 mL or 500 mg/100 mL of levofloxacin solution. The 250 mL flexible container contains 750 mg/150 mL of levofloxacin solution. The concentration of each container is 5 mg/mL. No further dilution of these preparations is necessary. Because the premix flexible containers are for single-use only, any unused portion should be discarded.Instructions for the Use of Levofloxacin Injection Premix in Flexible Containers:
1. Tear outer wrap at the notch and remove solution container. 2. Check the container for minute leaks by squeezing the inner bag firmly. If leaks are found, or if the seal is not intact, discard the solution, as the sterility may be compromised. 3. Do not use if the solution is cloudy or a precipitate is present. 4. Use sterile equipment. 5. WARNING: Do not use flexible containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.Preparation for Administration:
1. Close flow control clamp of administration set. 2. Remove cover from port at bottom of container. 3. Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton. 4. Suspend container from hanger. 5. Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Levofloxacin Injection Premix in Flexible Containers. 6. Open flow control clamp to expel air from set. Close clamp. 7. Regulate rate of administration with flow control clamp. -
Medsource Pharmaceuticals
Levofloxacin | Medsource Pharmaceuticals
2.1 Dosage in Adult Patients With Normal Renal FunctionThe usual dose of levofloxacin tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.
These recommendations apply to patients with creatinine clearance ≥ 50 mL/min. For patients with creatinine clearance < 50 mL/min, adjustments to the dosing regimen are required [ see Dosage and Administration ( 2.3) ].
Table 1: Dosage in Adult Patients With Normal Renal Function (Creatinine Clearance ≥ 50 mL/min) * Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. † Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [ see Indications and Usage ( 1.2) ]. ‡ Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [ see Indications and Usage ( 1.3) ]. § This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia. ¶ This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli. # Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies ( 14.9) ]. Þ The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions ( 5.10), Use in Specific Populations ( 8.4), and Clinical Studies ( 14.9) ]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ß Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.Type of Infection
Dosed Every 24 Hours
Duration (Days)*
Nosocomial Pneumonia
750 mg
7 to 14
Community Acquired Pneumonia †
500 mg
7 to 14
Community Acquired Pneumonia ‡
750 mg
5
Acute Bacterial Sinusitis
750 mg
5
500 mg
10 to 14
Acute Bacterial Exacerbation of Chronic Bronchitis
500 mg
7
Complicated Skin and Skin Structure Infections (SSSI)
750 mg
7 to 14
Uncomplicated SSSI
500 mg
7 to 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 #,Þ
Pediatric patients < 50 kg and ≥ 6 months of age #,Þ
500 mg
see Table 2 below
( 2.2)
60 Þ
60 Þ
Plague, adult and pediatric patients > 50 kg ß
500 mg
10 to 14
Pediatric patients < 50 kg and ≥ 6 months of age
see Table 2 below ( 2.2)
10 to 14
2.2 Dosage in Pediatric PatientsThe dosage in pediatric patients ≥ 6 months of age is described below in Table 2.
Table 2: Dosage in Pediatric Patients ≥ 6 Months of Age * Due to Bacillus anthracis [ see Indications and Usage ( 1.13) ] and Yersinia pestis [see Indications and Usage ( 1.14) ]. † Sequential therapy (intravenous to oral) may be instituted at the discretion of the physician. ‡ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [ see Clinical Studies ( 14.9) ]. § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [ see Warnings and Precautions ( 5.10), Use in Specific Populations ( 8.4), and Clinical Studies ( 14.9) ]. Prolonged levofloxacin tablet therapy should only be used when the benefit outweighs the risk. ¶ Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis.Type of Infection*
Dose
Freq. Once Every
Duration†
Inhalational Anthrax (post-exposure) ‡,§
Pediatric patients > 50 kg
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 §
Plague ¶
Pediatric patients > 50 kg
500 mg
24 hr
10 to 14 days
Pediatric patients < 50 kg and ≥ 6 months of age
8 mg/kg
(not to exceed 250 mg per dose)12 hr
10 to 14 days
2.3 Dosage Adjustment in Adults With Renal ImpairmentAdminister levofloxacin tablets with caution in the presence of renal insufficiency. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced.
No adjustment is necessary for patients with a creatinine clearance ≥ 50 mL/min.
In patients with impaired renal function (creatinine clearance < 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [ see Use in Specific Populations ( 8.6) ].
Table 3 shows how to adjust dose based on creatinine clearance.
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
2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, MultivitaminsLevofloxacin Tablets
Levofloxacin tablets 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 [ see Drug Interactions ( 7.1) and Patient Counseling Information ( 17.2) ].
2.5 Administration InstructionsFood and Levofloxacin Tablets
Levofloxacin tablets can be administered without regard to food.
Hydration for Patients Receiving Levofloxacin Tablets
Adequate hydration of patients receiving oral levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [ see Adverse Reactions ( 6.1) and Patient Counseling Information ( 17.2) ].
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