Levaquin - Dosage levofloxacin

LEVAQUIN (levofloxacin tablet, film coated) comes in different strengths and amounts, which is referred to as the dosing of Levaquin. The appearance of Levaquin can differ based on the dosing. Your doctor may change the dosage and prescription of Levaquin to get you the best results possible.

Dosage & Administration

  • Administer LEVAQUIN® Tablets to pediatric patients weighing 30 kg and greater only (2.1, 2.2).
  • LEVAQUIN® Tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of the available strengths. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg (2.2).
Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute ( 2.1. 2.2)
Type of Infection Dose Every 24 hours Duration (days)
Nosocomial Pneumonia (1.1) 750 mg 7 to 14
Community Acquired Pneumonia (1.2) 500 mg 7 to 14
Community Acquired Pneumonia (1.3) 750 mg 5
Complicated SSSI (1.4) 750 mg 7 to 14
Uncomplicated SSSI (1.5) 500 mg 7 to 10
Chronic Bacterial Prostatitis (1.6) 500 mg 28
Inhalational Anthrax (Post-Exposure) (1.7)
Adults and Pediatric Patients 50 kg or greater 500 mg 60
Pediatric Patients 30 kg to less than 50 kg (2.2) 250 mg every 12 hours 60
Plague (1.8)
Adults and Pediatric Patients 50 kg or greater 500 mg 10 to 14
Pediatric Patients 30 kg to less than 50 kg (2.2) 250 mg every 12 hours 10 to 14
Complicated UTI (1.9) or Acute Pyelonephritis (1.11) 750 mg 5
Complicated UTI (1.10) or Acute Pyelonephritis (1.11) 250 mg 10
Uncomplicated UTI (1.12) 250 mg 3
Acute Bacterial Exacerbation of Chronic Bronchitis (1.13) 500 mg 7
Acute Bacterial Sinusitis (1.14) 750 mg 5
500 mg 10 to 14
  • Adjust dose for creatinine clearance less than 50 mL/minute (2.3 , 8.6 , 12.3)

dosage of levaquin® tablets in adult patients with creatinine clearance ≥ 50 ml / minute

The usual dose of LEVAQUIN® 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/minute. For patients with creatinine clearance less than 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

Table 1: Dosage of LEVAQUIN ® Tablets in Adult Patients with Creatinine Clearance greater than or equal to 50 mL/minute)
Type of Infection
Due to the designated pathogens [see Indications and Usage (1)].
Dosed Every 24 hours Duration (days)
Sequential therapy (intravenous levofloxacin to oral LEVAQUIN ® tablets) may be instituted at the discretion of the healthcare provider.
Nosocomial Pneumonia 750 mg 7 to 14
Community Acquired Pneumonia
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)].
500 mg
7 to 14
Community Acquired Pneumonia
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)].
750 mg
5
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
Inhalational Anthrax (Post-Exposure), adult and pediatric patients weighing 50 kg
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 LEVAQUIN ® 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 (5.12) , Use in Specific Populations (8.4) , and Clinical Studies (14.9)]. Prolonged LEVAQUIN ® therapy should only be used when the benefit outweighs the risk.

or greater

500 mg 60
Pediatric patients weighing 30 kg to less than 50 kg

,

see Table 2 below (2.2) 60
Plague, adult and pediatric patients weighing 50 kg
Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of LEVAQUIN ® typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

or greater
Pediatric patients weighing 30 kg to less than 50 kg

500 mg 10 to 14
see Table 2 below (2.2) 10 to 14
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
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.
750 mg 5
Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)
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.
250 mg
10
Uncomplicated Urinary Tract Infection 250 mg 3
Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB) 500 mg 7
Acute Bacterial Sinusitis (ABS) 750 mg 5
500 mg 10 to 14

dosage of levaquin® tablets in pediatric patients with inhalational anthrax or plague

The dosage of LEVAQUIN® Tablets for inhalational anthrax (post-exposure) and plague in pediatric patients who weigh 30 kg or greater is described below in Table 2. LEVAQUIN® Tablets cannot be administered to patients who weigh less than 30 kg because of the limitations of the available strength. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg.

Table 2: LEVAQUIN ® Tablets Dosage in Pediatric Patients Weighing 30 kg or greater with Inhalational Anthrax (Post-Exposure) and Plague
Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].
Type of Infection
Dose Frequency Duration
Sequential therapy (intravenous levofloxacin injection to oral LEVAQUIN ® Tablets) may be instituted at the discretion of the healthcare provider.
Inhalational Anthrax (post-exposure)
Begin LEVAQUIN ® Tablets as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis.

,

The safety of LEVAQUIN ® in pediatric patients for durations of therapy beyond 14 days has not been studied. [see Warnings and Precautions (5.12), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Begin LEVAQUIN ® Tablets as soon as possible after suspected or confirmed exposure to Yersinia pestis.
Pediatric patients weighing 50 kg or greater 500 mg every 24 hours 60 days
Pediatric patients weighing 30 kg to less than 50 kg 250 mg every 12 hours 60 days
Plague
Pediatric patients weighing 50 kg or greater 500 mg every 24 hours 10 to 14 days
Pediatric patients weighing 30 kg to less than 50 kg 250 mg every 12 hours 10 to 14 days

dosage adjustment in adults with renal impairment

Administer LEVAQUIN® with caution in patients with renal impairment. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced in these patients.

In patients with renal impairment (creatinine clearance less than 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)]. No adjustment is necessary for patients with a creatinine clearance greater than or equal to 50 mL/minute.

Table 3 shows how to adjust dose based on creatinine clearance.

Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (Creatinine Clearance less than 50 mL/minute)
Creatinine Clearance greater than or equal to 50 mL/minute Creatinine Clearance 20 to 49 mL/minute Creatinine Clearance 10 to 19 mL/minute Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
750 mg every 24 hours 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 every 24 hours 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 every 24 hours 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

drug interaction with chelation agents: antacids, sucralfate, metal cations, multivitamins

LEVAQUIN® 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)].

important administration instructions

LEVAQUIN® Tablets can be administered without regard to food.

If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

hydration for patients receiving levaquin® tablets

Adequate hydration of patients receiving LEVAQUIN® should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17)].

Dosage Form & Strengths

TABLETS, Film-coated, capsule-shaped

  • 250 mg terra cotta pink tablets, imprinted with "250" on one side and "LEVAQUIN" on the other side
  • 500 mg peach tablets, imprinted with "500" on one side and "LEVAQUIN" on the other side
  • 750 mg white tablets, imprinted with "750" on one side and "LEVAQUIN" on the other side

Tablets: 250 mg, 500 mg, and 750 mg

Overdosage

In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

LEVAQUIN® exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of LEVAQUIN®: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally (approximately 10 or 19 times MRHD in mice and rats, respectively) and 250 mg/kg IV produced significant mortality (estimated to be greater than or equal to 50%) in rodents.

Storage & Handling

LEVAQUIN® Tablets are supplied as 250, 500, and 750 mg capsule-shaped, coated tablets. LEVAQUIN® Tablets are packaged in bottles in the following configurations:

  • 250 mg tablets are terra cotta pink and are imprinted: "LEVAQUIN" on one side and "250" on the other side
    • –bottles of 50 (NDC 50458-920-50)
  • 500 mg tablets are peach and are imprinted: "LEVAQUIN" on one side and "500" on the other side
    • –bottles of 50 (NDC 50458-925-50)
  • 750 mg tablets are white and are imprinted "LEVAQUIN" on one side and "750" on the other side
    • –bottles of 20 (NDC 50458-930-20)

LEVAQUIN® Tablets should be stored at 15° to 30°C (59° to 86°F) in well-closed containers.


This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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