EXP: 3
DAYS (RT) /14 DAYS (REF)
Label: Refrigerate.
DOSAGE
AND ADMINISTRATION
Dosage in Adult Patients with Normal Renal
Function
The usual dose of LEVAQUIN® 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.
Table 1: Dosage in Adult
Patients with Normal Renal Function (creatinine
clearance ≥ 50 mL/min)
| Type
of Infection |
Dosed
Every 24 hours |
Duration
(days) |
| Nosocomial
Pneumonia |
750
mg |
7–14 |
| Community
Acquired Pneumonia‡ |
500
mg |
7–14 |
| Community
Acquired Pneumonia§ |
750
mg |
5 |
| Acute
Bacterial Sinusitis |
750
mg |
5 |
| 500
mg |
10–14 |
| Acute
Bacterial Exacerbation of Chronic
Bronchitis |
500
mg |
7 |
| Complicated
Skin and Skin Structure Infections (SSSI) |
750
mg |
7–14 |
| Uncomplicated
SSSI |
500
mg |
7–10 |
| Chronic
Bacterial Prostatitis |
500
mg |
28 |
Complicated
Urinary Tract Infection (cUTI) or
Acute Pyelonephritis (AP)¶ |
750
mg |
5 |
Complicated
Urinary Tract Infection (cUTI) or
Acute Pyelonephritis (AP)# |
250
mg |
10 |
| Uncomplicated
Urinary Tract Infection |
250
mg |
3 |
Inhalational
Anthrax (Post-Exposure), adult and
pediatric patients > 50 kg and ≥
6 months of age Ž,ß
Pediatric patients < 50 kg and
≥ 6 months of age Ž,ß |
500
mg see Table 3 below (2.2) |
60ß
60ß |
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
§- Due to Streptococcus pneumoniae
(excluding multi-drug-resistant strains [MDRSP]),
Haemophilus influenzae, Haemophilus
parainfluenzae, Mycoplasma pneumoniae, or
Chlamydophila pneumoniae
¶ - 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.
Ž- 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
ß-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. Prolonged
LEVAQUIN® therapy in adults should only
be used when the benefit outweighs the
risk. |
Dosage
Adjustment in Adults with Renal Impairment
Administer LEVAQUIN® 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.
Table 3 shows how to adjust dose based on
creatinine clearance.
Table 3: Dosage Adjustment in 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 |
Preparation
of Intravenous Product
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 LEVAQUIN® Injection with other
intravenous substances, additives or other
medications should not be added to LEVAQUIN®
Injection Premix in Single-Use Flexible Containers
and LEVAQUIN® 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 LEVAQUIN® Injection with an infusion
solution compatible with LEVAQUIN® Injection and
with any other drug(s) administered via this
common line.
LEVAQUIN ® Injection in Single-Use Vials
Single-use vials require dilution prior to
administration.
LEVAQUIN® 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
LEVAQUIN® 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 LEVAQUIN® 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
LEVAQUIN® Injection Following Dilution] .
Prepare the desired dosage of levofloxacin
according to Table 5:
Table 5: Preparation of
LEVAQUIN® 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 LEVAQUIN® Injection Following
Dilution: LEVAQUIN® 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.
DOSAGE
FORMS AND STRENGTHS
INJECTION, Single-Use Vials of concentrated
solution for dilution for intravenous infusion,
clear yellow to clear greenish-yellow in
appearance
* 20 mL vial of 25 mg/mL levofloxacin solution,
equivalent to 500 mg of levofloxacin
* 30 mL vial of 25 mg/mL levofloxacin solution,
equivalent to 750 mg of levofloxacin
INJECTION (5 mg/mL in 5% Dextrose) Premix in
Single-Use Flexible Containers, for intravenous
infusion
* 100 mL container, fill volume 50 mL (equivalent
to 250 mg levofloxacin)
* 100 mL container, fill volume 100 mL (equivalent
to 500 mg levofloxacin)
* 150 mL container, fill volume 150 mL (equivalent
to 750 mg levofloxacin)
|
