A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Maxaquin Indications, Dosage, Storage, Stability - Lomefloxacin
Maxaquin Indications, Dosage, Storage, Stability - Lomefloxacin
INDICATIONS
AND USES
Treatment:
Maxaquin (lomefloxacin HCl) film-coated tablets are indicated for the treatment
of adults with mild to moderate infections caused by susceptible strains of
the designated microorganisms in the conditions listed below: (See Dosage
and Administration for specific dosing recommen-dations.)
LOWER RESPIRATORY TRACT
Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus
influenzae or Moraxella catarrhalis. *
NOTE: MAXAQUIN IS NOT INDICATED FOR THE EMPIRIC TREATMENT OF ACUTE BACTERIAL
EXACERBATION OF CHRONIC BRONCHITIS WHEN IT IS PROBABLE THAT S PNEUMONIAE
IS A CAUSATIVE PATHOGEN. S PNEUMONIAE EXHIBITS IN VITRO RESISTANCE
TO LOMEFLOXACIN, AND THE SAFETY AND EFFICACY OF LOMEFLOXACIN IN THE TREATMENT
OF PATIENTS WITH ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS CAUSED BY
S PNEUMONIAE HAVE NOT BEEN DEMONSTRATED. IF LOMEFLOXACIN IS TO BE PRESCRIBED
FOR GRAM-STAIN-GUIDED EMPIRIC THERAPY OF ACUTE BACTERIAL EXACERBATION OF CHRONIC
BRONCHITIS, IT SHOULD BE USED ONLY IF SPUTUM GRAM STAIN DEMONSTRATES AN ADEQUATE
QUALITY OF SPECIMEN (>25 PMNs/LPF) AND THERE IS BOTH A PREDOMINANCE OF GRAM-NEGATIVE
MICROORGANISMS AND NOT A PREDOMINANCE OF GRAM-POSITIVE MICROORGANISMS.
URINARY TRACT
Uncomplicated Urinary Tract Infections (cystitis) caused by Escherichia
coli, Klebsiella pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus.
(See DOSAGE AND ADMINISTRATION
and CLINICAL STUDIES UNCOMPLICATED
CYSTITIS .)
Complicated Urinary Tract Infections caused by Escherichia coli, Klebsiella
pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter diversus,
* or Enterobacter cloacae. *
NOTE: In clinical trials with patients experiencing complicated urinary tract
infections (UTIs) due to P aeruginosa, 12 of 16 patients had the microorganism
eradicated from the urine after therapy with lomefloxacin. None of the patients
had concomitant bacteremia. Serum levels of lomefloxacin do not reliably exceed
the MIC of Pseudomonas isolates. THE SAFETY AND EFFICACY OF LOMEFLOXACIN
IN TREATING PATIENTS WITH PSEUDOMONAS BACTEREMIA HAVE NOT BEEN ESTABLISHED.
*Although treatment of infections due to this microorganism in this organ system
demonstrated a clinically acceptable overall outcome, efficacy was studied in
fewer than 10 infections.
Appropriate culture and susceptibility tests should be performed before antimicrobial
treatment in order to isolate and identify microorganisms causing infection
and to determine their susceptibility to lomefloxacin. In patients with UTIs,
therapy with Maxaquin film-coated tablets may be initiated before results of
these tests are known; once these results become available, appropriate therapy
should be continued. In patients with an acute bacterial exacerbation of chronic
bronchitis, therapy should not be started empirically with lomefloxacin when
there is a probability the causative pathogen is S pneumoniae.
Beta-lactamase production should have no effect on lome-floxacin activity.
Prevention/prophylaxis:
Maxaquin is indicated preoperatively for the prevention of infection in the
following situations:
- Transrectal prostate biopsy: to reduce the incidence of urinary tract infection,
in the early and late postoperative periods (3-5 days and 3-4 weeks postsurgery).
- Transurethral surgical procedures: to reduce the incidence of urinary tract
infection in the early postoperative period (3-5 days postsurgery).
Efficacy in decreasing the incidence of infections other than urinary tract
infection has not been established. Maxaquin, like all drugs for prophylaxis
of transurethral surgical procedures, usually should not be used in minor urologic
procedures for which prophylaxis is not indicated (eg, simple cystoscopy or
retrograde pyelography). (See Dosage and Administration .)
DOSAGE AND ADMINISTRATION
Maxaquin (lomefloxacin HCl) may be taken without regard to meals. Sucralfate
and antacids containing magnesium or aluminum, or Videx® (didanosine), chewable/buffered
tablets or the pediatric powder for oral solution should not be taken within
4 hours before or 2 hours after taking lomefloxacin. Risk of reaction to solar
UVA light may be reduced by taking Maxaquin at least 12 hours before exposure
to the sun (eg, in the evening). (See Clinical PHARMACOLOGY.)
See Indications and Usage for information on appropriate pathogens and
patient populations.
Treatment:
Patients with normal renal function : The recommended daily
dose of Maxaquin is described in the following chart:
|
Infection
|
Unit
Dose |
Frequency |
Duration |
Daily
Dose |
|
Acute bacterial exacerbation of
chronic bronchitis
|
400 mg |
qd |
10 days |
400 mg |
|
Uncomplicated cystitis in females
caused by E. coli
|
400 mg |
qd |
3 days |
400 mg |
|
|
(see CLINICAL STUDIES UNCOMPLICATED CYSTITIS.)
|
|
Uncomplicated cystitis caused by
K pneumoniae, P mirabilis,
or S saprophyticus
|
400 mg |
qd |
10 days |
400 mg |
|
Complicated UTI
|
400 mg |
qd |
14 days |
400 mg |
Elderly patients : No dosage adjustment is needed for elderly
patients with normal renal function (Cl Cr ≥ 40 mL/min/1.73 m
2 ).
Patients with impaired renal function : Lomefloxacin is primarily
eliminated by renal excretion. (See Clinical Pharmacology. ) Modification
of dosage is recommended in patients with renal dysfunction. In patients with
a creatinine clearance > 10 mL/min/1.73 m 2 but < 40 mL/min/1.73
m 2 , the recommended dosage is an initial loading dose of 400 mg
followed by daily maintenance doses of 200 mg (1/2 tablet) once daily for the
duration of treatment. It is suggested that serial determinations of lomefloxacin
levels be performed to determine any necessary alteration in the appropriate
next dosing interval.
If only the serum creatinine is known, the following formula may be used to
estimate creatinine clearance.
|
Men:
|
(weight in kg) × (140 - age)
|
| |
(72) × serum creatinine (mg/dL)
|
|
Women:
|
(0.85) × (calculated value for men)
|
Dialysis patients : Hemodialysis removes only a negligible
amount of lomefloxacin (3% in 4 hours). Hemodialysis patients should receive
an initial loading dose of 400 mg followed by daily maintenance doses of 200
mg (1/2 tablet) once daily for the duration of treatment.
Patients with cirrhosis : Cirrhosis does not reduce the nonrenal
clearance of lomefloxacin. The need for a dosage reduction in this population
should be based on the degree of renal function of the patient and on the plasma
concentrations. (See Clinical PHARMACOLOGYand Dosage and Administration-
Patients with impaired renal function. )
Prevention/prophylaxis:
The recommended dose of Maxaquin is described in the following chart:
|
Procedure
|
Dose
|
Oral Administration
|
|
Transrectal
prostate biopsy
|
400 mg
single dose
|
1-6 hours prior to
procedure
|
|
Transurethral
surgical procedures *
|
400 mg
single dose
|
2-6 hours prior to
procedure
|
|
* When preoperative prophylaxis is considered appropriate.
|
HOW SUPPLIED
Maxaquin (lomefloxacin HCl) is supplied as a scored, film-coated tablet containing
the equivalent of 400 mg of lomefloxacin base present as the hydrochloride.
The tablet is oval, white, and film-coated with "MAXAQUIN 400" debossed on one
side and scored on the other side and is supplied in:
NDC Number
Size
0051-1651-02 bottle
of 20
0051-1651-32 carton
of 100 unit dose
Store at 59° to 77°F (15° to 25°C).
REFERENCES
- National Committee for Clinical Laboratory Standards, Performance Standards
for Antimicrobial Disk Susceptibility Tests- 4th ed. Approved Standard
NCCLS Document M2-A4, vol 10, No. 7, NCCLS, Villanova, Pa, 1990. 2. National
Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial
Susceptibility Tests for Bacteria that Grow Aerobically- 2nd ed. Approved
Standard NCCLS Document M7-A2, vol 10, No. 8 NCCLS, Villanova, PA, 1990.
May 1999
Manufactured for
Unimed Pharmaceuticals, Inc.
Buffalo Grove IL 60089
by Searle & Co.
San Juan PR 00936
Maxaquin is a registered trademark of G.D. Searle & Co.
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