Source: European Medicines Agency (EU) Revision Year: 2005 Publisher: Pfizer Inc. - G.D. Searle LLC
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 recommendations).
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 GRAMSTAIN–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.
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 lomefloxacin activity.
Maxaquin is indicated preoperatively for the prevention of infection in the following situations:
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).
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Maxaquin and other antibacterial drugs, Maxaquin should 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.
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.
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 |
| 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 |
(see CLINICAL STUDIES-UNCOMPLICATED CYSTITIS.)
No dosage adjustment is needed for elderly patients with normal renal function (ClCr ≥40 mL/min/1.73 m²).
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 m² but <40 mL/min/1.73 m², the recommended dosage is an initial loading dose of 400 mg followed by daily maintenance doses of 200 mg (½ 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) x (140-age) / (72) x serum creatine (mg/dL)
Women: (0.85) x (calculated value for men)
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 (½ tablet) once daily for the duration of treatment.
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 Pharmacology and Dosage and Administration-Patients with impaired renal function).
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.
Information on overdosage in humans is limited. In the event of acute overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage, and the patient should be carefully observed and given supportive treatment. Adequate hydration must be maintained. Hemodialysis or peritoneal dialysis is unlikely to aid in the removal of lomefloxacin as <3% is removed by these modalities.
Clinical signs of acute toxicity in rodents progressed from salivation to tremors, decreased activity, dyspnea, and clonic convulsions prior to death. These signs were noted in rats and mice as lomefloxacin doses were increased.
Maxaquin (lomefloxacin HCl) is supplied as a scored, filmcoated 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 |
|---|---|
| 0025-5501-01 | bottle of 20 |
Store at 59° to 77°F (15° to 25°C).
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