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Noroxin (Norfloxacin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

NOROXIN is indicated for the treatment of adults with the following infections caused by susceptible strains of the designated microorganisms:

Urinary tract infections

Uncomplicated urinary tract infections (including cystitis) due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Staphylococcus epidermidis, Staphylococcus saprophyticus, Citrobacter freundii [

Efficacy for this organism in this organ system was studied in fewer than 10 infections.

] , Enterobacter aerogenes , Enterobacter cloacae , Proteus vulgaris , Staphylococcus aureus , or Streptococcus agalactiae .

Complicated urinary tract infections due to Enterococcus faecalis, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, or Serratia marcescens .

Sexually transmitted diseases

(see WARNINGS)

Uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.

Prostatitis

Prostatitis due to Escherichia coli.

(See DOSAGE AND ADMINISTRATION for appropriate dosing instructions.)

Penicillinase production should have no effect on norfloxacin activity.

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 norfloxacin. Therapy with norfloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be given. Repeat culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agents but also on the possible emergence of bacterial resistance.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN and other antibacterial drugs, NOROXIN 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.

DOSAGE AND ADMINISTRATION

Tablets NOROXIN should be taken at least one hour before or at least two hours after a meal or ingestion of milk and/or other dairy products. Multivitamins, other products containing iron or zinc, antacids containing magnesium and aluminum, sucralfate, or Videx® (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within 2 hours of administration of norfloxacin. Tablets NOROXIN should be taken with a glass of water. Patients receiving NOROXIN should be well hydrated (see PRECAUTIONS).

Normal Renal Function

The recommended daily dose of NOROXIN is as described in the following chart:

Infection


Description


Unit
Dose


Frequency


Duration


Daily
Dose


Urinary Tract

Uncomplicated UTI's (cystitis) due to E. coli,
K. pneumoniae, or P. mirabilis


400 mg

q12h

3 days

800 mg

Uncomplicated UTI's
due to other indicated organisms


400 mg

q12h

7-10
days

800 mg

Complicated UTI's


400 mg

q12h

10-21
days

800 mg

Sexually Transmitted Diseases


Uncomplicated Gonorrhea


800 mg

single
dose

1 day

800 mg

Prostatitis

Acute or Chronic


400 mg

q12h

28 days

800 mg

Renal Impairment

NOROXIN may be used for the treatment of urinary tract infections in patients with renal insufficiency. In patients with a creatinine clearance rate of 30 mL/min/1.73 m2 or less, the recommended dosage is one 400-mg tablet once daily for the duration given above. At this dosage, the urinary concentration exceeds the MICs for most urinary pathogens susceptible to norfloxacin, even when the creatinine clearance is less than 10 mL/min/1.73 m2.

When only the serum creatinine level is available, the following formula (based on sex, weight, and age of the patient) may be used to convert this value into creatinine clearance. The serum creatinine should represent a steady state of renal function.

Males:        (weight in kg) × (140 − age)
                   (72) × serum creatinine (mg/100 mL)

Females:   (0.85) × (above value)

Elderly

Elderly patients being treated for urinary tract infections who have a creatinine clearance of greater than 30 mL/min/1.73 m2 should receive the dosages recommended under Normal Renal Function .

Elderly patients being treated for urinary tract infections who have a creatinine clearance of 30 mL/min/1.73 m2 or less should receive 400 mg once daily as recommended under Renal Impairment .

HOW SUPPLIED

No. 8338 — Tablets NOROXIN 400 mg are white to off-white, oval shaped, film-coated tablets, coded 705 on one side and plain on the other. They are supplied as follows:

NDC 0006-0705-20 unit of use bottles of 20.

Storage

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

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