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To reduce the development of drug-resistant bacteria and maintain the effectiveness of FLOXIN® (ofloxacin tablets) Tablets and other antibacterial drugs, FLOXIN® (ofloxacin tablets) Tablets 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.
FLOXIN® (ofloxacin tablets) Tablets are indicated for the treatment of adults with mild to moderate infections (unless otherwise indicated) caused by susceptible strains of the designated microorganisms in the infections listed below. Please see DOSAGE AND ADMINISTRATION for specific recommendations.
Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae or Streptococcus pneumoniae.
Community-acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae.
Uncomplicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.
Acute, uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae. (See WARNINGS.)
Nongonococcal urethritis and cervicitis due to Chlamydia trachomatis. (See WARNINGS.)
Mixed Infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae. (See WARNINGS.)
Acute pelvic inflammatory disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae. (See WARNINGS.)
NOTE: If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.
Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus*, or Pseudomonas aeruginosa*.
Prostatitis due to Escherichia coli.
* = Although treatment of infections due to this organism in this organ system demonstrated a clinically significant outcome, efficacy was studied in fewer than 10 patients.
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 ofloxacin. Therapy with ofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be continued.
As with other drugs in this class, some strains of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with ofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information not only on the therapeutic effect of the antimicrobial agent but also on the possible emergence of bacterial resistance.
DOSAGE AND ADMINISTRATION
The usual dose of FLOXIN® (ofloxacin tablets) Tablets is 200 mg to 400 mg orally every 12 h as described in the following dosing chart. These recommendations apply to patients with normal renal function (i.e., creatinine clearance > 50 mL/min). For patients with altered renal function (i.e., creatinine clearance < 50 mL/min), see the Patients with Impaired Renal Function Subsection.
|Infection†||Unit Dose||Frequency||Duration||Daily Dose|
|Acute Bacterial Exacerbation of Chronic Bronchitis||400 mg||q12h||10 days||800 mg|
|Comm. Acquired Pneumonia||400 mg||q12h||10 days||800 mg|
|Uncomplicated Skin and Skin Structure Infections||400 mg||q12h||10 days||800 mg|
|Acute, Uncomplicated Urethral and Cervical Gonorrhea||400 mg||single dose||1 day||400 mg|
|Nongonococcal Cervicitis/Urethritis due to C. trachomatis||300 mg||q12h||7 days||600 mg|
|Mixed Infection of the urethra and cervix due to C. trachomatis and N. gonorrhoeae||300 mg||q12h||7 days||600 mg|
|Acute Pelvic Inflammatory Disease||400 mg||q12h||10-14 days||800 mg|
|Uncomplicated Cystitis due to E. coli or K. pneumoniae||200 mg||q12h||3 days||400 mg|
|Uncomplicated Cystitis due to other approved pathogens||200 mg||q12h||7 days||400 mg|
|Complicated UTI's||200 mg||q12h||10 days||400 mg|
|Prostatitis due to E.Coli||300 mg||q12h||6 weeks||600 mg|
|† DUE TO THE DESIGNATED PATHOGENS (See INDICATIONS AND USAGE.)|
Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or Videx® (didanosine) should not be taken within the two-hour period before or within the two-hour period after taking ofloxacin. (See PRECAUTIONS.)
Patients with Impaired Renal Function: Dosage should be adjusted for patients with a creatinine clearance < 50 mL/min. After a normal initial dose, dosage should be adjusted as follows:
|Creatinine Clearance||Maintenance Dose||Frequency|
|20-50 mL/min||the usual recommended unit dose||q24h|
|< 20 mL/min||½ the usual recommended unit dose||q24h|
When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.
|Men:||Creatinine Clearance (mL/min) =||(140 – age) x (actual body wt in kg)|
|72 x (serum creatinine)|
Women: 0.85 x the value calculated for men
The serum creatinine should represent a steady-state of renal function.
Patients with Cirrhosis:
The excretion of ofloxacin may be reduced in patients with severe liver function disorders (e.g., cirrhosis with or without ascites). A maximum dose of 400 mg of ofloxacin per day should therefore not be exceeded.
FLOXIN® (ofloxacin tablets) Tablets are supplied as 200 mg light yellow, 300 mg white, and 400 mg pale gold oval, straight-edged, coated tablets. Each tablet is distinguished by an imprint of “FLOXIN (ofloxacin) ” and the appropriate strength. FLOXIN® (ofloxacin) Tablets are packaged in bottles in the following configurations:
200 mg tablets - bottles of 50 (NDC 0062 - 1540-02)
300 mg tablets - bottles of 50 (NDC 0062 - 1541-02)
400 mg tablets - bottles of 100 (NDC 0062 - 1542-01)
FLOXIN® (ofloxacin) Tablets should be stored in well-closed containers. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Keep out of the reach of children.
Ortho-McNeil, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ USA 08869. Issued January 2011
Last reviewed on RxList: 4/15/2011
This monograph has been modified to include the generic and brand name in many instances.
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