Floxin (Ofloxacin) - Indications and Dosage

INDICATIONS AND USAGE

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 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.

Uncomplicated cystitis due to Citrobacter diversus, Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa.

Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Citrobacter diversus *, or Pseudomonas aeruginosa *.

Prostatitis due to Escherichia coli.

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* = 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.

Antacids containing calcium, magnesium, or aluminum; sucralfate; divalent or trivalent cations such as iron; or multivitamins containing zinc; or Videx®, (Didanosine), chewable/buffered tablets or the pediatric powder for oral solution 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:

When only the serum creatinine is known, the following formula may be used to estimate creatinine clearance.

Men:      Creatinine clearance (mL/min) =

   Weight (kg) × (140-age)   
72 × serum creatinine (mg/dL)

Women:    0.85 × 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.

HOW SUPPLIED

FLOXIN (ofloxacin tablets) Tablets are supplied as 200 mg light yellow, 300 mg white, and 400 mg pale gold film-coated tablets. Each tablet is distinguished by "FLOXIN" and the appropriate strength. FLOXIN Tablets are packaged in bottles and in unit-dose blister strips in the following configurations:

200 mg tablets--UROPAK unit-dose/6 tablets (NDC 0062-1540-09)

200 mg tablets--bottles of 50 (NDC 0062-1540-02)

200 mg tablets--unit-dose/100 tablets (NDC 0062-1540-05)

300 mg tablets--bottles of 50 (NDC 0062-1541-02)

300 mg tablets--unit-dose/100 tablets (NDC 0062-1541-05)

400 mg tablets--bottles of 100 (NDC 0062-1542-01)

400 mg tablets--unit-dose/100 tablets (NDC 0062-1542-05)

FLOXIN Tablets should be stored in well-closed containers. Store below 86°F (30°C).

ALSO AVAILABLE:

Ofloxacin is also available for intravenous administration in the following configurations:

FLOXIN (ofloxacin injection) I.V. IN SINGLE-USE VIALS (10 mL) containing a concentrated solution with the equivalent of 400 mg of ofloxacin.

FLOXIN (ofloxacin injection) I.V. PRE-MIXED IN FLEXIBLE CONTAINERS (50 mL and 100 mL) containing a dilute solution with the equivalent of 200 mg or 400 mg of ofloxacin, respectively, in 5% Dextrose (D₅ W).