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:

Acute Bacterial Exacerbations of Chronic Bronchitis (ABECB):

• Acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae or Streptococcus pneumoniae.

Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions and for some patients ABECB is self-limiting, reserve ofloxacin for treatment of ABECB in patients who have no alternative treatment options.

Community-Acquired Pneumonia:

• Community-acquired Pneumonia due to Haemophilus influenzae or Streptococcus pneumoniae.

Uncomplicated Skin and Skin Structure Infections:

• Uncomplicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Streptococcus pyogenes, or Proteus mirabilis.

Acute, Uncomplicated Urethral and Cervical Gonorrhea:

• Acute, uncomplicated urethral and cervical gonorrhea due to Neisseria gonorrhoeae.

Nongonococcal Urethritis and Cervicitis:

• Nongonococcal urethritis and cervicitis due to Chlamydia trachomatis.

Mixed Infections of the Urethra and Cervix:

• Mixed Infections of the urethra and cervix due to Chlamydia trachomatis and Neisseria gonorrhoeae.

Acute Pelvic Inflammatory Disease:

• Acute pelvic inflammatory disease (including severe infection) due to Chlamydia trachomatis and/or Neisseria gonorrhoeae.

If anaerobic microorganisms are suspected of contributing to the infection, appropriate therapy for anaerobic pathogens should be administered.

Uncomplicated Cystitis:

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

Because fluoroquinolones, including ofloxacin, have been associated with serious adverse reactions and for some patients uncomplicated cystitis is self-limiting, reserve ofloxacin for treatment of uncomplicated cystitis in patients who have no alternative treatment options.

Complicated Urinary Tract Infections:

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

Prostatitis:

• Prostatitis due to Escherichia coli.

Ofloxacin has not been shown to be effective in the treatment of syphilis.

Fluoroquinolones, including ofloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages. This adverse reaction most frequently involves the Achilles tendon, and rupture of the Achilles tendon and has been reported with the rotator cuff (the shoulder), the hand, the biceps, the thumb, and other tendons. Tendinitis or tendon rupture can occur within hours or days of starting ofloxacin, or as long as several months after completion of fluoroquinolone therapy. Tendinitis and tendon rupture can occur bilaterally.

The risk of developing fluoroquinolone-associated tendinitis and tendon rupture is increased in patients over 60 years of age, in those taking corticosteroid drugs, and in patients with kidney, heart or lung transplants. Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.  Tendinitis and tendon rupture have been reported in patients taking fluoroquinolones who do not have the above risk factors.

Fluoroquinolones, including ofloxacin, have been associated with an increased risk of peripheral neuropathy. Cases of sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias and weakness have been reported in patients receiving fluoroquinolones, including ofloxacin. Symptoms may occur soon after initiation of norfloxacin and may be irreversible in some patients.

Fluoroquinolones, including ofloxacin, have been associated with an increased risk of psychiatric adverse reactions, including toxic psychoses or hallucinations; agitation; delirium, confusion, disorientation, or disturbances in attention; nervousness or restlessness, memory impairment. If these reactions occur in patients receiving ofloxacin, the drug should be discontinued and appropriate measures instituted.

Fluoroquinolones have been associated with an increased risk of seizures (convulsions), increased intracranial pressure (pseudotumor cerebri), lightheadedness, or tremors. The effects of ofloxacin on brain function or on the electrical activity of the brain have not been tested. Therefore, until more information becomes available, ofloxacin, like all other quinolones, should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, and other factors which predispose to seizures.

Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis. Postmarketing serious adverse events, including deaths and requirement for ventilatory support, have been associated with fluoroquinolone use in persons with myasthenia gravis. Avoid ofloxacin in patients with known history of myasthenia gravis.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including FLOXIN, and may range in severity from mild diarrhea to fatal colitis.

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.

Adequate hydration of patients receiving ofloxacin should be maintained to prevent the formation of a highly concentrated urine.

Some quinolones, including ofloxacin, have been associated with prolongation of the QT interval on the electrocardiogram and infrequent cases of arrhythmia.

Elderly patients may be more sensitive to drug-associated effects on the QT interval. Therefore, precaution should be taken when using ofloxacin with concomitant drugs that can result in prolongation of the QT interval (e.g., Class IA or Class III antiarrhythmics) or in patients with risk factors for Torsade de pointes (e.g., known QT prolongation, uncorrected hypokalemia.

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including ofloxacin. These reactions often occur following the first dose. Some reactions have been accompanied by cardiovascular collapse, hypotension/shock, seizure, loss of consciousness, tingling, angioedema (including tongue, laryngeal, throat, or facial edema/swelling), airway obstruction (including bronchospasm, shortness of breath, and acute respiratory distress), dyspnea, urticaria, itching, and other serious skin reactions.

Moderate to severe photosensitivity/phototoxicity reactions, the latter of which may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) involving areas exposed to light (typically the face, “V” area of the neck, extensor surfaces of the forearms, dorsa of the hands), can be associated with the use of quinolones after sun or UV light exposure.

Antimicrobial agents used in high doses for short periods of time to treat gonorrhea may mask or delay the symptoms of incubating syphilis. All patients with gonorrhea should have a serologic test for syphilis at the time of diagnosis. Patients treated with ofloxacin for gonorrhea should have a follow-up serologic test for syphilis after three months and, if positive, treatment with an appropriate antimicrobial should be instituted.

Fluoroquinolones have been associated with disturbances of blood glucose, including symptomatic hyperglycemia and hypoglycemia, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., glyburide) or with insulin.

A possible interaction between oral hypoglycemic drugs (e.g., glyburide/glibenclamide) or with insulin and fluoroquinolone antimicrobial agents have been reported resulting in a potentiation of the hypoglycemic action of these drugs, sometimes resulting in coma or death.

Administration of quinolones with antacids containing calcium, magnesium, or aluminum, with sucralfate, with divalent or trivalent cations such as iron, or with multivitamins containing zinc or with didanosine, chewable/buffered tablets or the pediatric powder for oral solution may substantially interfere with the absorption of quinolones resulting in systemic levels considerably lower than desired. These agents should not be taken within the two-hour period before or within the two-hour period after ofloxacin administration.

Cimetidine has demonstrated interference with the elimination of some quinolones. This interference has resulted in significant increases in half-life and AUC of some quinolones.

Elevated serum levels of cyclosporine have been reported with concomitant use of cyclosporine with some other quinolones.

Most quinolone antimicrobial drugs inhibit cytochrome P450 enzyme activity. This may result in a prolonged half-life for some drugs that are also metabolized by this system (e.g., cyclosporine, theophylline/methylxanthines, warfarin) when coadministered with quinolones.

The concomitant administration of a non-steroidal anti-inflammatory drug with a quinolone, including ofloxacin, may increase the risk of CNS stimulation and convulsive seizures.

The concomitant use of probenecid with certain other quinolones has been reported to affect renal tubular secretion.

As with other quinolones, concomitant administration of ofloxacin may prolong the half-life of theophylline, elevate serum theophylline levels, and increase the risk of theophylline-related adverse reactions.

Some quinolones have been reported to enhance the effects of the oral anticoagulant warfarin or its derivatives.

Some quinolones, including ofloxacin, may produce false-positive urine screening results for opiates using commercially available immunoassay kits.

There are no adequate and well-controlled studies in pregnant women. Animal studies: decreased fetal body weight and increased fetal mortality.

In lactating females, a single oral 200 mg dose of ofloxacin resulted in concentrations of ofloxacin in milk that were similar to those found in plasma. Because of the potential for serious adverse reactions from ofloxacin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource 

• Use in patients under the age of 18. GoToSource 

• Dosage greater than 800 mg per day. GoToSource

• Diarrhea and dysentery. GoToSource

• Tuberculosis. GoToSource

• Prevent rebleeding following endoscopic therapy in patients with acute  gastroesophageal variceal bleeding. GoToSource

• Decrease toxicity of bacillus calmette-guerin for transitional cell carcinoma of the bladder. GoToSource

• Pyelonephritis. GoToSource

• Lower respiratory tract infections. GoToSource

• Acute sinusitis. GoToSource

• Complicated skin infections. GoToSource

• Empirical therapy in febrile neutropenic patients. GoToSource

• Bacillary dysentery. GoToSource 

• Treatment of Q fever. GoToSource

• Leprosy. GoToSource

• Typhoid fever. GoToSource 

• Uncomplicated urinary tract infections. GoToSource 

• Acute biliary tract infections. GoToSource

Kidney failure. GoToSource

Psychotic reactions. GoToSource

Hepatotoxicity (liver damage). GoToSource

Prolongation of QT interval (heart rhythm disorder). GoToSource

Clostridium difficile associated diarrhea. GoToSource

Tendinitis and tendon ruptures. Risk increases in older patients usually over 60 years of age, in patients taking corticosteroid drugs and in patients with kidney, heart or lung transplants. GoToSource

Peripheral neuropathy (damage to nerves outside of brain and spinal cord). GoToSource

Seizures. GoToSource

Stevens-johnson syndrome (severe skin reaction), photosensitivity (oversensitivity of skin to light) and  anaphylaxis (potentially life-threatening allergic reaction). GoToSource

Blood sugar disturbances including hypoglycemic coma. GoToSource

Exacerbations of myasthenia gravis (neuromuscular disease). GoToSource

Lawsuits filed for peripheral neuropathy.