VA Class: AM900
Chemical Name: ± - 9 - Fluoro - 2,3 - dihydro - 3 - methyl - 10 - (4 - methyl - 1 - piperazinyl) - 7 - oxo - 7H - pyrido[1,2,3 - de] - 1,4 - benzoxaz ine-6-carboxylicacid
CAS Number: 82419-36-1
Systemic fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.1 675 676 680 Risk of fluoroquinolone-associated tendinitis and tendon rupture is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 675 676 680 (See Tendinopathy and Tendon Rupture under Cautions.)
Uses for Ofloxacin
Bone and Joint Infections
Treatment of mild to moderate bone and joint infections† (including osteomyelitis) caused by susceptible Escherichia coli,233 252 262 263 491 Enterobacter,233 252 262 263 Klebsiella oxytoca,491 K. pneumoniae,233 252 263 Proteus mirabilis,252 262 Pseudomonas aeruginosa,233 252 262 263 414 491 502 Serratia,233 252 491 Staphylococcus aureus,233 252 262 263 413 414 491 502 or S. epidermidis.233 252 262 263 414 491 Consider that fluoroquinolone-resistant staphylococci have been reported with increasing frequency; probably should not be used alone in treatment of bone and joint infections known or suspected of being caused by staphylococci.502
Treatment of infectious diarrhea† caused by susceptible enterotoxigenic E. coli or Shigella.330 420 429 Active in vitro against most pathogens associated with infectious diarrhea (including E. coli, Shigella, Salmonella, Aeromonas, Vibrio, Yersinia enterocolitica, Campylobacter); may be a drug of choice for empiric treatment.242 243 321 327 426 429 539 Consider increasing emergence of fluoroquinolone-resistant Campylobacter secondary to widespread use of the drugs; use judiciously for treatment or prevention of enteropathogenic diarrhea.524 539 541
Treatment of shigellosis† caused by susceptible Shigella when anti-infectives indicated.461 Anti-infectives generally indicated in addition to fluid and electrolyte replacement for treatment of patients with severe shigellosis, dysentery, or underlying immunosuppression.292 412 Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common.292 Fluoroquinolones (e.g., ciprofloxacin, levofloxacin, moxifloxacin) are drugs of choice when susceptibility of isolate unknown or ampicillin- or co-trimoxazole-resistant strains involved.292 412 461 566
Treatment of travelers’ diarrhea†.305 525 557 590 612 If caused by bacteria, may be self-limited and resolve within 3–5 days without anti-infective treatment;525 588 589 590 if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment is recommended.305 525 588 589 590 Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, indicated.305 525 588 590 612 Azithromycin is a treatment alternative if fluoroquinolones should not be used (e.g., children, pregnant women) and a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., South and Southeast Asia) or when there is no response after 48 hours of fluoroquinolone treatment.305 525 Rifaximin is another alternative for treatment of travelers' diarrhea caused by noninvasive E. coli.305 525
Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug.305 525 CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;305 524 525 527 529 the principal preventive measures are prudent dietary practices.525 If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults;305 525 azithromycin and rifaximin are alternatives.305 Weigh use of anti-infective prophylaxis against use of prompt, early self-treatment with anti-infectives, a strategy that can limit duration of illness to 6–24 hours in most cases.525
Treatment of >Helicobacter pylori infection and duodenal ulcer disease† in conjunction with other agents.406 643 Additional study is needed and some clinicians state that efficacy of dual or triple therapy that includes a fluoroquinolone anti-infective currently is unproven for H. pylori infections.539 570
Respiratory Tract Infections
Treatment of acute bacterial exacerbations of chronic bronchitis caused by susceptible Haemophilus influenzae1 230 232 236 239 244 251 253 259 265 272 274 413 414 420 433 or Streptococcus pneumoniae.1 230 232 239 244 251 253 259 265 272 274 414 420
Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible H. influenzae1 230 232 236 251 253 259 272 413 414 420 or S. pneumoniae.1 230 232 251 253 259 272 414 420 IDSA and ATS state that other fluoroquinolones with enhanced activity against S. pneumoniae (gemifloxacin, levofloxacin, moxifloxacin) are drugs of choice for empiric treatment of CAP in outpatients at risk for infections caused by drug-resistant S. pneumoniae (DRSP) and also are drugs of choice for empiric treatment of CAP in inpatients.639
Has been used for treatment of respiratory tract infections caused by susceptible Moraxella catarrhalis†,236 239 244 251 272 433 S. aureus†,232 236 244 265 414 420 viridans streptococci†,484 Enterobacteriaceae†,230 232 251 259 265 414 420 484 or Ps. aeruginosa†.230 232 239 259 265 268 414 420
Has been used for treatment of acute exacerbations of bronchopulmonary Ps. aeruginosa infections in adults with cystic fibrosis†.126 170 177 264 413 420 464 As with other anti-infectives, Ps. aeruginosa may be cleared temporarily from the sputum, but a bacteriologic cure rarely is obtained and should not be expected.177 249 264 413
Skin and Skin Structure Infections
Treatment of mild to moderate uncomplicated skin and skin structure infections (e.g., cellulitis, subcutaneous abscesses, surgical wound infections, furunculosis, folliculitis) caused by susceptible S. aureus,1 255 420 462 S. epidermidis†,420 S. pyogenes (group A β-hemolytic streptococci),1 or P. mirabilis;1 also has been used for treatment of skin and skin structure infections caused by susceptible E. coli†255 or Ps. aeruginosa†.255
The increasing emergence of fluoroquinolone resistance in staphylococci limits usefulness of the drug for infections caused by these gram-positive bacteria.40 133 134 413 426 506 519 520 521 522 539 541
Urinary Tract Infections (UTIs) and Prostatitis
Treatment of uncomplicated cystitis caused by susceptible Citrobacter diversus,1 288 425 E. aerogenes,1 288 E. coli,1 277 278 280 282 288 423 478 490 K. pneumoniae,1 280 288 490 P. mirabilis,1 277 278 280 288 423 490 or Ps. aeruginosa;1 280 288 478 also has been used for cystitis caused by susceptible C. freundii†,490 E. cloacae†,490 or Morganella morganii†.280
Has been used treatment of uncomplicated UTIs caused by susceptible gram-positive bacteria, including S. aureus†,282 288 423 490 S. epidermidis†,277 278 423 490 S. saprophyticus†,277 282 423 478 Enterococcus faecalis†,277 278 288 490 viridans streptococci†,490 or Streptococcus agalactiae† (group B streptococci).278 Because of concerns about emergence of fluoroquinolone resistance in gram-positive bacteria (e.g., staphylococci), such use should be selective.40 133 134 406 506 519 520 521 522 539 541
Treatment of complicated UTIs caused by susceptible C. diversus,1 285 E. coli,1 279 281 285 K. pneumoniae,1 285 P. mirabilis,1 285 or Ps. aeruginosa;1 279 281 285 also has been used for complicated UTIs caused by susceptible C. freundii†,285 Enterobacter†,285 M. morganii†,285 or P. rettgeri†.285
Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria.237 241 243 275 282 417 426 Generally considered alternative for treatment of uncomplicated UTIs (e.g., acute cystitis) and used in these infections only when other urinary anti-infectives likely to be ineffective or cannot be used.143 237 241 243 275 282 283 426
Alternative for postexposure prophylaxis following suspected or confirmed exposure to aerosolized anthrax spores (inhalational anthrax)† when oral ciprofloxacin and oral doxycycline are not available.620
Alternative for treatment of inhalational anthrax† when a parenteral regimen is not available (e.g., supply or logistic problems because large numbers of individuals require treatment in a mass casualty setting).620 A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) is preferred for initial treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.620 483
Alternative for treatment of urogenital chlamydial infections.319 CDC and others recommend azithromycin or doxycycline as drugs of choice;319 328 erythromycin,319 328 ofloxacin,319 or levofloxacin319 328 are alternatives.
Gonorrhea and Associated Infections
Has been used for treatment of acute, uncomplicated urethral, endocervical, or rectal† gonorrhea or for follow-up treatment of disseminated gonococcal infections caused by susceptible Neisseria gonorrhoeae.1 289 290 291 294 296 300 486 487 500
Treatment of acute epididymitis†.319 328 CDC recommends an initial regimen of IM ceftriaxone and oral doxycycline in all patients;319 additional therapy includes ofloxacin or levofloxacin, but fluoroquinolones should be used alone only when epididymitis is most likely caused by sexually transmitted enteric bacteria (e.g., E. coli) or when nucleic acid amplification test (NAAT) is negative for N. gonorrhoeae.319 328
Because quinolone-resistant N. gonorrhoeae (QRNG) is widely disseminated worldwide, including in the US319 328 642 671 673 (see Resistance in Neisseria gonorrhoeae under Cautions), CDC and others no longer recommend ofloxacin for treatment of gonorrhea or any associated infections that may involve N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).319 328 671 673
CDC, ATS, and IDSA state that use of fluoroquinolones can be considered in patients with relapse, treatment failure, or Mycobacterium tuberculosis resistant to isoniazid and/or rifampin or when first-line drugs cannot be tolerated.638 There have been recent reports of extensively drug-resistant tuberculosis (XDR tuberculosis).645 646 XDR tuberculosis is caused by M. tuberculosis resistant to rifampin and isoniazid (multiple-drug resistant strains) that also are resistant to a fluoroquinolone and at least one parenteral second-line antimycobacterial (capreomycin, kanamycin, amikacin).645 646
Although there is clinical experience with several fluoroquinolones in the treatment of tuberculosis (e.g., ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin),456 563 638 647 653 655 656 657 658 levofloxacin and moxifloxacin are the fluoroquinolones recommended by CDC, ATS, and IDSA and levofloxacin may be preferred on the basis of cumulative experience.638 The most recent CDC, ATS, and IDSA recommendations for treatment of tuberculosis should be consulted for more specific information.638
Alternative for use in multiple-drug regimens for treatment of multibacillary leprosy†.566 613 617 WHO recommends ofloxacin as an alternative for multibacillary leprosy regimens in patients who will not accept or cannot tolerate clofazimine566 613 617 and when rifampin cannot be used because of adverse effects, intercurrent disease (e.g., chronic hepatitis), or infection with rifampin-resistant Mycobacterium leprae.613 617
Component of a single-dose rifampin-based multiple-drug regimen (ROM) for treatment of single-lesion paucibacillary leprosy† (i.e., a single skin lesion with definite loss of sensation but without nerve trunk involvement).613 614 617 618 619
Treatment of postoperative sternotomy wound or soft tissue infections caused by M. fortuitum†.256 317 332 333 479 Also has been used for treatment of M. fortuitum pulmonary infections104 332 479 or UTIs.489 ATS and IDSA recommend that M. fortuitum pulmonary infections be treated with a regimen consisting of at least 2 anti-infectives selected based on results of in vitro susceptibility testing and tolerability (e.g., amikacin, ciprofloxacin or ofloxacin, a sulfonamide, cefoxitin, imipenem, doxycycline).674
Nongonococcal Urethritis and Cervicitis
Pelvic Inflammatory Disease
Has been used for treatment of acute PID caused by susceptible C. trachomatis or N. gonorrhoeae.1 319 328 Do not use in any infections that may involve N. gonorrhoeae.319 328 671 673 (See Resistance in Neisseria gonorrhoeae under Cautions.)
When an oral regimen used for treatment of mild to moderately severe acute PID, CDC recommends a single IM dose of ceftriaxone, cefoxitin (with oral probenecid), or cefotaxime given in conjunction with oral doxycycline (with or without oral metronidazole).319 Although fluoroquinolones no longer recommended for PID, if a parenteral cephalosporin is not feasible, a regimen of oral levofloxacin or oral ofloxacin given with or without oral metronidazole may be considered if the community prevalence and individual risk of gonorrhea are low.319
Alternative for treatment of plague† caused by Yersinia pestis, including naturally occurring plague and plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.628 629 Regimen of choice is streptomycin (or gentamicin) with or without doxycycline;292 628 629 alternatives are doxycycline, chloramphenicol (drug of choice for plague meningitis), fluoroquinolones, or co-trimoxazole (may be less effective than other alternatives).292 566 628 629
Postexposure prophylaxis† following a high risk exposure to Y. pestis (e.g., household, hospital, or other close contact with an individual who has pneumonic plague; laboratory exposure to viable Y. pestis; confirmed exposure in the context of biologic warfare or bioterrorism).628 629 Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (e.g., ciprofloxacin, levofloxacin, ofloxacin); chloramphenicol is an alternative.628 629
Alternative to tetracyclines for treatment of rickettsial infections†.325 326 560 566 Has been used for treatment of acute Q fever pneumonia caused by Coxiella burnetii†325 560 and Mediterranean spotted fever caused by Rickettsia conorii†.326 Has been used in conjunction with doxycycline for long-term treatment of Q fever endocarditis†,490 560 but may be less effective than a regimen of doxycycline and hydroxychloroquine.490
Typhoid Fever and Other Salmonella Infections
Selective Decontamination of the GI Tract
Ofloxacin Dosage and Administration
May be given without regard to meals.1 Presence of food in the GI tract can decrease the rate and/or extent of absorption of ofloxacin; not usually considered clinically important.1 176 189 420 464 649 650 651 Milk and yogurt do not appear to affect GI absorption.649 650 (See Pharmacokinetics.)
Patients should be well hydrated and should be instructed to drink fluids liberally to avoid formation of highly concentrated urine.1
Single-lesion Paucibacillary Leprosy†Oral
Children 5–14 years of age: WHO recommends a single-dose ROM regimen that includes a single 300-mg dose of rifampin, a single 200-mg dose of ofloxacin, and a single 50-mg dose of minocycline.615
Children <5 years of age: WHO recommends that an appropriately adjusted dose of each drug in the above single-dose ROM regimen be used.615
General Adult Dosage
200–400 mg every 12 hours.1
Duration of treatment depends on the type and severity of infection and should be determined by clinical and bacteriologic response of the patient.344
Treatment of Travelers’ Diarrhea†Oral
Prevention of Travelers’ Diarrhea†Oral
Although anti-infective prophylaxis generally discouraged,305 525 some clinicians state it can be given during period of risk (for ≤3 weeks) beginning day of travel and continuing for 1 or 2 days after leaving area of risk.588 589 612
Respiratory Tract Infections
Acute Bacterial Exacerbations of Chronic BronchitisOral
400 mg every 12 hours for 10 days.1
400 mg every 12 hours for 10 days.1
Skin and Skin Structure Infections
400 mg every 12 hours for 10 days.1
Urinary Tract Infections (UTIs) and Prostatitis
Uncomplicated Cystitis Caused by E. coli or K. pneumoniaeOral
200 mg every 12 hours for 3 days.1
Uncomplicated Cystitis Caused by Other Susceptible BacteriaOral
200 mg every 12 hours for 7 days.1
200 mg every 12 hours for 10 days.1
Prostatitis Caused by E. coliOral
Postexposure Prophylaxis Following Exposure in the Context of Biologic Warfare or Bioterrorism†Oral
Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear,554 628 but prolonged postexposure prophylaxis usually required.620 628 A duration of 60 days may be adequate for a low-dose exposure, but a duration >4 months may be necessary to reduce the risk following a high-dose exposure.554 CDC, US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend that postexposure prophylaxis in unvaccinated individuals be continued for ≥60 days following a confirmed exposure (including in laboratory workers with confirmed exposures to B. anthracis cultures).532 620 621 628 The USPHS Advisory Committee on Immunization Practices (ACIP) and USAMRIID recommend that individuals who are partially or fully vaccinated against anthrax receive postexposure prophylaxis for ≥30 days;522 628 if given in conjunction with anthrax vaccine, continue prophylaxis for at least 7–14 days after the third vaccine dose.533 628
Treatment of Inhalational Anthrax in a Mass Casualty Setting†Oral
400 mg twice daily for ≥60 days.620
400 mg once daily in conjunction with oral rifampin (600 mg once daily) given for 6 weeks was effective in some patients.561
Gonorrhea and Associated Infections
Uncomplicated Urethral, Endocervical, or Rectal† GonorrheaOral
Not recommended by CDC or others for treatment of gonorrhea or any associated infections that may involve N. gonorrhoeae (e.g., PID, epididymitis).319 328 671 673 (See Gonorrhea and Associated Infections under Uses.)
Use only when epididymitis† most likely caused by sexually transmitted enteric bacteria (e.g., E. coli) or when NAAT negative for N. gonorrhoeae.319 328 (See Resistance in Neisseria gonorrhoeae under Cautions.)
400 mg every 12 hours for 2–3 weeks.564
Treatment of multibacillary leprosy† in adults who cannot receive rifampin because of adverse effects, intercurrent disease (e.g., chronic hepatitis), or infection with rifampin-resistant Mycobacterium leprae: WHO recommends supervised administration of a regimen of clofazimine (50 mg daily), ofloxacin (400 mg daily), and minocycline (100 mg daily) given for 6 months, followed by a regimen of clofazimine (50 mg daily) and minocycline (100 mg daily) given for at least an additional 18 months.613 616 617 618
Treatment of multibacillary leprosy† in adults who will not accept or cannot tolerate clofazimine:104 108 WHO recommends supervised administration of a once-monthly ROM regimen that includes rifampin (600 mg once monthly), ofloxacin (400 mg once monthly), and minocycline (100 mg once monthly) given for 24 months.613 617
Treatment of single-lesion paucibacillary leprosy† in certain patient groups: WHO recommends a single-dose ROM regimen that includes a single 600-mg dose of rifampin, a single 400-mg dose of ofloxacin, and a single 100-mg dose of minocycline.613 617
M. fortuitum Infections†Oral
Treatment of postoperative sternotomy wound or soft tissue infections: 300 mg once daily or 1.2 g daily in 3 or 4 divided doses has been given for 3–6 months in conjunction with amikacin (usually 250 mg IM or IV twice daily for 4–8 weeks).256
Treatment of pulmonary infections: ATS and IDSA recommend a regimen consisting of at least 2 anti-infectives (see Mycobacterial Infections under Uses) given for at least 12 months after negative sputum cultures are attained.674
Treatment of serious skin, bone, or soft tissue infections: ATS and IDSA recommend a regimen consisting of at least 2 anti-infectives (see Mycobacterial Infections under Uses)given for at least 4 months for infections involving skin or soft tissue or 6 months for those involving bone.674
Nongonococcal Urethritis and Cervicitis
Pelvic Inflammatory Disease
Use only when cephalosporins not feasible, community prevalence and individual risk of gonorrhea is low, and in vitro susceptibility confirmed.319 (See Pelvic Inflammatory Disease under Uses.)
Mediterranean Spotted Fever†Oral
200 mg every 12 hours for 7 days was effective in some patients.326
Typhoid Fever and Other Salmonella Infections†
Mild to Moderate Typhoid Fever†Oral
Maximum dosage of 400 mg daily in those with severe hepatic impairment (e.g., cirrhosis with or without ascites).1
Usual initial dose, then usual dose once every 24 hours1
Usual initial dose, then 50% of usual dose once every 24 hours1
No dosage adjustments except those related to renal impairment.1 (See Renal Impairment under Dosage and Administration.)
Cautions for Ofloxacin
Known hypersensitivity to ofloxacin or other quinolones.1
Tendinopathy and Tendon Rupture
Fluoroquinolones, including ofloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups.1 675 676 680 This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 675 676 680 (See Geriatric use under Cautions.)
Other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.675 676 680 Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any of these risk factors.680
Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair.675 676 680 Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also reported.680
Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.680
Discontinue if pain, swelling, inflammation, or rupture of a tendon occurs.1 675 676 680 Advise patients to rest and refrain from exercise and contact a clinician at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon; weakness or inability to use a joint).1 675 676 680 (See Advice to Patients.)
Myasthenia Gravis Patients
Avoid use in patients with known history of myasthenia gravis.1
Fluoroquinolones, including ofloxacin, cause arthropathy and osteochondrosis in immature animals of various species.1 339 342 359 413 417 420 421 428 446 464 Relevance of these adverse effects in immature animals to use in humans unknown.337 428 464 678 679 Safety and efficacy of ofloxacin not established in children and adolescents <18 years of age (see Pediatric Use under Cautions)or in pregnant or lactating women (see Pregnancy and see Lactation under Cautions).1
Seizures, toxic psychoses, and increased intracranial pressure and CNS stimulation, which may lead to tremor, restlessness/agitation, nervousness/anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and, rarely, suicidal thoughts or acts, have been reported with quinolones, including ofloxacin.1
Use with caution in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or other risk factors that predispose to seizures or lower the seizure threshold (e.g., certain drugs, renal impairment).1
If CNS effects occur, discontinue ofloxacin and institute appropriate measures.1
Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones, including ofloxacin.1 Symptoms may occur soon after initiation of the drug and may be irreversible.1
Immediately discontinue ofloxacin if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness) occur or if there are alterations in sensations (e.g., light touch, pain, temperature, position sense, vibratory sensation).1
Prolongation of QT Interval
Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluoroquinolones, including ofloxacin.1
Avoid use in patients with prolonged QT interval or uncorrected electrolyte disorders (e.g., hypokalemia, hypomagnesemia).1 Also avoid use in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.1 Risk may be increased in geriatric patients.1 (See Geriatric Use under Cautions.)
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 607 609 610 663 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) have been reported with nearly all anti-infectives, including ofloxacin, and may range in severity from mild diarrhea to fatal colitis.1 341 343 352 353 350 351 355 356 607 609 610 C. difficile produces toxins A and B which contribute to development of CDAD;1 607 hypertoxin-producing strains of C. difficile are associated with increased morbidity and mortality since they may be refractory to anti-infectives and colectomy may be required.1
Consider CDAD if diarrhea develops during or after anti-infective therapy and manage accordingly.1 607 609 610 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.1
If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.1 607 609 610 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 607 609 610
Some hypersensitivity reactions have been accompanied by cardiovascular collapse, hypotension or shock, seizures, loss of consciousness, tingling, angioedema (e.g., edema or swelling of the tongue, larynx, throat, or face), airway obstruction (e.g., bronchospasm, shortness of breath, acute respiratory distress), urticaria, pruritus, and other severe skin reactions.1
In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported most frequently after multiple doses.1 These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia and/or other hematologic effects.1
Discontinue ofloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity.1 Institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).1
Moderate to severe photosensitivity reactions reported with fluoroquinolones, including ofloxacin.1
Avoid unnecessary exposure to sunlight or artificial UV light (sunlamps, solariums).1
Discontinue ofloxacin if photosensitivity (e.g., skin eruption) occurs.1
Selection and Use of Anti-infectives
When prescribing a fluoroquinolone, consider potential benefits and risks for the individual patient.675 676 Most patients tolerate the drugs, but serious adverse reactions (e.g., CNS effects, QT prolongation, C. difficile-associated diarrhea and colitis, damage to liver, kidneys, or bone marrow, alterations in glucose homeostasis) may occur rarely.675 676
To reduce development of drug-resistant bacteria and maintain effectiveness of ofloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1
Resistance in Neisseria gonorrhoeae
US data indicate that QRNG has continued to increase among men who have sex with men and among heterosexual males and is now present in all regions of the country.671
CDC and others state that fluoroquinolones, including ofloxacin, should not be used to treat gonorrhea or any associated infections that may involve N. gonorrhoeae (e.g., PID, epididymitis).319 328 671 673
Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during therapy.1
AAP states use of fluoroquinolones may be justified in children <18 years of age in special circumstances after careful assessment of the risks and benefits for the individual patient and after these benefits and risks have been explained to the parents and/or caregivers.110 292
No substantial differences in safety and efficacy relative to younger adults.1
Risk of severe tendon disorders, including tendon rupture, is increased in geriatric adults >60 years of age.1 675 676 680 This risk is further increased in those receiving concomitant corticosteroids.1 675 676 680 (See Tendinopathy and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids.680
Risk of QT interval prolongation leading to ventricular arrhythmias may be increased in geriatric patients, especially those receiving concurrent therapy with other drugs that can prolong QT interval (e.g., class IA or III antiarrhythmic agents) or with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).1 (See Prolongation of QT Interval under Cautions.)
Consider age-related decreases in renal function when selecting dosage and adjust dosage if necessary.1 (See Renal Impairment under Dosage and Administration.)
Use with caution; perform appropriate hepatic function tests prior to and during therapy.1
Decreased clearance and increased half-life.1
Use with caution; perform appropriate renal function tests prior to and during therapy.1
Common Adverse Effects
GI effects (nausea, diarrhea, vomiting); nervous system effects (headache, dizziness, insomnia); rash; genital pruritus.1
Interactions for Ofloxacin
Drugs That Prolong QT Interval
Potential pharmacologic interaction (additive effect on QT interval prolongation).1 Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.1 (See Prolongation of QT Interval under Cautions.)
Specific Drugs and Laboratory Tests
Drug or Test
Antacids (aluminum-, magnesium-, or calcium-containing)
Anticoagulants, oral (warfarin)
Antidiabetic agents (glyburide, glibenclamide, insulin)
Blood glucose alterations (including hypoglycemia) reported in diabetic patients1
Closely monitor blood glucose concentrations1
No evidence of clinically important effects on pharmacokinetics of caffeine;1 189 365 366 398 399 400 401 402 427 454 some other fluoroquinolones (e.g., ciprofloxacin) may affect caffeine pharmacokinetics189 365 366 398 399 400 401 402 427 454
Restrictions on caffeine intake not considered necessary398
Decreased absorption of ofloxacin with buffered didanosine preparations1
Administer ofloxacin at least 2 hours before or after buffered didanosine (pediatric oral solution admixed with antacid) 1
Histamine H2-receptor antagonists (cimetidine, ranitidine)
Decreased absorption of ofloxacin1
Administer ofloxacin at least 2 hours before or after ferrous sulfate and dietary supplements containing iron1
Multivitamins and mineral supplements
Decreased absorption of ofloxacin1
Administer ofloxacin at least 2 hours before or after supplements containing zinc or iron1
Tests for opiates
Possible false-positive results with immunoassay kits for urine screening1
Confirmation of positive opiate test results using more specific methods may be necessary1
Possible increased theophylline concentrations and increased risk of theophylline-related adverse effects with fluoroquinolones1 181 189 191 365 366 367 368 378 379 380 382 383 384 385 386 387 389 391 392 393 394 395 396 397 416 427 464
Extent of this interaction varies considerably among the fluoroquinolones; the effect is less pronounced with norfloxacin or ofloxacin than with ciprofloxacin191 367 368 378 379 384 386 387 389 392 393 394 396 397 427
If used concomitantly, closely monitor patient and theophylline concentrations and make appropriate theophylline dosage adjustments as needed1
Food can decrease rate and/or extent of absorption of ofloxacin;1 172 176 189 420 464 649 650 651 not usually considered clinically important.1 172 189 464 649 Milk and yogurt do not appear to affect GI absorption.649 650
Widely distributed into body tissues and fluids,1 181 183 189 including bone,183 214 432 cartilage,432 bile,183 197 217 skin,1 sputum,1 183 189 195 214 430 bronchial secretions,189 196 206 214 230 pleural effusions,534 tonsils,203 saliva,185 186 192 gingival mucosa,186 nasal secretions,183 aqueous humor,214 215 tears,183 sweat,183 lung,1 183 189 205 219 228 430 blister fluid,1 183 189 192 226 pancreatic fluid,201 217 ascitic fluid,212 peritoneal fluid,225 458 gynecologic tissue,183 189 vaginal fluid,200 cervix,1 ovary,1 semen,453 prostatic fluid,1 181 183 198 202 214 and prostatic tissue.1 181 183 198 202 214
Plasma Protein Binding
<10% of a dose is metabolized;182 188 191 approximately 3–6% of the dose metabolized to desmethyl ofloxacin and 1–5% metabolized to ofloxacin N-oxide.169 175 182 190 191 Desmethyl ofloxacin is microbiologically active, but is less active against susceptible organisms than is ofloxacin; ofloxacin N-oxide has only minimal antibacterial activity.221
Ofloxacin and its metabolites eliminated in both urine and feces.1 175 185 Following a single oral dose, 65–90% of the dose eliminated unchanged in urine within 48 hours;1 169 171 175 178 210 <5% of the dose in urine as metabolites.1 175 210 Approximately 4–8% of the dose excreted in feces.1 169
In healthy geriatric adults 64–86 years of age with renal function normal for their age, half-life averages 6.4–8.5 hours.1 187 The slower elimination in geriatric individuals presumably is due to reduced renal function and clearance in this age group.1
Pharmacokinetics not fully evaluated in those with hepatic impairment.464
Serum concentrations are higher and half-life prolonged in adults with impaired renal function.1 174 181 182 189 220 221 222 223 224 225 226 227 420 431 458 464 Half-life averages 16.4 hours (range: 11–33.5 hours) in adults with Clcr 10–50 mL/minute and 21.7 hours (range: 16.9–28.4 hours) in those with Clcr <10 mL/minute.190 In patients with end-stage renal failure, half-life may range from 25–48 hours.227
Actions and Spectrum
Spectrum of activity includes many gram-positive aerobic bacteria, many gram-negative aerobic bacteria, and some other organisms (e.g., Chlamydia, Mycoplasma, Mycobacterium, Rickettsia).1 3 9 12 76 78 80 100 103 104 105 107 108 109 413 414 417 418 420 464 Inactive against fungi and viruses.413 464
In vitro activity against susceptible gram-positive bacteria approximately equal to that of ciprofloxacin;6 9 10 12 32 189 414 417 419 420 421 464 in vitro activity against susceptible gram-negative bacteria slightly less than that of ciprofloxacin.9 12 15 23 32 35 118 189 414 417 420 421 469 Generally less active against gram-positive than gram-negative bacteria.3 9 12 413 414 417 418 421
Gram-positive aerobic cocci: Active in vitro and in clinical infections against S. aureus (oxacillin-susceptible [methicillin-susceptible] strains only),1 S. epidermidis (oxacillin-susceptible strains only),1 S. pneumoniae (penicillin-susceptible strains),1 S. pyogenes (group A β-hemolytic streptococci),1 S. saprophyticus, and Enterococcus faecalis.3 6 12 13 14 15 16 17 19 21 22 23 25 26 27 28 31 32 34 74 114 504 Also active in vitro against some other staphylococci (e.g., S. haemolyticus, S. hominis), some penicillin-resistant S. pneumoniae, viridans streptococci, groups C, F, and G streptococci, and nonenterococcal group D streptococci.1 14 21 22 23 29 35
Gram-positive aerobic bacilli: Active against Bacillus anthracis,621 622 630 631 Corynebacterium,21 25 26 32 62 66 and Listeria monocytogenes.21 22 25 26 27 32 34 37 420 Nocardia asteroides usually are resistant.32 35 63 420 504
Gram-negative aerobes: Active in vitro and in clinical infections against Campylobacter jejuni, H. influenzae, H. parainfluenzae, M. catarrhalis, Ps. aeruginosa, and most Enterobacteriaceae (including Citrobacter, Edwardsiella, Enterobacter, E. coli, Klebsiella, M. morganii, P. mirabilis, P. vulgaris, Providencia, Salmonella, Shigella, Serratia, Yersinia enterocolitica).1 3 6 12 13 14 15 16 17 19 21 23 26 27 28 31 32 34 52 420 467 504 Also active in vitro against Acinetobacter, Aeromonas, Brucella, Francisella tularensis, Legionella pneumophila, Vibrio, and Yersinia pestis.3 13 21 22 25 27 32 34 37 75 79 92 97 420 469 623 624 625 627 Burkholderia cepacia are resistant.12 21 25 27 34 37 50 58 75
Other organisms: Active in vitro and in clinical infections against by C. pneumoniae,1 32 34 45 82 83 84 85 86 88 90 569 M. pneumoniae,87 91 420 464 568 M. tuberculosis,93 94 96 98 99 100 105 108 M. fortuitum,256 332 333 674 and other mycobacteria.98 99 104
N. gonorrhoeae with decreased susceptibility to ofloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) are widely disseminated worldwide, including in the US.319 578 580 581 583 584 585 642 671
Advice to Patients
Advise patients that antibacterials (including ofloxacin) should only be used to treat bacterial infections and not used to treat viral infections (e.g., the common cold).1
Importance of completing full course of therapy, even if feeling better after a few days.1
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness and increase the likelihood that bacteria will develop resistance and will not be treatable with ofloxacin or other antibacterials in the future.1
Importance of taking ofloxacin at least 2 hours before or after multivitamins containing calcium, magnesium, or zinc; aluminum- or magnesium-containing antacids; or buffered didanosine (pediatric oral solution admixed with antacid).1
May be taken without regard to meals.1
Importance of drinking sufficient quantities of fluids during therapy.1
Importance of discontinuing ofloxacin and informing clinician if rash, hives, or other manifestation suggesting allergic reaction (e.g., rapid heart beat, difficulty swallowing or breathing, swelling of lips, tongue, face, tightness in throat or hoarseness) occurs.1
Increased risk of tendinitis and tendon rupture in all age groups and further increased risk in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients.1 675 676 680 Importance of resting and refraining from exercise at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon; weakness or inability to use a joint), discontinuing the drug, and contacting a clinician regarding changing to an anti-infective that is not a fluoroquinolone.1 675 676 680 (See Tendinopathy and Tendon Rupture under Cautions.)
Advise patients that ofloxacin may worsen myasthenia gravis symptoms; importance of immediately contacting clinician if any worsening muscle weakness or breathing problems occur.1
Potential for ofloxacin to cause dizziness and lightheadedness; need for caution when operating machinery or driving a motor vehicle until effects of drug on individual are known.1
Advise patients to avoid excessive sunlight or artificial UV light during therapy and to discontinue ofloxacin if phototoxicity occurs.1
Advise patients that seizures have been reported and to contact clinicians before taking ofloxacin if they have a history of seizures.1
Advise patients that peripheral neuropathies have been reported with ofloxacin and that symptoms may occur soon after initiation of the drug and may be irreversible.1 Importance of immediately discontinuing the drug and contacting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness) occur.1
Importance of discontinuing ofloxacin and consulting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness) develop.1
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1
Advise diabetic patients that hypoglycemic reactions have been reported and to discontinue ofloxacin and contact a clinician if a hypoglycemic reaction occurs.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 11/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Ofloxacin 200MG Tablets (RANBAXY PHARMACEUTICALS): 14/$66.99 or 42/$179.97
Ofloxacin 300MG Tablets (TEVA PHARMACEUTICALS USA): 14/$65.99 or 42/$185.95
AHFS DI Essentials. © Copyright, 2004-2013, Selected Revisions October 12, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Teva Pharmaceuticals USA Inc. Ofloxacin tablets prescribing information. Sellersville, PA; 2013 Jul.
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