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
AUDIENCE: Family Practice, Infectious Disease, Neurology, Pharmacy, Patient
ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA's strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.
FDA has determined that fluoroquinolones should be reserved for use in patients who have no other treatment options for acute bacterial sinusitis, acute exacerbation of chronic bronchitis, and uncomplicated urinary tract infections because the risk of these serious side effects generally outweighs the benefits in these patients. For some serious bacterial infections the benefits of fluoroquinolones outweigh the risks, and it is appropriate for them to remain available as a therapeutic option.
FDA is continuing to assess safety issues with fluoroquinolones as part of FDA's usual ongoing review of drugs and will update the public if additional actions are needed. See the FDA Drug Safety Communication, available at: , for additional information, including a Data Summary and Additional Information for Health Care Professionals and Patients.
BACKGROUND: The labels of fluoroquinolone medicines already have a Boxed Warning for tendinitis, tendon rupture, and worsening of myasthenia gravis. The labels also include warnings about the risks of peripheral neuropathy and central nervous system effects. Other serious risks associated with fluoroquinolones are described in the labels, such as cardiac, dermatologic, and hypersensitivity reactions. After FDA's 2013 review that led to the additional warning that peripheral neuropathy may be irreversible, FDA evaluated post-marketing reports of apparently healthy patients who experienced disabling and potentially permanent side effects involving two or more body systems after being treated with a systemic fluoroquinolone
RECOMMENDATION: Patients must contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness in the arms or legs, confusion, and hallucinations. Talk with your health care professional if you have any questions or concerns (see List of Serious Side Effects from Fluoroquinolones in the FDA Drug Safety Communication, available at: ).
Health care professionals should not prescribe systemic fluoroquinolones to patients who have other treatment options for acute bacterial sinusitis (ABS), acute bacterial exacerbation of chronic bronchitis (ABECB), and uncomplicated urinary tract infections (UTI) because the risks outweigh the benefits in these patients. Stop fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient's treatment course.
AUDIENCE: Internal Medicine, Family Practice, Pharmacy, Patient
ISSUE: FDA is advising that the serious side effects associated with fluoroquinolone antibacterial drugs generally outweigh the benefits for patients with sinusitis, bronchitis, and uncomplicated urinary tract infections who have other treatment options. For patients with these conditions, fluoroquinolones should be reserved for those who do not have alternative treatment options.
An FDA safety review has shown that fluoroquinolones when used systemically (i.e. tablets, capsules, and injectable) are associated with disabling and potentially permanent serious side effects that can occur together. These side effects can involve the tendons, muscles, joints, nerves, and central nervous system.
As a result, FDA is requiring the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs to be updated to reflect this new safety information. FDA is continuing to investigate safety issues with fluoroquinolones and will update the public with additional information if it becomes available.
See the FDA Drug Safety Communication (see ) for a list of currently available FDA approved fluoroquinolones for systemic use.
BACKGROUND: The safety issues described in the Drug Safety Communication were also discussed at an FDA Advisory Committee (see ) meeting in November 2015.
RECOMMENDATION: Patients should contact your health care professional immediately if you experience any serious side effects while taking your fluoroquinolone medicine. Some signs and symptoms of serious side effects include tendon, joint and muscle pain, a “pins and needles” tingling or pricking sensation, confusion, and hallucinations. Patients should talk with your health care professional if you have any questions or concerns.
Health care professionals should stop systemic fluoroquinolone treatment immediately if a patient reports serious side effects, and switch to a non-fluoroquinolone antibacterial drug to complete the patient's treatment course.
For more information visit the FDA website at: and .
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
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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†.557 If caused by bacteria, may be self-limited and resolve within 3–5 days without anti-infective treatment;305 525 if diarrhea is moderate or severe, associated with fever or bloody stools, persisting for >3 days, or extremely disruptive to travel plans, short-term (1–3 days) anti-infective treatment usually recommended.305 525 Fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) usually drugs of choice when anti-infective treatment, including self-treatment, indicated.305 525 557 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.305 525 588 CDC and most experts do not recommend routine anti-infective prophylaxis in individuals traveling to areas of risk.305 524 525 527 529 Consider prophylaxis only in certain travelers, including short-term travelers who are high-risk individuals (e.g., HIV-infected or other immunocompromised individuals, travelers with poorly controlled diabetes mellitus or chronic renal failure) and those taking critical trips during which even a short episode of diarrhea could adversely affect the purpose of the trip.305 525 The principal preventive measures for travelers are prudent dietary practices.525 If anti-infective prophylaxis used, a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin) usually 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 drugs.406 594 595 596 643 Some clinicians suggest that multiple-drug regimens that include ofloxacin (with azithromycin or with tetracycline and metronidazole), omeprazole, and a bismuth salt can be considered second-line or rescue therapy in patients with H. pylori infection not eradicated with first-line multiple-drug treatment regimens.594 595 596
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.605
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)†.668 CDC, US Public Health Service Advisory Committee on Immunization Practices (ACIP), US Working Group on Civilian Biodefense, and US Army Medical Research Institute of Infectious Diseases (USAMRIID) recommend oral ciprofloxacin and oral doxycycline as initial drugs of choice for prophylaxis following such exposures, including exposures that occur in the context of biologic warfare or bioterrorism.663 668 683 686 Some of these experts state that levofloxacin or other oral fluoroquinolones (moxifloxacin, ofloxacin) are alternatives for postexposure prophylaxis when ciprofloxacin or doxycycline cannot be used.663 668
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).668 A multiple-drug parenteral regimen (ciprofloxacin or doxycycline and 1 or 2 other anti-infectives predicted to be effective) 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.668 686
Treatment of brucellosis† caused by Brucella melitensis; used in conjunction with other anti-infectives.561 562 772 Monotherapy with any drug usually associated with high relapse rate and not recommended.683 772
Alternative for treatment of urethral and cervical infections caused by Chlamydia trachomatis.1 319 CDC recommends azithromycin or doxycycline;319 alternatives are erythromycin, levofloxacin, or ofloxacin.319
Gonorrhea and Associated Infections
Because quinolone-resistant N. gonorrhoeae (QRNG) widely disseminated worldwide, including in the US114 116 319 642 (see Resistance in Neisseria gonorrhoeae under Cautions), CDC states fluoroquinolones no longer recommended for treatment of gonorrhea and should not be used routinely for any associated infections that may involve N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).114 116 319
Alternative for treatment of acute PID.319 (See Pelvic Inflammatory Disease under Uses.)
Alternative for treatment of acute epididymitis†.319 CDC recommends a single IM dose of ceftriaxone in conjunction with oral doxycycline for acute epididymitis most likely caused by sexually transmitted chlamydia and gonorrhea or a single IM dose of ceftriaxone in conjunction with oral levofloxacin or ofloxacin for treatment of acute epididymitis most likely caused by sexually transmitted chlamydia and gonorrhea and enteric bacteria (e.g., in men who practice insertive anal sex).319 Levofloxacin or ofloxacin can be used alone if acute epididymitis most likely caused by enteric bacteria (e.g., in men who have undergone prostate biopsy, vasectomy, or other urinary tract instrumentation procedure) and gonorrhea ruled out (e.g., by gram, methylene blue, or gentian violet stain).319
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.218 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),218 456 563 647 653 655 656 657 658 levofloxacin and moxifloxacin are the fluoroquinolones recommended by CDC, ATS, and IDSA and levofloxacin may be preferred on the basis of cumulative experience.218 The most recent CDC, ATS, and IDSA recommendations for treatment of tuberculosis should be consulted for more specific information.218
Alternative for use in multiple-drug therapy (MDT) for treatment of multibacillary leprosy† (Hansen's disease) caused by M. leprae.215 216 WHO and US National Hansen's Disease Program (NHDP) state ofloxacin can be used instead of clofazimine in treatment regimens in adults with multibacillary leprosy who will not accept or cannot tolerate clofazimine.215 216
Treatment of leprosy is complicated and should be undertaken in consultation with a specialist familiar with the disease.216 In the US, clinicians should contact NHDP at 800-642-2477 on weekdays from 9:00 a.m. to 5:30 p.m. Eastern Standard Time or via email at email@example.com for assistance with diagnosis or treatment of leprosy or assistance obtaining clofazimine for treatment of leprosy.216
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).671
Alternative for treatment of nongonococcal urethritis (NGU).1 287 299 300 301 302 307 308 309 311 319 436 447 449 450 503 CDC recommends azithromycin or doxycycline;319 alternatives are erythromycin, levofloxacin, or ofloxacin.319
Pelvic Inflammatory Disease
When combined IM and 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 If a parenteral cephalosporin not feasible (e.g., because of cephalosporin allergy), CDC states regimen of oral levofloxacin, ofloxacin, or moxifloxacin given in conjunction with oral metronidazole can be considered if community prevalence and individual risk of gonorrhea is low and diagnostic testing for gonorrhea performed.319 If QRNG are identified or if in vitro susceptibility cannot be determined (e.g., only nucleic acid amplification test [NAAT] for gonorrhea available), consultation with infectious disease specialist recommended.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.683 688 Streptomycin (or gentamicin) historically has been considered regimen of choice for treatment of plague;292 538 683 688 alternatives are doxycycline (or tetracycline), chloramphenicol (a drug of choice for plague meningitis), fluoroquinolones (ciprofloxacin [a drug of choice for plague meningitis], levofloxacin, moxifloxacin), or co-trimoxazole (may be less effective than other alternatives).292 538 683 688 Regimens recommended for treatment of naturally occurring or endemic bubonic, septicemic, or pneumonic plague also recommended for plague that occurs following exposure to Y. pestis in the context of biologic warfare or bioterrorism.683 688
Postexposure prophylaxis† following 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).683 688 Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (e.g., ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin); chloramphenicol is an alternative.683 688
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
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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
300 mg once daily.588
Anti-infective prophylaxis generally discouraged (see GI Infections under Uses);305 525 if such prophylaxis used, give during period of risk (not exceeding 2–3 weeks) beginning day of travel and continuing for 1 or 2 days after leaving area of risk.305 588
Helicobacter pylori Infection and Duodenal Ulcer Disease†Oral
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 of Anthrax†Oral
Optimum duration of postexposure prophylaxis after an inhalation exposure to B. anthracis spores is unclear.554 683 Because of possible persistence of spores in lung tissue following an aerosol exposure, CDC, ACIP, US Working Group on Civilian Biodefense, and USAMRIID recommend that anti-infective 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).668 682 683
If used in conjunction with anthrax vaccine, ACIP and USAMRIID recommend continuing anti-infective prophylaxis until 14 days after the third vaccine dose (even if this results in >60 days of anti-infective prophylaxis).663 683
Fully or partially vaccinated laboratory workers or other individuals working in occupations that result in repeated exposure to aerosolized B. anthracis spores: ACIP recommends anti-infective prophylaxis for ≥30 days in conjunction with any remaining indicated vaccine doses if there is any type of disruption of personal protective equipment.663
Unvaccinated workers following an occupational exposure to B. anthracis spores: ACIP recommends anti-infective prophylaxis for 60 days in conjunction with postexposure vaccination;663 continue anti-infective prophylaxis until 14 days after third vaccine dose (even if this results in >60 days of anti-infective prophylaxis).663
Treatment of Inhalational Anthrax†Oral
400 mg twice daily for ≥60 days.668
Initial parenteral treatment regimen preferred; use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).668 683 686 Continue for total duration of ≥60 days if inhalational anthrax occurred as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism.668 683 686
400 mg once daily in conjunction with oral rifampin (600 mg once daily) given for 6 weeks was effective in some patients.561 Alternatively, 400 mg twice daily for 6 weeks recommended for use in multiple-drug regimens.772
Gonorrhea and Associated Infections
No longer recommended by CDC for treatment of gonorrhea.319 (See Gonorrhea and Associated Infections under Uses.)
300 mg twice daily for 10 days recommended by CDC.319
400 mg every 12 hours for 2–3 weeks.622
Treatment of multibacillary leprosy† in adults who will not accept or cannot tolerate clofazimine: WHO recommends ofloxacin (400 mg once daily), rifampin (600 mg once monthly), and dapsone (100 mg once daily) given for 12 months.215 For US patients, NHDP recommends ofloxacin (400 mg once daily), rifampin (600 mg once daily), and dapsone (100 mg once daily) given for 24 months.216
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.671
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.671
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
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
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.1 533 607 609 610 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.114
CDC states that fluoroquinolones, including ofloxacin, no longer recommended for treatment of gonorrhea and should not be used routinely for any associated infections that may involve N. gonorrhoeae (e.g., PID, epididymitis).114 116 319
Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during therapy.1
Use during pregnancy only if potential benefits justify potential risks to fetus.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 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,160 183 197 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,159 214 tears,183 sweat,183 lung,1 183 189 205 219 228 430 blister fluid,1 183 189 192 226 pancreatic fluid,160 201 ascitic fluid,168 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 74 132 504 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, 621 630 631 682 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,256 332 333 671 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.114 319 578 580 581 583 584 585 642
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.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions July 26, 2016. 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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