Ofloxacin (Monograph)

Drug class: Quinolones
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

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Warning

Fluoroquinolones, including ofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that have occurred together.¹ Discontinue immediately and avoid use of fluoroquinolones, including ofloxacin, in patients who have experienced any of these serious adverse reactions.¹ (See Warnings under Cautions.)
Fluoroquinolones, including ofloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.¹ Avoid in patients with known history of myasthenia gravis.¹
Because of risk of serious adverse reactions, use ofloxacin for treatment of acute bacterial exacerbations of chronic bronchitis or uncomplicated urinary tract infections (UTIs) only when no other treatment options available.¹

Introduction

Antibacterial; fluoroquinolone.¹ ² ³ ⁵ ⁴²⁰ ⁴⁴² ⁴⁶⁴ ⁶³⁴ ⁶³⁶

Uses for Ofloxacin

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

Use for treatment of acute bacterial exacerbations of chronic bronchitis only when no other treatment options available.¹ ¹⁴⁰ ¹⁴⁵ Because systemic fluoroquinolones, including ofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient (see Cautions)¹ ¹⁴⁰ ¹⁴⁵ and because acute bacterial exacerbations of chronic bronchitis may be self-limiting in some patients,¹ risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with these infections.¹⁴⁰ ¹⁴⁵

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

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^{† [off-label]},⁴²⁰ S. pyogenes (group A β-hemolytic streptococci; GAS),¹ or P. mirabilis;¹ also has been used for treatment of skin and skin structure infections caused by susceptible E. coli^{† [off-label]}²⁵⁵ or Ps. aeruginosa^{† [off-label]}.²⁵⁵

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^{† [off-label]},⁴⁹⁰ E. cloacae^{† [off-label]},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; GBS).²⁷⁸

Use for treatment of uncomplicated UTIs only when no other treatment options available.¹ ¹⁴⁰ ¹⁴⁵ Because systemic fluoroquinolones, including ofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient (see Cautions)¹ ¹⁴⁰ ¹⁴⁵ and because uncomplicated UTIs may be self-limiting in some patients,¹ risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with uncomplicated UTIs.¹⁴⁰ ¹⁴⁵

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

Treatment of recurrent UTIs and chronic prostatitis in men caused by susceptible E. coli.¹ ²⁸⁴ ²⁸⁵ ²⁸⁶ ²⁸⁸

GI Infections

Has been used for treatment of shigellosis^† caused by susceptible Shigella^†.⁴⁷⁷ Anti-infectives may not be required for mild infections, but generally indicated in addition to fluid and electrolyte replacement for treatment of patients with severe shigellosis, dysentery, or underlying immunosuppression.²⁹² ⁴⁴⁰ Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common.²⁹² Fluoroquinolones (preferably ciprofloxacin or, alternatively, levofloxacin or moxifloxacin) generally have been recommended,²⁹² ⁴⁴⁰ ⁴⁷⁷ ⁵⁶⁶ but consider that fluoroquinolone-resistant Shigella reported in the US, especially in international travelers, the homeless, and men who have sex with men (MSM).⁴⁴⁰ Depending on in vitro susceptibility, other drugs recommended for treatment of shigellosis include co-trimoxazole, ceftriaxone, azithromycin (not recommended in those with bacteremia), or ampicillin.¹⁹⁷ ²⁹² ⁴⁴⁰ ⁴⁷⁷

Has been used for treatment of travelers’ diarrhea^†.⁵⁵⁷ If caused by bacteria, may be self-limited and resolve within 3–7 days without anti-infective treatment.³⁰⁵ ⁵²⁵ CDC states anti-infective treatment not recommended for mild travelers' diarrhea;⁵²⁵ CDC and others state empiric short-term anti-infective treatment (single dose or up to 3 days) may be used if diarrhea is moderate or severe, associated with fever or bloody stools, or extremely disruptive to travel plans.³⁰⁵ ⁵²⁵ Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) generally have been considered anti-infectives of choice for empiric anti-infective treatment, including self-treatment;³⁰⁵ ⁵²⁵ alternatives include azithromycin and rifaximin.³⁰⁵ ⁵²⁵ Consider that increasing incidence of enteric bacteria resistant to fluoroquinolones and other anti-infectives may limit usefulness of empiric treatment in individuals traveling in certain geographic areas;⁵²⁵ also consider possible adverse effects of the anti-infective and adverse consequences of such treatment (e.g., development of resistance, effect on normal gut microflora).⁵²⁵

Prevention of travelers’ diarrhea^† in individuals traveling for relatively short periods to areas of risk.⁵⁸⁸ CDC and others do not recommend anti-infective prophylaxis in most travelers.³⁰⁵ ⁵²⁴ ⁵²⁵ ⁵²⁷ ⁵²⁹ May consider prophylaxis in 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 purpose of trip.³⁰⁵ ⁵²⁵ If anti-infective prophylaxis used, fluoroquinolones (e.g., ciprofloxacin, levofloxacin) usually have been recommended;³⁰⁵ ⁵²⁵ alternatives include azithromycin and rifaximin.³⁰⁵ ⁵²⁵ Weigh use of anti-infective prophylaxis against use of prompt, early self-treatment with an empiric anti-infective if moderate to severe travelers' diarrhea occurs.⁵²⁵ Also consider increasing incidence of fluoroquinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter, Salmonella, Shigella).³⁰⁵ ⁵²⁵

Has been used as a component of various multiple-drug regimens for treatment of infections caused by Helicobacter pylori^†.⁴⁰⁶ ⁵⁹⁴ ⁵⁹⁵ ⁵⁹⁶ ⁶⁴³ Levofloxacin is the fluoroquinolone usually included in multiple-drug regimens recommended for first- or second-line and salvage therapy of such infections.²³⁵ Data are limited regarding prevalence of fluoroquinolone-resistant H. pylori in the US;²³⁵ possible impact of such resistance on efficacy of fluoroquinolone-containing regimens used for treatment of H. pylori infection not known.²³⁵

Anthrax

Alternative for postexposure prophylaxis following suspected or confirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax)^†.⁶⁶⁸ CDC, AAP, 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.⁶⁶⁸ ⁶⁷¹ ⁶⁷³ ⁶⁸³ ⁶⁸⁶ Other oral fluoroquinolones (levofloxacin, moxifloxacin, ofloxacin) are alternatives for postexposure prophylaxis when ciprofloxacin or doxycycline cannot be used.⁶⁶⁸ ⁶⁷¹ ⁶⁷³

Has been suggested as a possible 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 should be used for initial treatment of inhalational anthrax that occurs as the result of exposure to anthrax spores in the context of biologic warfare or bioterrorism;⁶⁶⁸ ⁶⁷¹ ⁶⁷³ ⁶⁸⁶ parenteral regimen may not be possible if large numbers of individuals require treatment in a mass casualty setting and it may be necessary to use an oral regimen.⁶⁶⁸

Brucellosis

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

Chlamydial Infections

Alternative for treatment of urethral and cervical infections caused by Chlamydia trachomatis.¹ ³⁴⁴ CDC recommends azithromycin or doxycycline;³⁴⁴ alternatives are erythromycin, levofloxacin, or ofloxacin.³⁴⁴

Gonorrhea and Associated Infections

Was used in the past for treatment of acute, uncomplicated gonorrhea caused by susceptible Neisseria gonorrhoeae.¹ ²⁸⁹ ²⁹⁰ ²⁹¹ ²⁹⁴ ²⁹⁶ ³⁰⁰ ⁴⁸⁶ ⁴⁸⁷ ⁴⁹⁸

Because quinolone-resistant N. gonorrhoeae (QRNG) widely disseminated worldwide, including in the US,¹¹⁴ ¹¹⁶ ³⁴⁴ ⁶⁴² ⁸⁵⁷ 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).¹¹⁴ ¹¹⁶ ³⁴⁴

Alternative for treatment of acute PID.³⁴⁴ (See Pelvic Inflammatory Disease under Uses.)

Alternative for treatment of acute epididymitis^†.³⁴⁴ 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).³⁴⁴ 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).³⁴⁴

Mycobacterial Infections

Has been used in multiple-drug regimens for treatment of active tuberculosis^† caused by Mycobacterium tuberculosis.⁹⁴ ⁴¹⁷ ⁴⁵⁶ ⁴⁶⁴ ⁵⁴⁵ ⁵⁶⁴

ATS, CDC, and IDSA state that use of fluoroquinolones as alternative (second-line) agents can be considered for treatment of active tuberculosis in patients intolerant of certain first-line agents or in those with relapse, treatment failure, or M. tuberculosis resistant to certain first-line agents.²¹⁸ ⁴⁴⁰ However, if a fluoroquinolone is used in multiple-drug regimens for treatment of active tuberculosis, levofloxacin or moxifloxacin is recommended.²¹⁸ ²³¹ ²⁷⁶ ⁴⁴⁰

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

Component of a single-dose MDT regimen for treatment of single-lesion paucibacillary leprosy^†.²¹¹ ²¹² ²¹⁷

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 nhdped@hrsa.gov 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).⁶⁷⁵

Nongonococcal Urethritis

Alternative for treatment of nongonococcal urethritis (NGU).¹ ¹²⁴ ²⁸⁷ ²⁹⁹ ³⁰⁰ ³⁰¹ ³⁰⁷ ³⁰⁸ ³⁰⁹ ³¹¹ ³⁴⁴ ⁴³⁶ ⁴⁴⁷ ⁴⁴⁹ ⁴⁵⁰ ⁵⁰³ CDC recommends azithromycin or doxycycline;³⁴⁴ alternatives are erythromycin, levofloxacin, or ofloxacin.³⁴⁴

Pelvic Inflammatory Disease

Alternative for treatment of acute PID.¹ ³⁴⁴ Do not use in any infections that may involve N. gonorrhoeae.¹¹⁴ ¹¹⁶ ³⁴⁴

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).³⁴⁴ 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.³⁴⁴ 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.³⁴⁴

Plague

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;¹⁹⁷ ²⁹² ⁶⁸³ ⁶⁸⁸ 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).¹⁹⁷ ²⁹² ⁶⁸³ ⁶⁸⁸ 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).⁶⁸³ ⁶⁸⁸

Rickettsial Infections

Has been used for treatment of some rickettsial infections^†,³²⁵ ³²⁶ ⁵⁶⁰ ⁵⁶⁶ including Mediterranean spotted fever caused by Rickettsia conorii^†.³²⁶

Doxycycline is drug of choice for treatment of all tickborne rickettsial diseases.¹⁹⁷ ⁵⁰⁰ Although some fluoroquinolones have in vitro activity against Rickettsiae,⁵⁰⁰ CDC states that fluoroquinolones are not recommended for treatment of Rocky Mountain spotted fever.⁵⁰⁰

Has been used for treatment of acute Q fever pneumonia caused by Coxiella burnetii^†.³²⁵ ⁵⁶⁰ 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

Has been used for treatment of typhoid fever^† (enteric fever) caused by susceptible Salmonella enterica serovar Typhi, including chloramphenicol-resistant strains.³¹⁸ ³²⁰ ³³¹ ⁴²⁹ ⁴⁸¹ ⁴⁹²

Although fluoroquinolones have been recommended for empiric treatment of Salmonella enteric fever, resistance to fluoroquinolones reported in >80% of such infections in travelers to South and Southeast Asia and treatment failures will occur.⁵²⁵

Ofloxacin Dosage and Administration

Administration

Oral Administration

Administer orally.¹ ⁴¹⁷ ⁴²⁷ ⁴⁶⁴

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

Dosage

Adults

General Adult Dosage

Oral

200–400 mg every 12 hours.¹

Respiratory Tract Infections

Acute Bacterial Exacerbations of Chronic Bronchitis

Oral

400 mg every 12 hours for 10 days.¹ (See Respiratory Tract Infections under Uses.)

Community-acquired Pneumonia

Oral

400 mg every 12 hours for 10 days.¹

Skin and Skin Structure Infections

Uncomplicated Infections

Oral

400 mg every 12 hours for 10 days.¹

Urinary Tract Infections (UTIs) and Prostatitis

Uncomplicated Cystitis Caused by E. coli or K. pneumoniae

Oral

200 mg every 12 hours for 3 days.¹ (See Urinary Tract Infections [UTIs] and Prostatitis under Uses.)

Uncomplicated Cystitis Caused by Other Susceptible Bacteria

Oral

200 mg every 12 hours for 7 days.¹ (See Urinary Tract Infections [UTIs] and Prostatitis under Uses.)

Complicated UTIs

Oral

200 mg every 12 hours for 10 days.¹

Prostatitis Caused by E. coli

Oral

300 mg every 12 hours for 6 weeks¹ or longer.²⁸⁴ ²⁸⁵

GI Infections

Treatment of Travelers’ Diarrhea†

Oral

300 mg twice daily.⁵⁵⁷ Recommended treatment duration is 1–3 days.³⁰⁵ ⁵⁵⁷

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†

Oral

200 mg twice daily for 7–14 days has been given as part of a multiple-drug regimen.⁴⁰⁶ ⁵⁹⁴ ⁵⁹⁵ ⁵⁹⁶ (See GI Infections under Uses.)

Anthrax†

Postexposure Prophylaxis of Anthrax (Biologic Warfare or Bioterrorism Exposure)†

Oral

Some experts recommend 400 mg twice daily.⁶⁶⁸

Initiate prophylaxis as soon as possible following suspected or confirmed exposure to aerosolized B. anthracis.⁶⁶⁸ ⁶⁷³ ⁶⁸³

Because of possible persistence of B. anthracis spores in lung tissue following an aerosol exposure, CDC and others recommend that anti-infective postexposure prophylaxis be continued for 60 days following a confirmed exposure.⁶⁶⁸ ⁶⁷³ ⁶⁸² ⁶⁸³

Treatment of Inhalational Anthrax (Biologic Warfare or Bioterrorism Exposure)†

Oral

400 mg twice daily.⁶⁶⁸

Initial multiple-drug parenteral treatment regimen recommended; use oral regimen after clinical improvement occurs or when a parenteral regimen not available (e.g., mass casualty setting).⁶⁶⁸ ⁶⁸³ ⁶⁸⁶

Because of possible persistence of B. anthracis spores in lung tissue following an aerosol exposure, continue for total duration of 60 days if inhalational anthrax occurred as the result of exposure to B. anthracis spores in the context of biologic warfare or bioterrorism.⁶⁶⁸ ⁶⁸³ ⁶⁸⁶

Brucellosis†

Oral

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

Chlamydial Infections

Urogenital Infections

Oral

300 mg twice daily for 7 days.¹ ³⁰¹ ³⁰⁷ ³⁰⁹ ³⁴⁴

Gonorrhea and Associated Infections

Uncomplicated Urethral and Cervical Gonorrhea

Oral

400 mg as a single dose recommended by manufacturer for infections caused by susceptible N. gonorrhoeae.¹

No longer recommended by CDC for treatment of gonorrhea.³⁴⁴ (See Gonorrhea and Associated Infections under Uses.)

Epididymitis†

Oral

300 mg twice daily for 10 days recommended by CDC.³⁴⁴

Use only when epididymitis^† most likely caused by sexually transmitted enteric bacteria (e.g., E. coli) and N. gonorrhoeae ruled out.³⁴⁴ (See Gonorrhea and Associated Infections under Uses.)

Mycobacterial Infections†

Leprosy†

Oral

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

Treatment of single-lesion paucibacillary leprosy^†: A single 600-mg dose of rifampin, a single 400-mg dose of ofloxacin, and a single 100-mg dose of minocycline has been used.²¹¹ ²¹² ²¹⁷

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.⁶⁷⁵

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.⁶⁷⁵

Nongonococcal Urethritis

Oral

300 mg twice daily for 7 days.¹ ³⁰¹ ³⁰⁷ ³⁰⁹ ³⁴⁴ ⁴⁴⁷

Pelvic Inflammatory Disease

Oral

400 mg every 12 hours for 10–14 days recommended by manufacturer.¹ CDC recommends 400 mg twice daily for 14 days given in conjunction with oral metronidazole (500 mg twice daily for 14 days).³⁴⁴

Use only when cephalosporins not feasible, community prevalence and individual risk of gonorrhea is low, and in vitro susceptibility confirmed.³⁴⁴ (See Pelvic Inflammatory Disease under Uses.)

Rickettsial Infections†

Mediterranean Spotted Fever†

Oral

200 mg every 12 hours for 7 days was effective in some patients.³²⁶

Q Fever†

Oral

Acute Q fever^† pneumonia caused by Coxiella burnetii: 600 mg daily for up to 16 days has been used.⁵⁶⁰

Q fever endocarditis^†: 200 mg 3 times daily in conjunction with oral doxycycline (100 mg twice daily); long-term treatment (≥4 years) may be required.⁴⁶⁰

Typhoid Fever†

Mild to Moderate Typhoid Fever†

Oral

200–400 mg every 12 hours for 7–14 days has been used.³¹⁸ ³²⁰ ³³¹ ⁴²⁹ ⁴⁸¹ ⁴⁹² (See Typhoid Fever under Uses.)

Special Populations

Hepatic Impairment

Maximum dosage of 400 mg daily in those with severe hepatic impairment (e.g., cirrhosis with or without ascites).¹

Renal Impairment

Dosage adjustments required in adults with Cl_cr ≤50 mL/minute.¹ ¹⁸² ²²⁰ ²²³ ²²⁴ ²²⁵

Dosage in Adults with Renal Impairment
Cl_cr (mL/min)	Dosage
20–50	Usual initial dose, then usual dose once every 24 hours¹
<20	Usual initial dose, then 50% of usual dose once every 24 hours¹
Hemodialysis Patients	Initial 200-mg dose, then 100 mg once daily;²²² ⁴³¹ supplemental doses not required after dialysis²²² ²²³

Geriatric Patients

No dosage adjustments except those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Ofloxacin

Contraindications

Known hypersensitivity to ofloxacin or other quinolones.¹

Warnings/Precautions

Warnings

Disabling and Potentially Irreversible Serious Adverse Reactions

Systemic fluoroquinolones, including ofloxacin, are associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient.¹ ¹⁴⁰ ¹⁴⁵ May occur within hours to weeks after a systemic fluoroquinolone is initiated;¹ have occurred in all age groups and in patients without preexisting risk factors for such adverse reactions.¹

Immediately discontinue ofloxacin at first signs or symptoms of any serious adverse reactions.¹ ¹⁴⁰ ¹⁴⁵

Avoid systemic fluoroquinolones, including ofloxacin, in patients who have experienced any of the serious adverse reactions associated with fluoroquinolones.¹ ¹⁴⁰ ¹⁴⁵

Tendinitis and Tendon Rupture

Systemic fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.¹ ⁶⁷⁶ ⁸⁵¹

Risk of fluoroquinolone-associated tendinitis and tendon rupture is increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.¹ (See Geriatric Use under Cautions.)

Other factors that may independently increase the risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.¹ Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any risk factors for such adverse reactions.¹

Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon;¹ also reported in rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites.¹

Tendinitis and tendon rupture can occur within hours or days after ofloxacin is initiated or as long as several months after completion of therapy and can occur bilaterally.¹

Immediately discontinue ofloxacin if pain, swelling, inflammation, or rupture of a tendon occurs.¹ ⁶⁷⁶ ⁸⁵¹ (See Advice to Patients.)

Avoid systemic fluoroquinolones, including ofloxacin, in patients who have a history of tendon disorders or have experienced tendinitis or tendon rupture.¹

Peripheral Neuropathy

Systemic fluoroquinolones, including ofloxacin, are associated with an increased risk of peripheral neuropathy.¹

Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with systemic fluoroquinolones, including ofloxacin.¹ ¹³⁰ Symptoms may occur soon after initiation of the drug and, in some patients, may be irreversible.¹ ¹³⁰

Immediately discontinue ofloxacin if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur or if there are other alterations in sensations (e.g., light touch, pain, temperature, position sense, vibratory sensation).¹ ¹³⁰ (See Advice to Patients.)

Avoid systemic fluoroquinolones, including ofloxacin, in patients who have experienced peripheral neuropathy.¹

CNS Effects

Systemic fluoroquinolones, including ofloxacin, are associated with increased risk of psychiatric adverse effects, including toxic psychosis,¹ hallucinations,¹ agitation,¹ delirium,¹ ¹⁷¹ confusion,¹ disorientation,¹ ¹⁷¹ disturbances in attention,¹ ¹⁷¹ nervousness,¹ ¹⁷¹ restlessness,¹ and memory impairment.¹ ¹⁷¹ These adverse effects may occur after first dose.¹

Systemic fluoroquinolones are associated with increased risk of convulsions (seizures), increased intracranial pressure (pseudotumor cerebri), lightheadedness, and tremors.¹ Use ofloxacin 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 psychiatric or other CNS effects occur, immediately discontinue ofloxacin and institute appropriate measures.¹ (See Advice to Patients.)

Exacerbation of Myasthenia Gravis

Fluoroquinolones, including ofloxacin, have neuromuscular blocking activity and may exacerbate muscle weakness in myasthenia gravis patients;¹ death or need for ventilatory support reported.¹

Avoid use in patients with known history of myasthenia gravis.¹ (See Advice to Patients.)

Sensitivity Reactions

Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions reported in patients receiving fluoroquinolones, including ofloxacin.¹ These reactions may occur with first dose.¹

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

Other serious and sometimes fatal adverse reactions reported with fluoroquinolones, including ofloxacin, that may or may not be related to hypersensitivity reactions include one or more of the following: 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

Immediately discontinue ofloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity.¹ Initiate appropriate therapy (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen) as indicated.¹

Photosensitivity Reactions

Moderate to severe photosensitivity/phototoxicity reactions reported with fluoroquinolones, including ofloxacin.¹

Phototoxicity may manifest as exaggerated sunburn reactions (e.g., burning, erythema, exudation, vesicles, blistering, edema) on areas exposed to sun or artificial ultraviolet (UV) light (usually the face, neck, extensor surfaces of forearms, dorsa of hands).¹

Avoid unnecessary exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment).¹ If patient needs to be outdoors, they should wear loose-fitting clothing that protects skin from sun exposure and use other sun protection measures (sunscreen).¹

Discontinue ofloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.¹

Other Warnings and Precautions

Risk of Aortic Aneurysm and Dissection

Rupture or dissection of aortic aneurysms reported in patients receiving systemic fluoroquinolones.¹⁷² Epidemiologic studies indicate an increased risk of aortic aneurysm and dissection within 2 months following use of systemic fluoroquinolones, particularly in geriatric patients.¹ Cause for this increased risk not identified.¹ ¹⁷²

Unless there are no other treatment options, do not use systemic fluoroquinolones, including ofloxacin, in patients who have an aortic aneurysm or are at increased risk for an aortic aneurysm.¹ ¹⁷² This includes geriatric patients and patients with peripheral atherosclerotic vascular disease, hypertension, or certain genetic conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome).¹⁷²

If patient reports adverse effects suggestive of aortic aneurysm or dissection, immediately discontinue the fluoroquinolone.¹⁷² (See Advice to Patients.)

Hypoglycemia or Hyperglycemia

Systemic fluoroquinolones are associated with alterations in blood glucose concentrations, including symptomatic hypoglycemia and hyperglycemia.¹ ¹⁷¹ Blood glucose disturbances during fluoroquinolone therapy usually have occurred in patients with diabetes mellitus receiving an oral antidiabetic agent (e.g., glyburide) or insulin.¹ ¹⁷¹

Severe cases of hypoglycemia resulting in coma or death reported with some systemic fluoroquinolones.¹ ¹⁷¹ Although most reported cases of hypoglycemic coma involved patients with risk factors for hypoglycemia, (e.g., older age, diabetes mellitus, renal insufficiency, concomitant use of antidiabetic agents [especially sulfonylureas]), some involved patients receiving a fluoroquinolone who were not diabetic and not receiving an oral antidiabetic agent or insulin.¹⁷¹

Carefully monitor blood glucose concentrations when ofloxacin used in diabetic patients receiving antidiabetic agents.¹ ¹⁷¹

If hypoglycemic reaction occurs, discontinue ofloxacin and immediately initiate appropriate therapy.¹ (See Advice to Patients.)

Musculoskeletal Effects

Fluoroquinolones, including ofloxacin, cause arthropathy and osteochondrosis in immature animals of various species.¹ ³³⁹ ³⁴² ³⁵⁹ ⁴¹³ ⁴¹⁷ ⁴²⁰ ⁴²¹ ⁴²⁸ ⁴⁴⁶ ⁴⁶⁴ 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

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 history of 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 of prolonged QT interval may be increased in geriatric patients.¹ (See Geriatric Use under Cautions.)

Hepatotoxicity

Severe hepatotoxicity, including acute hepatitis and fatalities, reported.¹

Superinfection/C. difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible bacteria or fungi.⁴²⁰ ⁴³⁹

Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides difficile (formerly known as Clostridium difficile).¹ ³⁰² ³⁰³ ³⁰⁴ ⁵³³ 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.¹ ³⁰² ³⁰³ ³⁰⁴ ³⁴¹ ³⁴³ ³⁵² ³⁵³ ³⁵⁰ ³⁵¹ ³⁵⁵ ³⁵⁶ C. difficile produces toxins A and B which contribute to development of CDAD;¹ ³⁰² 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.¹ ³⁰² ³⁰³ ³⁰⁴ Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.¹

If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile as soon as possible.³⁰² Manage using appropriate anti-infective therapy directed against C. difficile (e.g., vancomycin, fidaxomicin, metronidazole), supportive therapy (e.g., fluid and electrolyte management, protein supplementation), and surgical evaluation as clinically indicated.¹ ³⁰² ³⁰³ ³⁰⁴

Selection and Use of Anti-infectives

Use for treatment of acute bacterial exacerbations of chronic bronchitis or uncomplicated UTIs only when no other treatment options available.¹ ¹⁴⁰ ¹⁴⁵ Because ofloxacin, like other systemic fluoroquinolones, has been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that can occur together in the same patient, risks of serious adverse reactions outweigh benefits for patients with these infections.¹⁴⁰ ¹⁴⁵

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

Laboratory Monitoring

Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during therapy.¹

Specific Populations

Pregnancy

No adequate and well-controlled studies in pregnant women;¹ safety and efficacy not established.¹

Use during pregnancy only if potential benefits justify potential risks to fetus.¹

Animal studies (rats and rabbits) did not reveal evidence of teratogenicity,¹ but fetotoxicity (decreased fetal body weight, increased fetal mortality) reported.¹

Lactation

Distributed into milk;¹ discontinue nursing or the drug.¹

Pediatric Use

Safety and efficacy not established in children and adolescents <18 years of age.¹

Fluoroquinolones cause arthropathy in juvenile animals.¹ ³³⁹ ³⁴² ³⁵⁹ ⁴²⁰ ⁴²¹ ⁴²⁸ ⁴⁴⁶ (See Musculoskeletal Effects under Cautions.)

AAP states use of a systemic fluoroquinolone may be justified in children <18 years of age in certain specific circumstances when there are no safe and effective alternatives and the drug is known to be effective.²⁹² ²⁹³

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.¹

Risk of fluoroquinolone-associated tendon disorders, including tendon rupture, is increased in geriatric adults >60 years of age.¹ ⁶⁷⁶ ⁸⁵¹ This risk is further increased in those receiving concomitant corticosteroids.¹ ⁶⁷⁶ ⁸⁵¹ (See Tendinitis and Tendon Rupture under Cautions.) Use caution in geriatric adults, especially those receiving concomitant corticosteroids.¹

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.)

Risk of fluoroquinolone-associated aortic aneurysm and dissection may be increased in geriatric patients.¹ (See Risk of Aortic Aneurysm and Dissection 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.)

Hepatic Impairment

Use with caution; perform appropriate hepatic function tests prior to and during therapy.¹

Renal Impairment

Decreased clearance and increased half-life.¹

Use with caution; perform appropriate renal function tests prior to and during therapy.¹

Decrease dosage in those with Cl_cr ≤50 mL/minute.¹ ¹⁸² ²²⁰ ²²³ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

GI effects (nausea, diarrhea, vomiting); nervous system effects (headache, dizziness, insomnia); rash; genital pruritus.¹

Drug Interactions

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	Interaction	Comments
Aminoglycosides	In vitro evidence of additive or synergistic antibacterial effects against Enterobacteriaceae and Ps. aeruginosa;³⁷¹ ³⁷³ ³⁷⁵ synergism unpredictable and indifference or antagonism also reported ³⁷⁵
Antacids (aluminum-, magnesium-, or calcium-containing)	Decreased absorption of ofloxacin¹ ¹⁸⁹ ³⁶⁷ ⁴⁰⁴ ⁴⁰⁵ ⁴¹⁴ ⁴²⁰ ⁴²⁷ ⁴⁶⁴	Administer ofloxacin at least 2 hours before or after such antacids¹ ⁴⁰⁴ ⁴¹⁴ ⁴²⁷ ⁵³⁶
Anticoagulants, oral (warfarin)	Potential for enhanced warfarin effects¹ ³⁶⁷ ⁴⁰³ ⁴²⁷ ⁵⁹³	Use with caution; monitor PT¹ ³⁶⁷ ⁴⁰³ ⁴²⁷ ⁵⁹³
Antidiabetic agents (glyburide, glibenclamide, insulin)	Blood glucose alterations (including hypoglycemia) reported in diabetic patients¹	Closely monitor blood glucose concentrations¹
β-lactam antibiotics	In vitro evidence of additive or synergistic antibacterial effects against some gram-positive bacteria;³⁷² indifference against Enterobacteriaceae or Ps aeruginosa¹²
Caffeine	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
Corticosteroids	Increased risk of tendinitis or tendon rupture, especially in patients >60 years of age¹
Cyclosporine	Increased cyclosporine concentrations reported with some fluoroquinolones;¹ unclear whether this occurs with ofloxacin¹
Didanosine	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)	No evidence of pharmacokinetic interaction⁴²⁰ ⁴²⁷ ⁴⁶⁴
Iron preparations	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
NSAIAs	Possible increased risk of CNS stimulation, seizures;¹ ³⁶⁶ ⁴¹⁵ ⁴²⁷ animal studies using other fluoroquinolones suggest risk may vary depending on the specific NSAIA⁶⁷⁰
Probenecid	Decreased clearance of some quinolones (e.g., ciprofloxacin);¹ data regarding ofloxacin not available¹
Sucralfate	Possible decreased GI absorption of ofloxacin¹ ⁵⁹²	Administer ofloxacin at least 2 hours before or after sucralfate¹ ⁵⁹²
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
Theophylline	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

Ofloxacin Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed from GI tract.¹ ¹⁵⁴ ¹⁵⁶ ¹⁷⁵ ¹⁸³ ¹⁸⁸ ¹⁹⁴ ⁴⁶⁴ Does not undergo appreciable first-pass metabolism.¹⁷⁵

Oral bioavailability is 85–100%;¹ ¹⁶⁹ ¹⁷⁵ ¹⁸⁸ ¹⁸⁹ ²¹⁰ peak serum concentrations attained within 0.5–2 hours.¹ ¹⁵⁴ ¹⁶⁹ ¹⁷⁵ ¹⁷⁶ ¹⁷⁸ ¹⁸⁵ ¹⁹⁴ ⁴²⁰ ⁴⁶⁴

Food

Food can decrease rate and/or extent of absorption of ofloxacin;¹ ¹⁵⁶ ¹⁷⁶ ¹⁸⁹ ⁴²⁰ ⁴⁶⁴ ⁶⁴⁹ ⁶⁵⁰ ⁶⁵¹ not usually considered clinically important.¹ ¹⁵⁶ ¹⁸⁹ ⁴⁶⁴ ⁶⁴⁹ Milk and yogurt do not appear to affect GI absorption.⁶⁴⁹ ⁶⁵⁰

Distribution

Extent

Widely distributed into body tissues and fluids,¹ ¹⁸¹ ¹⁸³ ¹⁸⁹ including bone,¹⁸³ ²¹⁴ ⁴³² cartilage,⁴³² bile,⁷⁷ ¹⁶⁰ ¹⁸³ 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

Distributed into CSF following oral administration;¹⁸⁹ ¹⁹⁹ ²⁰³ ²⁰⁸ ²¹⁴ ⁴⁷⁵ ⁴⁷⁶ peak CSF concentrations may be 28–87% of concurrent serum concentrations.¹⁸⁹ ²⁰⁷ ²¹⁴ ⁴⁶⁴ ⁴⁷⁵ ⁴⁷⁶

Crosses placenta and is distributed into cord blood and amniotic fluid.²⁰⁹ ⁴²⁰ Distributed into milk.²⁰⁹ ²¹³ ⁴²⁰

Plasma Protein Binding

20–32% bound to serum proteins.¹ ¹⁶⁹ ¹⁷⁵ ²¹⁰ ⁴²⁰

Elimination

Metabolism

<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

Elimination Route

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;¹ ¹⁵⁴ ¹⁶⁹ ¹⁷⁵ ¹⁷⁸ ²¹⁰ <5% of the dose in urine as metabolites.¹ ¹⁷⁵ ²¹⁰ Approximately 4–8% of the dose excreted in feces.¹ ¹⁶⁹

Half-life

Distribution half-life averages 0.5–0.6 hours and terminal elimination half-life averages 4–8 hours.¹⁵⁴ ¹⁶⁹ ¹⁷⁵ ¹⁷⁶ ¹⁷⁸ ¹⁸⁵ ¹⁹⁴ ⁴²⁰ ⁴⁶⁴ ⁵³⁵

Special Populations

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 Cl_cr 10–50 mL/minute and 21.7 hours (range: 16.9–28.4 hours) in those with Cl_cr <10 mL/minute.¹⁹⁰ In patients with end-stage renal failure, half-life may range from 25–48 hours.²²⁷

Stability

Storage

Oral

Tablets

20–25°C; tight, light-resistant containers.¹

Actions and Spectrum

Usually bactericidal.¹ ³ ¹⁴ ¹⁴⁷ ¹⁴⁸ ¹⁵² ⁴²⁰ ⁴⁶⁶
Like other fluoroquinolones, ofloxacin inhibits bacterial DNA gyrase and topoisomerase IV.¹ ⁶³² ⁶³³ ⁶³⁴ ⁶³⁵ ⁶³⁶
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 ³² ³⁴ ³³ 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 ³² ³³ 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,²⁵⁶ ³³² ³³³ ⁶⁷⁵ 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.¹¹⁴ ³⁴⁴ ⁵⁷⁸ ⁵⁸⁰ ⁵⁸¹ ⁵⁸³ ⁵⁸⁴ ⁵⁸⁵ ⁶⁴²
Resistance to fluoroquinolones, including ofloxacin, can occur as the result of mutations in the target DNA type II topoisomerase enzymes and mutations that result in alterations in membrane permeability and/or efflux pumps.³ ¹¹³ ¹¹⁵ ¹²¹ ¹²³ ¹²⁶ ¹²⁷ ¹³² ¹³⁴ ⁴²⁰ ⁴⁹⁷ ⁶³² ⁶³⁴ ⁶³⁵ ⁶³⁶
Some cross-resistance occurs between ofloxacin and other fluoroquinolones.¹¹⁸ ⁴¹⁴ ⁴¹⁸ ⁴²⁰ ⁴²¹ ⁴⁴¹

Advice to Patients

Advise patients to read manufacturer’s patient information (medication guide) prior to initiating ofloxacin therapy and each time prescription refilled.¹
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
Inform patients that systemic fluoroquinolones, including ofloxacin, have been associated with disabling and potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture, peripheral neuropathy, CNS effects) that may occur together in same patient.¹ ¹⁴⁰ ¹⁴⁵ Advise patients to immediately discontinue ofloxacin and contact clinician if they experience any signs or symptoms of serious adverse effects (e.g., unusual joint or tendon pain, muscle weakness, a “pins and needles” tingling or pricking sensation, numbness of the arms or legs, confusion, hallucinations) while taking the drug.¹ ¹⁴⁰ ¹⁴⁵ Advise patients to talk with clinician if they have any questions or concerns.¹ ¹⁴⁰ ¹⁴⁵
Inform patients that systemic fluoroquinolones, including ofloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups and this risk is increased in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients.¹ ⁶⁷⁶ ⁸⁵¹ 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 or weakness or inability to use a joint) and importance of immediately discontinuing the drug and contacting a clinician.¹ ⁶⁷⁶ ⁸⁵¹ (See Tendinitis and Tendon Rupture under Cautions.)
Inform patients that peripheral neuropathies have been reported with systemic fluoroquinolones, including ofloxacin, and that symptoms may occur soon after initiation of the drug and may be irreversible.¹ Importance of immediately discontinuing ofloxacin and contacting a clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur.¹
Inform patients that systemic fluoroquinolones, including ofloxacin, have been associated with CNS effects (e.g., convulsions, dizziness, lightheadedness, increased intracranial pressure).¹ Importance of informing clinician of any history of convulsions before initiating therapy with the drug.¹ Importance of contacting a clinician if persistent headache with or without blurred vision occurs.¹
Advise patients that ofloxacin may cause dizziness and lightheadedness;¹ caution patients not to engage in activities requiring mental alertness and motor coordination (e.g., driving a vehicle, operating machinery) until effects of the drug on the individual are known.¹
Advise patients that systemic fluoroquinolones, including ofloxacin, may worsen myasthenia gravis symptoms;¹ importance of informing clinician of any history of myasthenia gravis.¹ Importance of immediately contacting a clinician if any worsening muscle weakness or breathing problems occur.¹
Inform patients that ofloxacin may be associated with hypersensitivity reactions, even after first dose.¹ Importance of immediately discontinuing ofloxacin and contacting a clinician if rash, hives, jaundice, or other manifestation suggesting allergic reaction (e.g., rapid heartbeat, difficulty swallowing or breathing, swelling of lips, tongue, face, tightness in throat or hoarseness) occurs.¹
Inform patients that photosensitivity/phototoxicity reactions reported following exposure to sun or UV light in patients receiving fluoroquinolones.¹ Importance of avoiding or minimizing exposure to sunlight or artificial UV light (e.g., tanning beds, UVA/UVB treatment) and using protective measures (e.g., wearing loose-fitting clothes, sunscreen) if outdoors during ofloxacin therapy.¹ Importance of discontinuing ofloxacin and contacting a clinician if a sunburn-like reaction or skin eruption occurs.¹
Inform patients that systemic fluoroquinolones may increase risk of aortic aneurysm and dissection;¹⁷² importance of informing clinician of any history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.¹⁷² Advise patients to seek immediate medical treatment if they experience sudden, severe, and constant pain in the stomach, chest, or back.¹ ¹⁷²
Inform patients that hypoglycemia reported when systemic fluoroquinolones used in some patients receiving antidiabetic agents.¹⁷¹ Advise patients with diabetes mellitus receiving oral antidiabetic agents or insulin to discontinue fluoroquinolone treatment and contact a clinician if they experience hypoglycemia or symptoms of hypoglycemia.¹⁷¹
Inform patients that severe hepatotoxicity, including acute hepatitis and fatalities, reported.¹ Importance of discontinuing ofloxacin and contacting a clinician if symptoms of hepatotoxicity (e.g., loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin or eyes, light colored bowel movements, dark colored urine) occur.¹
Importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia) and of current therapy with any drugs that may affect QT interval (e.g., class IA [quinidine, procainamide] or class III [e.g., amiodarone, sotalol] antiarrhythmic agents).¹ Importance of contacting clinician if symptoms of prolonged QT interval (e.g., prolonged heart palpitations, loss of consciousness) occur.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 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
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., drugs that may affect QT interval), as well as any concomitant illnesses.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.)

Preparations

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

Ofloxacin
Routes	Dosage Forms	Strengths	Brand Names
Oral	Tablets, film-coated	200 mg*	Ofloxacin Tablets
		300 mg*	Ofloxacin Tablets
		400 mg*	Ofloxacin Tablets

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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