Ofloxacin (Systemic)

Drug class: Antineoplastic Agents

Usage of Ofloxacin (Systemic)

Respiratory Tract Infections

Treatment of acute bacterial exacerbations of chronic bronchitis caused by susceptible Haemophilus influenzae or Streptococcus pneumoniae.

Use for treatment of acute bacterial exacerbations of chronic bronchitis only when no other treatment options available. 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) and because acute bacterial exacerbations of chronic bronchitis may be self-limiting in some patients, risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with these infections.

Treatment of mild to moderate community-acquired pneumonia (CAP) caused by susceptible H. influenzae or S. pneumoniae.

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

Urinary Tract Infections (UTIs) and Prostatitis

Treatment of uncomplicated cystitis caused by susceptible Citrobacter diversus, E. aerogenes, E. coli, K. pneumoniae, P. mirabilis, or Ps. aeruginosa; also has been used for cystitis caused by susceptible C. freundii† [off-label], E. cloacae† [off-label], or MorganElla morganii†.

Has been used treatment of uncomplicated UTIs caused by susceptible gram-positive bacteria, including S. aureus†, S. epidermidis†, S. saprophyticus†, Enterococcus faecalis†, viridans streptococci†, or Streptococcus agalactiae† (group B streptococci; GBS).

Use for treatment of uncomplicated UTIs only when no other treatment options available. 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) and because uncomplicated UTIs may be self-limiting in some patients, risks of serious adverse reactions outweigh benefits of fluoroquinolones for patients with uncomplicated UTIs.

Treatment of complicated UTIs caused by susceptible C. diversus, E. coli, K. pneumoniae, P. mirabilis, or Ps. aeruginosa; also has been used for complicated UTIs caused by susceptible C. freundii†, Enterobacter†, M. morganii†, or P. rettgeri†.

Treatment of recurrent UTIs and chronic prostatitis in men caused by susceptible E. coli.

GI Infections

Has been used for treatment of shigellosis† caused by susceptible Shigella†. 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. Empiric treatment regimen can be used initially, but in vitro susceptibility testing indicated since resistance is common. Fluoroquinolones (preferably ciprofloxacin or, alternatively, Levofloxacin or moxifloxacin) generally have been recommended, but consider that fluoroquinolone-resistant Shigella reported in the US, especially in international travelers, the homeless, and men who have sex with men (MSM). 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.

Has been used for treatment of travelers’ diarrhea†. If caused by bacteria, may be self-limited and resolve within 3–7 days without anti-infective treatment. CDC states anti-infective treatment not recommended for mild travelers' diarrhea; 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. Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) generally have been considered anti-infectives of choice for empiric anti-infective treatment, including self-treatment; alternatives include azithromycin and rifaximin. 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; 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).

Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas of risk. CDC and others do not recommend anti-infective prophylaxis in most travelers. 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. If anti-infective prophylaxis used, fluoroquinolones (e.g., ciprofloxacin, levofloxacin) usually have been recommended; alternatives include azithromycin and rifaximin. 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. Also consider increasing incidence of fluoroquinolone resistance in pathogens that cause travelers’ diarrhea (e.g., Campylobacter, Salmonella, Shigella).

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

Anthrax

Alternative for postexposure prophylaxis following suspected or cOnfirmed exposure to aerosolized Bacillus anthracis spores (inhalational anthrax)†. 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. Other oral fluoroquinolones (levofloxacin, moxifloxacin, ofloxacin) are alternatives for postexposure prophylaxis when ciprofloxacin or doxycycline cannot be used.

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). 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; 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.

Brucellosis

Treatment of brucellosis† caused by Brucella melitensis; used in conjunction with other anti-infectives. Monotherapy with any drug usually associated with high relapse rate and not recommended.

Chlamydial Infections

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

Gonorrhea and Associated Infections

Was used in the past for treatment of acute, uncomplicated gonorrhea caused by susceptible Neisseria gonorrhoeae.

Because quinolone-resistant N. gonorrhoeae (QRNG) widely disseminated worldwide, including in the US, 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).

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

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

Mycobacterial Infections

Has been used in multiple-drug regimens for treatment of active tuberculosis† caused by Mycobacterium tuberculosis.

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. However, if a fluoroquinolone is used in multiple-drug regimens for treatment of active tuberculosis, levofloxacin or moxifloxacin is recommended.

Alternative for use in multiple-drug therapy (MDT) for treatment of multibacillary leprosy† (Hansen's disease) caused by M. leprae. 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.

Component of a single-dose MDT regimen for treatment of single-lesion paucibacillary leprosy†.

Treatment of leprosy is complicated and should be undertaken in consultation with a specialist familiar with the disease. 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 protected] for assistance with diagnosis or treatment of leprosy or assistance obtaining clofazimine for treatment of leprosy.

Treatment of postoperative sternotomy wound or soft tissue infections caused by M. fortuitum†. Also has been used for treatment of M. fortuitum pulmonary infections or UTIs. 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).

Nongonococcal Urethritis

Alternative for treatment of nongonococcal urethritis (NGU). CDC recommends azithromycin or doxycycline; alternatives are erythromycin, levofloxacin, or ofloxacin.

Pelvic Inflammatory Disease

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

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). 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. 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.

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. Streptomycin (or Gentamicin) historically has been considered regimen of choice for treatment of plague; 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). 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.

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). Drugs of choice for such prophylaxis are doxycycline (or tetracycline) or a fluoroquinolone (e.g., ciprofloxacin, levofloxacin, moxifloxacin, ofloxacin).

Rickettsial Infections

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

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

Has been used for treatment of acute Q fever pneumonia caused by Coxiella burnetii†. Has been used in conjunction with doxycycline for long-term treatment of Q fever endocarditis†, but may be less effective than a regimen of doxycycline and hydroxyChloroquine.

Typhoid Fever

Has been used for treatment of typhoid fever† (enteric fever) caused by susceptible Salmonella enterica serovar Typhi, including chloramphenicol-resistant strains.

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.

Relate drugs

How to use Ofloxacin (Systemic)

Administration

Oral Administration

Administer orally.

May be given without regard to meals. Presence of food in the GI tract can decrease the rate and/or extent of absorption of ofloxacin; not usually considered clinically important. Milk and yogurt do not appear to affect GI absorption. (See Pharmacokinetics.)

Patients should be well hydrated and should be instructed to drink fluids liberally to avoid formation of highly concentrated urine.

Dosage

Adults

General Adult Dosage Oral

200–400 mg every 12 hours.

Respiratory Tract Infections Acute Bacterial Exacerbations of Chronic Bronchitis Oral

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

Community-acquired Pneumonia Oral

400 mg every 12 hours for 10 days.

Skin and Skin Structure Infections Uncomplicated Infections Oral

400 mg every 12 hours for 10 days.

Urinary Tract Infections (UTIs) and Prostatitis Uncomplicated Cystitis Caused by E. coli or K. pneumoniae Oral

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

Complicated UTIs Oral

200 mg every 12 hours for 10 days.

Prostatitis Caused by E. coli Oral

300 mg every 12 hours for 6 weeks or longer.

GI Infections Treatment of Travelers’ Diarrhea† Oral

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

Prevention of Travelers’ Diarrhea† Oral

300 mg once daily.

Anti-infective prophylaxis generally discouraged (see GI Infections under Uses); 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.

Helicobacter pylori Infection† Oral

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

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

Some experts recommend 400 mg twice daily.

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

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.

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

400 mg twice daily.

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).

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.

Brucellosis† Oral

400 mg once daily in conjunction with oral rifampin (600 mg once daily) given for 6 weeks was effective in some patients. Alternatively, 400 mg twice daily for 6 weeks recommended for use in multiple-drug regimens.

Chlamydial Infections Urogenital Infections Oral

300 mg twice daily for 7 days.

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.

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

Epididymitis† Oral

300 mg twice daily for 10 days recommended by CDC.

Use only when epididymitis† most likely caused by sexually transmitted enteric bacteria (e.g., E. coli) and N. gonorrhoeae ruled out. (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. 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.

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.

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).

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.

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.

Nongonococcal Urethritis Oral

300 mg twice daily for 7 days.

Pelvic Inflammatory Disease Oral

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

Use only when cephalosporins not feasible, community prevalence and individual risk of gonorrhea is low, and in vitro susceptibility confirmed. (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.

Q Fever† Oral

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

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.

Typhoid Fever† Mild to Moderate Typhoid Fever† Oral

200–400 mg every 12 hours for 7–14 days has been used. (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).

Renal Impairment

Dosage adjustments required in adults with Clcr ≤50 mL/minute.

Dosage in Adults with Renal Impairment

Clcr (mL/min)

Dosage

20–50

Usual initial dose, then usual dose once every 24 hours

<20

Usual initial dose, then 50% of usual dose once every 24 hours

Hemodialysis Patients

Initial 200-mg dose, then 100 mg once daily; supplemental doses not required after dialysis

Geriatric Patients

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

Warnings

Contraindications

  • Known hypersensitivity to ofloxacin or other quinolones.

    • 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. May occur within hours to weeks after a systemic fluoroquinolone is initiated; have occurred in all age groups and in patients without preexisting risk factors for such adverse reactions.

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

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

    Tendinitis and Tendon Rupture

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

    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. (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. Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any risk factors for such adverse reactions.

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

    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.

    Immediately discontinue ofloxacin if pain, swelling, inflammation, or rupture of a tendon occurs. (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.

    Peripheral Neuropathy

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

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

    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). (See Advice to Patients.)

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

    CNS Effects

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

    Systemic fluoroquinolones are associated with increased risk of convulsions (seizures), increased intracranial pressure (pseudotumor cerebri), lightheadedness, and tremors. 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).

    If psychiatric or other CNS effects occur, immediately discontinue ofloxacin and institute appropriate measures. (See Advice to Patients.)

    Exacerbation of Myasthenia Gravis

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

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

    Sensitivity Reactions

    Hypersensitivity Reactions

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

    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.

    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.

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

    Photosensitivity Reactions

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

    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).

    Avoid unnecessary exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment). 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).

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

    Other Warnings and Precautions

    Risk of Aortic Aneurysm and Dissection

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

    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. This includes geriatric patients and patients with peripheral atherosclerotic vascular disease, hypertension, or certain genetic conditions (e.g., Marfan syndrome, Ehlers-Danlos syndrome).

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

    Hypoglycemia or Hyperglycemia

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

    Severe cases of hypoglycemia resulting in coma or death reported with some systemic fluoroquinolones. 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.

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

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

    Musculoskeletal Effects

    Fluoroquinolones, including ofloxacin, cause arthropathy and osteochondrosis in immature animals of various species. 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).

    Prolongation of QT Interval

    Prolonged QT interval leading to ventricular arrhythmias, including torsades de pointes, reported with some fluoroquinolones, including ofloxacin.

    Avoid use in patients with history of prolonged QT interval or uncorrected electrolyte disorders (e.g., hypokalemia, hypomagnesemia). Also avoid use in those receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.

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

    Hepatotoxicity

    Severe hepatotoxicity, including acute hepatitis and fatalities, reported.

    Superinfection/C. difficile-associated Diarrhea and Colitis

    Possible emergence and overgrowth of nonsusceptible bacteria or fungi.

    Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridioides difficile (formerly known as Clostridium difficile). 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. C. difficile produces toxins A and B which contribute to development of CDAD; 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.

    Consider CDAD if diarrhea develops during or after anti-infective therapy and manage accordingly. Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.

    If CDAD suspected or confirmed, discontinue anti-infectives not directed against C. difficile as soon as possible. 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.

    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. 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.

    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.

    When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

    Laboratory Monitoring

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

    Specific Populations

    Pregnancy

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

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

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

    Lactation

    Distributed into milk; discontinue nursing or the drug.

    Pediatric Use

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

    Fluoroquinolones cause arthropathy in juvenile animals. (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.

    Geriatric Use

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

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

    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). (See Prolongation of QT Interval under Cautions.)

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

    Consider age-related decreases in renal function when selecting dosage and adjust dosage if necessary. (See Renal Impairment under Dosage and Administration.)

    Hepatic Impairment

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

    Renal Impairment

    Decreased clearance and increased half-life.

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

    Decrease dosage in those with Clcr ≤50 mL/minute. (See Renal Impairment under Dosage and Administration.)

    Common Adverse Effects

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

    What other drugs will affect Ofloxacin (Systemic)

    Drugs That Prolong QT Interval

    Potential pharmacologic interaction (additive effect on QT interval prolongation). Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents. (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; synergism unpredictable and indifference or antagonism also reported

    Antacids (aluminum-, magnesium-, or calcium-containing)

    Decreased absorption of ofloxacin

    Administer ofloxacin at least 2 hours before or after such antacids

    Anticoagulants, oral (warfarin)

    Potential for enhanced warfarin effects

    Use with caution; monitor PT

    Antidiabetic agents (glyburide, glibenclamide, insulin)

    Blood glucose alterations (including hypoglycemia) reported in diabetic patients

    Closely monitor blood glucose concentrations

    β-lactam antibiotics

    In vitro evidence of additive or synergistic antibacterial effects against some gram-positive bacteria; indifference against Enterobacteriaceae or Ps aeruginosa

    Caffeine

    No evidence of clinically important effects on pharmacokinetics of caffeine; some other fluoroquinolones (e.g., ciprofloxacin) may affect caffeine pharmacokinetics

    Restrictions on caffeine intake not considered necessary

    Corticosteroids

    Increased risk of tendinitis or tendon rupture, especially in patients >60 years of age

    Cyclosporine

    Increased cyclosporine concentrations reported with some fluoroquinolones; unclear whether this occurs with ofloxacin

    Didanosine

    Decreased absorption of ofloxacin with buffered didanosine preparations

    Administer ofloxacin at least 2 hours before or after buffered didanosine (pediatric oral solution admixed with antacid)

    Histamine H2-receptor antagonists (cimetidine, ranitidine)

    No evidence of pharmacokinetic interaction

    Iron preparations

    Decreased absorption of ofloxacin

    Administer ofloxacin at least 2 hours before or after Ferrous Sulfate and dietary supplements containing iron

    Multivitamins and mineral supplements

    Decreased absorption of ofloxacin

    Administer ofloxacin at least 2 hours before or after supplements containing zinc or iron

    NSAIAs

    Possible increased risk of CNS stimulation, seizures; animal studies using other fluoroquinolones suggest risk may vary depending on the specific NSAIA

    Probenecid

    Decreased clearance of some quinolones (e.g., ciprofloxacin); data regarding ofloxacin not available

    Sucralfate

    Possible decreased GI absorption of ofloxacin

    Administer ofloxacin at least 2 hours before or after sucralfate

    Tests for opiates

    Possible false-positive results with immunoassay kits for urine screening

    Confirmation of positive opiate test results using more specific methods may be necessary

    Theophylline

    Possible increased theophylline concentrations and increased risk of theophylline-related adverse effects with fluoroquinolones

    Extent of this interaction varies considerably among the fluoroquinolones; the effect is less pronounced with ofloxacin than with ciprofloxacin

    If used concomitantly, closely monitor patient and theophylline concentrations and make appropriate theophylline dosage adjustments as needed

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