VA Class: AM900
Chemical Name: 1-Ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid
CAS Number: 70458-96-7
Systemic fluoroquinolones, including norfloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups.1 372 373 This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 372 373 (See Tendinopathy and Tendon Rupture under Cautions.)
Fluoroquinolones, including norfloxacin, may exacerbate muscle weakness in patients with myasthenia gravis.1 Avoid norfloxacin in patients with known history of myasthenia gravis.1
Antibacterial; fluoroquinolone.1 17 18 20
Uses for Norfloxacin
Urinary Tract Infections (UTIs) and Prostatitis
Treatment of uncomplicated UTIs (including cystitis) caused by susceptible Citrobacter freundii, Enterobacter aerogenes, E. cloacae, Escherichia coli, Klebsiella pneumoniae, Morganella morganii†, Proteus mirabilis, P. vulgaris, Providencia rettgeri†, Pseudomonas aeruginosa, or Serratia marcescens†.1 107 114 115 116 117 118 123 124 127 128 129 134 135 201 230 231 280 283 309 Also used for treatment of uncomplicated UTIs caused by susceptible Staphylococcus aureus, S. epidermidis, S. saprophyticus, or Streptococcus agalactiae (group B streptococci), or Enterococcus faecalis.1 107 116 117 118 124 127 129 134 135 201 230 231
Treatment of complicated UTIs caused by susceptible E. coli, K. pneumoniae, P. mirabilis, Ps. aeruginosa, S. marcescens, or E. faecalis.1
Treatment of prostatitis caused by E. coli.1
Usually reserved for treatment of complicated UTIs, especially those caused by multidrug-resistant bacteria; generally not recommended for uncomplicated UTIs (e.g., acute cystitis) unless more commonly employed urinary anti-infectives are contraindicated or not tolerated.111 251 253
Treatment of gastroenteritis† caused by susceptible enterotoxigenic E. coli,71 193 232 Aeromonas hydrophila,193 232 Plesiomonas shigelloides,71 Salmonella,71 193 232 or Shigella (including Sh. boydii,71 Sh. dysenteriae,36 71 131 193 Sh. flexneri,71 193 Sh. sonnei).71
Treatment of cholera†, including infections caused by Vibrio cholerae serotypes 01 or 0139.310 311 341 344 Tetracyclines generally drugs of choice when an anti-infective indicated as an adjunct to fluid and electrolyte replacement;43 292 309 311 azithromycin also a recommended treatment.292 Alternatives for V. cholerae resistant to tetracyclines include co-trimoxazole, fluoroquinolones, or furazolidone.43 292 309 311 341
Treatment of travelers’ diarrhea†.301 305 306 335 525 If caused by bacteria, may be self-limited and resolve within 3–5 days without anti-infective treatment;305 525 if diarrhea is moderate or severe, persists for >3 days, or is associated with fever or bloody stools, short-term (1–3 days) anti-infective treatment recommended.305 525 Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, indicated.305 312 335 337 525 Azithromycin is a treatment alternative if fluoroquinolones should not be used (e.g., children, pregnant women) and a drug of choice for travelers in areas with high prevalence of fluoroquinolone-resistant Campylobacter (e.g., South and Southeast Asia) or when there is no response after 48 hours of fluoroquinolone treatment.305 525 Rifaximin is another alternative for treatment of travelers' diarrhea caused by noninvasive E. coli.305 525
Prevention of travelers’ diarrhea† in individuals traveling for relatively short periods to areas where enterotoxigenic E. coli and other causative bacterial pathogens (e.g., Shigella) are known to be susceptible to the drug.109 131 193 301 307 308 335 337 525 CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;305 308 312 525 the principal preventive measures are prudent dietary practices.329 330 525 If anti-infective prophylaxis is used (e.g., in immunocompromised individuals such as those with HIV infection), a fluoroquinolone (ciprofloxacin, levofloxacin, ofloxacin, norfloxacin) is recommended for nonpregnant adults;305 525 azithromycin and rifaximin are alternatives.305 Weigh use of anti-infective prophylaxis against use of prompt, early self-treatment with anti-infectives, a strategy that can limit duration of illness to 6–24 hours in most cases.525
Gonorrhea and Associated Infections
Has been used for treatment of uncomplicated urethral, endocervical, orrectal† gonorrhea caused by susceptible Neisseria gonorrhoeae.1 17 18 21 71 111 119 132 193 195 196 229 297 298 301 319
Because quinolone-resistant N. gonorrhoeae (QRNG) is widely disseminated worldwide, including in the US319 320 328 338 358 360 (see Resistance in Neisseria gonorrhoeae under Cautions), CDC and others no longer recommend norfloxacin for treatment of gonorrhea or any associated infections that may involve N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).319 328 358 360
Norfloxacin Dosage and Administration
Give tablets with a glass of water at least 1 hour before or at least 2 hours after a meal or dairy products (e.g., milk, yogurt).1 2 (See Pharmacokinetics.)
Patients receiving norfloxacin should be well hydrated and should be instructed to drink fluids liberally.1 240 (See Renal Effects under Cautions.)
Urinary Tract Infections (UTIs) and Prostatitis
400 mg every 12 hours.1 17 114 116 117 118 124 127 128 201 205 Usual duration is 3 days for treatment of uncomplicated UTIs caused by susceptible E. coli, K. pneumoniae, or P. mirabilis or 7–10 days for treatment of uncomplicated UTIs caused by other susceptible bacteria.1
400 mg every 12 hours.1 17 114 116 128 135 201 205 Usual duration is ≥10–21 days.1 17 135
Acute or Chronic Prostatitis Caused by E. coliOral
400 mg every 12 hours for 28 days.1
Gastroenteritis Caused by Susceptible Bacteria†Oral
400 mg twice daily for 5 days.36 71 131 193 A duration of 3 days may be sufficient for some infections, including shigellosis or some E. coli infections.43
400 mg twice daily for 3 days in conjunction with fluid and electrolyte replacement.341 344 A single 800-mg dose has been used in adults, but there is some evidence that a multiple-dose regimen is more effective than a single-dose regimen for treatment of severe cholera caused by V. cholerae 0139.341
Treatment of Travelers’ Diarrhea†Oral
400 mg twice daily for 1–3 days.305 306
Prevention of Travelers’ Diarrhea†Oral
400 mg once daily.305 329 330 335
Although anti-infective prophylaxis generally discouraged,305 308 312 337 525 some clinicians state it can be given during period of risk (for ≤3 weeks) beginning day of travel and continuing for 1 or 2 days after leaving area of risk.305 329 330 335
Uncomplicated Urethral, Endocervical, or Rectal† GonorrheaOral
Single 800-mg dose recommended by manufacturer.1
Not recommended by CDC or others for treatment of gonorrhea or any associated infections that may involve N. gonorrhoeae (e.g., PID, epididymitis).319 328 358 360 (See Gonorrhea and Associated Infections under Uses.)
Maximum 400 mg twice daily because of the risk of crystalluria.1
Dosage adjustments necessary in patients with severe renal impairment.1 2 7 8 17 143
Adults with Clcr ≤30 mL/minute per 1.73 m2 should receive 400 mg once daily.1
No dosage adjustments except those related to renal impairment.1 (See Renal Impairment under Dosage and Administration.)
Select dosage with caution because of possible age-related decreases in renal impairment.1
Cautions for Norfloxacin
Hypersensitivity to norfloxacin or any quinolone.1 240
History of tendinitis or tendon rupture with norfloxacin or any quinolone.1
Tendinopathy and Tendon Rupture
Fluoroquinolones, including norfloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups.1 372 373 This risk is further increased in older adults (usually those >60 years of age), individuals receiving concomitant corticosteroids, and kidney, heart, or lung transplant recipients.1 372 373
Other factors that may independently increase risk of tendon rupture include strenuous physical activity, renal failure, and previous tendon disorders such as rheumatoid arthritis.1 372 373 Tendinitis and tendon rupture have been reported in patients receiving fluoroquinolones who did not have any of these risk factors.1
Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair.1 Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also reported.1
Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.1
Discontinue if pain, swelling, inflammation, or rupture of a tendon occurs.1 372 373 Advise patients to rest and refrain from exercise and contact a clinician at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon or weakness or inability to use a joint).1 372 373 (See Advice to Patients.)
Myasthenia Gravis Patients
May exacerbate muscle weakness in myasthenia gravis patients;1 need for ventilatory support and death reported.1
Avoid use in patients with known history of myasthenia gravis.1
Fluoroquinolones, including norfloxacin, cause arthropathy and osteochondrosis in immature animals of various species.1 2 233 240 362 363 364 365 366 369 370 Relevance of these adverse effects in immature animals to use in humans unknown.213 241 361 367 368 369 Safety and efficacy of norfloxacin 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
Possibility of seizures, increased intracranial pressure, toxic psychoses, and CNS stimulation leading to tremors, restlessness, lightheadedness, confusion, and hallucinations.1 21 233 240 257 258
Use with caution in patients with known or suspected CNS disorders that may predispose to seizures or lower seizure threshold (e.g., severe cerebral arteriosclerosis, epilepsy).1
If a severe adverse CNS reaction (e.g., seizures, increased intracranial pressure, CNS stimulation, toxic psychosis) occurs, discontinue the drug and institute appropriate therapeutic measures.1
Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with fluoroquinolones, including norfloxacin.1 Symptoms may occur soon after initiation of the drug and may be irreversible.1
Immediately discontinue norfloxacin if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness) occur or if there are alterations in sensations (e.g., light touch, pain, temperature, position sense, vibratory sensation).1
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Possible emergence and overgrowth of nonsusceptible bacteria or fungi.1 Institute appropriate therapy if superinfection occurs.1
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 345 347 348 354 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including norfloxacin, and may range in severity from mild diarrhea to fatal colitis.1 242 267 345 347 348 351 355 356 C. difficile produces toxins A and B, which contribute to the development of CDAD;1 345 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
Outbreaks of severe CDAD caused by fluoroquinolone-resistant C. difficile have been reported with increasing frequency over the last several years.350 351 352 353 355
Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 345 347 348 354 Obtain careful medical history since CDAD may occur as late as 2 months or longer after anti-infective therapy is discontinued.1 345 347 348
If CDAD is suspected or confirmed, discontinue anti-infective therapy not directed against C. difficile whenever possible.1 345 347 348 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 345 347 348
Serious and occasionally fatal (anaphylactic) hypersensitivity reactions, which may occur following first dose, reported with some quinolones, including norfloxacin.1 193 293 294 295
Some reactions have been accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.1 293 294 295
In addition, other possible severe and potentially fatal reactions (may be hypersensitivity reactions or of unknown etiology) have been reported, most frequently after multiple doses.1 These include fever, rash or other severe dermatologic reactions (e.g., toxic epidermal necrolysis, Stevens-Johnson syndrome), vasculitis, arthralgia, myalgia, serum sickness, allergic pneumonitis, interstitial nephritis, acute renal insufficiency or failure, hepatitis, jaundice, acute hepatic necrosis or failure, anemia (including hemolytic and aplastic), thrombocytopenia (including thrombotic thrombocytopenic purpura), leukopenia, agranulocytosis, pancytopenia, and/or other hematologic effects.1
Discontinue norfloxacin at first appearance of rash, jaundice, or any other sign of hypersensitivity and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, and maintenance of an adequate airway and oxygen).1
Moderate to severe photosensitivity/phototoxicity reactions have been reported with fluoroquinolones, including norfloxacin.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
Relative potential of the various fluoroquinolones to cause photosensitivity/phototoxicity unclear.291 Factors that contribute to susceptibility to this adverse effect during fluoroquinolone therapy include patient's skin pigmentation, frequency and duration of exposure to sun and UV light, use of protective clothing and sunscreen, concomitant use of other drugs, and dosage and duration of fluoroquinolone therapy.291
Avoid unnecessary or excessive exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment) while receiving norfloxacin.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 norfloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.1
Possible crystalluria;1 2 21 71 138 193 generally associated with alkaline urine and high dosage.21 138 193 221
Adequate fluid intake necessary to ensure proper hydration and adequate urinary output;1 2 240 avoid alkaline urine and do not exceed usual dosage.1 2 240
Hemolytic reactions reported rarely in patients with latent or actual defects in glucose-6-phosphate dehydrogenase (G-6-PD).1
Prolongation of QT Interval
Prolonged QT interval and ventricular arrhythmias (including torsades de pointes) reported with some fluoroquinolones, including norfloxacin.1
Avoid or use with caution in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents or other drugs that may affect QT interval (e.g., cisapride [available in the US only under a limited-access protocol], erythromycin, antipsychotic agents, tricyclic antidepressants) and in patients with risk factors for torsades de pointes (e.g., known QT prolongation, uncorrected hypokalemia).1
Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.1
Selection and Use of Anti-infectives
When prescribing a fluoroquinolone, consider potential benefits and risks for the individual patient.372 373 Most patients tolerate the drugs, but serious adverse reactions (e.g., CNS effects, QT prolongation, C. difficile-associated diarrhea and colitis, damage to liver, kidneys, or bone marrow, alterations in glucose homeostasis) may occur rarely.372 373
To reduce development of drug-resistant bacteria and maintain effectiveness of norfloxacin and other antibacterials, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.1
When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing.1 In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.1
Resistance in Neisseria gonorrhoeae
N. gonorrhoeae with decreased susceptibility to norfloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) has been reported with increasing frequency over the past decade.319 320 322 323 324 325 326 327 328 336 358
US data indicate that QRNG has continued to increase among men who have sex with men and among heterosexual males and is now present in all regions of the country.358
CDC and others state that fluoroquinolones, including norfloxacin, should not be used to treat gonorrhea or any associated infections that may involve N. gonorrhoeae (e.g., PID, epididymitis).319 328 358 360
Not known whether distributed into milk;1 other quinolones are distributed into milk.1 Discontinue nursing or the drug.1
Safety and efficacy not established in children and adolescents <18 years of age.1 Norfloxacin causes arthropathy in juvenile animals.1 233 (See Musculoskeletal Effects under Cautions.)
AAP states use of fluoroquinolones may be justified in children <18 years of age in special circumstances after careful assessment of the risks and benefits for the individual patient and after these benefits and risks have been explained to parents and/or caregivers.110 292
No substantial differences in safety and efficacy relative to younger adults, but increased risk of some adverse effects cannot be ruled out.1
Risk of severe tendon disorders, including tendon rupture, is increased in geriatric adults >60 years of age.1 372 373 This risk is further increased in those receiving concomitant corticosteroids.1 372 373 (See Tendinopathy 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.)
Substantially eliminated by the kidney and age-related decline in renal function may increase risk of adverse reactions.1
Consider age-related decreases in renal function when selecting dosage; renal function monitoring may be useful.1
Increased norfloxacin serum concentrations and prolonged half-life.1 17 18
Dosage adjustments necessary in patients with severe renal impairment.1 2 7 8 17 143 (See Renal Impairment under Dosage and Administration.)
Common Adverse Effects
GI effects (nausea, abdominal cramping);1 17 18 21 71 116 124 193 205 233 CNS effects (headache, dizziness, asthenia);1 17 18 21 71 116 124 193 205 233 rash.1
Interactions for Norfloxacin
Drugs Metabolized by Hepatic Microsomal Enzymes
Inhibits cytochrome P-450 (CYP) isoenzyme 1A2.1 Potential pharmacokinetic interaction with CYP1A2 substrates (e.g., caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine) resulting in increased drug concentrations if given in usual dosages.1 Carefully monitor patients receiving norfloxacin concomitantly with drugs metabolized by CYP1A2.1
Drugs that Prolong QT Interval
Potential pharmacologic interaction (additive effect on QT interval prolongation).1 Avoid or use with caution in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents or other drugs that may affect QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants).1 (See Prolongation of QT Interval under Cautions.)
In vitro evidence of additive or synergistic antibacterial effects against some Enterobacteriaceae and Ps. aeruginosa;150 155 177 synergism unpredictable and indifference or antagonism also has been reported48 155
Antacids (aluminum- or magnesium-containing)
Decreased absorption of norfloxacin1 2 18 71 240 266
Administer norfloxacin tablets at least 2 hours before or after such antacids1 219
Anticoagulants, oral (warfarin)
Potential for enhanced warfarin effects1 276 289
Use with caution;276 289 monitor PT or other appropriate coagulation tests1
No in vitro evidence of synergism or antagonism against gram-positive or -negative bacteria when used with ampicillin, cefotaxime, or cefoxitin48
Possible prolonged half-life of caffeine with some quinolones (e.g., ciprofloxacin)241 244 269 270 271 272 273
The possibility of exaggerated or prolonged effects of caffeine during concomitant use with a quinolone should be considered244 270
Increased risk of tendinitis or tendon rupture, especially in patients >60 years of age1 372 373
Possible increased concentrations of cyclosporine1
Monitor cyclosporine concentrations and adjust cyclosporine dosage if needed1
Decreased absorption of norfloxacin with buffered didanosine preparations1
Administer norfloxacin tablets at least 2 hours before or after buffered didanosine preparations (pediatric oral solution admixed with antacid)1
Severe hypoglycemia reported1
Monitor blood glucose1
Decreased absorption of norfloxacin1
Administer norfloxacin tablets at least 2 hours before or after ferrous sulfate and dietary supplements containing iron1
Multivitamins and mineral supplements
Decreased absorption of norfloxacin1
Administer norfloxacin tablets at least 2 hours before or after supplements containing zinc or iron1
Some in vitro evidence of antagonism between norfloxacin and nitrofurantoin1
Clinical importance unknown; should not be used concomitantly1
Increased risk of CNS stimulation and convulsive seizures1
Animal studies suggest norfloxacin may have greater convulsant activity than some other fluoroquinolones (e.g., levofloxacin) and the potential risk associated with concomitant therapy may vary depending on the specific NSAIA357
Use with caution1
Decreased clearance of norfloxacin;1 2 3 139 serum concentrations139 and half-life of norfloxacin generally not affected2 3
Possible decreased GI absorption of norfloxacin1 333
Some clinicians suggest that concomitant use should be avoided; if used concomitantly, give norfloxacin tablets at least 2 hours before or after sucralfate1 333
Possible increased theophylline concentrations and increased risk of theophylline-related adverse effects1 18 21 205 216 224 225 234 244 245 246 255
Although risk of norfloxacin inducing substantial alterations in theophylline pharmacokinetics appears to be less than with some other quinolones (e.g., ciprofloxacin),244 245 246 255 256 theophylline-related adverse effects have been reported in patients receiving norfloxacin concomitantly1
Some clinicians suggest that the interaction between norfloxacin and theophylline may not be clinically important in most patients;234 255 256 275 287 others suggest that norfloxacin should be used with caution in patients receiving theophylline205 219 244 246 255
Manufacturer of norfloxacin states that consideration should be given to monitoring plasma theophylline concentrations and theophylline dosage should be adjusted as required1
Rapidly, but incompletely, absorbed from GI tract following oral administration.1 2 3 4 17 18 21 22 136 142 205
At least 30–50% of an oral dose is absorbed from GI tract;1 2 4 peak serum concentrations generally attained within 1–2 hours.1 2 3 4 7 17 18 22 138 142 144 Steady-state serum concentrations attained by the second day of therapy.1
Food and/or dairy products (milk, yogurt) in the GI tract may decrease absorption.1 2 3 17 339 340
Distributed into renal parenchyma,1 6 17 205 gallbladder,17 136 205 liver,17 prostatic tissue,1 6 17 141 205 testicles,1 seminal fluid,1 140 uterus,1 fallopian tubes,1 cervical and vaginal tissue,1 blister fluid,3 18 22 142 144 tonsils,17 maxillary sinus mucosa,17 sputum,17 and bile.1 2 3 17 136
Crosses the placenta and is distributed into cord blood and amniotic fluid.2 3 17 Not known whether norfloxacin is distributed into milk;1 2 17 some other quinolones (e.g., ciprofloxacin, ofloxacin) are distributed into milk.1 2 281
Plasma Protein Binding
10–15% bound to serum proteins.1 2 3 17
Partially metabolized by modification of the piperazinyl group to 6 metabolites,1 2 3 17 19 22 151 designated —1, —2, —3, —4, —4, and —5.2 Although some of the metabolites are microbiologically active, they are less active than the parent drug.1 2 3 17 19 22 151
Eliminated by renal and nonrenal mechanisms.1 2 3 5 17 18 21
Norfloxacin and its metabolites excreted in urine,1 2 17 18 19 21 138 139 with unchanged norfloxacin being excreted by both glomerular filtration and tubular secretion.3 139 Norfloxacin also excreted in feces,1 2 5 14 194 236 principally as unabsorbed drug17 221 and, to a small extent, via biliary elimination.1 17
Approximately 25–40% of a dose excreted in urine as unchanged drug and 5–10% as metabolites within 24–48 hours;1 2 3 17 ≥30% (range: 10–50%) is excreted in feces within 48 hours.1 5
Does not appear to be removed by hemodialysis;143 not known whether the drug is removed by peritoneal dialysis.221
Adults with normal renal function: 2.3–4 hours.1 2 7 8 18 21 22 71 142 143 144
Geriatric individuals 65–75 years of age with renal function normal for their age: half-life averages 4 hours.1 2
Limited data suggest that half-life is not substantially affected by hepatic impairment.4
In adults with renal impairment, half-life of norfloxacin averages 4.4, 6.6, or 7.6 hours in those with Clcr 30–80, 10–29, or <10 mL/minute per 1.73 m2, respectively.143
Tight container at 25°C (may be exposed to 15–30°C).1
Actions and Spectrum
Usually bactericidal.1 2 11 17 18 20 47 59 106 145
Like other fluoroquinolones, norfloxacin inhibits bacterial DNA gyrase and topoisomerase IV.2 13 15 20 70 145 205 206 207 214
Spectrum of activity includes many gram-positive aerobic bacteria, many gram-negative aerobic bacteria, a few gram-positive anaerobic bacteria, and some other organisms (e.g., Chlamydia, Mycoplasma, Mycobacterium).1 17 18 19 20 29 30 33 34 41 45 66 71 78 80 102 159 178 185 189 205 207 209 Not usually active against obligate anaerobes.1 2 17 18 19 20 46 54 56 71 176 187 189 205 Inactive against fungi and viruses.17 153
Gram-positive aerobic cocci: Active in vitro and in clinical infections against S. aureus,1 2 33 34 39 41 45 46 48 51 56 57 58 60 62 80 81 82 84 88 90 94 97 100 159 162 163 165 171 176 178 183 184 S. epidermidis,1 2 33 34 41 45 48 56 60 80 82 88 90 159 162 165 171 178 S. saprophyticus,1 2 80 166 170 177 184 S. agalactiae (group B streptococci),1 33 41 46 48 57 58 60 81 82 100 163 165 176 189 and Enterococcus faecalis.1 2 18 33 34 41 45 46 48 56 57 58 60 62 80 81 84 88 89 96 100 159 163 165 171 176 178 288 Although some strains of Streptococcus pneumoniae,33 34 39 41 46 57 58 60 81 82 100 159 176 189 S. pyogenes (group A β-hemolytic streptococci),33 34 41 46 48 56 58 60 81 82 100 159 162 163 165 171 176 189 groups C and G streptococci,33 34 60 165 176 189 viridans streptococci,20 33 41 82 and nonenterococcal group D streptococci33 39 are inhibited in vitro by norfloxacin, many strains of these gram-positive bacteria are relatively resistant to the drug.17 18 20 28 33 41 60 82 189
Gram-positive aerobic bacilli: Active in vitro against Bacillus cereus,2 Corynebacterium,23 33 74 and Listeria monocytogenes.33 34 41 60 165 177 179 Nocardia asteroides usually are resistant.44
Gram-negative aerobes: Active in vitro and in clinical infections against Ps. aeruginosa1 2 17 33 34 37 39 41 45 46 48 56 57 58 60 62 80 81 82 84 88 90 92 96 100 159 162 165 178 184 189 205 and most Enterobacteriaceae (including C. freundii, E. aerogenes, E. cloacae, E. coli, K. pneumoniae, P. mirabilis, P. vulgaris, S. marcescens).1 17 18 19 20 29 33 34 36 37 38 39 40 41 48 55 56 57 58 60 80 81 82 159 166 176 189 205 207 Also active in vitro against Acinetobacter,2 33 34 41 45 46 48 56 60 62 84 88 96 165 189 205 Aeromonas,31 33 34 40 41 53 165 173 C. diversus,1 Edwardsiella tarda,1 E. agglomerans,1 Haemophilus ducreyi,1 H. influenzae,33 34 39 45 46 48 58 81 82 84 100 159 162 165 171 184 189 K. oxytoca,1 Moraxella catarrhalis,33 34 45 46 179 187 189 204 Morganella morganii,1 Providencia (including P. alcalifaciens, P. rettgeri, P. stuartii),1 other Pseudomonas (e.g., Ps. acidovorans, Ps. fluorescens, Ps. putida, Ps. stutzeri),1 46 62 96 and Vibrio.2 17 25 167 173
Other organisms: Has some in vitro activity against Chlamydia trachomatis,30 52 66 78 185 215 Mycoplasma hominis,64 159 M. pneumoniae,158 Ureaplasma urealyticum,52 64 M. tuberculosis,28 32 222 and some other mycobacteria.28 32 222
N. gonorrhoeae with decreased susceptibility to norfloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) are widely disseminated worldwide, including in the US.319 320 322 323 324 325 326 327 328 336 358
Some cross-resistance occurs between norfloxacin and other fluoroquinolones.17 56 71 145 237 320 323 326
Advice to Patients
Advise patients that antibacterials (including norfloxacin) 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 norfloxacin or other antibacterials in the future.1
Importance of taking norfloxacin tablets at least 1 hour before or at least 2 hours after a meal or dairy products (e.g., milk, yogurt) since absorption of the drug may be decreased.1
Importance of taking norfloxacin tablets at least 2 hours before or after multivitamins containing iron or zinc; aluminum- or magnesium-containing antacids; or didanosine chewable/dispersible buffered tablets, buffered powder for oral solution, or pediatric powder for oral solution prepared as an admixture with antacid.1
Importance of taking norfloxacin tablets with a glass of water and drinking sufficient quantities of fluids during therapy.1
Increased risk of tendinitis and tendon rupture in all age groups and further increased risk in adults >60 years of age, individuals receiving corticosteroids, and kidney, heart, or lung transplant recipients.1 372 373 Importance of resting and refraining from exercise at the first sign of tendinitis or tendon rupture (e.g., pain, swelling, or inflammation of a tendon, weakness or inability to use a joint) and discontinuing the drug and contacting a clinician regarding changing to an anti-infective that is not a fluoroquinolone.1 372 373 (See Tendinopathy and Tendon Rupture under Cautions.)
Advise patients that norfloxacin may worsen myasthenia gravis symptoms; importance of immediately contacting clinician if any worsening muscle weakness or breathing problems occur.1
Potential for norfloxacin to cause dizziness and lightheadedness; need for caution when operating machinery or driving a motor vehicle until effects of drug on individual are known.1
May be associated with hypersensitivity reactions (including anaphylactic reactions), even following the first dose.1 Importance of immediately discontinuing the drug and informing clinician at the first sign of rash, jaundice, or any other sign of hypersensitivity.1
Risk of photosensitivity/phototoxicity reactions following exposure to sun or UV light while 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 norfloxacin therapy.1 Discontinue norfloxacin and inform a clinician if a sunburn-like reaction or skin eruption occurs.1
Advise patients that seizures have been reported and to contact clinicians before taking norfloxacin if they have a history of seizures.1
Advise patients that peripheral neuropathies have been reported with norfloxacin and that symptoms may occur soon after initiation of the drug and may be irreversible.1 Importance of immediately discontinuing the drug and contacting clinician if symptoms of peripheral neuropathy (e.g., pain, burning, tingling, numbness, weakness) occur.1
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued.1 Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.1
Advise patients that norfloxacin may cause ECG changes (QT prolongation) and the importance of informing clinician of personal or family history of QT interval prolongation or proarrhythmic conditions (e.g., hypokalemia, bradycardia, recent myocardial ischemia).1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, especially drugs that may affect QT interval (e.g., cisapride, erythromycin, antipsychotic agents, tricyclic antidepressants) or antiarrhythmic agents (e.g., amiodarone, quinidine, procainamide, sotalol).1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of advising patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
AHFS DI Essentials. © Copyright 2017, Selected Revisions October 15, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
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48. Stamm JM, Hanson CW, Chu DT et al. In vitro evaluation of A-56619 (difloxacin) and A-56620: new aryl-fluoroquinolones. Antimicrob Agents Chemother. 1986; 29:193-200. [PubMed 3087274]
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50. Smith SM. In vitro comparison of A-56619, A-56620, amifloxacin, ciprofloxacin, enoxacin, norfloxacin, and ofloxacin against methicillin-resistant Staphylococcus aureus. Antimicrob Agents Chemother. 1986; 29:325-6. (IDIS 212794)
51. Cornett JB, Wagner RB, Dobson RA et al. In vitro and in vivo antibacterial activities of the fluoroquinolone WIN 49375 (amifloxacin). Antimicrob Agents Chemother. 1985; 27:4-10. [PubMed 3885845]
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55. Reinhardt JF, Fowlston S, Jones J et al. Comparative in vitro activities of selected antimicrobial agents against Edwardsiella tarda. Antimicrob Agents Chemother. 1985; 27:966-7. (IDIS 201053)
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Other brands: Noroxin