Generic Name: Norfloxacin
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
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.)
FDA approved a REMS for norfloxacin to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of norfloxacin and consists of the following: medication guide. See the FDA REMS page () or the ASHP REMS Resource Center ().
Uses for Noroxin
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 are drugs of choice when an anti-infective is indicated as an adjunct to fluid and electrolyte replacement;43 309 311 334 alternative agents for V. cholerae resistant to tetracyclines include co-trimoxazole, fluoroquinolones, or furazolidone.43 309 311 334 341
Treatment of travelers’ diarrhea†.210 301 304 305 306 335 374 Replacement therapy with oral fluids and electrolytes may be sufficient for mild to moderate disease.210 304 305 335 Generally self-limited and may resolve within 3–4 days without anti-infective treatment;210 304 305 334 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 may be indicated.210 304 305 334 374 Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, is indicated.304 305 312 335 337 374 Azithromycin is a treatment alternative for those who should not receive fluoroquinolones (e.g., children, pregnant women) and may be a drug of choice for travelers in areas with a high prevalence of fluoroquinolone-resistant Campylobacter (e.g., Thailand, India) or those who have not responded after 48 hours of fluoroquinolone treatment.304 305 334 374 Rifaximin is another alternative for treatment of travelers' diarrhea caused by noninvasive E. coli.304 305 374
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.109 131 193 301 304 307 308 335 337 374 CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk;210 304 305 308 312 334 374 the principal preventive measures are prudent dietary practices.210 304 329 330 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,304 305 374 although the increasing incidence of quinolone resistance in pathogens that cause travelers' diarrhea (e.g., Campylobacter) should be considered.304 305
Gonorrhea and Associated Infections
Although fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) were previously considered drugs of choice for treatment of uncomplicated gonorrhea,319 358 CDC currently states that fluoroquinolones should not be used for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., pelvic inflammatory disease [PID], epididymitis).328 358 359 360
Quinolone-resistant N. gonorrhoeae (QRNG) has been reported with increasing frequency worldwide and is widespread in the US.319 320 328 338 358 359 360 (See Resistance in Neisseria gonorrhoeae under Cautions.)
For treatment of uncomplicated cervical, urethral, or rectal gonorrhea, CDC and others recommend IM ceftriaxone or oral cefixime; IM ceftriaxone is drug of choice for pharyngeal infections.319 328 358 359
Noroxin Dosage and Administration
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
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 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
Prevention of Travelers’ Diarrhea†Oral
Although anti-infective prophylaxis generally is discouraged,210 304 305 308 312 334 337 374 some clinicians state that it can be given during the period of risk (for ≤3 weeks) beginning the day of travel and continuing for 1 or 2 days after leaving the area of risk.329 330 335 374
Uncomplicated Urethral, Endocervical, or Rectal† GonorrheaOral
Because of increased prevalence of quinolone-resistant Neisseria gonorrhoeae (QRNG), CDC no longer recommends fluoroquinolones for treatment of gonorrhea or any associated infections involving N. gonorrhoeae (e.g., PID, epididymitis).328 358 359 360 (See Gonorrhea and Associated Infections under Uses.)
Unless the presence of coexisting chlamydial infection has been excluded by appropriate testing, patients being treated for gonorrhea should also receive an anti-infective regimen effective for presumptive treatment of chlamydia (e.g., a single dose of oral azithromycin or a 7-day regimen of oral doxycycline).319
Maximum 400 mg twice daily because of the risk of crystalluria.1
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 Noroxin
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.)
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
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 quinolones, including norfloxacin.1
To prevent development of an irreversible condition, discontinue norfloxacin if symptoms of neuropathy (e.g., pain, burning, tingling, numbness, and/or weakness) occur or if there are deficits in light touch, pain, temperature, position sense, vibratory sensation, and/or motor strength.1
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile.1 345 346 347 348 349 354 C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including norfloxacin, and may range in severity from mild diarrhea to fatal colitis.1 242 267 345 346 347 348 349 351 355 356 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 Hyper toxin-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 therapy and manage accordingly.1 345 346 347 348 349 354 Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.1 345 346 347 348 349
If CDAD is suspected or confirmed, norfloxacin may need to be discontinued.1 345 346 347 348 349 Some mild cases may respond to discontinuance alone.345 346 347 348 349 Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, appropriate anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.1 345 346 347 348 349
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.292 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.292
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
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
Myasthenia Gravis Patients
Possible exacerbation of signs of myasthenia gravis, which may lead to life-threatening weakness of respiratory muscles, reported with quinolones, including norfloxacin; use with caution in patients with myasthenia gravis.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 homeostatis) 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 several years.319 320 322 323 324 325 326 327 328 336 358
Recent 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
AAP states use of fluoroquinolones may be justified in children <18 years of age in special circumstances after careful assessment of the risks and benefits for the individual patient and after these benefits and risks have been explained to the parents or caregivers.334
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
Common Adverse Effects
Interactions for Noroxin
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)
Anticoagulants, oral (warfarin)
No in vitro evidence of synergism or antagonism against gram-positive or -negative bacteria when used with ampicillin, cefotaxime, or cefoxitin48
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
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
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
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
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
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
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
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-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
Strains of N. gonorrhoeae with decreased susceptibility to norfloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) reported with increasing frequency.319 320 322 323 324 325 326 327 328 336 358
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.)
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 importance of discontinuing the drug and contacting clinician if symptoms such as pain, burning, tingling, numbness, and/or 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.
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Noroxin 400MG Tablets (MERCK SHARP & DOHME): 20/$85.51 or 60/$235.14
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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