Fluoroquinolones, including norfloxacin, are associated with an increased risk of tendinitis and tendon rupture in all age groups. 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. (See Tendinopathy and Tendon Rupture under Cautions.)
REMS:
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 ([Web]) or the ASHP REMS Resource Center ([Web]).
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†. 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.
Treatment of complicated UTIs caused by susceptible E. coli, K. pneumoniae, P. mirabilis, Ps. aeruginosa, S. marcescens, or E. faecalis.
Treatment of prostatitis caused by E. coli.
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.
GI Infections
Treatment of gastroenteritis† caused by susceptible enterotoxigenic E. coli, Aeromonas hydrophila, Plesiomonas shigelloides, Salmonella, or Shigella (including Sh. boydii, Sh. dysenteriae, Sh. flexneri, Sh. sonnei).
Treatment of cholera†, including infections caused by Vibrio cholerae serotypes 01 or 0139. Tetracyclines generally are drugs of choice when an anti-infective is indicated as an adjunct to fluid and electrolyte replacement; alternative agents for V. cholerae resistant to tetracyclines include co-trimoxazole, fluoroquinolones, or furazolidone.
Treatment of travelers’ diarrhea†. Replacement therapy with oral fluids and electrolytes may be sufficient for mild to moderate disease. Generally self-limited and may resolve within 3–4 days without anti-infective treatment; 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. Fluoroquinolones (ciprofloxacin, levofloxacin, norfloxacin, ofloxacin) usually drugs of choice when treatment, including self-treatment, is indicated. 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. Rifaximin is another alternative for treatment of travelers' diarrhea caused by noninvasive E. coli.
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. CDC and others do not recommend anti-infective prophylaxis in most individuals traveling to areas of risk; the principal preventive measures are prudent dietary practices. 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, although the increasing incidence of quinolone resistance in pathogens that cause travelers' diarrhea (e.g., Campylobacter) should be considered.
Gonorrhea and Associated Infections
Has been used for treatment of uncomplicated urethral, endocervical, or rectal† gonorrhea caused by susceptible Neisseria gonorrhoeae.
Although fluoroquinolones (ciprofloxacin, levofloxacin, ofloxacin) were previously considered drugs of choice for treatment of uncomplicated gonorrhea, 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).
Quinolone-resistant N. gonorrhoeae (QRNG) has been reported with increasing frequency worldwide and is widespread in the US. (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.
Dosage and Administration
Administration
Oral Administration
Administer orally.
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). (See Pharmacokinetics.)
Patients receiving norfloxacin should be well hydrated and should be instructed to drink fluids liberally. (See Renal Effects under Cautions.)
Dosage
Adults
Urinary Tract Infections (UTIs) and Prostatitis
Uncomplicated UTIs
Oral
400 mg every 12 hours. 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.
Complicated UTIs
Oral
400 mg every 12 hours. Usual duration is ≥10–21 days.
Acute or Chronic Prostatitis Caused by E. coli
Oral
400 mg every 12 hours for 28 days.
GI Infections
Gastroenteritis Caused by Susceptible Bacteria
Oral
400 mg twice daily for 5 days. A duration of 3 days may be sufficient for some infections, including shigellosis or some E. coli infections.†
Cholera
Oral
400 mg twice daily for 3 days in conjunction with fluid and electrolyte replacement. 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.†
Treatment of Travelers’ Diarrhea
Oral
400 mg twice daily for 1–3 days.†
Prevention of Travelers’ Diarrhea
Oral
400 mg once daily.†
Although anti-infectiveprophylaxis generally is discouraged, 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.†
Gonorrhea
Uncomplicated Urethral, Endocervical, or Rectal Gonorrhea
Oral
A single 800-mg dose.†
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). (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).†
Prescribing Limits
Adults
Oral
Maximum 400 mg twice daily because of the risk of crystalluria.
Special Populations
Renal Impairment
Dosage adjustments necessary in patients with severe renal impairment.
Adults with Clcr ≤30 mL/minute per 1.73 m2 should receive 400 mg once daily.
Geriatric Patients
No dosage adjustments except those related to renal impairment. (See Renal Impairment under Dosage and Administration.)
Select dosage with caution because of possible age-related decreases in renal impairment.
History of tendinitis or tendon rupture with norfloxacin or any quinolone.
Warnings/Precautions
Warnings
Tendinopathy and Tendon Rupture
Fluoroquinolones, including norfloxacin, are associated with increased risk of tendinitis and tendon rupture in all age groups. 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.
Other factors that may independently increase 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 of these risk factors.
Fluoroquinolone-associated tendinitis and tendon rupture most frequently involve the Achilles tendon and may require surgical repair. Tendinitis and tendon rupture in the rotator cuff (shoulder), hand, biceps, thumb, and other tendon sites also reported.
Tendon rupture can occur during or following fluoroquinolone therapy and has been reported up to several months after completion of therapy.
Discontinue if pain, swelling, inflammation, or rupture of a tendon occurs. 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). (See Advice to Patients.)
Musculoskeletal Effects
Fluoroquinolones, including norfloxacin, cause arthropathy and osteochondrosis in immature animals of various species. Relevance of these adverse effects in immature animals to use in humans unknown. 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).
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).
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.
Peripheral Neuropathy
Sensory or sensorimotor axonal polyneuropathy affecting small and/or large axons resulting in paresthesias, hypoesthesias, dysesthesias, and weakness reported with quinolones, including norfloxacin.
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.
Superinfection/Clostridium difficile-associated Diarrhea and Colitis (CDAD)
Possible emergence and overgrowth of nonsusceptible bacteria or fungi. Institute appropriate therapy if superinfection occurs.
Treatment with anti-infectives alters normal colon flora and may permit overgrowth of Clostridium difficile. 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. Outbreaks of severe CDAD caused by fluoroquinolone-resistant C. difficile have been reported with increasing frequency over the last several years. 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.
Consider CDAD if diarrhea develops during or after therapy and manage accordingly. 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.
If CDAD is suspected or confirmed, norfloxacin may need to be discontinued. Some mild cases may respond to discontinuance alone. 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.
Sensitivity Reactions
Hypersensitivity Reactions
Serious and occasionally fatal (anaphylactic) hypersensitivity reactions, which may occur following first dose, reported with some quinolones, including norfloxacin.
Some reactions have been accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching.
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. 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.
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).
Photosensitivity Reactions
Moderate to severe photosensitivity/phototoxicity reactions have been reported with fluoroquinolones, including norfloxacin.
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).
Relative potential of the various fluoroquinolones to cause photosensitivity/phototoxicity unclear. 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.
Avoid unnecessary or excessive exposure to sunlight or artificial UV light (tanning beds, UVA/UVB treatment) while receiving norfloxacin. 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 norfloxacin if photosensitivity or phototoxicity (sunburn-like reaction, skin eruption) occurs.
General Precautions
Renal Effects
Possible crystalluria; generally associated with alkaline urine and high dosage.
Adequate fluid intake necessary to ensure proper hydration and adequate urinary output; avoid alkaline urine and do not exceed usual dosage.
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.
Laboratory Monitoring
Periodically assess organ system functions, including renal, hepatic, and hematopoietic, during prolonged therapy.
Selection and Use of Anti-infectives
When prescribing a fluoroquinolone, consider potential benefits and risks for the individual patient. 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.
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.
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.
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.
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.
CDC states that fluoroquinolones should not be used to treat proven or suspected gonorrhea, including infections acquired within the US or acquired while traveling abroad.
Specific Populations
Pregnancy
Category C.
Lactation
Not known whether distributed into milk; other quinolones are distributed into milk. Discontinue nursing or the drug.
Pediatric Use
Safety and efficacy not established in children and adolescents <18 years of age. Norfloxacin causes arthropathy in juvenile animals. (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 the parents or caregivers.
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults, but increased risk of some adverse effects cannot be ruled out.
Risk of severe 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 Tendinopathy 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.)
Substantially eliminated by the kidney and age-related decline in renal function may increase risk of adverse reactions.
Consider age-related decreases in renal function when selecting dosage; renal function monitoring may be useful.
Renal Impairment
Increased norfloxacin serum concentrations and prolonged half-life.
Dosage adjustments necessary in patients with severe renal impairment. (See Renal Impairment under Dosage and Administration.)
Inhibits cytochrome P-450 (CYP) isoenzyme 1A2. Potential pharmacokinetic interaction with CYP1A2 substrates (e.g., caffeine, clozapine, ropinirole, tacrine, theophylline, tizanidine) resulting in increased drug concentrations if given in usual dosages. Carefully monitor patients receiving norfloxacin concomitantly with drugs metabolized by CYP1A2.
In vitro evidence of additive or synergistic antibacterial effects against some Enterobacteriaceae and Ps. aeruginosa; synergism unpredictable and indifference or antagonism also has been reported
Some in vitro evidence of antagonism between norfloxacin and nitrofurantoin
Clinical importance unknown; should not be used concomitantly
NSAIAs
Increased risk of CNS stimulation and convulsive seizures
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 NSAIA
Some clinicians suggest that concomitant use should be avoided; if used concomitantly, give norfloxacin tablets at least 2 hours before or after sucralfate
Theophylline
Possible increased theophylline concentrations and increased risk of theophylline-related adverse effects
Although risk of norfloxacin inducing substantial alterations in theophylline pharmacokinetics appears to be less than with some other quinolones (e.g., ciprofloxacin), theophylline-related adverse effects have been reported in patients receiving norfloxacin concomitantly
Some clinicians suggest that the interaction between norfloxacin and theophylline may not be clinically important in most patients; others suggest that norfloxacin should be used with caution in patients receiving theophylline
Manufacturer of norfloxacin states that consideration should be given to monitoring plasma theophylline concentrations and theophylline dosage should be adjusted as required
Pharmacokinetics
Absorption
Bioavailability
Rapidly, but incompletely, absorbed from GI tract following oral administration.
At least 30–50% of an oral dose is absorbed from GI tract; peak serum concentrations generally attained within 1–2 hours. Steady-state serum concentrations attained by the second day of therapy.
Food
Food and/or dairy products (milk, yogurt) in the GI tract may decrease absorption.
Distribution
Extent
Distributed into renal parenchyma, gallbladder, liver, prostatic tissue, testicles, seminal fluid, uterus, fallopian tubes, cervical and vaginal tissue, blister fluid, tonsils, maxillary sinus mucosa, sputum, and bile.
Crosses the placenta and is distributed into cord blood and amniotic fluid. Not known whether norfloxacin is distributed into milk; some other quinolones (e.g., ciprofloxacin, ofloxacin) are distributed into milk.
Plasma Protein Binding
10–15% bound to serum proteins.
Elimination
Metabolism
Partially metabolized by modification of the piperazinyl group to 6 metabolites, designated —1, —2, —3, —4[1], —4[2], and —5. Although some of the metabolites are microbiologically active, they are less active than the parent drug.
Elimination Route
Eliminated by renal and nonrenal mechanisms.
Norfloxacin and its metabolites excreted in urine, with unchanged norfloxacin being excreted by both glomerular filtration and tubular secretion. Norfloxacin also excreted in feces, principally as unabsorbed drug and, to a small extent, via biliary elimination.
Approximately 25–40% of a dose excreted in urine as unchanged drug and 5–10% as metabolites within 24–48 hours; ≥30% (range: 10–50%) is excreted in feces within 48 hours.
Geriatric individuals 65–75 years of age with renal function normal for their age: half-life averages 4 hours.
Limited data suggest that half-life is not substantially affected by hepatic impairment.
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.
Stability
Storage
Oral
Tablets
Tight container at 25°C (may be exposed to 15–30°C).
Actions
Usually bactericidal.
Like other fluoroquinolones, norfloxacin inhibits bacterial DNA gyrase and topoisomerase IV.
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). Not usually active against obligate anaerobes. Inactive against fungi and viruses.
Gram-positive aerobic cocci: Active in vitro and in clinical infections against S. aureus, S. epidermidis, S. saprophyticus, S. agalactiae (group B streptococci), and Enterococcus faecalis. Although some strains of Streptococcus pneumoniae, S. pyogenes (group A β-hemolytic streptococci), groups C and G streptococci, viridans streptococci, and nonenterococcal group D streptococci are inhibited in vitro by norfloxacin, many strains of these gram-positive bacteria are relatively resistant to the drug.
Gram-positive aerobic bacilli: Active in vitro against Bacillus cereus, Corynebacterium, and Listeria monocytogenes. Nocardia asteroides usually are resistant.
Gram-negative aerobes: Active in vitro and in clinical infections against Ps. aeruginosa and most Enterobacteriaceae (including C. freundii, E. aerogenes, E. cloacae, E. coli, K. pneumoniae, P. mirabilis, P. vulgaris, S. marcescens). Also active in vitro against Acinetobacter,Aeromonas, C. diversus, Edwardsiella tarda, E. agglomerans, Haemophilus ducreyi, H. influenzae, K. oxytoca, Moraxella catarrhalis, Morganella morganii, Providencia (including P. alcalifaciens, P. rettgeri, P. stuartii), other Pseudomonas (e.g., Ps. acidovorans, Ps. fluorescens, Ps. putida, Ps. stutzeri), and Vibrio.
Other organisms: Has some in vitro activity against Chlamydia trachomatis, Mycoplasma hominis, M. pneumoniae, Ureaplasma urealyticum, M. tuberculosis, and some other mycobacteria.
Strains of N. gonorrhoeae with decreased susceptibility to norfloxacin and other fluoroquinolones (quinolone-resistant N. gonorrhoeae; QRNG) reported with increasing frequency.
Some cross-resistance occurs between norfloxacin and other fluoroquinolones.
Importance of completing full course of therapy, even if feeling better after a few days.
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.
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.
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.
Importance of taking norfloxacin tablets with a glass of water and drinking sufficient quantities of fluids during therapy.
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. 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. (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.
May be associated with hypersensitivity reactions (including anaphylactic reactions), even following the first dose. Importance of immediately discontinuing the drug and informing clinician at the first sign of rash, jaundice, or any other sign of hypersensitivity.
Risk of photosensitivity/phototoxicity reactions following exposure to sun or UV light while receiving fluoroquinolones. 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. Discontinue norfloxacin and inform a clinician if a sunburn-like reaction or skin eruption occurs.
Advise patients that seizures have been reported and to contact clinicians before taking norfloxacin if they have a history of seizures.
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.
Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. 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.
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).
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of advising patients of other important precautionary information. (See Cautions.)
Preparations
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 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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