Side effects of norfloxacin: Norfloxacin Uses, Side Effects & Warnings

08.10.202309.07.2023 by alexxlab

Содержание

Norfloxacin Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Warnings:

Quinolone antibiotics (including norfloxacin) may cause serious and possibly permanent tendon damage (such as tendonitis, tendon rupture), nerve problems in the arms and legs (peripheral neuropathy), and nervous system problems. Get medical help right away if you have any of the following symptoms: pain/numbness/burning/tingling/weakness in your arms/hands/legs/feet, changes in how you sense touch/pain/temperature/vibration/body position, severe/lasting headache, vision changes, shaking (tremors), seizures, mental/mood changes (such as agitation, anxiety, confusion, hallucinations, depression, rare thoughts of suicide).

Tendon damage may occur during or after treatment with this medication. Stop exercising, rest, and get medical help right away if you develop joint/muscle/tendon pain or swelling. Your risk for tendon problems is greater if you are over 60 years of age, if you are taking corticosteroids (such as prednisone), or if you have a kidney, heart, or lung transplant.

This medication may make a certain muscle condition (myasthenia gravis) worse. Tell your doctor right away if you have new or worsening muscle weakness (such as drooping eyelids, unsteady walk) or trouble breathing.

Discuss the risks and benefits with your doctor before using this medication.

Warnings:

Discuss the risks and benefits with your doctor before using this medication.

Uses

Norfloxacin is used to treat a variety of bacterial infections. This medication belongs to a class of drugs known as quinolone antibiotics. It works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

How to use Norfloxacin Tablet

Read the Medication Guide provided by your pharmacist before you start taking norfloxacin and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually twice a day (every 12 hours) with a full glass of water (8 ounces/240 milliliters). Do not have any food or dairy products (such as milk/yogurt) within 2 hours before or 1 hour after taking norfloxacin. Drink plenty of fluids while taking this drug unless your doctor tells you otherwise. The dosage and length of treatment are based on your medical condition and response to treatment.

Take this medication at least 2 hours before or 2 hours after taking other products that may make it work less well. Examples include quinapril, sucralfate, vitamins/minerals (including iron, zinc), and products that contain magnesium, aluminum, or calcium (such as antacids, didanosine solution, calcium-enriched juice), among others. Ask your pharmacist about all the products you take.

Avoid taking large amounts caffeine (such as coffee, energy drinks) since this drug may increase and/or make the effects of caffeine last longer.

For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same times every day.

Continue to take this medication until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection.

Tell your doctor if your condition lasts or gets worse.

Side Effects

Precautions

Before taking norfloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics such as ciprofloxacin, gemifloxacin, levofloxacin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: joint/tendon problems (such as tendonitis, bursitis), kidney disease, mental/mood disorders (such as depression), a certain muscle condition (myasthenia gravis), nerve problems (such as peripheral neuropathy), seizure disorder, blood vessel problems (such as aneurysm or blockage of the aorta or other blood vessels, hardening of the arteries), high blood pressure, certain genetic conditions (Marfan syndrome, Ehlers-Danlos syndrome).

Norfloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using norfloxacin, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using norfloxacin safely.

This medication may rarely cause serious changes in blood sugar, especially if you have diabetes. Check your blood sugar regularly as directed and share the results with your doctor. Watch for symptoms of high blood sugar, such as increased thirst/urination. Also watch for symptoms of low blood sugar such as sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or by drinking fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Your doctor may need to switch you to another antibiotic or adjust your diabetes medications if any reaction occurs.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you more sensitive to the sun. Limit your time in the sun. Avoid tanning booths and sunlamps. Use sunscreen and wear protective clothing when outdoors. Tell your doctor right away if you get sunburned or have skin blisters/redness.

Norfloxacin may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using norfloxacin before having any immunizations/vaccinations.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Children may be at greater risk for joint/tendon problems while using this drug. Discuss the risks and benefits with the doctor.

Older adults may be at greater risk for tendon problems (especially if they are also taking corticosteroids such as prednisone or hydrocortisone), QT prolongation, and a sudden tear/break in the main blood vessel (aorta).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Interactions

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless your doctor tells you to.

Lab tests (such as kidney function, complete blood count, blood sugar, cultures) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Norfloxacin – LiverTox – NCBI Bookshelf

Last Update: March 10, 2020.

OVERVIEW

Introduction

Norfloxacin is a first generation fluoroquinolone that is typically used to treated urinary tract infections and prostatitis. Norfloxacin has been linked to rare instances of acute hepatocellular injury.

Background

Norfloxacin (nor flox’ a sin) is a first generation fluoroquinolone that has been available for treatment of bacterial infections for many years, but which now has limited indications and is not commonly used. Like other fluoroquinolones, norfloxacin is active against a wide range of aerobic gram-positive and gram-negative organisms and is believed to act by inhibition of bacterial DNA gyrase and topoisomerase IV that are required for synthesis of bacterial mRNAs (transcription) and DNA replication. In contrast, DNA gyrases are not present in human [and other eukarotic] cells and the equivalent topoisomerases are not sensitive to fluoroquinolone inhibition. Norfloxacin was first approved for use in the United States in 1986. Current indications are for urinary tract infections, sexually transmitted diseases and prostatitis due to sensitive organisms. Based upon studies from Europe, norfloxacin has also been used off-label as prophylaxis against spontaneous bacterial peritonitis in patients with cirrhosis and ascites. Norfloxacin is available as 400 mg tablets under the trade name Noroxin. Typical doses are 400 mg every 12 hours for 3 to 10 days, but chronic therapy has been used for antibacterial prophylaxis. Common side effects include gastrointestinal upset, headaches, skin rash and allergic reactions. Less common, but more severe side effects of norfloxacin include prolongation of the QT interval, seizures, hallucinations, tendon rupture, hypersensitivity reactions, angioedema, Stevens Johnson syndrome, photosensitivity and peripheral neuropathy.

Hepatotoxicity

Norfloxacin like other fluoroquinolones is associated with a low rate (1% to 3%) of serum enzyme elevations during therapy. These abnormalities are generally mild, asymptomatic and transient, resolving even with continuation of therapy. Norfloxacin has also been linked to rare but occasionally severe and even fatal cases of acute liver injury. While the numbers of cases have been few, the clinical pattern has been consistent with short latency period of 1 day to 3 weeks and abrupt onset of hepatocellular injury. The pattern of serum enzyme elevations can be either hepatocellular or cholestatic, cases with the shorter times to onset usually being more hepatocellular with markedly elevated ALT levels, and occasionally with rapid worsening of prothrombin time and signs of hepatic failure. The onset of illness may occur a few days after the medication is stopped. Many (but not all) cases have had allergic manifestations with fever, rash and eosinophilia. Autoantibodies are usually not present. Cholestatic and mixed patterns of injury have also been described particularly with delayed recognition of the liver injury. These features are typical of all fluoroquinolone associated hepatotoxicity and the injury is believed to be class specific.

Likelihood score: C (probable rare cause of clinically apparent liver injury).

Mechanism of Injury

The cause of hepatic injury is unknown, but appears to be hypersensitivity.

Outcome and Management

The severity of liver injury caused by norfloxacin ranges from mild and transient serum enzyme elevations to self-limited but severe hepatitis, to acute liver failure and death. Complete recovery is expected after stopping the drug and recovery is usually rapid (2 to 8 weeks). Cross reactivity of the hepatic injury between different fluoroquinolones has not been well documented, but is suspected based upon the similarity of clinical patterns of injury and latency. Thus, patients should be advised to avoid further exposure to the fluoroquinolones.

Drug Class: Antiinfective Agents

Other Drugs in the Subclass, Fluoroquinolones: Ciprofloxacin, Delafloxacin, Gemifloxacin, Levofloxacin, Moxifloxacin, Ofloxacin

CASE REPORT

CHEMICAL FORMULA AND STRUCTURE

DRUG	CAS REGISTRY NO	MOLECULAR FORMULA	STRUCTURE
Te_1_1_1_1″ scope=”row” rowspan=”1″ colspan=”1″>Norfloxacin	70458-96-7	C16-h28-F-N3-O3

CITED REFERENCE

1.: Romero-Gómez M, Suárez García E, Fernández MC. Norfloxacin-induced acute cholestatic hepatitis in a patient with alcoholic liver cirrhosis. Am J Gastroenterol. 1999;94:2324–5. [PubMed: 10445586]

ANNOTATED BIBLIOGRAPHY

References updated: 10 March 2020

Zimmerman HJ. Quinolones. In, Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. 2nd ed. Philadelphia: Lippincott, 1999. p 603.
(Expert review of hepatotoxicity published in 1999; mentions that cinoxacin, nalidixic acid, ciprofloxacin, norfloxacin, enoxacin, and ofloxacin are associated with minor serum enzyme elevations during therapy and with rare instances of clinically apparent liver injury).
Moseley RH. Fluoroquinolones. Hepatotoxicity of antimicrobial and antifungal agents. In, Kaplowitz N, DeLeve LD, eds. Drug-induced liver disease. 3rd Edition. Amsterdam: Elsevier, 2013. p. 468-9.
(Review of hepatotoxicity of antibiotics mentions that hepatocellular and cholestatic forms of injury have been reported due to the quinolones, including cases of ductopenia, acute liver failure and death).
MacDougall C. The quinolones. Sulfonamides, trimethoprim-sulfamethoxazole, quinolones, and agents for urinary tract infections. In, Brunton LL, Hilal-Dandan R, Knollman BC, eds. Goodman & Gilman’s the pharmacological basis of therapeutics. 13th ed. New York: McGraw-Hill, 2018, pp. 1015-8.
(Textbook of pharmacology and therapeutics).
Corrado ML, Struble WE, Peter C, Hoagland V, Sabbaj J. Norfloxacin: a review of safety studies. Am J Med. 1987;82 Suppl 6B:22–6. [PubMed: 3605158]
(Early report on safety of norfloxacin from the sponsor; states that adverse events are uncommon and usually mild and that ALT elevations are rare [0. 1%]).
Halkin H. Adverse effects of the fluoroquinolones. Rev Infect Dis. 1988;10 Suppl 1:S258–61. [PubMed: 3279499]
(Combined analysis of databases provided by manufacturers on adverse events of fluoroquinolones in approximately 30,000 persons receiving ciprofloxacin, ofloxacin, pefloxacin, norfloxacin and enoxacin found similar types and rates of adverse events among the agents, overall in 4-8%, elevated liver enzymes in 1.8-2.5%, but eosinophilia in 2.4% with ciprofloxacin and 5-19% with ofloxacin).
López-Navidad A, Domingo P, Cadafalch J, Farrerons J. Norfloxacin-induced hepatotoxicity. J Hepatol. 1990;11:277–8. [PubMed: 2254636]
(72 year old woman developed abdominal pain 7 days after starting norfloxacin [peak bilirubin 1.0 mg/dL, ALT 310 U/L, Alk P 271 U/L], resolving within a few weeks upon stopping).
Wolfson JS, Hooper DC. Overview of fluoroquinolone safety. Am J Med. 1991;91 Suppl 6A:153S–61S. [PubMed: 1767803]
(Review of side effects reported in 22 clinical trials of fluoroquinolones; elevations in ALT and/or Alk P levels occurred in 1. 8-2.7% of patients on cipro-, nor-, or ofloxacin).
Davoren P, Mainstone K. Norfloxacin-induced hepatitis. Med J Aust 1993; 159: 423, 426. [PubMed: 8377697]
(25 year old woman developed abdominal pain, fever and jaundice within 2 days of starting norfloxacin [bilirubin 3.7 mg/dL, ALT 2726 U/L, Alk P 168 U/L], resolving within 3 weeks of stopping).
Lucena MI, Andrade RJ, Sanchez-Martinez H, Perez-Serrano JM, Gomez-Outes A. Norfloxacin-induced cholestatic jaundice. Am J Gastroenterol. 1998;93:2309–11. [PubMed: 9820434]
(70 year old man developed jaundice and pruritus 12 days after starting norfloxacin [bilirubin 10 mg/dL, ALT 178 U/L, Alk P 443 U/L], resolving within 4 weeks of stopping).
Romero-Gómez M, Suárez García E, Fernández MC. Norfloxacin-induced acute cholestatic hepatitis in a patient with alcoholic liver cirrhosis. Am J Gastroenterol. 1999;94:2324–5. [PubMed: 10445586]
(58 year old man with alcoholic cirrhosis but normal liver tests developed jaundice 5 days after starting oral norfloxacin for prophylaxis against spontaneous bacterial peritonitis [bilirubin 14. 9 mg/dL, ALT 214 U/L, AST 121 U/L, Alk P 1921 U/L], with return to baseline within 1 month of stopping).
Björnsson E, Olsson R, Remotti H. Norfloxacin-induced eosinophilic necrotizing granulomatous hepatitis. Am J Gastroenterol. 2000;95:3662–4. [PubMed: 11151924]
(71 year old woman developed fever and eosinophilia [61%] after a week of therapy with norfloxacin and at 2 weeks had liver test abnormalities [bilirubin normal, ALT 69 Alk P 960 U/L], which returned to normal with stopping; recurrence of fever, eosinophilia [55%] and ALT elevations [102 U/L] within a day of reexposure).
Orman ES, Conjeevaram HS, Vuppalanchi R, Freston JW, Rochon J, Kleiner DE, Hayashi PH., DILIN Research Group. Clinical and histopathologic features of fluoroquinolone-induced liver injury. Clin Gastroenterol Hepatol. 2011;9:517–23.e3. [PMC free article: PMC3718017] [PubMed: 21356330]
(Among 679 cases of drug induced liver injury presenting between 2004 and 2010 at 8 US medical centers, 12 [1. 8%] were attributed to fluoroquinolones including 6 cipro-, 4 moxi-, 1 levo-, and 1 gatifloxacin, but not from norfloxacin; average time to onset was 4 days [range 1-39], with both hepatocellular and cholestatic enzyme patterns, seven with rash or fever, mortality limited to those with hepatocellular injury and jaundice; hepatic injury appeared to be class specific).
Reuben A, Koch DG, Lee WM., Acute Liver Failure Study Group. Drug-induced acute liver failure: results of a U.S. multicenter, prospective study. Hepatology. 2010;52:2065–76. [PMC free article: PMC3992250] [PubMed: 20949552]
(Among 1198 patients with acute liver failure enrolled in a US prospective study between 1998 and 2007, 133 were attributed to drug induced liver injury, including one due to ciprofloxacin, but none to norfloxacin).
Björnsson ES, Bergmann OM, Björnsson HK, Kvaran RB, Olafsson S. Incidence, presentation and outcomes in patients with drug-induced liver injury in the general population of Iceland. Gastroenterology. 2013;144:1419–25. [PubMed: 23419359]
(In a population based study of drug induced liver injury from Iceland, 96 cases were identified over a 2 year period, none of which were attributed to a fluoroquinolone).
Kwon H, Lee SH, Kim SE, Lee JH, Jee YK, Kang HR, Park BJ, et al. Spontaneously reported hepatic adverse drug events in Korea: multicenter study. J Korean Med Sci. 2012;27:268–73. [PMC free article: PMC3286773] [PubMed: 22379337]
(Summary of 2 years of adverse event reporting in Korea; of 9360 reports, 567 were liver related, including 29 [5.1%] attributed to quinolones).
Harr T, French LE. Stevens-Johnson syndrome and toxic epidermal necrolysis. Chem Immunol Allergy. 2012;97:149–66. [PubMed: 22613860]
(Review of the clinical features, epidemiology, genetics and pathogenesis of SJS and TEN).
Hernández N, Bessone F, Sánchez A, di Pace M, Brahm J, Zapata R, A, Chirino R, et al. Profile of idiosyncratic drug induced liver injury in Latin America. An analysis of published reports. Ann Hepatol. 2014;13:231–9. [PubMed: 24552865]
(Systematic review of literature of drug induced liver injury in Latin American countries published from 1996 to 2012 identified 176 cases, one due to trovafloxacin [acute liver failure], but none attributed to ciprofloxacin or other fluoroquinolones).
Alshammari TM, Larrat EP, Morrill HJ, Caffrey AR, Quilliam BJ, LaPlante KL. Risk of hepatotoxicity associated with fluoroquinolones: a national case-control safety study. Am J Health Syst Pharm. 2014;71:37–43. [PubMed: 24352180]
(Retrospective analysis of Veterans Affairs patients receiving a fluoroquinolone [n=7862] found a higher relative risk of developing acute liver injury after receipt of ciprofloxacin compared to matched controls [adjusted odds ratio: OR=1.29], but not after receipt of levofloxacin [OR=1.16) or moxifloxacin [OR=0.98]).
Lontos S, Shelton E, Angus PW, Vaughan R, Roberts SK, Gordon A, Gow PJ. A randomized controlled study of trimethoprim-sulfamethoxazole versus norfloxacin for the prevention of infection in cirrhotic patients. J Dig Dis. 2014;15:260–7. [PubMed: 24612987]
(Among 80 patients with advanced cirrhosis given oral prophylaxis with daily trimethoprim-sulfamethoxazole or norfloxacin, infection rates were similar in the two groups as were rates of death and liver transplantation as well as adverse event rates; no instances of drug induced liver injury).
Goldberg DS, Forde KA, Carbonari DM, Lewis JD, Leidl KB, Reddy KR, Haynes K, et al. Population-representative incidence of drug-induced acute liver failure based on an analysis of an integrated health care system. Gastroenterology 2015; 148: 1353-61. e3. [PMC free article: PMC4446162] [PubMed: 25733099]
(Analysis of Kaiser Permanente health care database from 2004 to 2011 identified 62 patients with suspected acute liver failure, 32 [52%] of whom had a presumed drug etiology, the most common being acetaminophen [18: 56%] and various herbal products [5: 16%], with single instances attributed to imatinib, simvastatin, leflunomide, isoniazid and valproate, but none to ciprofloxacin or other fluoroquinolones).
Chalasani N, Bonkovsky HL, Fontana R, Lee W, Stolz A, Talwalkar J, Reddy KR, et al.; United States Drug Induced Liver Injury Network. Features and outcomes of 899 patients with drug-induced liver injury: The DILIN Prospective Study. Gastroenterology 2015; 148: 1340-52. e7. [PMC free article: PMC4446235] [PubMed: 25754159]
(Among 899 cases of drug induced liver injury enrolled in a US prospective study between 2004 and 2013, 38 cases [4%] were attributed to fluoroquinolones, including 16 due to ciprofloxacin [the 8th most common prescription drug cause], 13 due to levofloxacin and 8 to moxifloxacin).
Elliott TR, Symes T, Kannourakis G, Angus P. Resolution of norfloxacin-induced acute liver failure after N-acetylcysteine therapy: further support for the use of NAC in drug-induced ALF? BMJ Case Rep. 2016;2016:bcr2015213189. pii. [PMC free article: PMC4716361] [PubMed: 26740270]
(77 year old woman developed jaundice 2 weeks after a 3 day course of norfloxacin [bilirubin 8. 5 mg/dL, ALT 248 U/L, Alk P 256 U/L], with progression to hepatic failure [INR 2.7], but dramatic clinical improvement after a 2 day infusion of N-acetylcysteine, liver tests normalizing 3 months later).
Bonkovsky HL, Kleiner DE, Gu J, Odin JA, Russo MW, Navarro VM, Fontana RJ, Ghabril MS, et al. U.S. Drug Induced Liver Injury Network Investigators. Clinical presentations and outcomes of bile duct loss caused by drugs and herbal and dietary supplements. Hepatology. 2017;65:1267–77. [PMC free article: PMC5360519] [PubMed: 27981596]
(Among 363 patients with drug induced liver injury who underwent liver biopsy, 26 [7%] had bile duct loss of whom 94% developed evidence of chronic liver injury suggestive of vanishing bile duct syndrome, 2 of which were due to fluoroquinolones, 1 to moxifloxacin and 1 levofloxacin).
Yim HJ, Suh SJ, Jung YK, Yim SY, Seo YS, Lee YR, Park SY, Jang JY, Kim YS, Kim HS, Kim BI, Um SH. Daily norfloxacin vs. weekly ciprofloxacin to prevent spontaneous bacterial peritonitis: a randomized controlled trial. Am J Gastroenterol. 2018;113:1167–76. [PubMed: 29946179]
(Among 124 patients with cirrhosis and ascites given prophylaxis with daily norfloxacin [400 mg] or weekly oral ciprofloxacin [750 mg], subsequent rates of bacterial peritonitis were similar [7% vs 5%] as were rates of liver transplantation and death).
Moreau R, Elkrief L, Bureau C, Perarnau JM, Thévenot T, Saliba F, Louvet A, et al. NORFLOCIR Trial Investigators. Effects of long-term norfloxacin therapy in patients with advanced cirrhosis. Gastroenterology. 2018;155:1816–27.e9. [PubMed: 30144431]
(Among 291 patients with advanced cirrhosis treated for 6 to 12 months with daily oral norfloxacin or placebo, 6-month mortality rate was less with norfloxacin [15% vs 19%] as were gram-negative bacterial infections and no norfloxacin related severe adverse events were identified).
Comparison table: some systemic fluoroquinolones. Med Lett Drugs Ther. 2018;60:e57–e58. [PubMed: 29635268]
(Table comparing 4 fluoroquinolones [cipro-, levo-, dela- and moxifloxacin] mentions that ALT and AST elevations are a class adverse event).
Kuula LSM, Viljemaa KM, Backman JT, Blom M. Fluoroquinolone-related adverse events resulting in health service use and costs: A systematic review. PLoS One. 2019;14:e0216029. [PMC free article: PMC6485715] [PubMed: 31026286]
(Systematic review of observational studies on safety of fluoroquinolones concluded that due to lack of published literature, health service and costs could not be evaluated).

Norfloxacin instructions for use: indications, contraindications, side effects – description of Norfloxacin tab., coated. film coated, 400 mg: 5, 10, 20, 30, 40, 50, 60, 80, 100 or 200 pcs. (43314)

💊 Composition of Norfloxacin

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Description of the active ingredients of the preparation

Norfloxacin
(Norfloxacin)

The scientific information provided is general and cannot be used to make decisions.
decisions about the use of a particular drug.

Update date: 2020.05.06

Marketing authorization holder:

ATOLL, OOO
(Russia)

Manufactured:

OZON, OOO

(Russia)

ATX code:

J01MA06

(Norfloxacin)

Active substance:
norfloxacin
(norfloxacin)

Rec.INN

WHO registered

Dosage form

Norfloxacin

Tab. , coated film coated, 400 mg: 10, 20, 30, 40, 50, 60, 80 or 100 pcs.

reg. No.: LP-(000987)-(RG-RU)
from 06.07.22
– Indefinitely

Previous reg. No.: LP-002653

Release form, packaging and composition
drug Norfloxacin

Film-coated tablets white or off-white, round, biconvex, scored; two layers are visible on the cross section – the core from white to light yellow and the film membrane.

Excipients : microcrystalline cellulose (MCC-101) – 98 mg; lactose monohydrate (milk sugar) – 85 mg, croscarmellose sodium – 37 mg, povidone K25 – 24 mg, purified water – 10 mg, magnesium stearate – 6 mg.

Composition of the film shell: hypromellose – 11 mg, titanium dioxide – 6 mg, macrogol-4000 – 3 mg.

10 pcs. – cellular contour packings (1) – packs of cardboard.
10 pcs. – cellular contour packings (2) – packs of cardboard.
10 pcs. – cellular contour packings (3) – packs of cardboard.
10 pcs. – cellular contour packings (4) – packs of cardboard.
10 pcs. – cellular contour packings (5) – packs of cardboard.
20 pcs. – cellular contour packings (1) – packs of cardboard.
20 pcs. – cellular contour packings (2) – packs of cardboard.
20 pcs. – cellular contour packings (3) – packs of cardboard.
20 pcs. – cellular contour packings (4) – packs of cardboard.
20 pcs. – cellular contour packings (5) – packs of cardboard.

Clinical and pharmacological group:

Antibacterial drug of the fluoroquinolone group

Pharmacotherapeutic group:

Antibacterial agents of systemic action; quinolone derivatives; fluoroquinolones

Pharmacological action

Antimicrobial synthetic agent of the fluoroquinolone group with a wide spectrum of activity. It has a bactericidal effect. By inhibiting DNA gyrase, it disrupts the process of DNA supercoiling.

Highly active against most Gram-negative bacteria: Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Morganella morganii, Klebsiella spp. (including Klebsiella pneumoniae), Enterobacter spp., Serratia spp., Citrobacter spp., Yersinia spp., Providencia spp., Haemophilus influenzae, Pseudomonas aeruginosa, Neisseria gonorrhoeae, Neisseria meningitidis.

Active against certain Gram-positive bacteria (including Staphylococcus aureus).

Anaerobic bacteria are resistant to norfloxacin, Enterococcus spp. and Acinetobacter spp.

β-lactamase resistant.

Pharmacokinetics

When taken orally, about 30-40% is absorbed, food intake reduces the rate of absorption. Plasma protein binding is 14%. Norfloxacin is well distributed in the tissues of the urogenital system. Penetrates through the placental barrier. About 30% is excreted in the urine unchanged.

Indications of the active substances of the drug
Norfloxacin

Infectious and inflammatory diseases caused by microorganisms sensitive to norfloxacin.

For oral administration: diseases of the urinary tract, prostate, gastrointestinal tract, gonorrhea, prevention of recurrence of urinary tract infections, bacterial infections in patients with granulocytopenia, “travelers’ diarrhea”.

For topical use: conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute inflammation of the meibomian glands and dacryocystitis, prevention of eye infections after removal of a foreign body from the cornea or conjunctiva, after chemical damage, before and after eye surgery ; otitis externa, acute otitis media, chronic otitis media, prevention of infectious complications during surgical interventions on the organ of hearing.

Open list of ICD-10 codes

A09	Other gastroenteritis and colitis of infectious and unspecified origin
A54	Gonococcal infection
H01.0	Blepharitis
H04.3	Acute and unspecified inflammation of lacrimal ducts
H04.4	Chronic inflammation of the tear ducts
h20.2	Other acute conjunctivitis
h20.4	Chronic conjunctivitis
h20.5	Blepharoconjunctivitis
h26	Keratitis
h26. 0	Corneal ulcer
H60	Otitis externa
H66	Suppurative and unspecified otitis media
H68	Inflammation and blockage of the auditory [Eustachian] tube
K81.0	Acute cholecystitis
K81.1	Chronic cholecystitis
K83.0	Cholangitis
N10	Acute tubulointerstitial nephritis (acute pyelonephritis)
N11	Chronic tubulointerstitial nephritis (chronic pyelonephritis)
N30	Cystitis
N34	Urethritis and urethral syndrome
N41	Inflammatory diseases of the prostate
N74. 3	Gonococcal inflammatory diseases of the female pelvic organs
N77.1	Vaginitis, vulvitis and vulvovaginitis in infectious and parasitic diseases classified elsewhere
Z29.2	Other prophylactic chemotherapy (prophylactic administration of antibiotics)

Dosage regimen

The method of administration and dosing regimen of a particular drug depends on its form of release and other factors. The optimal dosage regimen is determined by the doctor. Compliance of the dosage form of a particular drug with indications for use and dosing regimen should be strictly observed.

Individual. A single oral dose is 400-800 mg, the frequency of use is 1-2 times / day. The duration of treatment is determined individually.

Used topically in ophthalmology and ENT practice.

Side effects

From the digestive system: nausea, heartburn, anorexia, diarrhea, abdominal pain.

From the side of the central nervous system: headache, dizziness, fatigue, sleep disturbances, irritability, anxiety.

Allergic reactions: skin rash, itching, angioedema.

On the side of the urinary system: interstitial nephritis.

Contraindications for use

Pregnancy, lactation (breastfeeding), childhood and adolescence (up to 15 years), deficiency of glucose-6-phosphate dehydrogenase, hypersensitivity to norfloxacin and other drugs of the quinolone series.

Use in pregnancy and lactation

Norfloxacin is contraindicated in pregnancy and lactation (breastfeeding) because experimental studies have shown that it causes arthropathy.

Use in hepatic impairment

Use with caution in patients with severe hepatic impairment.

Use in impaired renal function

Use with caution in patients with severe renal impairment.

Use in children

Contraindicated in children and adolescents (under 15 years of age).

Special instructions

Use with caution in patients with epilepsy, convulsive syndrome of another etiology, with severe impairment of kidney and liver function. During the treatment period, patients should receive a sufficient amount of fluid (under the control of diuresis).

Norfloxacin should be taken at least 2 hours before or 2 hours after taking antacids or preparations containing iron, zinc, magnesium, calcium, or sucralfate.

Drug interactions

Co-administration of norfloxacin with warfarin enhances the anticoagulant effect of the latter.

With the simultaneous use of norfloxacin with cyclosporine, an increase in the concentration of the latter in the blood plasma is noted.

While taking norfloxacin and antacids or preparations containing iron, zinc, magnesium, calcium or sucralfate, the absorption of norfloxacin is reduced due to the formation of chelators with metal ions (the interval between their intake should be at least 4 hours).

When taken concomitantly, norfloxacin reduces the clearance of theophylline by 25%, therefore, when used simultaneously, the dose of theophylline should be reduced.

Co-administration of norfloxacin with medicinal products with the potential to lower blood pressure may cause a dramatic decrease in blood pressure. In this regard, in such cases, as well as with the simultaneous administration of barbiturates, anesthetics, heart rate, blood pressure, ECG indicators should be monitored. Simultaneous use with drugs that reduce the epileptic threshold may lead to the development of epileptiform seizures.

Reduces the effect of nitrofurans.

Keep

If you want to place a link to the description of this drug – use this code

Norfloxacin . Description of the drug in the reference book Vidal.

Norfloxacin instructions for use: indications, contraindications, side effects – description of Norfloxacin tab.

, coated. shell, 200 mg: 10, 20, 21, 30, 49or 70 pcs. (5496)

💊 Ingredients of Norfloxacin