Side effects of norfloxacin. Norfloxacin: Uses, Side Effects, and Crucial Warnings for Safe Usage

07.10.202309.07.2023 by alexxlab

What are the primary uses of norfloxacin. How does norfloxacin work against bacterial infections. What are the most common side effects of norfloxacin. Why is it important to be aware of potential tendon damage when taking norfloxacin. How should norfloxacin be taken for optimal effectiveness.

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Understanding Norfloxacin: A Powerful Antibiotic in the Quinolone Class

Norfloxacin is a potent antibiotic belonging to the quinolone class of medications. It is widely prescribed to combat various bacterial infections, offering an effective solution for patients struggling with specific types of bacterial ailments. However, like all powerful medications, it comes with its own set of considerations and potential side effects that both healthcare providers and patients need to be aware of.

What is Norfloxacin?

Norfloxacin is a synthetic antibacterial agent that falls under the category of fluoroquinolones. Its primary function is to inhibit bacterial DNA gyrase, an enzyme crucial for bacterial DNA replication. By interfering with this process, norfloxacin effectively stops the growth and multiplication of bacteria, leading to the resolution of the infection.

The Spectrum of Bacterial Infections Treated by Norfloxacin

Norfloxacin demonstrates effectiveness against a wide range of bacterial infections. It is particularly useful in treating:

Urinary tract infections (UTIs)
Prostatitis
Gonorrhea
Certain gastrointestinal infections

Its broad-spectrum activity makes it a valuable tool in the medical arsenal against bacterial diseases.

How does Norfloxacin differ from other antibiotics?

Norfloxacin stands out due to its ability to penetrate bacterial cells effectively and its broad spectrum of activity. Unlike some other antibiotics that may only work against either gram-positive or gram-negative bacteria, norfloxacin is effective against both types, making it a versatile choice for various infections.

Proper Administration of Norfloxacin: Ensuring Optimal Effectiveness

The correct administration of norfloxacin is crucial for its effectiveness and to minimize potential side effects. Here are the key points to remember:

Dosage: Typically taken twice a day, every 12 hours
Administration: Should be taken with a full glass of water (8 ounces/240 milliliters)
Timing with food: Avoid food or dairy products within 2 hours before or 1 hour after taking norfloxacin
Duration: Complete the full prescribed course, even if symptoms improve

It’s essential to follow these guidelines to ensure the medication works as intended and to prevent the development of antibiotic-resistant bacteria.

Can norfloxacin be taken with other medications?

Norfloxacin can interact with several other medications and substances. It’s important to take it at least 2 hours before or 2 hours after products containing magnesium, aluminum, calcium, iron, or zinc. This includes antacids, some vitamins and minerals, and certain other medications. Always consult with your healthcare provider or pharmacist about potential interactions.

Critical Warnings: Understanding the Risks Associated with Norfloxacin

While norfloxacin is an effective antibiotic, it comes with several important warnings that patients and healthcare providers must be aware of. These warnings are not meant to discourage the use of the medication when necessary but to ensure it’s used safely and appropriately.

What are the most serious potential side effects of norfloxacin?

The most severe potential side effects of norfloxacin include:

Tendon damage (including tendonitis and tendon rupture)
Peripheral neuropathy (nerve problems in arms and legs)
Central nervous system effects (including seizures and mental health changes)
Exacerbation of myasthenia gravis

These side effects, while rare, can be serious and in some cases permanent. It’s crucial to seek immediate medical attention if any symptoms related to these conditions occur.

Tendon Damage: A Unique Risk of Quinolone Antibiotics

One of the most significant warnings associated with norfloxacin and other quinolone antibiotics is the risk of tendon damage. This can occur during treatment or even months after discontinuing the medication.

Who is at higher risk for tendon problems when taking norfloxacin?

Certain groups are at an increased risk of experiencing tendon problems while taking norfloxacin:

Individuals over 60 years of age
Patients taking corticosteroids (such as prednisone)
Those who have had a kidney, heart, or lung transplant

If you fall into any of these categories, it’s crucial to discuss the risks and benefits of norfloxacin with your healthcare provider before starting treatment.

Recognizing and Responding to Potential Side Effects of Norfloxacin

While norfloxacin is generally well-tolerated, it’s important to be aware of potential side effects and know how to respond to them. Common side effects may include nausea, diarrhea, dizziness, headache, or trouble sleeping. These are usually mild and often resolve on their own. However, if these effects persist or worsen, it’s important to consult your healthcare provider.

What symptoms require immediate medical attention when taking norfloxacin?

Certain symptoms warrant immediate medical attention:

Pain, numbness, burning, tingling, or weakness in arms, hands, legs, or feet
Changes in sensation of touch, pain, temperature, or body position
Severe or persistent headache
Vision changes
Tremors or seizures
Mental or mood changes (such as agitation, confusion, or hallucinations)
Joint, muscle, or tendon pain or swelling

If you experience any of these symptoms, stop taking norfloxacin and seek medical help immediately.

Special Considerations: Norfloxacin and Myasthenia Gravis

Patients with myasthenia gravis, a condition characterized by muscle weakness, require special consideration when it comes to norfloxacin use. This medication can potentially exacerbate the symptoms of myasthenia gravis, leading to increased muscle weakness or breathing difficulties.

How does norfloxacin affect patients with myasthenia gravis?

In patients with myasthenia gravis, norfloxacin can potentially:

Worsen existing muscle weakness
Cause new onset of muscle weakness
Lead to breathing difficulties

If you have myasthenia gravis and are prescribed norfloxacin, it’s crucial to monitor for any worsening of symptoms and report them to your healthcare provider immediately.

Maximizing the Benefits of Norfloxacin While Minimizing Risks

While the warnings associated with norfloxacin may seem daunting, it’s important to remember that many patients take this medication without experiencing serious side effects. The key to safe and effective use lies in proper administration, vigilant monitoring, and open communication with your healthcare provider.

How can patients ensure they’re using norfloxacin safely?

To maximize the benefits of norfloxacin while minimizing risks:

Follow dosing instructions precisely
Complete the full course of antibiotics as prescribed
Avoid caffeine and certain foods and medications as advised
Stay hydrated unless instructed otherwise by your doctor
Monitor for any unusual symptoms and report them promptly
Discuss all medications and supplements you’re taking with your healthcare provider

By adhering to these guidelines, patients can help ensure they’re using norfloxacin as safely and effectively as possible.

The Importance of Responsible Antibiotic Use in the Age of Resistance

In an era where antibiotic resistance is a growing concern, the responsible use of antibiotics like norfloxacin is more crucial than ever. Misuse or overuse of antibiotics can lead to the development of resistant bacteria, making infections harder to treat in the future.

Why is it important to use norfloxacin only for bacterial infections?

Norfloxacin, like all antibiotics, is only effective against bacterial infections. It will not work for viral infections such as the common cold or flu. Using antibiotics unnecessarily or inappropriately can:

Contribute to the development of antibiotic-resistant bacteria
Expose patients to potential side effects without any benefit
Reduce the effectiveness of antibiotics when they’re truly needed

Always follow your healthcare provider’s instructions and only use norfloxacin for diagnosed bacterial infections.

Navigating the Decision to Use Norfloxacin: A Balanced Approach

The decision to use norfloxacin should be made after careful consideration of its benefits and potential risks. While it’s a powerful tool against bacterial infections, the associated warnings and potential side effects necessitate a thoughtful approach to its use.

How do healthcare providers decide when to prescribe norfloxacin?

Healthcare providers consider several factors when deciding to prescribe norfloxacin:

The type and severity of the infection
The patient’s medical history and current health status
Potential drug interactions with other medications the patient is taking
The risk of side effects based on the patient’s individual characteristics
The local patterns of antibiotic resistance

This balanced approach ensures that norfloxacin is used when its benefits outweigh the potential risks.

Future Perspectives: The Evolving Role of Quinolone Antibiotics

As our understanding of antibiotics and bacterial resistance continues to evolve, so too does the role of quinolone antibiotics like norfloxacin in medical practice. Ongoing research aims to further clarify the risks associated with these medications and to develop strategies to mitigate these risks while preserving their therapeutic benefits.

What developments can we expect in the future use of norfloxacin and similar antibiotics?

Future developments in the use of norfloxacin and other quinolone antibiotics may include:

More targeted use based on improved diagnostic techniques
Development of new formulations with reduced side effect profiles
Implementation of advanced monitoring strategies to detect adverse effects early
Integration of genetic testing to identify patients at higher risk for certain side effects

These advancements could help to optimize the use of norfloxacin, maximizing its benefits while minimizing risks.

In conclusion, norfloxacin remains a valuable antibiotic in the treatment of various bacterial infections. While its potential side effects and warnings are significant, proper use under medical supervision can help ensure safe and effective treatment. As with all medications, the key lies in informed decision-making, careful monitoring, and open communication between patients and healthcare providers. By understanding both the benefits and risks of norfloxacin, we can harness its power responsibly in the ongoing fight against bacterial infections.

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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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

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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).
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(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).
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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]
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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)

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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.

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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