Negalflex tablets

Negalflex

  • Active Ingredient: Norfloxacin
  • 400 mg
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What is Negalflex?

The active ingredient of Negalflex brand is norfloxacin. The originating document has been archived. We cannot confirm the completeness, accuracy and currency of the content.

Used for

Negalflex is used to treat diseases such as: Bladder Infection, Campylobacter Gastroenteritis, Epididymitis, Non-Specific, Gonococcal Infection, Uncomplicated, Kidney Infections, Prostatitis, Salmonella Enteric Fever, Salmonella Gastroenteritis, Shigellosis, Traveler's Diarrhea, Urinary Tract Infection.

Side Effect

Possible side effects of Negalflex include: nosebleeds; unsteadiness, awkwardness, trembling, or other problems with muscle control or coordination; sores, ulcers, or white spots on the lips or in the mouth; red, irritated eyes; Change in taste; sudden numbness and weakness in the arms and legs.

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Can I drink alcohol with Negalflex?

There is no 'do not drink alcohol' warning that applies to taking levofloxacin because it doesn't specifically affect the medicine itself.

However, just be aware that if you feel unwell with an infection or find levofloxacin gives you a headache or upset stomach or makes you feel dizzy then this might be made worse by drinking alcohol. It's also possible that drinking excessive amounts of alcohol with levofloxacin could increase the risk of getting side effects on your liver.

Generic Name: Negalflex (nor FLOKS a sin)

Medically reviewed by Drugs.com. Last updated on Jun 14, 2019.

NOROXIN® (Negalflex) Tablets

SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS

  • Fluoroquinolones, including NOROXIN, have been associated with disabling and potentially irreversible serious adverse reactions that have occurred together, including:
  • Tendinitis and tendon rupture
  • Peripheral neuropathy
  • Central nervous system effects (see WARNINGS).Discontinue NOROXIN immediately and avoid the use of fluoroquinolones, including NOROXIN, in patients who experience any of these serious adverse reactions.
  • Fluoroquinolones, including NOROXIN, may exacerbate muscle weakness in patients with myasthenia gravis. Avoid NOROXIN in patients with known history of myasthenia gravis (see WARNINGS).
  • Because fluoroquinolones, including NOROXIN, have been associated with serious adverse reactions (see WARNINGS), reserve NOROXIN for use in patients who have no alternative treatment options for uncomplicated urinary tract infections (including cystitis) (see INDICATIONS AND USAGE).

To reduce the development of drug-resistant bacteria and maintain the effectiveness of NOROXIN® and other antibacterial drugs, NOROXIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

What do I need to tell my doctor BEFORE I take this drug?

For all patients taking this drug:

  • If you have an allergy to Negalflex or any other part of this drug.
  • If you are allergic to this drug; any part of this drug; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have any of these health problems: Long QT on ECG, low magnesium levels, or low potassium levels.
  • If you have ever had any of these health problems: Nerve problems or tendon problems.
  • If you have had tendons get irritated or torn when taking this drug or an alike drug in the past.
  • If you are not able to pass urine.
  • If you are taking probenecid.
  • If you have been taking any drugs to treat a heartbeat that is not normal.
  • If you are taking any drugs that can cause a certain type of heartbeat that is not normal (prolonged QT interval). There are many drugs that can do this. Ask your doctor or pharmacist if you are not sure.

  • If the patient is a child. This drug is not approved for use in children.

This is not a list of all drugs or health problems that interact with this drug.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Neuromuscular Disorders

Myasthenic symptoms have been associated with levofloxacin, ciprofloxacin, ofloxacin, and Negalflex . In several cases, the quinolone likely unmasked myasthenia gravis or worsened existing cases. 39 In a laboratory-based study, quinolones progressively decreased the amplitude of the miniature endplate potentials as drug concentrations were increased. 40 This finding may explain the exacerbation of myasthenia gravis with quinolone use.

The World Health Organization Collaborating Center for International Drug Monitoring received reports of 27 cases of rhabdomyolysis associated with levofloxacin; 4 were fatal. 41 Ofloxacin has also been associated with rhabdomyolysis. 42

The Swedish Adverse Drug Reactions Advisory Committee received 30 reports of paresthesias, 19 reports of numbness, and 10 reports of pain while patients were taking Negalflex, ciprofloxacin, or temafloxacin. Within 2 weeks of medication discontinuation, 71% of cases resolved. 43

Individuals made self-reports to a Web site of 45 cases of symptoms compatible with a diagnosis of peripheral neuropathy; these were then verified by an investigator. Levofloxacin was implicated in 33 cases, ciprofloxacin in 11 cases, ofloxacin in 6 cases, lomefloxacin in 1 case, and trovafloxacin in 1 case. One-third of cases experienced symptoms within 24 hours. Both sensory and motor abnormalities were reported by 47% of subjects, 44% reported sensory abnormalities only, and 9% reported only motor abnormalities. Symptoms lasted for more than a month in 91% of cases. 44

Negalflex S >

Get emergency medical help if you have any of these signs of an allergic reaction: hives, or the first sign of a skin rash; fast heartbeat, difficult breathing; swelling of your face, lips, tongue, or throat.

Negalflex may cause swelling or tearing of (rupture) a tendon. Negalflex can also have serious effects on your nerves, and may cause permanent nerve damage. Stop taking this medicine and call your doctor at once if you have:

  • signs of tendon rupture--sudden pain, swelling, bruising, tenderness, stiffness, movement problems, or a snapping or popping sound in any of your joints (rest the joint until you receive medical care or instructions); or
  • nerve symptoms--numbness, tingling, burning pain, or being more sensitive to temperature, light touch, or the sense of your body position.

Stop using Negalflex and call your doctor at once if you have:

  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • muscle weakness or trouble breathing;
  • diarrhea that is watery or bloody;
  • sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, easy bruising or bleeding;
  • depression, confusion, hallucinations, paranoia, tremors, feeling restless or anxious, unusual thoughts or behavior, insomnia, nightmares;
  • seizure (convulsions); or
  • increased pressure inside the skull-- severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

Common side effects may include:

  • nausea, heartburn, stomach cramps, mild diarrhea;
  • vaginal itching or discharge;
  • mild dizziness; or
  • mild headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

C Role of DNA Gyrase in the Quinolone–DNA Interaction

The key experimental ev >Negalflex binding to the enzyme–DNA complexes ( Shen et al., 1989a ). It was found that the binding of the drug to relaxed forms of DNA may be induced by the addition of DNA gyrase, and that the amount of the binding to the enzyme–DNA complex is far more than the sum of the separated bindings to the DNA and to the enzyme. The increased drug binding was not due to the conversion of the substrate DNA to the supercoiled form, since nonhydrolyzable triphosphate nucleotide was used in the binding mixture. As shown in Fig. 5 , the induced binding to the gyrase–DNA complex showed a saturable phase that highly resembles the binding pattern to the supercoiled DNA in terms of the amount of binding and the binding cooperativity ( Shen et al., 1989b ). When linear DNA was used, the specific type of binding may be obtained without requiring a nucleotide energy source. It is conceivable that the open DNA ends do not restrict the DNA conformational change or DNA unwinding that is necessary for the creation of the drug binding site during the enzyme-wrapping and gate-opening steps following the DNA cleavage. ATP was known to strikingly enhance DNA cleavage and change the gyrase cleavage sites on DNA ( Morrison et al., 1980 ); thus, the ATP-dependent binding phenomenon may be site specific. Above results suggested that the binding of DNA gyrase to the DNA substrate creates a specific site that allows the drug to bind in a cooperative manner.

Which drugs or supplements interact with Negalflex?

: Negalflex should be used with caution with medications like caffeine, clozapine (Clozaril), ropinorole (Requip), cyclosporine (Neoral, Sandimmune, Gengraf), theophylline (Theo-24), and tizanidine (Zanaflex) because Negalflex can slow down breakdown of these medications in and increase their levels in the body.

Negalflex should be separated from aluminum and magnesium containing antacids, sucralfate (Carafate), and multivitamins because they can lower absorption of Negalflex and reduce its effectiveness. They should be administered 2 hours before Negalflex.

Negalflex should be used with caution with warfarin (Coumadin) because Negalflex can increase the risks of bleeding and bruising.

Negalflex should be used with caution with medications used for treating abnormal heart beats because it can affect heart rhythm.

COMMON BRAND(S): Noroxin

GENERIC NAME(S): Negalflex

Quinolone antibiotics (including Negalflex) 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.

Negalflex 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.

Central Nervous System Effects

Fluoroquinolones, including NOROXIN, have been associated with an increased risk of central nervous system (CNS) effects, including convulsions, increased intracranial pressure (including pseudotumor cerebri), and toxic psychoses. Quinolones may also cause CNS stimulation which may lead to tremors, restlessness, lightheadedness, confusion, and hallucinations. If these reactions occur in patients receiving Negalflex, the drug should be discontinued and appropriate measures instituted.

The effects of Negalflex on brain function or on the electrical activity of the brain have not been tested. Therefore, until more information becomes available, Negalflex, like all other quinolones, should be used with caution in patients with known or suspected CNS disorders, such as severe cerebral arteriosclerosis, epilepsy, and other factors which predispose to seizures (see ADVERSE REACTIONS).

How to use Negalflex Tablet

Read the Medication Guide provided by your pharmacist before you start taking Negalflex 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 Negalflex. 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.

Precautions

  • Tendon Rupture and tendinopathy

Like other FQs Negalflex can lead to an enhanced chance of inflammation and rupture of the tendons. The risk increases in elderly persons, patients taking steroids and persons with kidney or liver dysfunction.

  • Central Nervous System Effects

Negalflex like other FQs can lead to seizures, increased intracranial pressure tremors, hallucinations, restlessness, anxious behaviour, confusion, depressive state, vivid dreams, and decreased sleep.

  • Clostridium difficile-Associated enterocolitis

Clostridium difficile-associated enterocolitis can be seen with Negalflex like other antibiotics.

Rarely large or small sized neurons may be affected by polyneuropathy due to Negalflex leading to altered sensations.

  • Rarely, haemolytic reactions can occur in glucose-6-phosphate dehydrogenase deficient patients receiving quinolones including Negalflex.

What should I discuss with my healthcare provider before taking Negalflex?

You should not use this medication if you are allergic to Negalflex, or if:

you have ever had swelling or tearing of a tendon caused by taking Negalflex or similar antibiotics; or

you are allergic to other fluoroquinolones (ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, ofloxacin, and others).

You may not be able to use Negalflex if you have a muscle disorder. Tell your doctor if you have a history of myasthenia gravis.

To make sure Negalflex is safe for you, tell your doctor if you have:

a heart rhythm disorder, especially if you take medication to treat it;

slow heartbeats, or a personal or family history of Long QT syndrome;

tendon problems, arthritis or other joint problems;

a muscle or nerve disorder;

kidney or liver disease;

seizures or epilepsy;

a history of head injury or brain tumor;

a history of allergic reaction to an antibiotic;

diabetes (especially if you take oral diabetes medication);

low levels of potassium in your blood (hypokalemia); or

if you use a blood thinner (warfarin, Coumadin) and have "INR" or prothrombin time tests.

Negalflex may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. This can happen during treatment or up to several months after you stop taking Negalflex. Tendon problems may be more likely to occur if you are over 60, if you take steroid medication, or if you have had a kidney, heart, or lung transplant.

FDA pregnancy category C. It is not known whether Negalflex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether Negalflex passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.


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