Noroxin

DRUG DESCRIPTION

NOROXIN (Norfloxacin) is a synthetic, broad-spectrum antibacterial agent for oral administration. Norfloxacin, a fluoroquinolone, is 1-ethyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3quinolinecarboxylic acid. Its empirical formula is C16H18FN3O3 and the structural formula is:

NOROXIN® (Norfloxacin) Structural Formula Illustration

Norfloxacin is a white to pale yellow crystalline powder with a molecular weight of 319.34 and a melting point of about 221°C. It is freely soluble in glacial acetic acid, and very slightly soluble in ethanol, methanol and water.

NOROXIN (norfloxacin) is available in 400-mg tablets. Each tablet contains the following inactive ingredients: cellulose, croscarmellose sodium, hydroxypropyl cellulose, hydroxypropyl methylcellulose, magnesium stearate, and titanium dioxide.

Norfloxacin, a fluoroquinolone, differs from non-fluorinated quinolones by having a fluorine atom at the 6 position and a piperazine moiety at the 7 position.

What are the possible side effects of norfloxacin (Noroxin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using norfloxacin and call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • seizure (convulsions);
  • confusion, hallucinations, unusual thoughts or behavior;
  • dizziness, fainting, fast or pounding heartbeat;
  • sudden pain, snapping or popping sound, bruising, loss of...

Read All Potential Side Effects and See Pictures of Noroxin »

What are the precautions when taking norfloxacin (Noroxin)?

Before taking norfloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics such as ciprofloxacin, gemifloxacin, levofloxacin, moxifloxacin, or ofloxacin; 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: certain metabolic disorder (G6PD deficiency), diabetes, heart problems (e.g., recent heart attack), joint/tendon problems (e.g., tendonitis, bursitis), kidney disease, myasthenia gravis, nervous system disorder (e.g., peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (e.g.,...

Read All Potential Precautions of Noroxin »


Noroxin Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, diarrhea, dizziness, lightheadedness, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., anxiety, confusion, hallucinations, depression, rare thoughts of suicide), shaking (tremors), sunburn (sun sensitivity).

Tell your doctor immediately if any of these rare but very serious side effects occur: unusual bruising/bleeding, signs of a new infection (e.g., new/persistent fever, persistent sore throat), seizures, unusual change in the amount of urine, signs of liver problems (e.g., unusual tiredness, stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine), vision changes.

Seek immediate medical attention if any of these rare but very serious side effects occur: severe dizziness, fainting, fast/irregular heartbeat.

Norfloxacin may rarely cause serious nerve problems that may be reversible if identified and treated early. Seek immediate medical attention if you develop any of the following symptoms: pain/numbness/burning/tingling/weakness in any part of the body, changes in how you sense touch/pain/temperature/body position/vibration.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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, moxifloxacin, or ofloxacin; 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: certain metabolic disorder (G6PD deficiency), diabetes, heart problems (e.g., recent heart attack), joint/tendon problems (e.g., tendonitis, bursitis), kidney disease, myasthenia gravis, nervous system disorder (e.g., peripheral neuropathy), seizure disorder, conditions that increase your risk of seizures (e.g., brain/head injury, brain tumors, cerebral atherosclerosis).

Norfloxacin may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using norfloxacin, tell your doctor or pharmacist 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 levels, especially if you have diabetes. Watch for symptoms of high blood sugar including increased thirst and urination. Also watch for symptoms of low blood sugar such as nervousness, shakiness, fast heartbeat, sweating, or hunger. Check your blood sugar regularly as directed by your doctor and report any changes. If you experience symptoms of low blood sugar, you may raise your blood sugar by using glucose tablets/gel or eating a quick source of sugar such as table sugar, honey, or candy, or drinking fruit juice or non-diet soda. Tell your doctor immediately 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.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Caution is advised when using this medication in children younger than 18 years because they may be at greater risk for joint/tendon problems. Discuss the risks and benefits with the doctor.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, older adults may be more sensitive to its side effects (e.g., blood sugar or tendon problems), especially if they are also taking corticosteroids (e.g., prednisone, hydrocortisone).

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.


Noroxin Patient Information Including Side Effects

Brand Names: Noroxin

Generic Name: norfloxacin (Pronunciation: nor FLOX a sin)

  • What is norfloxacin (Noroxin)?
  • What are the possible side effects of norfloxacin (Noroxin)?
  • What is the most important information I should know about norfloxacin (Noroxin)?
  • What should I discuss with my healthcare provider before taking norfloxacin (Noroxin)?
  • How should I take norfloxacin (Noroxin)?
  • What happens if I miss a dose (Noroxin)?
  • What happens if I overdose (Noroxin)?
  • What should I avoid while taking norfloxacin (Noroxin)?
  • What other drugs will affect norfloxacin (Noroxin)?
  • Where can I get more information?

What is norfloxacin (Noroxin)?

Norfloxacin is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Norfloxacin fights bacteria in the body.

Norfloxacin is used to treat bacterial infections of the prostate and urinary tract. Norfloxacin also treats gonorrhea.

Norfloxacin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of norfloxacin (Noroxin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using norfloxacin and call your doctor at once if you have any of these serious side effects:

  • diarrhea that is watery or bloody;
  • seizure (convulsions);
  • confusion, hallucinations, unusual thoughts or behavior;
  • dizziness, fainting, fast or pounding heartbeat;
  • sudden pain, snapping or popping sound, bruising, loss of movement, or swelling near your joints (especially in your arm or ankle);
  • urinating less than usual or not at all;
  • numbness, burning, pain, or tingly feeling in your hands or feet;
  • pain in your upper stomach, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, easy bruising or bleeding, weakness;
  • fever, swollen glands, general ill feeling;
  • sore throat, and headache with a severe blistering, peeling, and red skin rash; or
  • the first sign of any skin rash, no matter how mild.

Less serious side effects may include:

  • nausea, vomiting, mild stomach pain, constipation;
  • feeling restless or anxious;
  • headache, dizziness;
  • muscle pain;
  • sleep problems (insomnia or nightmares);
  • vaginal itching or discharge; or
  • mild skin itching.

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.

What is the most important information I should know about norfloxacin (Noroxin)?

You should not use this medication if you are allergic to norfloxacin or similar antibiotics such as ciprofloxacin (Cipro), levofloxacin (Levaquin), moxifloxacin (Avelox), ofloxacin (Floxin), lomefloxacin (Maxaquin), and others.

Before taking norfloxacin, tell your doctor if you have kidney or liver disease, myasthenia gravis, joint problems, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."

Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take norfloxacin. These other medicines can make norfloxacin much less effective when taken at the same time.

Taking norfloxacin can make your skin more sensitive to sunlight. Avoid exposure to sunlight, sun lamps, or tanning beds.

Norfloxacin 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. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking norfloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions.

Do not share this medication with another person (especially a child), even if they have the same symptoms you do.

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