[Posted 08/15/2013] ISSUE: ISSUE: FDA has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy. This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.
BACKGROUND: The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive). The topical formulations of fluoroquinolones, applied to the ears or eyes, are not known to be associated with this risk.
RECOMMENDATION: Make sure your patients know to contact you if they develop symptoms of peripheral neuropathy. Make sure your patients receive the Medication Guide with every prescription. If a patient develops symptoms of peripheral neuropathy, the fluoroquinolone should be stopped, and the patient should be switched to another, non-fluoroquinolone antibacterial drug, unless the benefit of continued treatment with a fluoroquinolone outweighs the risk. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
For more information visit the FDA website at: http://www.fda.gov/Safety/MedWatch/SafetyInformation and http://www.fda.gov/Drugs/DrugSafety.
Taking norfloxacin increases the risk that you will develop tendinitis (swelling of a fibrous tissue that connects a bone to a muscle) or have a tendon rupture (tearing of a fibrous tissue that connects a bone to a muscle) during your treatment or for up to several months afterward. These problems may affect tendons in your shoulder, your hand, the back of your ankle, or in other parts of your body. Tendinitis or tendon rupture may happen to people of any age, but the risk is highest in people over 60 years of age. Tell your doctor if you have or have ever had a kidney, heart, or lung transplant; kidney disease; a joint or tendon disorder such as rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function); or if you participate in regular physical activity. Also tell your doctor if you have ever had any tendon problems during or after your treatment with norfloxacin or another quinolone or fluoroquinolone antibiotic. Tell your doctor and pharmacist if you are taking oral or injectable steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), or prednisone (Sterapred). If you experience any of the following symptoms of tendinitis, stop taking norfloxacin, rest, and call your doctor immediately: pain, swelling, tenderness, stiffness, or difficulty in moving a muscle. If you experience any of the following symptoms of tendon rupture, stop taking norfloxacin and get emergency medical treatment: hearing or feeling a snap or pop in a tendon area, bruising after an injury to a tendon area, or inability to move or bear weight on an affected area.
Taking norfloxacin may worsen muscle weakness in people with myasthenia gravis (a disorder of the nervous system that causes muscle weakness) and cause severe difficulty breathing or death. Tell your doctor if you have myasthenia gravis. Your doctor may tell you not to take norfloxacin. If you have myasthenia gravis and your doctor tells you that you should take norfloxacin, call your doctor immediately if you experience muscle weakness or difficulty breathing during your treatment.
Talk to your doctor about the risks of taking norfloxacin.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with norfloxacin. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or check the manufacturer's website to obtain the Medication Guide.
Norfloxacin is used to treat certain types of infections, including infections of the urinary tract and prostate (a male reproductive gland). Norfloxacin is in a class of antibiotics called fluoroquinolones. It works by killing bacteria that cause infections. Antibiotics will not work for colds, flu, or other viral infections.
Norfloxacin comes as a tablet to take by mouth. It is usually taken twice a day for 3 to 28 days. The length of treatment depends on the type of infection being treated. Your doctor will tell you how long to take norfloxacin. Take norfloxacin at around the same times every day and try to space your doses 12 hours apart. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take norfloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Take norfloxacin at least 1 hour before or 2 hours after meals or after drinking milk or eating dairy products.
Swallow the tablets with a full glass of water.
You should begin to feel better during the first few days of your treatment with norfloxacin. If your symptoms do not improve or if they get worse, call your doctor.
Take norfloxacin until you finish the prescription, even if you feel better. Do not stop taking norfloxacin unless you experience the symptoms of tendinitis or tendon rupture described in the IMPORTANT WARNING section or the symptoms of allergic reaction described in the SIDE EFFECTS section. If you stop taking norfloxacin too soon or if you skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
Norfloxacin is also sometimes used to treat certain infections of the stomach and intestines. Talk to your doctor about the risks of using this medication for your condition.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Do not drink or eat a lot of caffeine-containing products as coffee, tea, energy drinks, cola, or chocolate. Norfloxacin may increase nervousness, sleeplessness, heart pounding, and anxiety caused by caffeine.
Make sure you drink plenty of water or other fluids every day while you are taking norfloxacin.
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one and do not take more than 2 doses of norfloxacin in one day.
severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
difficulty breathing or swallowing
swelling of the face, lips, tongue, or throat
loss of consciousness
blistering or peeling skin
yellowing of the skin or eyes
muscle or joint pain
shortness of breath
unusual bruising or bleeding
fast, pounding, or irregular heartbeat
hallucinations (seeing things or hearing voices that do not exist)
not trusting others or feeling that others want to harm you
uncontrollable shaking of a part of the body
pain, numbness, burning, tingling, or weakness in the arms, hands, legs, or feet
Norfloxacin may cause problems with bones, joints, and tissues around joints in children. Norfloxacin should not be given to children younger than 18 years of age. Talk to your child's doctor about the risks of giving norfloxacin to your child.
Norfloxacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to norfloxacin.
Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish taking norfloxacin, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Last Revised - 09/15/2013
AHFS® Consumer Medication Information. © Copyright, 2013. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.