LEVOFLOXACIN- levofloxacin tablet, film coated
17.1 Antibacterial Resistance
Antibacterial drugs including levofloxacin should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When levofloxacin is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by levofloxacin or other antibacterial drugs in the future.
17.2 Administration With Food, Fluids, and Concomitant Medications
Patients should be informed that levofloxacin tablets may be taken with or without food. The tablet should be taken at the same time each day.
Patients should drink fluids liberally while taking levofloxacin to avoid formation of a highly concentrated urine and crystal formation in the urine.
Antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or two hours after oral levofloxacin administration.
17.3 Serious and Potentially Serious Adverse Reactions
Patients should be informed of the following serious adverse reactions that have been associated with levofloxacin or other fluoroquinolone use:
17.4 Drug Interactions With Insulin, Oral Hypoglycemic Agents, and Warfarin
Patients should be informed that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue levofloxacin and consult a physician.
Patients should be informed that concurrent administration of warfarin and levofloxacin has been associated with increases of the International Normalized Ratio (INR) or prothrombin time and clinical episodes of bleeding. Patients should notify their physician if they are taking warfarin, be monitored for evidence of bleeding, and also have their anticoagulation tests closely monitored while taking warfarin concomitantly.
17.5 Plague and Anthrax Studies
Patients given levofloxacin for these conditions should be informed that efficacy studies could not be conducted in humans for ethical and feasibility reasons. Therefore, approval for these conditions was based on efficacy studies conducted in animals.
Manufactured In Israel By:
TEVA PHARMACEUTICAL IND. LTD.
Jerusalem, 91010, Israel
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Rev. H 8/2013
LEVOFLOXACIN [lee voe FLOX a sin] TABLETS
Read this Medication Guide before you start taking levofloxacin tablets and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about levofloxacin tablets?
Levofloxacin tablets, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects could result in death.
If you have any of the following serious side effects while you take levofloxacin tablets, get medical help right away. Talk with your healthcare provider about whether you should continue to take levofloxacin tablets.
1. Tendon rupture or swelling of the tendon (tendinitis).
Tendon problems can happen in people who do not have the above risk factors when they take levofloxacin tablets.Other reasons that can increase your risk of tendon problems can include: physical activity or exercisekidney failuretendon problems in the past, such as in people with rheumatoid arthritis (RA).
Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking levofloxacin tablets until tendinitis or tendon rupture has been ruled out by your healthcare provider. Avoid exercise and using the affected area. The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of levofloxacin tablets. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.Tendon rupture can happen while you are taking or after you have finished taking levofloxacin tablets. Tendon ruptures have happened up to several months after people have finished taking their fluoroquinolone.Get medical help right away if you get any of the following signs or symptoms of a tendon rupture:hear or feel a snap or pop in a tendon areabruising right after an injury in a tendon area
unable to move the affected area or bear weight
2. Worsening of myasthenia gravis (a problem that causes muscle weakness).
Fluoroquinolones like levofloxacin tablets may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.
See “What are the possible side effects of levofloxacin tablets?”
What are levofloxacin tablets?
Levofloxacin tablets are a fluoroquinolone antibiotic medicine used in adults age 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:
Studies of levofloxacin tablets for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
Levofloxacin tablets are also used to treat children who are 6 months of age or older and may have breathed in anthrax germs, have plague, or been exposed to plague germs.
It is not known if levofloxacin tablets are safe and effective in children under 6 months of age.
The safety and effectiveness in children treated with levofloxacin tablets for more than 14 days is not known.
Who should not take levofloxacin tablets?
Do not take levofloxacin tablets if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to levofloxacin or any of the ingredients in levofloxacin tablets. See the end of this leaflet for a complete list of ingredients in levofloxacin tablets.What should I tell my healthcare provider before taking levofloxacin tablets?
Before you take levofloxacin tablets, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.Levofloxacin tablets and other medicines can affect each other causing side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if any of your medicines are listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
Taking all of your levofloxacin tablets doses will help make sure that all of the bacteria are killed. Taking all of your levofloxacin tablets doses will help you lower the chance that the bacteria will become resistant to levofloxacin tablets. If your infection does not get better while you take levofloxacin tablets, it may mean that the bacteria causing your infection may be resistant to levofloxacin tablets. If your infection does not get better, call your healthcare provider. If your infection does not get better, levofloxacin tablets and other similar antibiotic medicines may not work for you in the future.
If you take too many levofloxacin tablets, call your healthcare provider or get medical help right away.
What should I avoid while taking levofloxacin tablets?
What are the possible side effects of levofloxacin tablets?
Levofloxacin tablets can cause serious side effects, including:
Skin rash may happen in people taking levofloxacin tablets, even after only 1 dose. Stop taking levofloxacin tablets at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to levofloxacin tablets.
Stop taking levofloxacin tablets and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to levofloxacin tablets (a liver problem).
Central Nervous System Effects. Seizures have been reported in people who take fluoroquinolone antibiotics including levofloxacin tablets. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking levofloxacin tablets will change your risk of having a seizure.
Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of levofloxacin tablets. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
Intestine infection (Pseudomembranous colitis)
Pseudomembranous colitis can happen with many antibiotics, including levofloxacin tablets. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.
Changes in sensation and nerve damage (Peripheral Neuropathy)
Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including levofloxacin tablets. Stop levofloxacin tablets and talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
The nerve damage may be permanent.