LEVOFLOXACIN (2024)

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:

Tendon Disorders: Patients should contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue levofloxacin treatment. The risk of severe tendon disorders with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
Exacerbation of Myasthenia Gravis: Patients should inform their physician of any history of myasthenia gravis. Patients should notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.
Hypersensitivity Reactions: Patients should be informed that levofloxacin can cause hypersensitivity reactions, even following the first dose. Patients should discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (e.g., swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
Hepatotoxicity: Severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking levofloxacin. Patients should inform their physician and be instructed to discontinue levofloxacin treatment immediately if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.
Convulsions: Convulsions have been reported in patients taking fluoroquinolones, including levofloxacin. Patients should notify their physician before taking this drug if they have a history of convulsions.
Neurologic Adverse Effects (e.g., Dizziness, Lightheadedness, Increased Intracranial Pressure): Patients should know how they react to levofloxacin before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Patients should notify their physician if persistent headache with or without blurred vision occurs.
Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.
Peripheral Neuropathies: Patients should be informed that peripheral neuropathy has been associated with levofloxacin use. Symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness, and/or weakness develop, patients should immediately discontinue treatment and contact their physician.
Prolongation of the QT Interval: Patients should inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Patients should notify their physicians if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.
Musculoskeletal Disorders in Pediatric Patients: Parents should inform their child’s physician if their child has a history of joint-related problems before taking this drug. Parents of pediatric patients should also notify their child’s physician of any tendon or joint-related problems that occur during or following levofloxacin therapy [see Warnings and Precautions (5.10) and Use in Specific Populations (8.4)].
Photosensitivity/Phototoxicity: Patients should be advised that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolone antibiotics. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking fluoroquinolones. If patients need to be outdoors when taking fluoroquinolones, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn like reaction or skin eruption occurs, patients should contact their physician.

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.

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TEVA PHARMACEUTICAL IND. LTD.

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:

nosocomial pneumonia
community-acquired pneumonia
acute sinus infection
acute worsening of chronic bronchitis
skin infections, complicated and uncomplicated
chronic prostate infection
urinary tract infections, complicated and uncomplicated
acute kidney infection (pyelonephritis)
inhalational anthrax
plague

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:

have tendon problems
have a problem that causes muscle weakness (myasthenia gravis)
have central nervous system problems such as seizures (epilepsy)
have nerve problems
have or anyone in your family has an irregular heartbeat, especially a condition called “QT prolongation”
have low blood potassium (hypokalemia)
have bone problemshave joint problems including rheumatoid arthritis (RA)
have kidney problems. You may need a lower dose of levofloxacin tablets if your kidneys do not work well.
have liver problemshave diabetes or problems with low blood sugar (hypoglycemia)
are pregnant or plan to become pregnant. It is not known if levofloxacin tablets will harm your unborn child.
are breastfeeding or plan to breastfeed. It is not known if levofloxacin passes into your breast milk. You and your healthcare provider should decide if you will take levofloxacin tablets or breastfeed. You should not do both.

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:

a steroid medicine.
an anti-psychotic medicine
a tricyclic antidepressant
a water pill (diuretic)
certain medicines may keep levofloxacin tablets from working correctly. Take levofloxacin tablets either 2 hours before or 2 hours after taking these medicines or supplements:an antacid, multivitamin, or other medicines or supplements that have magnesium, aluminum, iron, or zincsucralfate (Carafate®)didanosine (Videx®, Videx® EC)
a blood thinner (warfarin, Coumadin®, Jantoven®)
an oral anti-diabetes medicine or insulin
an NSAID (Non-Steroidal Anti-Inflammatory Drug). Many common medicines for pain relief are NSAIDs. Taking an NSAID while you take levofloxacin tablets or other fluoroquinolones may increase your risk of central nervous system effects and seizures.
theophylline (Theo-24®, Elixophyllin®, Theochron®, Uniphyl®, Theolair®)
a medicine to control your heart rate or rhythm (antiarrhythmics)

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.

How should I take levofloxacin tablets?
Take levofloxacin tablets exactly as your healthcare provider tells you to take them.
Take levofloxacin tablets at about the same time each day.
Drink plenty of fluids while you take levofloxacin tablets.
Levofloxacin tablets can be taken with or without food.
If you miss a dose of levofloxacin tablets, take it as soon as you remember. Do not take more than 1 dose in 1 day.
Do not skip any doses of levofloxacin tablets or stop taking them, even if you begin to feel better, until you finish your prescribed treatment unless:you have tendon problems. See “What is the most important information I should know about levofloxacin tablets?”.you have a serious allergic reaction. See “What are the possible side effects of levofloxacin tablets?”.your healthcare provider tells you to stop taking levofloxacin tablets.

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?

Levofloxacin tablets can make you feel dizzy and lightheaded. Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how levofloxacin tablets affect you.
Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin tablets can make your skin sensitive to the sun (photosensitivity) and the light from sunlamps and tanning beds. You could get severe sunburn, blisters or swelling of your skin. If you get any of these symptoms while you take levofloxacin tablets, call your healthcare provider right away. You should use a sunscreen and wear a hat and clothes that cover your skin if you have to be in sunlight.

What are the possible side effects of levofloxacin tablets?

Levofloxacin tablets can cause serious side effects, including:

See “What is the most important information I should know about levofloxacin tablets?”Serious allergic reactions.Allergic reactions can happen in people taking fluoroquinolones, including levofloxacin tablets, even after only 1 dose. Stop taking levofloxacin tablets and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:hivestrouble breathing or swallowingswelling of the lips, tongue, facethroat tightness, hoarsenessrapid heartbeatfaintskin rash

skin rash

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.

Liver damage (hepatotoxicity):Hepatotoxicity can happen in people who take levofloxacin tablets. Call your healthcare provider right away if you have unexplained symptoms such as:nausea or vomitingstomach painfeverweaknessabdominal pain or tendernessitchingunusual tirednessloss of appetitelight colored bowel movementsdark colored urineyellowing of your skin or the whites of your eyes.

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:

seizures
hear voices, see things, or sense things that are not there (hallucinations)
feel restless
tremors
feel anxious or nervous
confusion
depression
trouble sleeping
nightmares
feel lightheaded
feel more suspicious (paranoia)
suicidal thoughts or actsa headache that will not go away, with or without blurred vision.

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:

pain
burning
tingling
numbness
weakness

The nerve damage may be permanent.