Levofloxacin (Page 16 of 17)

17.3 Serious and Potentially Serious Adverse Reactions

Patients should be informed of the following serious adverse reactions that have been associated with levofloxacin tablets 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 tablets 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 tablets. 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 tablets 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 tablets 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 tablets 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.

17.6 FDA-Approved Medication Guide

.

Medication Guide

Levofloxacin Tablets

250 mg, 500 mg, and 750 mg

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 of all ages who take levofloxacin tablets. Tendons are tough cords of tissue that connect muscles to bones.Some tendon problems include pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
The risk of getting tendon problems while you take levofloxacin tablets is higher if you:
are over 60 years of age
are taking steroids (corticosteroids)
have had a kidney, heart, or lung transplant.
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 exercise
kidney failure
tendon 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 area
bruising 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:

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 problems
have 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 problems
have diabetes or problems with low blood sugar (hypoglycemia)
are pregnant or plan to become pregnant. It is not known if levofloxacin will harm your unborn child.
are breastfeeding or plan to breastfeed. It is not known if levofloxacin pass 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 zinc
sucralfate (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 it.
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 it,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 dose will help make sure that all of the bacteria are killed. Taking all of your levofloxacin tablets dose will help you lower the chance that the bacteria will become resistant to levofloxacin. 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. 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 much 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 affects 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:

hives
trouble breathing or swallowing
swelling of the lips, tongue, face
throat tightness, hoarseness
rapid heartbeat
faint
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 vomiting
stomach pain
fever
weakness
abdominal pain or tenderness
itching
unusual tiredness
loss of appetite
light colored bowel movements
dark colored urine
yellowing 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 acts
a 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.

Serious heart rhythm changes (QT prolongation and torsades de pointes)

Tell your healthcare provider right away if you have a change in your heart beat (a fast or irregular heartbeat), or if you faint. Levofloxacin tablets may cause a rare heart problem known as prolongation of the QT interval. This condition can cause an abnormal heartbeat and can be very dangerous. The chances of this happening are higher in people:

who are elderly
with a family history of prolonged QT interval
with low blood potassium (hypokalemia)
who take certain medicines to control heart rhythm (antiarrhythmics)
Joint Problems

Increased chance of problems with joints and tissues around joints in children can happen. Tell your child’s healthcare provider if your child has any joint problems during or after treatment with levofloxacin tablets.

Changes in blood sugar

People who take levofloxacin tablets and other fluoroquinolone medicines with oral anti-diabetes medicines or with insulin can get low blood sugar (hypoglycemia) and high blood sugar (hyperglycemia). Follow your healthcare provider’s instructions for how often to check your blood sugar. If you have diabetes and you get low blood sugar while taking levofloxacin tablets, stop taking levofloxacin tablets and call your healthcare provider right away. Your antibiotic medicine may need to be changed.

Sensitivity to sunlight (photosensitivity)

See “What should I avoid while taking levofloxacin tablets ?”.

The most common side effects of levofloxacin tablets include:

nausea
headache
diarrhea
insomnia
constipation
dizziness

In children 6 months and older who take levofloxacin tablets to treat anthrax disease or plague, vomiting is also common.

Levofloxacin tablets may cause false-positive urine screening results for opiates when testing is done with some commercially available kits. A positive result should be confirmed using a more specific test.

These are not all the possible side effects of levofloxacin tablets. Tell your healthcare provider about any side effect that bothers you or that does not go away.

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

How should I store levofloxacin tablets?

Store levofloxacin tablets at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep the container closed tightly.

Keep levofloxacin tablets and all medicines out of the reach of children.

General information about the safe and effective use of levofloxacin tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use levofloxacin tablets for a condition for which it is not prescribed. Do not give levofloxacin tablets to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about levofloxacin tablets. If you would like more information about levofloxacin tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about levofloxacin tablets that is written for healthcare professionals.

For more information call Sandoz Inc. at 1-800-525-8747.

What are the ingredients in levofloxacin tablets?

250 mg, 500 mg, 750 mg levofloxacin film-coated tablets:

Active ingredient: levofloxacin

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, ferric oxide yellow, glycerol behenate, hydroxypropyl cellulose, hypromellose, lactose monohydrate, polyethylene glycol 400, povidone K 30, sodium starch glycolate, talc, titanium dioxide

The brands listed are the registered trademarks of their respective owners and are not trademarks of Sandoz Inc.

Manufactured in Slovenia by Lek Pharmaceuticals d.d.

for Sandoz Inc., Princeton, NJ 08540

Revised: August 2013

Repackaged by Proficient Rx LP, Thousand Oaks, CA 91320

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