Levofloxacin

Levofloxacin comes as a tablet and a solution (liquid) to take by mouth. It is usually taken once a day. The length of your treatment depends on the type of infection you have. Your doctor will tell you how long to take levofloxacin. The tablet may be taken with or without food. The solution should be taken 1 hour before or 2 hours after eating. Take levofloxacin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take levofloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

You should begin to feel better during the first few days of treatment with levofloxacin. If your symptoms do not improve or if they get worse, call your doctor.

Take levofloxacin until you finish the prescription, even if you feel better. Do not stop taking levofloxacin without talking to your doctor unless you experience certain serious side effects listed in the IMPORTANT WARNING or SIDE EFFECTS sections. If you stop taking levofloxacin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.

Levaquin comes in the various forms:

• Film coated oral tablets of 250 milligrams (mg), 500 mg, and 750 mg
• Oral solutions of 25 mg per milliliter (mL), which should be taken 1 hour before or 2 hours after eating
• Premixed, single-use injection in flexible containers, containing a solution equivalent to 250 mg, 500 mg, or 750 mg of levofloxacin
• Single-use injection vials containing concentrated levofloxacin solution equivalent to 500 mg or 750 mg, which need to be further diluted with the appropriate solution

Only take Levaquin as advised by your doctor.

Dosage and length of treatment differs depending on the type of infection that needs to be treated; adults with kidney problems, as well as children, must follow an adjusted treatment schedule.

Levaquin Overdose

According to animal studies, Levaquin is toxic in high doses, causing a number of muscular and nervous system symptoms, such as tremors, convulsions, and loss of control of bodily movements.

Call your local poison control center or visit the nearest emergency hospital room if you've overdosed on Levaquin to have your stomach emptied.

Call 9-1-1 if you think someone has overdosed and has collapsed or isn't breathing.

Missed Dose of Levaquin

Take the missed dose as soon as you remember it, unless it's almost time for next dose.

Never double your dose to make up for a missed dose of Levaquin.

In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

Levofloxacin exhibits a low potential for acute toxicity. Mice, rats, dogs and monkeys exhibited the following clinical signs after receiving a single high dose of Levofloxacin: ataxia, ptosis, decreased locomotor activity, dyspnea, prostration, tremors, and convulsions. Doses in excess of 1500 mg/kg orally and 250 mg/kg IV produced significant mortality in rodents.

Levofloxacin
(lee voe FLOX a sin) Oral Solution (25 mg/mL)

Read this Medication Guide before you start taking Levofloxacin 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?

Levofloxacin, 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, get medical help right away. Talk with your healthcare provider about whether you should continue to take Levofloxacin.

1. Tendon rupture or swelling of the tendon (tendinitis ).

• Tendon problems can happen in people of all ages who take Levofloxacin. 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 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.
• 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 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. 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. 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 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?”

What is Levofloxacin?

Levofloxacin is 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 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 is 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 is safe and effective in children under 6 months of age.

The safety and effectiveness in children treated with Levofloxacin for more than 14 days is not known.

Who should not take Levofloxacin?

Do not take Levofloxacin 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. See the end of this leaflet for a complete list of ingredients in Levofloxacin.

What should I tell my healthcare provider before taking Levofloxacin?

Before you take Levofloxacin, 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 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 passes into your breast milk. You and your healthcare provider should decide if you will take Levofloxacin or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Levofloxacin 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 from working correctly. Take Levofloxacin Oral Solution 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 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?

• Take Levofloxacin exactly as your healthcare provider tells you to take it.
• Take Levofloxacin at about the same time each day.
• Drink plenty of fluids while you take Levofloxacin.
• Take Levofloxacin Oral Solution 1 hour before or 2 hours after eating.
• If you miss a dose of Levofloxacin, take it as soon as you remember. Do not take more than 1 dose in 1 day.
• Do not skip any doses of Levofloxacin 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?”.
  • you have a serious allergic reaction. See “What are the possible side effects of Levofloxacin?”.
  • your healthcare provider tells you to stop taking Levofloxacin
    Taking all of your Levofloxacin doses will help make sure that all of the bacteria are killed. Taking all of your Levofloxacin doses 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, 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 and other similar antibiotic medicines may not work for you in the future.
• If you take too much Levofloxacin, call your healthcare provider or get medical help right away.

What should I avoid while taking Levofloxacin?

• Levofloxacin 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 affects you.
• Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin 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, 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?

Levofloxacin can cause serious side effects, including:

• See “What is the most important information I should know about Levofloxacin?”
• Serious allergic reactions.
  Allergic reactions can happen in people taking fluoroquinolones, including Levofloxacin, even after
• only 1 dose. Stop taking Levofloxacin 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, even after only 1 dose. Stop taking Levofloxacin 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.
• Liver damage (hepatotoxicity): Hepatotoxicity can happen in people who take Levofloxacin. 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 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 (a liver problem).
• Central Nervous System Effects . Seizures have been reported in people who take fluoroquinolone antibiotics including Levofloxacin. Tell your healthcare provider if you have a history of seizures. Ask your healthcare provider whether taking Levofloxacin 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. 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. 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. Stop Levofloxacin 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 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.
• Changes in blood sugar
  People who take Levofloxacin 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, stop taking Levofloxacin 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?”

The most common side effects of Levofloxacin include:

• nausea
• headache
• diarrhea
• insomnia
• constipation
• dizziness

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

Levofloxacin 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. 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?

• Store Levofloxacin Oral Solution at 59°F to 86° F (15°C to 30°C).

Keep Levofloxacin and all medicines out of the reach of children.

General information about the safe and effective use of Levofloxacin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Levofloxacin for a condition for which it is not prescribed. Do not give Levofloxacin 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. If you would like more information about Levofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Levofloxacin that is written for healthcare professionals.

For more information, please call 1-800-667-8570.

What are the ingredients in Levofloxacin?

Levofloxacin Oral Solution:

Active ingredient: levofloxacin

Levofloxacin Oral Solution:

Inactive ingredients: artificial and natural flavors, ascorbic acid, benzyl alcohol, caramel color, glycerin, hydrochloric acid, propylene glycol, purified water, sucralose and sucrose. It may also contain a solution of sodium hydroxide for pH adjustment.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Tell your doctor about all your medical conditions, including if you:

• have tendon problems
• have central nervous system problems (such as 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 a history of seizures
• have bone and joint problems
• have kidney problems. You may need a lower dose of levofloxacin if your kidneys do not work well.
• have liver problems
• have rheumatoid arthritis (RA) or other history of joint problems
• are pregnant or planning to become pregnant. It is not known if levofloxacin will harm your unborn child.
• are breast-feeding or planning to breast-feed. Levofloxacin is thought to pass into breast milk. You and your doctor should decide whether you will take levofloxacin or breast-feed.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal and dietary supplements. Levofloxacin and other medicines can affect each other causing side effects. Especially tell your doctor if you take:

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

Not metabolized by and does not inhibit CYP isoenzymes.1 Pharmacokinetic interactions with drugs metabolized by CYP isoenzymes unlikely.1

Drugs That Prolong QT Interval

Potential pharmacologic interaction (additive effect on QT interval prolongation).1 Avoid use in patients receiving class IA (e.g., quinidine, procainamide) or class III (e.g., amiodarone, sotalol) antiarrhythmic agents.1 (See Prolongation of QT Interval under Cautions.)

Specific Drugs and Laboratory Tests

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Diarrhea

• Abdominal or stomach cramps or pain (severe)
• agitation
• blisters
• confusion
• diarrhea (watery and severe) which may also be bloody
• feeling that others can hear your thoughts or control your behavior
• fever
• pain, inflammation, or swelling in the calves of the legs, shoulders, or hands
• redness and swelling of the skin
• seeing, hearing, or feeling things that are not there
• sensation of burning on the skin
• severe mood or mental changes
• skin rash, itching, or redness
• trembling
• unusual behavior

• Black, tarry stools
• blurred vision
• burning, numbness, tingling, or painful sensations
• convulsions
• cough
• dark-colored urine
• difficulty with breathing
• difficulty with chewing, talking, or swallowing
• drooping eyelids
• fast or irregular heartbeat
• general body swelling
• hives
• hoarseness
• joint or muscle pain
• muscle cramps, spasms, pain, or stiffness
• peeling or loosening of the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe dizziness
• severe tiredness
• tightness in the chest
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes
• voice changes
• weakness in the arms, hands, legs, or feet

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain or discomfort
• change in taste
• constipation
• dizziness
• drowsiness
• headache
• lightheadedness
• nausea
• nervousness
• trouble sleeping
• vaginal itching and discharge
• vomiting

• Feeling faint
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• sweating

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Levofloxacin Injection is indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. Levofloxacin Injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form).

Nosocomial Pneumonia

Levofloxacin is indicated for the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. Adjunctive therapy should be used as clinically indicated. Where Pseudomonas aeruginosa is a documented or presumptive pathogen, combination therapy with an anti-pseudomonal β-lactam is recommended [see Clinical Studies (14.1)].

Community-Acquired Pneumonia: 7–14 day Treatment Regimen

Levofloxacin is indicated for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant Streptococcus pneumoniae [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.2)].

MDRSP isolates are isolates resistant to two or more of the following antibacterials: penicillin (MIC ≥2 mcg/mL), 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

Community-Acquired Pneumonia: 5-day Treatment Regimen

Levofloxacin is indicated for the treatment of community-acquired pneumonia due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Dosage and Administration (2.1) and Clinical Studies (14.3)].

Complicated Skin and Skin Structure Infections

Levofloxacin is indicated for the treatment of complicated skin and skin structure infections due to methicillin-susceptible Staphylococcus aureus, Enterococcus faecalis, Streptococcus pyogenes, or Proteus mirabilis [see Clinical Studies (14.5)].

Uncomplicated Skin and Skin Structure Infections

Levofloxacin is indicated for the treatment of uncomplicated skin and skin structure infections (mild to moderate) including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to methicillin-susceptible Staphylococcus aureus, or Streptococcus pyogenes.

Chronic Bacterial Prostatitis

Levofloxacin is indicated for the treatment of chronic bacterial prostatitis due to Escherichia coli, Enterococcus faecalis, or methicillin-susceptible Staphylococcus epidermidis [see Clinical Studies (14.6)].

Inhalational Anthrax (Post-Exposure)

Levofloxacin is indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis. The effectiveness of Levofloxacin is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of Levofloxacin in adults for durations of therapy beyond 28 days or in pediatric patients for durations of therapy beyond 14 days has not been studied. Prolonged Levofloxacin therapy should only be used when the benefit outweighs the risk [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.9)].

Plague

Levofloxacin is indicated for treatment of plague, including pneumonic and septicemic plague, due to Yersinia pestis (Y. pestis) and prophylaxis for plague in adults and pediatric patients, 6 months of age and older. Efficacy studies of Levofloxacin could not be conducted in humans with plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals [see Dosage and Administration (2.1, 2.2) and Clinical Studies (14.10)].

Complicated Urinary Tract Infections: 5-day Treatment Regimen

Levofloxacin is indicated for the treatment of complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis [see Clinical Studies (14.7)].

Complicated Urinary Tract Infections: 10-day Treatment Regimen

Levofloxacin is indicated for the treatment of complicated urinary tract infections (mild to moderate) due to Enterococcus faecalis, Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, or Pseudomonas aeruginosa [see Clinical Studies (14.8)].

Acute Pyelonephritis: 5 or 10-day Treatment Regimen

Levofloxacin is indicated for the treatment of acute pyelonephritis caused by Escherichia coli, including cases with concurrent bacteremia [see Clinical Studies (14.7, 14.8)].

Uncomplicated Urinary Tract Infections

Levofloxacin is indicated for the treatment of uncomplicated urinary tract infections (mild to moderate) due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus.

Because fluoroquinolones, including Levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.14)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve Levofloxacin for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.

Acute Bacterial Exacerbation of Chronic Bronchitis

Levofloxacin is indicated for the treatment of acute bacterial exacerbation of chronic bronchitis (ABECB) due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Because fluoroquinolones, including Levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.14)] and for some patients ABECB is self-limiting, reserve Levofloxacin for treatment of ABECB in patients who have no alternative treatment options.

Acute Bacterial Sinusitis: 5-day and 10–14 day Treatment Regimens

Levofloxacin is indicated for the treatment of acute bacterial sinusitis (ABS) due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis [see Clinical Studies (14.4)].

Because fluoroquinolones, including Levofloxacin, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.14)] and for some patients ABS is self-limiting, reserve Levofloxacin for treatment of ABS in patients who have no alternative treatment options.

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Levofloxacin and other antibacterial drugs, Levofloxacin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Culture and susceptibility testing

Appropriate culture and susceptibility tests should be performed before treatment in order to isolate and identify organisms causing the infection and to determine their susceptibility to Levofloxacin [see Microbiology (12.4)]. Therapy with Levofloxacin may be initiated before results of these tests are known; once results become available, appropriate therapy should be selected.

As with other drugs in this class, some isolates of Pseudomonas aeruginosa may develop resistance fairly rapidly during treatment with Levofloxacin. Culture and susceptibility testing performed periodically during therapy will provide information about the continued susceptibility of the pathogens to the antimicrobial agent and also the possible emergence of bacterial resistance.

Serious and Otherwise Important Adverse Reactions

The following serious and otherwise important adverse drug reactions are discussed in greater detail in other sections of labeling:

• Disabling and Potentially Irreversible Serious Adverse Reactions [see Warnings and Precautions (5.1)]
• Tendinitis and Tendon Rupture [see Warnings and Precautions (5.2)]
• Peripheral Neuropathy [see Warnings and Precautions (5.3)]
• Central Nervous System Effects [see Warnings and Precautions (5.4)]
• Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.5)]
• Other Serious and Sometimes Fatal Reactions [see Warnings and Precautions (5.6)]
• Hypersensitivity Reactions [see Warnings and Precautions (5.7)]
• Hepatotoxicity [see Warnings and Precautions (5.8)]
• Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.9)]
• Prolongation of the QT Interval [see Warnings and Precautions (5.10)]
• Musculoskeletal Disorders in Pediatric Patients [see Warnings and Precautions (5.11)]
• Blood Glucose Disturbances [see Warnings and Precautions (5.12)]
• Photosensitivity/Phototoxicity [see Warnings and Precautions (5.13)]
• Development of Drug Resistant Bacteria [see Warnings and Precautions (5.14)]

Hypotension has been associated with rapid or bolus intravenous infusion of Levofloxacin. Levofloxacin should be infused slowly over 60 to 90 minutes, depending on dosage [see Dosage and Administration (2.5)].

Crystalluria and cylindruria have been reported with quinolones, including Levofloxacin. Therefore, adequate hydration of patients receiving Levofloxacin should be maintained to prevent the formation of a highly concentrated urine [see Dosage and Administration (2.5)].

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data described below reflect exposure to Levofloxacin in 7,537 patients in 29 pooled Phase 3 clinical trials. The population studied had a mean age of 50 years (approximately 74% of the population was < 65 years of age), 50% were male, 71% were Caucasian, 19% were Black. Patients were treated with Levofloxacin for a wide variety of infectious diseases [see Indications and Usage (1)]. Patients received Levofloxacin doses of 750 mg once daily, 250 mg once daily, or 500 mg once or twice daily. Treatment duration was usually 3–14 days, and the mean number of days on therapy was 10 days.

The overall incidence, type and distribution of adverse reactions was similar in patients receiving Levofloxacin doses of 750 mg once daily, 250 mg once daily, and 500 mg once or twice daily. Discontinuation of Levofloxacin due to adverse drug reactions occurred in 4.3% of patients overall, 3.8% of patients treated with the 250 mg and 500 mg doses and 5.4% of patients treated with the 750 mg dose. The most common adverse drug reactions leading to discontinuation with the 250 and 500 mg doses were gastrointestinal (1.4%), primarily nausea (0.6%); vomiting (0.4%); dizziness (0.3%); and headache (0.2%). The most common adverse drug reactions leading to discontinuation with the 750 mg dose were gastrointestinal (1.2%), primarily nausea (0.6%), vomiting (0.5%); dizziness (0.3%); and headache (0.3%).

Adverse reactions occurring in ≥1% of Levofloxacin-treated patients and less common adverse reactions, occurring in 0.1 to <1% of Levofloxacin-treated patients, are shown in Table 4 and Table 5, respectively. The most common adverse drug reactions (≥3%) are nausea, headache, diarrhea, insomnia, constipation, and dizziness.

In clinical trials using multiple-dose therapy, ophthalmologic abnormalities, including cataracts and multiple punctate lenticular opacities, have been noted in patients undergoing treatment with quinolones, including Levofloxacin. The relationship of the drugs to these events is not presently established.

Postmarketing Experience

Table 6 lists adverse reactions that have been identified during post-approval use of Levofloxacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

Levofloxacin Injection

There are no data concerning an interaction of intravenous fluoroquinolones with oral antacids, sucralfate, multivitamins, didanosine, or metal cations. However, no fluoroquinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line [see Dosage and Administration (2.5)].

Warfarin

No significant effect of Levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for R- and S- warfarin was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of warfarin on Levofloxacin absorption and disposition was observed. However, there have been reports during the postmarketing experience in patients that Levofloxacin enhances the effects of warfarin. Elevations of the prothrombin time in the setting of concurrent warfarin and Levofloxacin use have been associated with episodes of bleeding. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if Levofloxacin is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding [see Adverse Reactions (6.3); Patient Counseling Information (17.4)].

Antidiabetic Agents

Disturbances of blood glucose, including hyperglycemia and hypoglycemia, have been reported in patients treated concomitantly with fluoroquinolones and an antidiabetic agent. Therefore, careful monitoring of blood glucose is recommended when these agents are co-administered [see Warnings and Precautions (5.12); Adverse Reactions (6.2), Patient Counseling Information (17.4)].

Non-Steroidal Anti-Inflammatory Drugs

The concomitant administration of a non-steroidal anti-inflammatory drug with a fluoroquinolone, including Levofloxacin, may increase the risk of CNS stimulation and convulsive seizures [see Warnings and Precautions (5.4)].

Theophylline

No significant effect of Levofloxacin on the plasma concentrations, AUC, and other disposition parameters for theophylline was detected in a clinical study involving healthy volunteers. Similarly, no apparent effect of theophylline on Levofloxacin absorption and disposition was observed. However, concomitant administration of other fluoroquinolones with theophylline has resulted in prolonged elimination half-life, elevated serum theophylline levels, and a subsequent increase in the risk of theophylline-related adverse reactions in the patient population. Therefore, theophylline levels should be closely monitored and appropriate dosage adjustments made when Levofloxacin is co-administered. Adverse reactions, including seizures, may occur with or without an elevation in serum theophylline levels [see Warnings and Precautions (5.4)].

Cyclosporine

No significant effect of Levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for cyclosporine was detected in a clinical study involving healthy volunteers. However, elevated serum levels of cyclosporine have been reported in the patient population when co-administered with some other fluoroquinolones. Levofloxacin Cmax and ke were slightly lower while Tmax and t1/2 were slightly longer in the presence of cyclosporine than those observed in other studies without concomitant medication. The differences, however, are not considered to be clinically significant. Therefore, no dosage adjustment is required for Levofloxacin or cyclosporine when administered concomitantly.

Digoxin

No significant effect of Levofloxacin on the peak plasma concentrations, AUC, and other disposition parameters for digoxin was detected in a clinical study involving healthy volunteers. Levofloxacin absorption and disposition kinetics were similar in the presence or absence of digoxin. Therefore, no dosage adjustment for Levofloxacin or digoxin is required when administered concomitantly.

Probenecid and Cimetidine

No significant effect of probenecid or cimetidine on the Cmax of Levofloxacin was observed in a clinical study involving healthy volunteers. The AUC and t1/2 of Levofloxacin were higher while CL/F and CLR were lower during concomitant treatment of Levofloxacin with probenecid or cimetidine compared to Levofloxacin alone. However, these changes do not warrant dosage adjustment for Levofloxacin when probenecid or cimetidine is co-administered.

Interactions with Laboratory or Diagnostic Testing

Some fluoroquinolones, including Levofloxacin, may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.

Levofloxacin [Lee-voe-FLOX-a-sin] (in 5% Dextrose) Injection
for Intravenous Use

Read this Medication Guide before you start taking Levofloxacin 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?

Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects can happen at the same time and could result in death.

If you have any of the following serious side effects while you take Levofloxacin, you should stop taking Levofloxacin immediately and get medical help right away.

• Tendon problems can happen in people of all ages who take Levofloxacin. Tendons are tough cords of tissue that connect muscles to bones.
  Some tendon problems include pain, swelling, tears, and swelling 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 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.
• 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)
• Stop taking Levofloxacin immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. 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. 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. Tendon ruptures can happen within hours or days of taking Levofloxacin and have happened up to several months after people have finished taking their fluoroquinolone.
• Stop taking Levofloxacin immediately and 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

The nerve damage may be permanent.

What is Levofloxacin?

Levofloxacin is 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)
• inhalation anthrax
• plague

Studies of Levofloxacin 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 should not be used in patients with uncomplicated urinary tract infections, acute bacterial exacerbation of chronic bronchitis, or acute bacterial sinusitis if there are other treatment options available.

Levofloxacin is 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 is safe and effective in children under 6 months of age.

The safety and effectiveness in children treated with Levofloxacin for more than 14 days is not known.

Who should not take Levofloxacin?

Do not take Levofloxacin 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. See the end of this leaflet for a complete list of ingredients in Levofloxacin.

What should I tell my healthcare provider before taking Levofloxacin?

Before you take Levofloxacin, tell your healthcare provider if you:

• have tendon problems; Levofloxacin should not be used in patients who have a history of tendon problems
• have a problem that causes muscle weakness (myasthenia gravis); Levofloxacin should not be used in patients who have a known history of myasthenia gravis
• have central nervous system problems such as seizures (epilepsy)
• have nerve problems; Levofloxacin should not be used in patients how have a history of a nerve problem called peripheral neuropathy
• 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 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 passes into your breast milk. You and your healthcare provider should decide if you will take Levofloxacin 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 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)
• 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 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?

• Take Levofloxacin exactly as your healthcare provider tells you to take it.
• Take Levofloxacin at about the same time each day.
• Drink plenty of fluids while you take Levofloxacin.
• If you miss a dose of Levofloxacin, take it as soon as you remember. Do not take more than 1 dose in 1 day.
• Levofloxacin for Injection is given by slow intravenous (I.V.) infusion into your vein over 60 or 90 minutes as prescribed by your healthcare provider.
• Do not skip any doses of Levofloxacin 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?".
  • you have a nerve problem. See "What are the possible side effects of Levofloxacin?". you have a central nervous system problem. See "What are the possible side effects of Levofloxacin?".
  • you have a serious allergic reaction. See "What are the possible side effects of Levofloxacin?".
    • your healthcare provider tells you to stop taking Levofloxacin

Taking all of your Levofloxacin doses will help make sure that all of the bacteria are killed. Taking all of your Levofloxacin doses 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, 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 and other similar antibiotic medicines may not work for you in the future.

• If you take too much Levofloxacin, call your healthcare provider or get medical help right away.

What should I avoid while taking Levofloxacin?

• Levofloxacin 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 affects you.
• Avoid sunlamps, tanning beds, and try to limit your time in the sun. Levofloxacin 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, 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?

Levofloxacin can cause serious side effects, including:

• See "What is the most important information I should know about Levofloxacin?"
• Serious allergic reactions.
  Allergic reactions can happen in people taking fluoroquinolones, including Levofloxacin, even after only one dose. Stop taking Levofloxacin 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, even after only 1 dose. Stop taking Levofloxacin at the first sign of a skin rash and immediately call your healthcare provider. Skin rash may be a sign of a more serious reaction to Levofloxacin.

• Liver damage (hepatotoxicity): Hepatotoxicity can happen in people who take Levofloxacin. 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 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 (a liver problem).

• Intestine infection (Pseudomembranous colitis)
  Pseudomembranous colitis can happen with many antibiotics, including Levofloxacin. 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.
• 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 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.
• Changes in blood sugar
  People who take Levofloxacin 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, stop taking Levofloxacin 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?"

The most common side effects of Levofloxacin include:

• nausea
• headache
• diarrhea
• insomnia
• constipation
• dizziness

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

Low blood pressure can happen when Levofloxacin is given too fast by IV injection. Tell your healthcare provider if you feel dizzy or faint during a treatment with Levofloxacin injection.

Levofloxacin 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. 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.

Keep Levofloxacin and all medicines out of the reach of children.

General information about the safe and effective use of Levofloxacin

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Levofloxacin for a condition for which it is not prescribed. Do not give Levofloxacin 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. If you would like more information about Levofloxacin, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Levofloxacin that is written for healthcare professionals.

For more information go to www.hospira.com or call 1-800-615-0187.

What are the ingredients in Levofloxacin?

Levofloxacin Injection Premix in Single-Use Flexible Containers:

Inactive ingredients: Dextrose (D5W). Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH.

Active ingredient: Levofloxacin

Hospira, Inc., Lake Forest, IL 60045 USA

Revised: 08/2017

Applies to levofloxacin: oral solution, oral syrup, oral tablet

Other dosage forms:

• intravenous solution

Along with its needed effects, levofloxacin may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking levofloxacin:

• Diarrhea

• Abdominal or stomach cramps or pain (severe)
• agitation
• blisters
• confusion
• diarrhea (watery and severe) which may also be bloody
• feeling that others can hear your thoughts or control your behavior
• fever
• pain, inflammation, or swelling in the calves of the legs, shoulders, or hands, including tendon rupture or swelling of the tendon (tendinitis)
• redness and swelling of the skin
• seeing, hearing, or feeling things that are not there
• sensation of burning on the skin
• severe mood or mental changes
• skin rash, itching, or redness
• trembling
• unusual behavior

• Black, tarry stools
• blurred vision
• burning, numbness, tingling, or painful sensation including peripheral neuropathy.
• convulsions
• cough
• dark-colored urine
• difficulty with breathing
• difficulty with chewing, talking, or swallowing
• drooping eyelids
• fast or irregular heartbeat
• general body swelling
• hives
• hoarseness
• joint or muscle pain including tendon rupture or swelling of the tendon (tendinitis).
• muscle cramps, spasms, pain, or stiffness
• peeling or loosening of the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe dizziness
• severe tiredness
• tightness in the chest
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vision changes
• voice changes
• weakness in the arms, hands, legs, or feet including worsening of myasthenia gravis.

Some side effects of levofloxacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Abdominal or stomach pain or discomfort
• change in taste
• constipation
• dizziness
• drowsiness
• headache
• lightheadedness
• nausea
• nervousness
• trouble sleeping
• vaginal itching and discharge
• vomiting

• Feeling faint
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• sweating

Applies to levofloxacin: compounding powder, intravenous solution, oral solution, oral tablet

General

The most frequently reported side effects with the IV and oral formulations included nausea, headache, diarrhea, insomnia, constipation, and dizziness. Therapy was discontinued due to side effects in 4.3% of patients overall (3.8% treated with 250 mg and 500 mg doses; 5.4% treated with 750 mg dose). The most common side effects leading to discontinuation were gastrointestinal (primarily nausea, vomiting), dizziness, and headache.

Cough/productive cough, dysgeusia, and fatigue/asthenia were reported most often with the nebulizer solution formulation.[Ref]

Gastrointestinal

During 1 study, C difficile-associated diarrhea occurred in 11 of 490 study patients (2.2%) receiving this drug.

Hemorrhagic diarrhea has been reported, which in very rare cases was indicative of enterocolitis (including pseudomembranous colitis).[Ref]

Common (1% to 10%): Nausea, diarrhea, constipation, abdominal pain, dyspepsia, vomiting
Uncommon (0.1% to 1%): Gastroenteritis, pancreatitis, glossitis, gastritis, esophagitis, flatulence, stomatitis, pseudomembranous/Clostridium difficile colitis
Frequency not reported: Dry mouth, dysphagia, gastrointestinal hemorrhage, tongue edema, gastroesophageal reflux, melena, taste perversion, intestinal perforation, intestinal obstruction, C difficile-associated diarrhea, hemorrhagic diarrhea, enterocolitis

Nebulizer Solution:
-Common (1% to 10%): Nausea, vomiting, abdominal pain, diarrhea, constipation
-Uncommon (0.1% to 1%): Retching, dyspepsia, flatulence, oral fungal infection[Ref]

Nervous system

Cases of sensory or sensorimotor axonal polyneuropathy (affecting small and/or large axons) resulting in paresthesias, hypoesthesias, dysesthesias, and weakness have been reported.

One survey reported 33 cases of peripheral neuropathy associated with this drug, ranging in severity from mild and reversible to severe and persistent. In 1 case, a 51-year-old female developed "electrical" sensations, numbness, allodynia, multiple severe tendinitis, partial tendon rupture, impaired memory, confusion, and impaired concentration, with some symptoms persisting after 1 year.[Ref]

Common (1% to 10%): Headache, dizziness
Uncommon (0.1% to 1%): Convulsions, hyperkinesias, hypertonia, paresthesia, somnolence, tremor, vertigo, abnormal gait, syncope, dysgeusia
Rare (0.01% to 0.1%): Tinnitus
Frequency not reported: Abnormal coordination, coma, hypoesthesia, dysesthesia, weakness, involuntary muscle contractions, hyperesthesia, paralysis, speech disorder, stupor, encephalopathy, leg cramps, ataxia, migraine, seizures, benign intracranial hypertension, hearing loss, hearing impaired, peripheral sensory neuropathy/sensory axonal polyneuropathy, peripheral sensory motor neuropathy/sensorimotor axonal polyneuropathy, dyskinesia, extrapyramidal disorder, hypoglycemic coma
Postmarketing reports: Abnormal electroencephalogram (EEG), exacerbation of myasthenia gravis, anosmia, ageusia, parosmia, encephalopathy (isolated reports), pseudotumor cerebri, hypoacusis, peripheral neuropathy (sometimes irreversible)

Nebulizer Solution:
-Very common (10% or more): Dysgeusia (30%)
-Common (1% to 10%): Headache, dizziness, tinnitus
-Uncommon (0.1% to 1%): Hyposmia, somnolence, hearing loss[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Abnormal dreams, agitation, anxiety, confusional state, nervousness, depression, hallucination, nightmare, sleep disorder
Rare (0.01% to 0.1%): Psychotic reactions (with hallucination, paranoia)
Frequency not reported: Aggressive reaction, delirium, emotional lability, impaired concentration, manic reaction, mental deficiency, toxic psychoses, withdrawal syndrome, psychotic disorders with self-endangering behavior (including suicidal ideation, suicide attempt)
Postmarketing reports: Psychosis, paranoia, suicide attempt (isolated reports), suicidal ideation (isolated reports)

Nebulizer Solution:
-Common (1% to 10%): Insomnia
-Uncommon (0.1% to 1%): Anxiety, depression[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus
Uncommon (0.1% to 1%): Urticaria, hyperhidrosis
Rare (0.01% to 0.1%): Angioedema
Frequency not reported: Dry skin, skin disorder, skin exfoliation, skin ulceration, erythematous rash, alopecia, maculopapular rash, erythema nodosum, eczema, mucocutaneous reactions
Postmarketing reports: Photosensitivity/phototoxicity reaction, bullous eruptions (including Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme), leukocytoclastic vasculitis

Nebulizer Solution:
-Common (1% to 10%): Rash
-Uncommon (0.1% to 1%): Urticaria, pruritus[Ref]

Mucocutaneous reactions have been reported, sometimes after the first dose.

A 78-year-old female developed toxic epidermal necrolysis 2 days after parenteral therapy. The rash initially manifested as an erythematous rash, blistering, and mucosal sloughing but progressed to exfoliation involving three-quarters of the patient's body surface area including mucosa. A positive Nikolsky sign was noted.

A 15-year-old male developed fatal toxic epidermal necrolysis taking this drug for 9 days. The rash progressed over 40 hours to involve 80% of his body surface area with a positive Nikolsky sign and involvement of the eyes and oral, nasal, and perianal mucosa.[Ref]

Musculoskeletal

Achilles tendon rupture occurred in 4 of 489 study patients (3217 treatment days) after 1 to 10 days of this drug.

Severe rhabdomyolysis occurred in a 77-year-old female after 6 days of oral therapy. She developed acute renal failure (serum creatinine 678 micromole/L), hyperkalemia (6.8 micromole/L), anuria, elevated creatine kinase (30,400 international units/L), myoglobinemia (86,000 mcg/L), and acute hepatic cytolysis (AST 555 international units/L, ALT 249 international units/L). The fluid/electrolyte disorders and creatine kinase and myoglobin levels improved with hemodialysis; however, the patient died of a myocardial infarction and respiratory failure after 13 days.[Ref]

Uncommon (0.1% to 1%): Arthralgia, myalgia, skeletal pain, tendinitis
Rare (0.01% to 0.1%): Tendon disorders (including tendinitis [e.g., Achilles tendon]), muscular weakness
Frequency not reported: Arthritis, arthrosis, pathological fracture, osteomyelitis, synovitis , back pain, ligament rupture
Postmarketing reports: Tendon rupture (e.g., Achilles tendon), muscle injury (including rupture), increased muscle enzymes, rhabdomyolysis

Nebulizer Solution:
-Common (1% to 10%): Arthralgia, myalgia
-Uncommon (0.1% to 1%): Tendinitis, costochondritis, joint stiffness[Ref]

Cardiovascular

Common (1% to 10%): Phlebitis
Uncommon (0.1% to 1%): Cardiac arrest, palpitation, ventricular arrhythmia, ventricular tachycardia
Rare (0.01% to 0.1%): Tachycardia, hypotension
Frequency not reported: Angina pectoris, arrhythmia, atrial fibrillation, bradycardia, cardiac failure, cerebrovascular disorder, circulatory failure, coronary thrombosis, heart block, hypertension, aggravated hypertension, myocardial infarction, postural hypotension, purpura, supraventricular tachycardia, deep thrombophlebitis, vasculitis, ventricular fibrillation
Postmarketing reports: Vasodilation, QT interval prolongation/prolonged ECG QT, torsade de pointes

Nebulizer Solution:
-Uncommon (0.1% to 1%): Tachycardia, prolonged ECG QT[Ref]

Ventricular arrhythmia and torsade de pointes have been reported, mainly in patients with risk factors of QT prolongation.

This drug was associated with 13 cases of torsade de pointes reported to the FDA between 1996 and 2001.

An 88-year-old woman developed a prolonged QTc interval during treatment with this drug (500 mg once a day). The QTc interval increased from 450 msec to 577 msec by the fourth day of treatment. This drug was discontinued after the patient experienced runs of ventricular tachycardia. The QTc interval then decreased to 437 msec 2 days after discontinuing this drug.

A 65-year-old woman with hypokalemia (2.8 mEq/L), hypomagnesemia (1.5 mEq/L), and renal insufficiency (serum creatinine 7.7 mg/dL, BUN 34 mg/dL) developed a QTc interval of 605 ms (baseline 435 to 485 ms), several episodes of torsade de pointes, and cardiac arrest after 3 days of this drug (250 mg/day IV). The QTc interval decreased to 399 ms and no further arrhythmias occurred after discontinuation of this drug and electrolyte replacement.

Hypotension has been associated with rapid or bolus IV infusion.[Ref]

Other

Decreased weight was reported during clinical trials for the nebulizer solution, but was primarily considered disease-related rather than drug-related.[Ref]

Common (1% to 10%): Chest pain, edema, moniliasis
Uncommon (0.1% to 1%): Asthenia, increased alkaline phosphatase, fungal infection (including Candida infection), pathogen resistance
Rare (0.01% to 0.1%): Pyrexia
Frequency not reported: Malaise, increased LDH, elevated serum triglycerides, elevated serum cholesterol, rigors, substernal chest pain, ascites, changed temperature sensation, ear disorder (unspecified), enlarged abdomen, hot flashes, gangrene, influenza-like symptoms, leg pain, multiple organ failure, earache, abscess, herpes simplex, bacterial infection, viral infection, otitis media, sepsis, pain (including pain in back, chest, extremities), fatigue, face edema, flushing, aggravated condition
Postmarketing reports: Multi-organ failure

Nebulizer Solution:
-Very common (10% or more): Fatigue/asthenia (25%), decreased exercise tolerance, decreased weight
-Common (1% to 10%): Pyrexia
-Uncommon (0.1% to 1%): Increased blood alkaline phosphatase[Ref]

Hepatic

Severe liver injury (including fatal cases with acute liver failure) has been reported, primarily in patients with severe underlying diseases.

A 74-year-old female developed hepatotoxicity and significantly increased AST (4962 units/L), ALT (7071 units/L), alkaline phosphatase (90 units/L), and total bilirubin (2.5 mg/dL) after starting this drug. Levels returned to normal within a week after discontinuation.

Severe hepatotoxicity usually occurred within 14 days (most within 6 days) after starting this drug and most cases were not associated with hypersensitivity. The majority of fatal hepatotoxicity cases occurred in patients 65 years or older and most were not associated with hypersensitivity.[Ref]

Common (1% to 10%): Increased hepatic enzymes (ALT/AST, alkaline phosphatase, GGT)
Uncommon (0.1% to 1%): Abnormal hepatic function, increased blood bilirubin
Frequency not reported: Acute hepatocellular injury, cholecystitis, cholelithiasis, hepatic coma, hepatic necrosis, bilirubinemia, severe liver injury (including fatal cases with acute liver failure)
Postmarketing reports: Severe hepatotoxicity (including acute hepatitis and fatal events), hepatic failure (including fatal cases), hepatitis, jaundice

Nebulizer Solution:
-Common (1% to 10%): Increased ALT, increased AST
-Uncommon (0.1% to 1%): Hepatitis, hyperbilirubinemia, abnormal liver function test[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Allergic reaction
Rare (0.01% to 0.1%): Hypersensitivity
Postmarketing reports: Hypersensitivity reactions (sometimes fatal and including anaphylactic/anaphylactoid reactions, anaphylactic/anaphylactoid shock, serum sickness, angioneurotic edema)

Nebulizer Solution:
-Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Anaphylactic and anaphylactoid reactions have been reported, sometimes after the first dose.[Ref]

Respiratory

Common (1% to 10%): Dyspnea
Uncommon (0.1% to 1%): Epistaxis
Frequency not reported: Rhinitis, sinusitis, pharyngitis, bronchitis, chronic obstructive airway disease, laryngitis, pleurisy, pneumonitis, upper respiratory tract infection, asthma, cough, hemoptysis, hiccough, hypoxia, pleural effusion, pulmonary embolism, respiratory insufficiency, airway obstruction, acute respiratory distress syndrome, aspiration, bronchospasm, emphysema, pneumonia, pneumothorax, pulmonary collapse, pulmonary edema, respiratory depression, respiratory disorder
Postmarketing reports: Allergic pneumonitis (isolated reports), dysphonia

Nebulizer Solution:
-Very common (10% or more): Cough/productive cough (54%), dyspnea, changes in bronchial secretions (volume, viscosity), hemoptysis, decreased forced expiratory volume
-Common (1% to 10%): Dysphonia, decreased pulmonary function test, abnormal breath sounds
-Uncommon (0.1% to 1%): Bronchospasm, bronchial hyper-reactivity, obstructive airways disorder[Ref]

Hematologic

Uncommon (0.1% to 1%): Anemia, granulocytopenia, thrombocytopenia, eosinophilia, leukopenia
Rare (0.01% to 0.1%): Neutropenia
Frequency not reported: Decreased lymphocytes, abnormal WBCs (unspecified), abnormal platelets, agranulocytosis, hematoma, leukocytosis, lymphadenopathy, decreased prothrombin, purpura, thrombocythemia, serious hematological side effects (e.g., pancytopenia, agranulocytosis, hemolytic anemia)
Postmarketing reports: Hemolytic anemia, pancytopenia, aplastic anemia, prothrombin time prolonged, INR prolonged

Nebulizer Solution:
-Uncommon (0.1% to 1%): Anemia, neutropenia, increased eosinophil count, decreased platelet count[Ref]

Serious hematological side effects (e.g., pancytopenia, agranulocytosis, hemolytic anemia) have been reported after systemic administration of this drug.[Ref]

Renal

A 73-year-old male developed vasculitis and acute renal failure within 3 days of starting oral therapy. Symptoms included significantly decreased urine output (0.5 to 0.7 L/day), palpable purpura, erythematous skin lesions, and increased serum creatinine (6.4 mg/dL) and BUN (190 mg/dL). The condition resolved within 4 weeks after discontinuation of this drug. Due to the possibility that this may have been an allergic reaction, rechallenge was not attempted.[Ref]

Uncommon (0.1% to 1%): Abnormal renal function, acute renal failure (e.g., due to interstitial nephritis), increased blood creatinine
Frequency not reported: Renal calculi, allergic interstitial nephritis, increased nonprotein nitrogen
Postmarketing reports: Interstitial nephritis

Nebulizer Solution:
-Common (1% to 10%): Increased blood creatinine
-Uncommon (0.1% to 1%): Renal failure[Ref]

Metabolic

Hypoglycemia has been reported, especially in diabetic patients.

A 79-year-old male with type 2 diabetes mellitus developed severe hypoglycemia (blood glucose 6 mg/dL) and became unresponsive 6 hours after receiving 1 dose of this drug (250 mg IV). Blood glucose levels subsequently ranged between 40 to 159 mg/dL with dextrose doses and infusions; however, he did not regain consciousness and expired 2 days later.

Attacks of porphyria in patients with porphyria have been associated with fluoroquinolone use.[Ref]

Uncommon (0.1% to 1%): Anorexia, hyperglycemia, hyperkalemia, hypoglycemia
Frequency not reported: Decreased blood glucose, hypomagnesemia, thirst, aggravated diabetes mellitus, dehydration, hypokalemia, gout, hypernatremia, hypophosphatemia, weight decrease, fluid overload, hyponatremia, acidosis, symptomatic hypoglycemia, electrolyte abnormalities

Nebulizer Solution:
-Very common (10% or more): Anorexia
-Common (1% to 10%): Increased and decreased blood glucose

Fluoroquinolones:
-Frequency not reported: Attacks of porphyria[Ref]

Genitourinary

Common (1% to 10%): Vaginitis
Uncommon (0.1% to 1%): Genital moniliasis
Frequency not reported: Dysmenorrhea, hematuria, dysuria, oliguria, urinary incontinence, urinary retention, leukorrhea, genital pruritus, ejaculation failure, impotence, albuminuria, candiduria, crystalluria, cylindruria, vaginal candidiasis, urinary tract infection

Nebulizer Solution:
-Common (1% to 10%): Vulvovaginal mycotic infection[Ref]

Ocular

Rare (0.01% to 0.1%): Visual disturbances (e.g., blurred vision)
Frequency not reported: Ophthalmologic abnormalities (including cataracts, multiple punctate lenticular opacities), abnormal vision, eye pain, nystagmus, conjunctivitis, transient vision loss
Postmarketing reports: Vision disturbance (including diplopia), reduced visual acuity, blurred vision, scotomata, uveitis

Nebulizer Solution:
-Uncommon (0.1% to 1%): Visual disturbance[Ref]

Oncologic

Frequency not reported: Carcinoma[Ref]

Local

Common (1% to 10%): Injection site reactions (pain, reddening)
Frequency not reported: Injection site pain, injection site inflammation[Ref]

Some side effects of levofloxacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

750 mg orally or IV every 24 hours for 7 to 14 days

Comments:
-Adjunctive therapy recommended as clinically indicated.
-Coadministration with an antipseudomonal beta-lactam recommended if Pseudomonas aeruginosa is a documented/possible pathogen.
-Current guidelines should be consulted for additional information.

Use: For the treatment of nosocomial pneumonia due to methicillin-susceptible Staphylococcus aureus, P aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae

250 mg orally or IV every 24 hours for 3 days

Comments:
-Since fluoroquinolones (including this drug) have been associated with serious side effects and uncomplicated UTI is self-limiting for some patients, this drug should be saved for treatment of uncomplicated UTIs in patients with no alternative treatment options.

Use: For the treatment of mild to moderate uncomplicated UTIs due to E coli, K pneumoniae, or S saprophyticus

6 months or older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours
-Maximum dose: 250 mg/dose
At least 50 kg: 500 mg orally or IV every 24 hours

Duration of therapy: 60 days

Comments:
-Drug administration should begin as soon as possible after suspected/confirmed exposure to aerosolized B anthracis.
-Efficacy based on plasma levels reached in humans, a surrogate endpoint reasonably likely to predict clinical benefit; this drug has not been tested in humans for postexposure prevention of inhalation anthrax.
-Safety of this drug has not been established for therapy durations exceeding 14 days; increased rate of musculoskeletal side effects compared to controls; prolonged therapy recommended only when the benefit outweighs the risk.

Use: For inhalational anthrax (postexposure) to reduce incidence/progression of infection after exposure to aerosolized B anthracis

American Academy of Pediatrics Recommendations for Children 1 Month or Older:
Less than 50 kg: 8 mg/kg orally or IV every 12 hours
-Systemic anthrax when meningitis has been excluded: 10 mg/kg IV every 12 hours
Maximum dose: 250 mg/dose

At least 50 kg: 500 mg orally or IV every 24 hours

Duration of Therapy:
Postexposure prophylaxis for B anthracis infection: 60 days after exposure

Systemic anthrax:
-With possible/confirmed meningitis: At least 2 to 3 weeks or until patient is clinically stable (whichever is longer)
-When meningitis has been excluded: At least 14 days or until patient is clinically stable (whichever is longer)
-Patients will require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Cutaneous anthrax without systemic involvement:
-Bioterrorism-related cases: To complete an antimicrobial regimen of up to 60 days from onset of illness
-Naturally-acquired cases: 7 to 10 days

Follow-up for severe anthrax: To complete a regimen of 14 days or longer
-Patients may require prophylaxis to complete an antimicrobial regimen of up to 60 days from onset of illness.

Comments:
-Recommended as an alternative oral drug for postexposure prophylaxis, for the treatment of cutaneous anthrax without systemic involvement, and follow-up therapy for severe anthrax
-Recommended as an alternative IV drug for the treatment of systemic anthrax
-Recommended for all strains (regardless of penicillin susceptibility or if susceptibility unknown) when used for postexposure prophylaxis, systemic anthrax when meningitis has been excluded, follow-up therapy for severe anthrax, or cutaneous anthrax without systemic involvement
-Recommended for use with a protein synthesis inhibitor when used for systemic anthrax (including follow-up); the addition of a bactericidal antimicrobial (beta-lactam or glycopeptide) is recommended with possible/confirmed meningitis.
-Systemic anthrax includes anthrax meningitis, inhalation anthrax, injection anthrax, gastrointestinal anthrax, and cutaneous anthrax with systemic involvement, extensive edema, or lesions of the head or neck.
-Current guidelines should be consulted for additional information.

Administration advice:
-Administer the injection only by IV infusion; not for IM, intrathecal, intraperitoneal, or subcutaneous administration.
-Infuse 250 and 500 mg IV doses over at least 60 minutes and 750 mg doses over at least 90 minutes; avoid rapid or bolus IV infusion (associated with hypotension).
-Do not use injection in flexible containers in series connections.
-If the same IV line is used for sequential infusion of several drugs, flush the line before and after infusion of this drug with an infusion solution compatible to all drugs.
-May switch from IV to oral therapy when clinically indicated at the physician's discretion; no dose adjustment needed.
-May administer the tablets without regard to meals; administer the oral solution 1 hour before or 2 hours after eating.
-Administer the tablets and the oral solution at the same time each day.
-Maintain adequate hydration of patients to prevent formation of highly-concentrated urine.
-Administer oral doses at least 2 hours before or 2 hours after iron-, zinc-, aluminum-, or magnesium-containing products (e.g., antacids, sucralfate, mineral supplements/multivitamins, buffered didanosine).

Storage requirements:
-IV Injection (premixed solution in flexible container): Store at or below 25C (77F); brief exposure up to 40C (104F) does not harm product; avoid excessive heat; protect from freezing and light.
-IV Injection (vials): Store at controlled room temperature; protect from light.
-Oral Solution: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
-Tablets: Store at 15C to 30C (59F to 86F); close bottle well.

Reconstitution/preparation techniques:
-The manufacturer product information should be consulted.

IV compatibility:
-Limited data regarding compatibility with other IV products; additives or other drugs should not be added to this drug or infused concurrently through the same IV line.

General:
-This drug is indicated for the treatment of adults with mild, moderate, and severe infections due to susceptible isolates of the designated bacteria.
-Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.
-Appropriate culture and susceptibility testing recommended before therapy to isolate and identify infecting organisms and to establish susceptibility to this drug. Therapy may be started before test results are known; appropriate therapy should be continued when results are available.
-Some isolates of P aeruginosa may develop resistance relatively quickly during therapy.
-IV injection recommended when route is beneficial to patient (e.g., oral dosing is not tolerated).

Monitoring:
-Infections/Infestations: Culture and susceptibility (periodically during therapy)
-Metabolic: Blood glucose in diabetics

Patient advice:
-Read the US FDA-approved Medication Guide.
-Drink plenty of fluids.
-Avoid missing doses and complete the entire course of therapy.
-Stop this drug immediately and contact healthcare provider if a serious side effect occurs.
-Stop this drug and contact healthcare provider if tendon pain, swelling, or inflammation develops or you have weakness or are unable to use 1 of your joints; rest and do not exercise. If your child has any joint-related problems during or after therapy, contact your child's physician.
-Stop this drug at once and contact physician if symptoms of peripheral neuropathy develop.
-Contact physician if persistent headache (with or without blurred vision), any symptoms of muscle weakness (including respiratory problems) or QT interval prolongation (including prolonged heart palpitations, loss of consciousness), signs/symptoms of liver injury, or watery and bloody stools occur.
-Stop this drug at first sign of skin rash, hives or other skin reactions, rapid heartbeat, problems swallowing or breathing, swelling suggestive of angioedema, or other symptoms of allergic reaction occur.
-Do not drive, operate machinery, or engage in other tasks that require mental alertness or coordination until you know how the drug affects you.
-Avoid or minimize exposure to natural or artificial sunlight; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Contact physician if sunburn-like reaction or skin eruption develops.

• Levofloxacin is an antibiotic which means that it kills bacteria. Levofloxacin inhibits two bacterial enzymes, topoisomerase IV and DNA gyrase, both of which are vital for the manufacture and repair of DNA and other DNA processes.
• Levofloxacin belongs to a group of medicines called fluoroquinolone antibiotics.

Levofloxacin treats a wide range of bacterial infections; however, it can cause some very severe and potentially irreversible side effects such as tendonitis or tendon rupture and should only be used to treat infections that have not responded to alternative treatment options.