Label: LEVAQUIN- levofloxacin tablet, film coated

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 27, 2020

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  • Medication Guide Section

    MEDICATION GUIDE


    MEDICATION GUIDE
    Levofloxacin Tablets
    (LEE-voe-FLOX-a-sin)

    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 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 tablets, you should stop taking levofloxacin tablets immediately and get medical help right away.

    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:
    o Pain
    o swelling
    o 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 tablets is higher if you:
    o are over 60 years of age
    o are taking steroids (corticosteroids)
    o 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:
    o physical activity or exercise
    o kidney failure
    o tendon problems in the past, such as in people with rheumatoid arthritis (RA)
    • Stop taking levofloxacin tablets 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 tablets. Tendon ruptures can happen within hours or days of taking levofloxacin tablets and have happened up to several months after people have finished taking their fluoroquinolone.

    • Stop taking levofloxacin tablets immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
    o hear or feel a snap or pop in a tendon area
    o bruising right after an injury in a tendon area
    o unable to move the affected area or bear weight
    The tendon problems may be permanent.

    2. Changes in sensation and possible nerve damage (Peripheral Neuropathy). Damage to the nerves in arms, hands, legs, or feet can happen in people who take fluoroquinolones, including levofloxacin tablets. Stop taking levofloxacin tablets immediately and talk to your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:
    • pain • numbness
    • burning • weakness
    • tingling

    The nerve damage may be permanent

    3. Central Nervous System (CNS) effects. Mental health problems and seizures have been reported in people who take fluoroquinolone antibacterial medicines, including levofloxacin tablets. Tell your healthcare provider if you have a history of mental health problems, including depression, or have a history of seizures before you start taking levofloxacin tablets. CNS side effects may happen as soon as after taking the first dose of levofloxacin tablets. Stop taking levofloxacin tablets immediately and talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:
    • seizures • nightmares
    • hear voices, see things, or sense things that are not there(hallucinations) • feel lightheaded or dizzy
    • feel restless or agitated • feel more suspicious (paranoia)
    • tremors • suicidal thoughts or acts
    • feel anxious or nervous • headaches that will not go away, with or without blurred vision
    • confusion • memory problems
    • depression • false or strange thoughts or beliefs
    • reduced awareness of surroundings
    • trouble sleeping

    The CNS changes may be permanent.

    4. 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. Tell your healthcare provider if you have a history of myasthenia gravis before you start taking levofloxacin tablets. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

    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 • plague
    • community acquired pneumonia • urinary tract infections, complicated and uncomplicated

    • skin infections, complicated and uncomplicated • acute kidney infection (pyelonephritis)
    • chronic prostate infection • acute sinus infection
    • inhalation anthrax germs • acute worsening or chronic bronchitis

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

    Levofloxacin tablets is also used to treat children who weigh at least 66 pounds (or at least 30 kilograms) and may have breathed in anthrax germs, have plague, or been exposed to plague germs.

    It is not known if levofloxacin tablets is 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.

    Before you take levofloxacin tablets, tell your healthcare provider about all of your medical conditions, including if you:

    • have tendon problems. Levofloxacin tablets should not be used in people who have a history of tendon problems.
    • have a problem that causes muscle weakness (myasthenia gravis). Levofloxacin tablets should not be used in people who have a known history of myasthenia gravis.
    • have a history of mental health problems, including depression.
    • have central nervous system problems such as seizures (epilepsy).
    • have nerve problems. Levofloxacin tablets should not be used in people who 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 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 tablets will harm your unborn child.

    • are breastfeeding or plan to breastfeed. It is not known if levofloxacin passes into your breast milk. You should not breastfeed during treatment with levofloxacin and for 2 days after taking your last dose of levofloxacin. You may pump your breast milk and throw it away during treatment with levofloxacin and for 2 days after taking your last dose of levofloxacin.

    Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter 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:
    o an antacid, multivitamin, or other medicines or supplements that have magnesium, aluminum, iron, or zinc
    o sucralfate (Carafate®)
    o 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 and it is:
    o 8 hours or more until your next scheduled dose, take your missed dose right away. Then take the next dose at your regular time.
    o less than 8 hours until your next scheduled dose, do not take the missed dose. Take the next dose at your regular time.

    • 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:
    o you have tendon problems. See “What is the most important information I should know about levofloxacin tablets?”.

    o you have a nerve problem. See “What is the most important information I should know about levofloxacin tablets?”.

    o you have a central nervous sytem problem. See “What is the most important information I should know about levofloxacin tablets?”.

    o you have a serious allergic reaction. See “What are the possible side effects of levofloxacin tablets?”.

    o your healthcare provider tells you to stop taking levofloxacin tablets

    Taking all of your levofloxacin tablets doses will help make sure that all of the bacteria are killed. Taking all of your levofloxacin tablets doses will help you lower the chance that the bacteria will become resistant to levofloxacin tablets. If your infection does not get better while you take levofloxacin tablets, it may mean that the bacteria causing your infection may be resistant to levofloxacin tablets. If your infection does not get better, call your healthcare provider. If your infection does not get better, levofloxacin tablets and other similar antibiotic medicines may not work for you in the future.

    • If you take too 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 may 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:
    o hives o rapid heartbeat
    o trouble breathing or swallowing o faint
    o swelling of the lips, tongue, face o skin rash
    o throat tightness, hoarseness

    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 immediately 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:
    o nausea or vomiting o unusual tiredness
    o stomach pain o loss of appetite
    o fever o light colored bowel movements
    o weakness o dark colored urine
    o pain or tenderness in the upper right side of stomach-area o yellowing of your skin or the whites of your eyes
    o itching

    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).

    • Aortic aneurysm and dissection
    Tell your healthcare provider if you have ever been told that you have an aortic aneurysm, a swelling of the large artery that carries blood from the heart to the body. Get emergency medical help right away if you have sudden chest, stomach, or back pain.

    • Intestine infection (Clostridium difficile-associated diarrhea). Clostridium difficile-associated diarrhea (CDAD) 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. CDAD 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 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:
    o who are elderly
    o with a family history of prolonged QT interval
    o with low blood potassium (hypokalemia)
    o 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:
    o nausea o insomnia
    o headache o constipation
    o diarrhea o dizziness

    In children 6 months and older who take levofloxacin 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.

    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 20º to 25º C (68º to 77º F); excursions permitted to 15º to 30º C (59º to 86º F).
    • Keep levofloxacin tablets in a tightly closed container.

    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 health professionals.

    For more information, call 1-888-943-3210

    What are the ingredients in levofloxacin tablets?

    Active ingredient: levofloxacin.
    All Levofloxacin tablets:

    Inactive ingredients: hypromellose, crospovidone, microcrystalline cellulose, magnesium stearate, polyethylene glycol, titanium dioxide, polysorbate 80.

    Levofloxacin tablets 250 mg also contain synthetic red iron oxide, levofloxacin tablets 500 mg also contain synthetic red and yellow iron oxides.

    The brands listed are trademarks of their respective owners.

    Manufactured for:
    Macleods Pharma USA, Inc.,
    Plainsboro, NJ 08536

    Manufactured by:
    Macleods Pharmaceutical Ltd.
    Baddi, Himachal Pradesh, India.

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

    Revised: August 2019

  • Dosage and Administration Section

    2 DOSAGE & ADMINISTRATION

    2.1 Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance > 50mL/minute

    The usual dose of Levofloxacin Tablets is 250 mg, 500 mg, or 750 mg administered orally every 24 hours, as indicated by infection and described in Table 1.

    These recommendations apply to patients with creatinine clearance ≥ 50 mL/minute. For patients with creatinine clearance less than 50 mL/min, adjustments to the dosing regimen are required [see Dosage and Administration (2.3)].

    Table 1: Dosage of Levofloxacin Tablets in Adult Patients with Creatinine Clearance greater than or equal to 50 mL/minute)

    Type of Infection*
    Dosed Every 24 hours
    Duration (days)†
    Nosocomial Pneumonia
    750 mg
    7 to 14
    Community Acquired Pneumonia‡
    500 mg‡
    7 to 14‡
    Community Acquired Pneumonia§
    750 mg§

    Complicated Skin and Skin Structure Infections (SSSI)
    750 mg
    7 to 14
    Uncomplicated SSSI
    500 mg
    7 to 10
    Chronic Bacterial Prostatitis
    500 mg
    28
    Inhalational Anthrax (Post-Exposure), adult and pediatric patients weighing 50 kg Þ,ß or greater
    Pediatric patients weighing 30 kg to less than 50 kg Þ,ß
    500 mg

    see Table 2 below (2.2)
    60ß

    60ß
    Plague, adult and pediatric patients weighing 50 kg à or greater Pediatric patients weighing 30 kg to less than 50 kg
    500 mg
    see Table 2 below (2.2)
    10 to 14
    10 to 14
    Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)¶
    750 mg
    5
    Complicated Urinary Tract Infection (cUTI) or Acute Pyelonephritis (AP)#
    250 mg#
    10#
    Uncomplicated Urinary Tract Infection
    250 mg
    3
    Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB)
    500 mg
    7
    Acute Bacterial Sinusitis (ABS)
    750 mg
    5
    500 mg
    10 to 14

    * Due to the designated pathogens [see Indications and Usage (1)].
    † Sequential therapy (intravenous levofloxacin to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider.
    ‡ Due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydophila pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae [see Indications and Usage (1.2)].

    § Due to Streptococcus pneumoniae (excluding multi-drug-resistant isolates [MDRSP]), Haemophilus influenzae, Haemophilus parainfluenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae [see Indications and Usage (1.3)].

    ¶ This regimen is indicated for cUTI due to Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis and AP due to E. coli, including cases with concurrent bacteremia.

    # This regimen is indicated for cUTI due to Enterococcus faecalis, Enterococcus cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa; and for AP due to E. coli.

    Þ Drug administration should begin as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis. This indication is based on a surrogate endpoint. Levofloxacin plasma concentrations achieved in humans are reasonably likely to predict clinical benefit [see Clinical Studies (14.9)].

    ß The safety of levofloxacin tablets in adults for durations of therapy beyond 28 days or in pediatric patients for durations beyond 14 days has not been studied. An increased incidence of musculoskeletal adverse events compared to controls has been observed in pediatric patients [see Warnings and Precautions (5.12), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Prolonged levofloxacin tablets therapy should only be used when the benefit outweighs the risk.

    à Drug administration should begin as soon as possible after suspected or confirmed exposure to Yersinia pestis. Higher doses of levofloxacin tablets typically used for treatment of pneumonia can be used for treatment of plague, if clinically indicated.

    2.2 Dosage of Levofloxacin Tablets in Pediatric Patients with Inhalational Anthrax or Plague

    The dosage of levofloxacin tablets for inhalational anthrax (post-exposure) and plague in pediatric patients who weigh 30 kg or greater is described below in Table 2. Levofloxacin Tablets cannot be administered to patients who weigh less than 30 kg because of the limitations of the available strength. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less than 30 kg.
    Table 2: Levofloxacin Tablets Dosage in Pediatric Patients Weighing 30 kg or greater with Inhalational Anthrax (Post-Exposure) and Plague*

    Type of Infection*
    Dose
    Frequency
    Duration†
    Inhalational Anthrax (post-exposure)‡,§
    Pediatric patients weighing 50 kg or greater
    500 mg
    every 24 hours
    60 days§
    Pediatric patients weighing 30 kg to less than 50kg
    250 mg
    every 12 hours
    60 days§
    Plague¶
    Pediatric patients weighing 50 kg or greater
    500 mg
    every 24 hours
    10 to 14 days
    Pediatric patients weighing 30 kg to less than 50 kg
    250 mg
    every 12 hours
    10 to 14 days

    * Due to Bacillus anthracis [see Indications and Usage (1.13)] and Yersinia pestis [see Indications and Usage (1.14)].

    † Sequential therapy (intravenous levofloxacin injection to oral levofloxacin tablets) may be instituted at the discretion of the healthcare provider.

    ‡ Begin levofloxacin tablets as soon as possible after suspected or confirmed exposure to aerosolized B. anthracis.

    § The safety of levofloxacin tablets in pediatric patients for durations of therapy beyond 14 days has not been studied. [see Warnings and Precautions (5.12), Use in Specific Populations (8.4), and Clinical Studies (14.9)]. Begin levofloxacin tablets as soon as possible after suspected or confirmed exposure to Yersinia pestis.

    2.3 Dosage Adjustment in Adults With Renal Impairment

    Administer levofloxacin with caution in patients with renal impairment. Careful clinical observation and appropriate laboratory studies should be performed prior to and during therapy since elimination of levofloxacin may be reduced in these patients.


    In patients with renal impairment (creatinine clearance less than 50 mL/min), adjustment of the dosage regimen is necessary to avoid the accumulation of levofloxacin due to decreased clearance [see Use in Specific Populations (8.6)]. No adjustment is necessary for patients with a creatinine clearance greater than or equal to 50mL/minute

    Table 3 shows how to adjust dose based on creatinine clearance.


    Table 3: Dosage Adjustment in Adult Patients with Renal Impairment (Creatinine Clearance less than 50 mL/minute)

    Creatinine Clearance greater than or equal to 50 mL/ minute Creatinine Clearance
    20 to 49 mL/min Creatinine Clearance
    10 to 19 mL/min Hemodialysis or Chronic Ambulatory Peritoneal Dialysis (CAPD)
    750 mg every 24 hours
    750 mg every 48 hours

    750 mg initial dose, then
    500 mg every 48 hours
    750 mg initial dose, then
    500 mg every 48 hours
    500 mg every 24 hours

    500 mg initial dose, then
    250 mg every 24 hours
    500 mg initial dose, then
    250 mg every 48 hours
    500 mg initial dose, then
    250 mg every 48 hours
    250 mg every 24 hours
    No dosage adjustment required

    250 mg every 48 hours.
    If treating uncomplicated UTI, then no dosage adjustment is required No information on dosing adjustment is available


    2.4 Drug Interaction With Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

    Levofloxacin Tablets should be administered at least two hours before or two hours after antacids containing magnesium, aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine chewable/buffered tablets or the pediatric powder for oral solution [see Drug Interactions (7.1) and Patient Counseling Information (17)].

    2.5 Important Administration Instructions

    Levofloxacin tablets can be administered without regard to food.
    If patients miss a dose, they should take it as soon as possible anytime up to 8 hours prior to their next scheduled dose. If less than 8 hours remain before the next dose, wait until their next scheduled dose.

    2.6 Hydration for Patients Receiving Levofloxacin Tablets

    Adequate hydration of patients receiving levofloxacin should be maintained to prevent the formation of highly concentrated urine. Crystalluria and cylindruria have been reported with quinolones [see Adverse Reactions (6.1) and Patient Counseling Information (17)].

  • Indications and Usage Section

    1 INDICATIONS & USAGE

    1.1 Nosocomial Pneumonia

    Levofloxacin tablets are indicated in adult patients for the treatment of nosocomial pneumonia due to methicillinsusceptible 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 antipseudomonal β-lactam is recommended [see Clinical Studies (14.1)].

    1.2 Community-Acquired Pneumonia: 7 to 14 day Treatment Regimen

    Levofloxacin tablets are indicated in adult patients for the treatment of community-acquired pneumonia due to methicillin-susceptible Staphylococcus aureus, Streptococcus pneumoniae (including multidrug-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 strains 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.

    1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen

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

    1.4 Complicated Skin and Skin Structure Infections

    Levofloxacin tablets are indicated in adult patients 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)].

    1.5 Uncomplicated Skin and Skin Structure Infections

    Levofloxacin tablets are indicated in adult patients 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.

    1.6 Chronic Bacterial Prostatitis

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

    1.7 Inhalational Anthrax (Post-Exposure)

    Levofloxacin tablets are indicated for inhalational anthrax (post-exposure) to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis in adults and pediatric patients, 6 months of age and older [see Dosage and Administration (2.2)]. . The effectiveness of levofloxacin tablets are based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit. Levofloxacin tablets has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of levofloxacin tablets 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 tablets therapy should only be used when the benefit outweighs the risk [see Clinical Studies (14.9)].

    1.8 Plague

    Levofloxacin tablets are 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 [see Dosage and Administration (2.2)]. Efficacy studies of levofloxacin tablets 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 Clinical Studies (14.10)].


    1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen

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

    1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen

    Levofloxacin tablets are indicated in adult patients 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)].

    1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen

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

    1.12 Uncomplicated Urinary Tract Infections

    Levofloxacin tablets are indicated in adult patients 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 (5.1-5.15)] and for some patients uncomplicated urinary tract infection is self-limiting, reserve levofloxacin tablets for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.


    1.13 Acute Bacterial Exacerbation of Chronic Bhronchitis

    Levofloxacin tablets are indicated in adult patients 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 (5.1-5.15)] and for some patients ABECB is self-limiting, reserve levofloxacin tablets, USP for treatment of ABECB in patients who have no alternative treatment options.

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

    Levofloxacin tablets are indicated in adult patients 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 (5.1-5.15)] and for some patients ABS is self-limiting, reserve levofloxacin tablets for treatment of ABS in patients who have no alternative treatment options.


    1.15 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 tablets 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 tablets. 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

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    Levofloxacin 750mg tablets

  • INGREDIENTS AND APPEARANCE
    LEVAQUIN 
    levofloxacin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:80425-0076(NDC:33342-023)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14) LEVOFLOXACIN ANHYDROUS750 mg
    Product Characteristics
    Colorwhite (White) Scoreno score
    ShapeCAPSULESize22mm
    FlavorImprint Code ML;64
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0076-114 in 1 BOTTLE; Type 0: Not a Combination Product03/22/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20083903/22/2012
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0076)