Refer to the “Also Known As” section to reference different products that include the same medication as Levaquin.
Brand Name: Levaquin
Generic Name: LEVOFLOXACIN
Drug Type: HUMAN PRESCRIPTION DRUG
Dosage Form: TABLET, FILM COATED
Data Current As Of: 2019-07-22
indications & usage
LEVAQUIN® is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated (1 , 12.4).
- Pneumonia: Nosocomial (1.1) and Community Acquired (1.2, 1.3)
- Skin and Skin Structure Infections (SSSI): Complicated (1.4) and Uncomplicated (1.5)
- Chronic bacterial prostatitis (1.6)
- Inhalational Anthrax, Post-Exposure in adult and pediatric patients (1.7)
- Plague in adult and pediatric patients (1.8)
- Urinary Tract Infections (UTI): Complicated (1.9, 1.10) and Uncomplicated (1.12)
- Acute Pyelonephritis (1.11)
- Acute Bacterial Exacerbation of Chronic Bronchitis (1.13)
- Acute Bacterial Sinusitis (1.14)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria (1.15).
LEVAQUIN® is indicated in adult patients 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 to 14 day treatment regimen
LEVAQUIN® is indicated in adult patients 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
LEVAQUIN® is indicated in adult patients 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 & skin structure infections
LEVAQUIN® is 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)].
uncomplicated skin & skin structure infections
LEVAQUIN® is 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.
chronic bacterial prostatitis
LEVAQUIN® is 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)].
inhalational anthrax (post-exposure)
LEVAQUIN® is 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 LEVAQUIN® is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit.
LEVAQUIN® has not been tested in humans for the post-exposure prevention of inhalation anthrax. The safety of LEVAQUIN® 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 LEVAQUIN® therapy should only be used when the benefit outweighs the risk [see Clinical Studies (14.9)].
LEVAQUIN® 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 [see Dosage and Administration (2.2)].
Efficacy studies of LEVAQUIN® 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)].
complicated urinary tract infections: 5-day treatment regimen
LEVAQUIN® is 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)].
complicated urinary tract infections: 10-day treatment regimen
LEVAQUIN® is 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)].
acute pyelonephritis: 5 or 10-day treatment regimen
uncomplicated urinary tract infections
LEVAQUIN® is 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 LEVAQUIN®, 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 LEVAQUIN® for treatment of uncomplicated urinary tract infections in patients who have no alternative treatment options.
acute bacterial exacerbation of chronic bronchitis
LEVAQUIN® is 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 LEVAQUIN®, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.15)] and for some patients ABECB is self-limiting, reserve LEVAQUIN® for treatment of ABECB in patients who have no alternative treatment options.
acute bacterial sinusitis: 5-day & 10–14 day treatment regimens
LEVAQUIN® is 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 LEVAQUIN®, have been associated with serious adverse reactions [see Warnings and Precautions (5.1–5.15)] and for some patients ABS is self-limiting, reserve LEVAQUIN® for treatment of ABS in patients who have no alternative treatment options.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of LEVAQUIN® and other antibacterial drugs, LEVAQUIN® 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 LEVAQUIN® 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 LEVAQUIN®. 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.
patient counseling information
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Serious Adverse Reactions
Advise patients to stop taking LEVAQUIN® if they experience an adverse reaction and to call their healthcare provider for advice on completing the full course of treatment with another antibacterial drug.
Inform patients of the following serious adverse reactions that have been associated with LEVAQUIN® or other fluoroquinolone use:
- Disabling and Potentially Irreversible Serious Adverse Reactions That May Occur Together: Inform patients that disabling and potentially irreversible serious adverse reactions, including tendinitis and tendon rupture, peripheral neuropathies, and central nervous system effects, have been associated with use of LEVAQUIN® and may occur together in the same patient. Inform patients to stop taking LEVAQUIN® immediately if they experience an adverse reaction and to call their healthcare provider.
- Tendinitis and Tendon Rupture: Instruct patients to contact their healthcare provider if they experience pain, swelling, or inflammation of a tendon, or weakness or inability to use one of their joints; rest and refrain from exercise; and discontinue LEVAQUIN® treatment. Symptoms may be irreversible. The risk of severe tendon disorder with fluoroquinolones is higher in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart or lung transplants.
- Peripheral Neuropathies: Inform patients that peripheral neuropathies have been associated with levofloxacin use, symptoms may occur soon after initiation of therapy and may be irreversible. If symptoms of peripheral neuropathy including pain, burning, tingling, numbness and/or weakness develop, immediately discontinue LEVAQUIN® and tell them to contact their physician.
- Central Nervous System Effects (for example, convulsions, dizziness, lightheadedness, increased intracranial pressure): Inform patients that convulsions have been reported in patients receiving fluoroquinolones, including levofloxacin. Instruct patients to notify their physician before taking this drug if they have a history of convulsions. Inform patients that they should know how they react to LEVAQUIN® before they operate an automobile or machinery or engage in other activities requiring mental alertness and coordination. Instruct patients to notify their physician if persistent headache with or without blurred vision occurs.
- Exacerbation of Myasthenia Gravis: Instruct patients to inform their physician of any history of myasthenia gravis. Instruct patients to notify their physician if they experience any symptoms of muscle weakness, including respiratory difficulties.
- Hypersensitivity Reactions: Inform patients that levofloxacin can cause hypersensitivity reactions, even following a single dose, and to discontinue the drug at the first sign of a skin rash, hives or other skin reactions, a rapid heartbeat, difficulty in swallowing or breathing, any swelling suggesting angioedema (for example, swelling of the lips, tongue, face, tightness of the throat, hoarseness), or other symptoms of an allergic reaction.
- Hepatotoxicity: Inform patients that severe hepatotoxicity (including acute hepatitis and fatal events) has been reported in patients taking LEVAQUIN®. Instruct patients to inform their physician if they experience any signs or symptoms of liver injury including: loss of appetite, nausea, vomiting, fever, weakness, tiredness, right upper quadrant tenderness, itching, yellowing of the skin and eyes, light colored bowel movements or dark colored urine.
- Aortic aneurysm and dissection: Inform patients to seek emergency medical care if they experience sudden chest, stomach, or back pain.
- Diarrhea: Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, instruct patients to contact their physician as soon as possible.
- Prolongation of the QT Interval: Instruct patients to inform their physician of any personal or family history of QT prolongation or proarrhythmic conditions such as hypokalemia, bradycardia, or recent myocardial ischemia; if they are taking any Class IA (quinidine, procainamide), or Class III (amiodarone, sotalol) antiarrhythmic agents. Instruct patients to notify their physician if they have any symptoms of prolongation of the QT interval, including prolonged heart palpitations or a loss of consciousness.
- Musculoskeletal Disorders in Pediatric Patients: Instruct parents to inform their child's physician if the child has a history of joint-related problems before taking this drug. Inform parents of pediatric patients to notify their child's physician of any joint-related problems that occur during or following levofloxacin therapy [see Warnings and Precautions (5.12) and Use in Specific Populations (8.4)].
- Photosensitivity/Phototoxicity: Inform patients that photosensitivity/phototoxicity has been reported in patients receiving fluoroquinolones. Inform patients to minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while taking fluoroquinolones. If patients need to be outdoors while using fluoroquinolones, instruct them to wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. If a sunburn-like reaction or skin eruption occurs, instruct patients to contact their physician.
- Lactation: Advise a lactating woman that she may pump and discard during treatment with LEVAQUIN and for an additional 2 days after the last dose. Alternatively, advise a lactating woman that breastfeeding is not recommended during treatment with LEVAQUIN and for an additional 2 days after the last dose [see Use in Specific Populations (8.2)].
Antibacterial drugs including LEVAQUIN® should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When LEVAQUIN® is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by LEVAQUIN® or other antibacterial drugs in the future.
Administration with Food, Fluids, and Concomitant Medications
Patients should be informed that LEVAQUIN® Tablets may be taken with or without food. The tablets should be taken at the same time each day.
Patients should drink fluids liberally while taking LEVAQUIN® to avoid formation of a highly concentrated urine and crystal formation in the urine.
Antacids containing magnesium, or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc or didanosine should be taken at least two hours before or two hours after oral LEVAQUIN® administration.
Drug Interactions with Insulin, Oral Hypoglycemic Agents, and Warfarin
Patients should be informed that if they are diabetic and are being treated with insulin or an oral hypoglycemic agent and a hypoglycemic reaction occurs, they should discontinue LEVAQUIN® and consult a physician.
Patients should be informed that concurrent administration of warfarin and LEVAQUIN® has been associated with increases of the International Normalized Ratio (INR) or prothrombin time and clinical episodes of bleeding. Patients should notify their physician if they are taking warfarin, be monitored for evidence of bleeding, and also have their anticoagulation tests closely monitored while taking warfarin concomitantly.
Plague and Anthrax Studies
Patients given LEVAQUIN® for these conditions should be informed that efficacy studies could not be conducted in humans for ethical and feasibility reasons. Therefore, approval for these conditions was based on efficacy studies conducted in animals.
Active Ingredient Made in Japan
LEVAQUIN® Tablets are Manufactured by:
Janssen Ortho LLC, Gurabo, Puerto Rico 00778
Janssen Pharmaceuticals, Inc., Titusville, NJ 08560
© 1996, 2007 Janssen Pharmaceutical Companies
|This Medication Guide has been approved by the U.S. Food and Drug Administration||Revised: 06/2019|
| MEDICATION GUIDE |
LEVAQUIN® (Leave ah kwin)
What is the most important information I should know about LEVAQUIN?
LEVAQUIN, 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 LEVAQUIN, you should stop taking LEVAQUIN immediately and get medical help right away.
The tendon problems may be permanent.
| || |
|The nerve damage may be permanent. |
|The CNS changes may be permanent.|
What is LEVAQUIN?
LEVAQUIN 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:
Studies of LEVAQUIN for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.
LEVAQUIN 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.
LEVAQUIN 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 LEVAQUIN is safe and effective in children under 6 months of age.
The safety and effectiveness in children treated with LEVAQUIN for more than 14 days is not known.
Who should not take LEVAQUIN?
Do not take LEVAQUIN 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 LEVAQUIN. See the end of this leaflet for a complete list of ingredients in LEVAQUIN.
Before you take LEVAQUIN, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
LEVAQUIN and other medicines can affect each other causing side effects.
Especially tell your healthcare provider if you take:
Ask your healthcare provider if you are not sure if any of your medicines are listed above.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I take LEVAQUIN?
Taking all of your LEVAQUIN doses will help make sure that all of the bacteria are killed. Taking all of your LEVAQUIN doses will help you lower the chance that the bacteria will become resistant to LEVAQUIN. If your infection does not get better while you take LEVAQUIN, it may mean that the bacteria causing your infection may be resistant to LEVAQUIN. If your infection does not get better, call your healthcare provider. If your infection does not get better, LEVAQUIN and other similar antibiotic medicines may not work for you in the future.
What should I avoid while taking LEVAQUIN?
What are the possible side effects of LEVAQUIN?
| || |
|Skin rash may happen in people taking LEVAQUIN, even after only 1 dose. Stop taking LEVAQUIN 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 LEVAQUIN.|
| || |
|Stop taking LEVAQUIN 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 LEVAQUIN (a liver problem).|
|The most common side effects of LEVAQUIN include:|
|In children 6 months and older who take LEVAQUIN to treat anthrax disease or plague, vomiting is also common. |
LEVAQUIN 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 LEVAQUIN.
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 LEVAQUIN?
| General information about the safe and effective use of LEVAQUIN. |
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use LEVAQUIN for a condition for which it is not prescribed. Do not give LEVAQUIN 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 LEVAQUIN. If you would like more information about LEVAQUIN, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about LEVAQUIN that is written for health professionals.
| What are the ingredients in LEVAQUIN? |
Active ingredient: levofloxacin
Inactive ingredients: crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide.
LEVAQUIN 250 mg tablets also contain synthetic red iron oxide.
LEVAQUIN 500 mg tablets also contain synthetic red iron oxide and synthetic yellow iron oxide.
Active Ingredient Made in Japan
Finished Product Manufactured by:
∙Janssen Ortho LLC, Gurabo, Puerto Rico 00778
∙Janssen Pharmaceuticals, Inc., Titusville, NJ 08560
© 1996, 2007 Janssen Pharmaceutical Companies
For more information, go to www.levaquin.com or call 1-800-526-7736
also known as