LEVOFLOXACIN tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LEVOFLOXACIN (UNII: 6GNT3Y5LMF) (LEVOFLOXACIN ANHYDROUS - UNII:RIX4E89Y14)
Available from:
RPK Pharmaceuticals, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Levofloxacin tablets are 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) ]. Levofloxacin tablets are 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 i
Product summary:
Product: 53002-1391 NDC: 53002-1391-3 3 TABLET, FILM COATED in a BOTTLE NDC: 53002-1391-1 10 TABLET, FILM COATED in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
53002-1391-1, 53002-1391-3

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LEVOFLOXACIN - levofloxacin tablet, film coated

RPK Pharmaceuticals, Inc.

----------

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:

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 tablets is higher if you:

are over 60 years of age

are taking steroids (corticosteroids)

have had a kidney, heart or lung transplant.

Tendon problems can happen in people who do not have the above risk factors when they take

levofloxacin tablets.

Other reasons that can increase your risk of tendon problems can include:

physical activity or exercise

kidney failure

tendon problems in the past, such as in people with rheumatoid arthritis (RA)

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:

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 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 (delusion)

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 tablets 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 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 are safe and effective in children under 6 months of age.

The safety and effectiveness in children treated with levofloxacin tablets for more than 14 days is not

known.

Who should not take levofloxacin tablets?

Do not take levofloxacin tablets if you have ever had a severe allergic reaction to an antibiotic known as a

fluoroquinolone, or if you are allergic to levofloxacin or any of the ingredients in levofloxacin tablets. See

the end of this leaflet for a complete list of ingredients in levofloxacin tablets.

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 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. If you are

taking levofloxacin for inhalational anthrax, you and your healthcare provider should decide

whether you can continue breastfeeding while taking 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 exactly as your healthcare provider tells you to take it.

Take levofloxacin at the same time each day.

Drink plenty of fluids while you take levofloxacin.

Levofloxacin 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 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 ?”.

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

levofloxacin ?”.

o you have a central nervous system problem. See “What is the most important information I should

know about levofloxacin ?”.

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

o your healthcare provider tells you to stop taking levofloxacin

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 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 your 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. 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 room temperature between 59°F to 86° F (15°C to 30°C).

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 or 1-855-926-3384

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: October 2020

Revised: 12/2020

Document Id: 32095c58-82a6-489b-a33e-e84a199147af

34391-3

Set id: 75480aa3-0703-40bb-8fdf-12bc0d46d973

Version: 1

Effective Time: 20201221

RPK Pharmaceuticals, Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LEVOFLOXACIN TABLETS, safely and

effectively. See full prescribing information for LEVOFLOXACIN TABLETS.

LEVOFLOXACIN tablets, for oral use

Initial U.S. Approval: 1996

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE,

PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF

MYASTHENIA GRAVIS

See full prescribing information for complete boxed warning.

Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially

irreversible serious adverse reactions that have occurred together (5.1), including:

o Tendinitis and tendon rupture (5.2)

o Peripheral neuropathy (5.3)

o Central nervous system effects (5.4)

Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including levofloxacin, in

patients who experience any of these serious adverse reactions (5.1)

Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with myasthenia

gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see Warnings and

Precautions (5.5)].

Because fluoroquinolones, including levofloxacin, have been associated with serious adverse reactions

(5.1-5.15), reserve levofloxacin for use in patients who have no alternative treatment options for the

following indications:

o Uncomplicated urinary tract infection (1.12)

o Acute bacterial exacerbation of chronic bronchitis (1.13)

o Acute bacterial sinusitis (1.14)

RECENT MAJOR CHANGES

Indications and Usage – Oral solution and Injection Dosage Forms Removed (1) 7/2018

Dosage and Administration – Oral Solution and Injection Dosage Forms Removed (2) 7/2018

Warnings and Precautions,-Central Nervous System Effects (5.4) 10/2018

Warnings and Precautions,- Risk of Aortic Aneurysm and Dissection (5.9) 05/2019

Warnings and Precautions,- Blood Glucose Disturbances (5.13) 10/2018

INDICATIONS AND USAGE

Levofloxacin tablets are 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)

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other

antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly

suspected to be caused by bacteria (1.15).

DOSAGE AND ADMINISTRATION

Administer levofloxacin tablets to pediatric patients weighing 30 kg and greater only (2.1, 2.2).

Levofloxacin Tablets cannot be administered to pediatric patients who weigh less than 30 kg because of the limitations of

the available strengths. Alternative formulations of levofloxacin may be considered for pediatric patients who weigh less

than 30 kg (2.2).

Dosage in Adult and Pediatric Patients with Creatinine Clearance greater than or equal to 50 mL/minute (2.1.

2.2)

Type of Infection

Dose Every 24

hours

Duration (days)

Nosocomial Pneumonia (1.1)

750 mg

7 to 14

Community Acquired Pneumonia (1.2)

500 mg

7 to 14

Community Acquired Pneumonia (1.3)

750 mg

Complicated SSSI (1.4)

750 mg

7 to 14

Uncomplicated SSSI (1.5)

500 mg

7 to 10

Chronic Bacterial Prostatitis (1.6)

500 mg

Inhalational Anthrax (Post-Exposure) (1.7) Adults and Pediatric Patients 50

kg or greater Pediatric Patients 30 kg to less than 50 kg (2.2)

500 mg

250 mg every 12

hours

Plague (1.8) Adults and Pediatric Patients 50 kg or greater Pediatric Patients

30 kg to less than 50 kg (2.2)

500 mg

250 mg every 12

hours

10 to 14

10 to 14

Complicated UTI (1.9) or Acute Pyelonephritis (1.11)

750 mg

Complicated UTI (1.10) or Acute Pyelonephritis (1.11)

250 mg

Uncomplicated UTI (1.12)

250 mg

Acute Bacterial Exacerbation of Chronic Bronchitis (1.13)

500 mg

Acute Bacterial Sinusitis (1.14)

750 mg

500 mg

10 to 14

Adjust dose for creatinine clearance less than 50 mL/minute (2.3, 8.6, 12.3)

DOSAGE FORMS AND STRENGTHS

Tablets: 250 mg, 500 mg, and 750 mg (3)

CONTRAINDICATIONS

Known hypersensitivity to levofloxacin tablets or other quinolones (4, 5.7)

WARNINGS AND PRECAUTIONS

Anaphylactic reactions and allergic skin reactions, serious, occasionally fatal, may occur after first dose (4, 5.7)

Hematologic (including agranulocytosis, thrombocytopenia), and renal toxicities may occur after multiple doses (5.6)

Hepatotoxicity: Severe, and sometimes fatal, hepatotoxicity has been reported. Discontinue immediately if signs and

symptoms of hepatitis occur (5.8)

Clostridium difficile-associated colitis: evaluate if diarrhea occurs (5.10)

Prolongation of the QT interval and isolated cases of torsade de pointes have been reported. Avoid use in patients with

known prolongation, those with hypokalemia, and with other drugs that prolong the QT interval (5.11, 8.5)

ADVERSE REACTIONS

The most common reactions (≥3%) were nausea, headache, diarrhea, insomnia, constipation and dizziness (6.2).

To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or FDA

at 1-800-FDA-1088 or www.fda.gov/medwatch

DRUG INTERACTIONS

Interacting Drug Interacting Drug

Interaction Interaction

Interacting Drug

Interaction

Multivalent cation-containing products

including antacids, metal cations or

didanosine

Absorption of levofloxacin is decreased when the tablets are taken within 2 hours of

these products (2.4, 7.1)

Warfarin

Effect may be enhanced. Monitor prothrombin time, INR and watch for bleeding

(7.2)

Antidiabetic agents

Carefully monitor blood glucose (5.13, 7.3)

USE IN SPECIFIC POPULATIONS

Geriatrics: Severe hepatotoxicity has been reported. The majority of reports describe patients 65 years of age or

older (5.8,8.5, 17). May have increased risk of tendinopathy (including rupture), especially with concomitant

corticosteroid use (5.2, 8.5, 17). May be more susceptible to prolongation of the QT interval. (5.11, 8.5, 17).

Pediatrics: Musculoskeletal disorders (arthralgia, arthritis, tendinopathy, and gait abnormality) seen in more

levofloxacin treated patients than in comparator. Shown to cause arthropathy and osteochondrosis in juvenile animals

(5.12, 8.4, 13.2). Safety in pediatric patients treated for more than 14 days has not been studied. Risk-benefit

appropriate only for the treatment of inhalational anthrax (postexposure) (1.7, 2.2, 8.4, 14.9) and plague (1.8, 2.2, 8.4,

14.10)

Lactation: Breastfeeding is not recommended during treatment, but a lactating woman may pump and discard

breastmilk during treatment and an additional 2 days after the last dose. In patients treated for inhalational anthrax (post

exposure), consider the risks and benefits of continuing breastfeeding.

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 12/2020

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON

RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS

AND EXACERBATION OF MYASTHENIA GRAVIS

1 INDICATIONS & USAGE

1.1 Nosocomial Pneumonia

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

1.3 Community-Acquired Pneumonia: 5-day Treatment Regimen

1.4 Complicated Skin and Skin Structure Infections

1.5 Uncomplicated Skin and Skin Structure Infections

1.6 Chronic Bacterial Prostatitis

1.7 Inhalational Anthrax (Post-Exposure)

1.8 Plague

1.9 Complicated Urinary Tract Infections: 5-day Treatment Regimen

1.10 Complicated Urinary Tract Infections: 10-day Treatment Regimen

1.11 Acute Pyelonephritis: 5 or 10-day Treatment Regimen

1.12 Uncomplicated Urinary Tract Infections

1.13 Acute Bacterial Exacerbation of Chronic Bronchitis

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

1.15 Usage

2 DOSAGE & ADMINISTRATION

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

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

2.3 Dosage Adjustment in Adults with Renal Impairment

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

2.5 Important Administration Instructions

2.6 Hydration for Patients Receiving Levofloxacin Tablets

3 DOSAGE FORMS & STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Disabling and Potentially Irreversible Serious Adverse Reactions Including Tendinitis and

Tendon Rupture, Peripheral Neuropathy, and Central Nervous System Effects

5.2 Tendinitis and Tendon Rupture

5.3 Peripheral Neuropathy

5.4 Central Nervous System Effects

5.5 Exacerbation of Myasthenia Gravis

5.6 Other Serious and Sometimes Fatal Adverse Reactions

5.7 Hypersensitivity Reactions

5.8 Hepatotoxicity

5.9 Risk of Aortic Aneurysm and Dissection

5.10 Clostridium difficile- Associated Diarrhea

5.11 Prolongation of the QT Interval

5.12 Musculoskeletal Disorders in Pediatric Patients and Arthropathic Effects in Animals

5.13 Blood Glucose Disturbances

5.14 Photosensitivity/ Phototoxicity

5.15 Development of Drug Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trial Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Chelation Agents: Antacids, Sucralfate, Metal Cations, Multivitamins

7.2 Warfarin

7.3 Antidiabetic Agents

7.4 Non-Steroidal Anti-Inflammatory Drugs

7.5 Theophylline

7.6 Cyclosporine

7.7 Digoxin

7.8 Probenecid and Cimetidine

7.9 Interactions with Laboratory or Diagnostic Testing

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis & Mutagenesis & Impairment Of Fertility

13.2 Animal Toxicology & or Pharmacology

14 CLINICAL STUDIES

14.1 Nosocomial Pneumonia

14.2 Community-Acquired Pneumonia: 7-14 day Treatment Regimen

14.3 Community-Acquired Pneumonia: 5-day Treatment Regimen

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

14.5 Complicated Skin and Skin Structure Infections

14.6 Chronic Bacterial Prostatitis

14.7 Complicated Urinary Tract Infections and Acute Pyelonephritis: 5-day Treatment Regimen

14.8 Complicated Urinary Tract Infections and Acute Pyelonephritis: 10-day Treatment Regimen

14.9 Inhalational Anthrax (Post-Exposure)

14.10 Plague

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION

Sections or subsections omitted from the full prescribing information are not listed.

WARNING: SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON

RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS

AND EXACERBATION OF MYASTHENIA GRAVIS

Fluoroquinolones, including levofloxacin, have been associated with disabling and potentially

irreversible serious adverse reactions that have occurred together [see Warnings and Precautions

(5.1)], including:

o Tendinitis and tendon rupture [see Warnings and Precautions (5.2)]

o Peripheral neuropathy [see Warnings and Precautions (5.3)]

o Central nervous system effects [see Warnings and Precautions (5.4)]

Discontinue levofloxacin immediately and avoid the use of fluoroquinolones, including

levofloxacin, in patients who experience any of these serious adverse reactions [see Warnings and

Precautions (5.1)]

Fluoroquinolones, including levofloxacin, may exacerbate muscle weakness in patients with

myasthenia gravis. Avoid levofloxacin in patients with a known history of myasthenia gravis [see

Warnings and Precautions (5.5)].

Because fluoroquinolones, including levofloxacin, have been associated with serious adverse

reactions [see Warnings and Precautions (5.1-5.15)], reserve levofloxacin for use in patients who

have no alternative treatment options for the following indications:

o Uncomplicated urinary tract infection [see Indications and Usage (1.12)]

o Acute bacterial exacerbation of chronic bronchitis [see Indications and Usage (1.13)]

o Acute bacterial sinusitis [see Indications and Usage (1.14)].

1 INDICATIONS & USAGE

1.1 Nosocomial Pneumonia

Levofloxacin tablets are 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)].

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 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), 2

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 isolates [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 Bronchitis

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 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

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

Inhalational Anthrax (Post-Exposure), adult and pediatric

patients weighing 50 kg

or greater

Pediatric patients weighing 30 kg to less than 50 kg

500 mg

see Table 2 below (2.2)

Plague, adult and pediatric patients weighing 50 kg

greater Pediatric patients weighing 30 kg to less than 50

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

Complicated Urinary Tract Infection (cUTI) or Acute

Pyelonephritis (AP)

250 mg

Uncomplicated Urinary Tract Infection

250 mg

Acute Bacterial Exacerbation of Chronic Bronchitis

(ABECB)

500 mg

Acute Bacterial Sinusitis (ABS)

750 mg

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,ß

Þ,ß

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 mgevery 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 mgevery 24 hours10 to 14 days

Pediatric patients weighing 30 kg to less than 50 kg250 mg every 12 hours10 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/minute

Creatinine Clearance

10 to 19 mL/minute

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 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)].

3 DOSAGE FORMS & STRENGTHS

Levofloxacin Tablets, USP

250mg pink coloured, capsule shaped, biconvex tablets debossed 'ML 62' on one side and plain on

other side

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