LEVOFLOXACIN - levofloxacin injection, solution, concentrate 
AuroMedics Pharma LLC

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17.6 FDA-Approved Medication Guide

MEDICATION GUIDE
LEVOFLOXACIN (lee voe FLOX a sin) 
INJECTION
for Intravenous Use

Read this Medication Guide before you start taking levofloxacin and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about levofloxacin?

Levofloxacin, a fluoroquinolone antibiotic, can cause serious side effects. Some of these serious side effects could result in death.

If you have any of the following serious side effects while you take levofloxacin, get medical help right away. Talk with your healthcare provider about whether you should continue to take levofloxacin.

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

Some tendon problems include pain, swelling, tears, and inflammation of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.

The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. Talk to your healthcare provider about the risk of tendon rupture with continued use of levofloxacin. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.


2. Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like levofloxacin may cause worsening of myasthenia gravis symptoms, including muscle weakness and breathing problems. Call your healthcare provider right away if you have any worsening muscle weakness or breathing problems.

What is levofloxacin?

Levofloxacin is a fluoroquinolone antibiotic medicine used in adults age 18 years or older to treat certain infections caused by certain germs called bacteria. These bacterial infections include:

Studies of levofloxacin for use in the treatment of plague and anthrax were done in animals only, because plague and anthrax could not be studied in people.

Levofloxacin is also used to treat children who are 6 months of age or older and may have breathed in anthrax germs, have plague, or been exposed to plague germs.

It is not known if levofloxacin is safe and effective in children under 6 months of age.

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

Who should not take levofloxacin?

Do not take levofloxacin if you have ever had a severe allergic reaction to an antibiotic known as a fluoroquinolone, or if you are allergic to levofloxacin or any of the ingredients in levofloxacin injection. See the end of this leaflet for a complete list of ingredients in levofloxacin injection.

What should I tell my healthcare provider before taking levofloxacin?

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

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

Levofloxacin and other medicines can affect each other causing side effects.

Especially tell your healthcare provider if you take:

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?
 


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

What should I avoid while taking levofloxacin?

What are the possible side effects of levofloxacin?

Levofloxacincan cause serious side effects, including:

Allergic reactions can happen in people taking fluoroquinolones, including levofloxacin, even after only 1 dose. Stop taking levofloxacin and get emergency medical help right away if you have any of the following symptoms of a severe allergic reaction:

Skin rash may happen in people taking levofloxacin, even after only 1 dose. Stop taking levofloxacin at the first sign of a skin rash and call your healthcare provider. Skin rash may be a sign of a more serious reaction to levofloxacin.

Stop taking levofloxacin and tell your healthcare provider right away if you have yellowing of your skin or white part of your eyes, or if you have dark urine. These can be signs of a serious reaction to levofloxacin (a liver problem).

Central Nervous System (CNS) side effects may happen as soon as after taking the first dose of levofloxacin. Talk to your healthcare provider right away if you get any of these side effects, or other changes in mood or behavior:


Pseudomembranous colitis can happen with many antibiotics, including levofloxacin. Call your healthcare provider right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your antibiotic.

Damage to the nerves in arms, hands, legs, or feet can happen in people taking fluoroquinolones, including levofloxacin. Stop levofloxacin and talk with your healthcare provider right away if you get any of the following symptoms of peripheral neuropathy in your arms, hands, legs, or feet:

    The nerve damage may be permanent.

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


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.
 

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

See “What should I avoid while taking levofloxacin?”

The most common side effects of levofloxacin include:

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



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

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

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

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

How should I store levofloxacin?

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

General information about the safe and effective use of levofloxacin

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

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

For more information call 1-866-850-2876.

What are the ingredients in levofloxacin injection?

Active ingredient: levofloxacin.

Inactive ingredients: water for injection. Levofloxacin injection single-use vials do not contain any preservatives.

All brands listed are the trademarks of their respective owners and are not trademarks of Aurobindo Pharma Limited.

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

Manufactured for:
AuroMedics Pharma LLC
6 Wheeling Road
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
IDA, Pashamylaram - 502307
AP., India

Revised: July 2014

Revised: 07/2014
 
AuroMedics Pharma LLC