LEVOFLOXACIN- levofloxacin injection, solution 
Sagent Pharmaceuticals

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MEDICATION GUIDE

LEVOFLOXACIN (lee voe FLOX a sin) INJECTION

in 5% Dextrose

For Intravenous Use

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

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

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

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

  1. Tendon rupture or swelling of the tendon (tendinitis).
    • Tendon problems can happen in people of all ages who take LEVOFLOXACIN.
      Tendons are tough cords of tissue that connect muscles to bones.
      Some tendon problems include pain, swelling, tears, and swelling of tendons including the back of the ankle (Achilles), shoulder, hand, or other tendon sites.
    • The risk of getting tendon problems while you take LEVOFLOXACIN is higher if you:
      • are over 60 years of age
      • are taking steroids (corticosteroids)
      • have had a kidney, heart or lung transplant.
    • Tendon problems can happen in people who do not have the above risk factors when they take LEVOFLOXACIN.
    • Other reasons that can increase your risk of tendon problems can include:
      • physical activity or exercise
      • kidney failure
      • tendon problems in the past, such as in people with rheumatoid arthritis (RA)
    • Stop taking LEVOFLOXACIN immediately and get medical help right away at the first sign of tendon pain, swelling or inflammation. Avoid exercise and using the affected area.

      The most common area of pain and swelling is the Achilles tendon at the back of your ankle. This can also happen with other tendons. You may need a different antibiotic that is not a fluoroquinolone to treat your infection.
    • Tendon rupture can happen while you are taking or after you have finished taking LEVOFLOXACIN. Tendon ruptures can happen within hours or days of taking LEVOFLOXACIN and have happened up to several months after people have finished taking their fluoroquinolone.
    • Stop taking LEVOFLOXACIN immediately and get medical help right away if you get any of the following signs or symptoms of a tendon rupture:
      • hear or feel a snap or pop in a tendon area
      • bruising right after an injury in a tendon area
      • unable to move the affected area or bear weight
  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. Stop taking LEVOFLOXACIN 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
    • burning
    • tingling
    • numbness
    • weakness

    The nerve damage may be permanent.

  3. Central Nervous System (CNS) effects. Seizures have been reported in people who take fluoroquinolone antibacterial medicines, including LEVOFLOXACIN. Tell your healthcare provider if you have a history of seizures before you start taking LEVOFLOXACIN. CNS side effects may happen as soon as after taking the first dose of LEVOFLOXACIN. Stop taking LEVOFLOXACIN 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
    • hear voices, see things, or sense things that are not there (hallucinations)
    • feel restless
    • tremors
    • feel anxious or nervous
    • confusion
    • depression
    • trouble sleeping
    • nightmares
    • feel lightheaded or dizzy
    • feel more suspicious (paranoia)
    • suicidal thoughts or acts
    • headaches that will not go away, with or without blurred vision
  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. 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:

  • nosocomial pneumonia
  • community acquired pneumonia
  • acute sinus infection
  • acute worsening of chronic bronchitis
  • skin infections, complicated and uncomplicated
  • chronic prostate infection
  • urinary tract infections, complicated and uncomplicated
  • acute kidney infection (pyelonephritis)
  • inhalational anthrax
  • plague

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

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

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

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

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

Who should not take LEVOFLOXACIN?

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

What should I tell my healthcare provider before taking LEVOFLOXACIN?

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

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?

LEVOFLOXACIN can cause serious side effects, including:

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.

What are the ingredients in LEVOFLOXACIN?

LEVOFLOXACIN Injection in 5% dextrose in Single-Use Flexible Containers:

Brands listed are the trademarks of their respective owners.

NOVAPLUS®

Mfd. for SAGENT Pharmaceuticals
Schaumburg, IL 60195 (USA)
Made in Switzerland
NOVAPLUS is a registered trademark of Vizient, Inc.

Revised: October 2016

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

Revised: 10/2016
Sagent Pharmaceuticals