LEVAQUIN  - levofloxacin tablet, film coated 
PD-Rx Pharmaceuticals, Inc.

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MEDICATION GUIDE
LEVAQUIN® [Leave ah kwin]
(levofloxacin)
Tablets
LEVAQUIN® (levofloxacin)
Oral Solution
LEVAQUIN® (levofloxacin) Injection
for Intravenous Use
LEVAQUIN® (levofloxacin in 5% dextrose) Injection
for Intravenous Use

Read this Medication Guide before you start taking LEVAQUIN 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 LEVAQUIN?

LEVAQUIN, 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 LEVAQUIN, get medical help right away. Talk with your healthcare provider about whether you should continue to take LEVAQUIN.

1.
Tendon rupture or swelling of the tendon (tendinitis).
  • Tendon problems can happen in people of all ages who take LEVAQUIN. Tendons are tough cords of tissue that connect muscles to bones.
    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 risk of getting tendon problems while you take LEVAQUIN 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 LEVAQUIN.
  • 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)
  • Call your healthcare provider right away at the first sign of tendon pain, swelling or inflammation. Stop taking LEVAQUIN until tendinitis or tendon rupture has been ruled out by your healthcare provider. 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. Talk to your healthcare provider about the risk of tendon rupture with continued use of LEVAQUIN. 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 LEVAQUIN. Tendon ruptures have happened up to several months after people have finished taking their fluoroquinolone.
  • 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.
Worsening of myasthenia gravis (a problem that causes muscle weakness). Fluoroquinolones like LEVAQUIN 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 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 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 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.

What should I tell my healthcare provider before taking LEVAQUIN?

Before you take LEVAQUIN, 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.

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?

What should I avoid while taking LEVAQUIN?

What are the possible side effects of LEVAQUIN?

LEVAQUIN can cause serious side effects, including:

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.

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

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. 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 LEVAQUIN?

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

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 healthcare professionals.

For more information go to www.levaquin.com or call 1-800-526-7736.

What are the ingredients in LEVAQUIN?

LEVAQUIN Tablets, LEVAQUIN Oral Solution, LEVAQUIN Injection in Single-Use Vials and LEVAQUIN Injection Premix in Single-Use Flexible Containers:

Active ingredient: levofloxacin

All LEVAQUIN Tablets:

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

LEVAQUIN Oral Solution:

Inactive ingredients: sucrose, glycerin, sucralose, hydrochloric acid, purified water, propylene glycol, artificial and natural flavors, benzyl alcohol, ascorbic acid, and caramel color. It may also contain a solution of sodium hydroxide for pH adjustment.

LEVAQUIN Injection in Single-Use Vials:

Inactive ingredients: water for injection. LEVAQUIN for Injection Single Use Vials do not contain any preservatives.

LEVAQUIN Injection Premix in Single-Use Flexible Containers:

Inactive ingredients: Dextrose (D5W). Solutions of hydrochloric acid and sodium hydroxide may have been added to adjust the pH.

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

Active Ingredient Made in Japan

Finished Product Manufactured by:

Janssen Ortho LLC, Gurabo, Puerto Rico 00778 (Tablets).

Janssen Pharmaceutica N.V., Beerse, Belgium (Oral Solution, Injection Single-Use Vials).

Hospira, Inc., Austin, TX 78728 (Injection Premix).

Manufactured for:

Janssen Pharmaceuticals, Inc., Titusville, NJ 08560.

© Janssen Pharmaceuticals, Inc.

Revised April 2012

Revised: 04/2012
 
PD-Rx Pharmaceuticals, Inc.