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IMPORTANT SAFETY INFORMATION

Fluoroquinolones, including LEVAQUIN^®, are associated with an increased risk of tendinitis and tendon rupture in all ages. This risk is further increased in older patients usually over 60 years of age, in patients taking corticosteroid drugs, and in patients with kidney, heart, or lung transplants. Call your healthcare professional right away at the first sign of tendon pain, swelling, or inflammation. You should stop taking LEVAQUIN^® until tendinitis or tendon rupture have been ruled out, and avoid exercise and using the affected area.

LEVAQUIN^® is contraindicated in persons with known hypersensitivity to LEVAQUIN^® or other fluoroquinolone antibiotics. Serious and occasionally fatal allergic reactions, as well as some of unknown origin, have been reported in patients receiving therapy with fluoroquinolones, including LEVAQUIN^®. These reactions may occur following the first dose or multiple doses. The drug should be discontinued at the first appearance of a skin rash, hives, or other symptoms of an allergic reaction. Skin rash may be a sign of a more serious reaction to LEVAQUIN^®.

Hepatotoxicity (liver damage) has been reported in patients receiving LEVAQUIN^®. Call your healthcare professional right away if you have unexplained symptoms such as: nausea or vomiting, stomach pain, fever, weakness, abdominal pain or tenderness, itching, unusual or unexplained tiredness, loss of appetite, light colored bowel movements, dark colored urine or yellowing of your skin or the whites of your eyes.

Convulsions have been reported in patients receiving fluoroquinolone antibiotics including LEVAQUIN^®. Tell your physician if you have a history of convulsions. Central nervous system disorders including convulsions, confusion, insomnia, depression, and anxiety may occur after the first dose. You should talk to your physician right away if you experience these or other changes in mood or behavior.

Changes in sensation and possible nerve damage (peripheral neuropathy) including pain, burning, tingling, numbness, and/or weakness have been reported.

Diarrhea that usually ends after treatment is a common problem caused by antibiotics. An intestinal infection (pseudomembranous colitis) can happen with most antibiotics, including LEVAQUIN^®. Call your physician right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools (with or without stomach cramps and fever). This can occur during or up to 2 months after the use of antibiotics.

In a few people, LEVAQUIN^®, like some other antibiotics, has been linked to abnormal heart rhythms that can be dangerous. Tell your healthcare professional if you have a history of or currently have low potassium levels, abnormal heart rhythms, or are taking any medications for abnormal heart rhythms.

LEVAQUIN^® 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. Excessive exposure to the sun or UV light should be avoided.

Blood glucose disturbances have been reported with use of fluoroquinolones, usually in diabetic patients taking an oral anti-diabetes medicine or insulin.

If you develop any of these symptoms or side effects discussed above, contact your healthcare professional as soon as possible.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx^®* (didanosine) chewable/buffered tablets or the pediatric powder for oral solution, should not be taken within 2 hours before or after LEVAQUIN^® administration. If you are taking warfarin, concurrent treatment with LEVAQUIN^® has been associated with episodes of bleeding. Your physician should monitor you for evidence of bleeding and also monitor your anticoagulation tests closely.

LEVAQUIN^® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions from LEVAQUIN^® in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The risk-benefit assessment indicates that LEVAQUIN^® is only appropriate in pediatric patients >6 months of age for treatment of inhalational anthrax (post-exposure). An increased chance of problems with the joints and tissues around the joints has been observed in pediatric patients receiving LEVAQUIN^® and the safety in pediatric patients treated for more than 14 days has not been studied.

The most common adverse drug reactions (>3%) in US clinical trials were nausea, headache, diarrhea, insomnia, constipation, and dizziness.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

This product is available by prescription only. For information on Warnings, Precautions, Adverse Reactions, Drug Interactions, and Use in Specific Populations, please see Medication Guide and full Product Information, including Boxed Warning.

* Videx is a registered trademark of Bristol-Myers Squibb Company.