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Highly effective for a broad range of bacterial infections





 

Highly effective for a broad range of bacterial infections

About LEVAQUIN

To help you find out more about LEVAQUIN, the following areas of basic information are provided:

What is LEVAQUIN?
What is LEVAQUIN indicated to treat?
How does LEVAQUIN work?

 

What is LEVAQUIN?
LEVAQUIN is a broad-spectrum quinolone antibiotic used in adults to treat lung, sinus, skin, and urinary tract infections caused by certain germs called bacteria. LEVAQUIN kills many of the types of bacteria that can infect the lungs, sinuses, skin, and urinary tract and has been shown in a large number of clinical trials to be safe and effective for the treatment of many bacterial infections.

Sometimes viruses rather than bacteria may infect the lungs and sinuses (for example, the common cold). LEVAQUIN, like other antibiotics, does not kill viruses.

LEVAQUIN Tablets are terra cotta pink for the 250 mg tablet, peach colored for the 500 mg tablet, or white for the 750 mg tablet.  LEVAQUIN Oral Solution may range from clear yellow to clear greenish-yellow.

What is LEVAQUIN indicated to treat?
LEVAQUIN is a broad-spectrum quinolone antibiotic used in adults to treat lung, sinus, skin, and urinary tract infections caused by certain germs called bacteria.

Respiratory Infections:

  • Acute bacterial sinusitis
  • Acute bacterial exacerbation of chronic bronchitis
  • Pneumonia
    • Hospital-acquired (nosocomial)
    • Community-acquired

Skin Infections:

  • Complicated skin and skin structure infections
  • Uncomplicated skin and skin structure infections

Kidney & Urinary Tract Infections

  • Chronic bacterial prostatitis
  • Complicated urinary tract infections
  • Acute pyelonephritis
  • Uncomplicated urinary tract infections

Click here for approved LEVAQUIN uses.

How does LEVAQUIN work?
LEVAQUIN is concentration-dependent, meaning it kills bacteria most efficiently when the right amount of medicine has been absorbed into your body. LEVAQUIN Tablets are available in 3 different strengths (250 mg, 500 mg, 750 mg). Your prescriber will select the most appropriate strength and duration of therapy for your infection. Use only the antibiotic that your healthcare professional prescribed for your condition, and not one used by another person or for another illness. Take the prescribed amount of your drug at the correct times. Even if you start to feel better, continue taking your drug for the full course (prescribed number of days) to ensure that no bacteria can survive.


IMPORTANT SAFETY INFORMATION FOR LEVAQUIN

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 has been ruled out and avoid exercise and using the affected area.

LEVAQUIN® is contraindicated in persons with known hypersensitivity to LEVAQUIN® or other quinolone antibiotics. Serious and occasionally fatal allergic reactions, as well as some of unknown origin, have been reported in patients receiving therapy with quinolones, 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. Hepatotoxicity (liver damage) has been reported in patients receiving LEVAQUIN®. Call your doctor 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 quinolone 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. 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. Sometimes after starting treatment with antibiotics, you can develop watery and 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 doctor 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. Blood glucose disturbances have been reported with use of quinolones, usually in diabetic patients taking oral anti-diabetes medicines or insulin.

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

Safety and efficacy in pregnant women and nursing mothers have not been established. The risk-benefit assessment indicates that LEVAQUIN® is only appropriate in pediatric patients for treatment of inhalational anthrax (post-exposure). The safety in pediatric patients treated for more than 14 days has not been studied.

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.

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

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.