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Highly effective for a broad range of bacterial infections





 

Highly effective for a broad range of bacterial infections

What to expect with LEVAQUIN

LEVAQUIN is a broad-spectrum quinolone antibiotic used to treat lung, 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 bacterial infections.

Click here for approved LEVAQUIN uses.

The information provided below about use of LEVAQUIN does not take the place of discussions with your healthcare professional about your medical condition or your treatment.  All the benefits and risks of LEVAQUIN are not included in the information below.

How and when should I take LEVAQUIN?
LEVAQUIN should be taken once a day for 3, 5, 7, 10, 14 or 28 days depending on your prescription. LEVAQUIN Tablets should be swallowed and may be taken with or without food. LEVAQUIN Oral Solution should be taken 1 hour before or 2 hours after eating. Try to take the tablet and oral solution at the same time each day and drink fluids liberally.

You may begin to feel better quickly; however, in order to make sure that all bacteria are killed, you should complete the full course of medication. Do not take more than the prescribed dose of LEVAQUIN even if you missed a dose by mistake. You should not take a double dose.

Who should not take LEVAQUIN?
You should not take LEVAQUIN if you have ever had a severe allergic reaction to any of the group of antibiotics known as “quinolones” such as ciprofloxacin. Serious and occasionally fatal allergic reactions have been reported in patients receiving therapy with quinolones, including LEVAQUIN.

If you are pregnant or are planning to become pregnant while taking LEVAQUIN, talk to your healthcare professional before taking this medication. LEVAQUIN is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

LEVAQUIN is not recommended for children.

What are possible side effects of LEVAQUIN?
LEVAQUIN is generally well tolerated. The most common side effects caused by LEVAQUIN, which are usually mild, include nausea, diarrhea, itching, abdominal pain, dizziness, flatulence, rash and vaginitis in women.

You should be careful about driving or operating machinery until you are sure LEVAQUIN is not causing dizziness.

Allergic reactions have been reported in patients receiving quinolones including LEVAQUIN, even after just one dose. If you develop hives, skin rash or other symptoms of an allergic reaction, you should stop taking this medication and call your healthcare professional.

Ruptures of shoulder, hand, or Achilles tendons have been reported in patients receiving quinolones, including LEVAQUIN. If you develop pain, swelling, or rupture of a tendon you should stop taking LEVAQUIN and contact your healthcare professional.

Some quinolone antibiotics have been associated with the development of phototoxicity (“sunburns” and “blistering sunburns”) following exposure to sunlight or other sources of ultraviolet light such as artificial ultraviolet light used in tanning salons. LEVAQUIN has been infrequently associated with phototoxicity. You should avoid excessive exposure to sunlight or artificial ultraviolet light while you are taking LEVAQUIN.

If you have diabetes and you develop a hypoglycemic reaction while on LEVAQUIN, you should stop taking LEVAQUIN and call your healthcare professional.
Convulsions have been reported in patients receiving quinolone antibiotics including LEVAQUIN. If you have experienced convulsions in the past, be sure to let your physician know that you have a history of convulsions.

Quinolones, including LEVAQUIN, may also cause central nervous system stimulation which may lead to tremors, restlessness, anxiety, lightheadedness, confusion, hallucinations, paranoia, depression, nightmares, insomnia, and rarely, suicidal thoughts or acts.

If you notice any side effects not mentioned in this leaflet or you have concerns about the side effects you are experiencing, please inform your healthcare professional.

For more complete information regarding levofloxacin, please refer to the full prescribing information, which may be obtained from your healthcare professional, pharmacist, or the Physicians' Desk Reference (PDR).

What about other medicines I am taking?
Taking warfarin (Coumadin) and LEVAQUIN together can further predispose you to the development of bleeding problems. If you take warfarin, be sure to tell your healthcare professional.

Many antacids and multivitamins may interfere with the absorption of LEVAQUIN and may prevent it from working properly. You should take LEVAQUIN either 2 hours before or 2 hours after taking these products.

It is important to let your healthcare professional know all of the medicines you are using.

Other information
Take your dose of LEVAQUIN once a day.

Complete the course of medication even if you are feeling better.

Keep this medication out of the reach of children.

Some quinolones, including levofloxacin, may produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods may be necessary.

This information does not take the place of discussions with your doctor or healthcare professional about your medical condition or your treatment.

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.