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Drug Notebook

FDA Alerts

Special Alerts:

[Posted 03/16/2007] FDA notified healthcare professionals of new emerging safety concerns about linezolid (Zyvox) from a recent clinical study. This open-label, randomized trial compared linezolid to vancomycin, oxacillin, or dicloxacillin in the treatment of seriously ill patients with intravascular catheter-related bloodstream infections including those with catheter-site infections. Patients treated with linezolid had a higher chance of death than did patients treated with any comparator antibiotic, and the chance of death was related to the type of organism causing the infection. Patients with Gram positive infections had no difference in mortality according to their antibiotic treatment. In contrast, mortality was higher in patients treated with linezolid who were infected with Gram negative organisms alone, with both Gram positive and Gram negative organisms, or who had no infection when they entered the study.

Linezolid is not approved for the treatment of catheter-related bloodstream infections, catheter-site infections, or for the treatment of infections caused by Gram negative bacteria. If infection with Gram negative bacteria is known or suspected, appropriate therapy should be started immediately. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Zyvox and http://www.fda.gov/cder/drug/infopage/linezolid/default.htm.

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linezolid
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(li NE zoh lid)

What is this medicine?

LINEZOLID (li NE zoh lid) is an oxazolidinone antibiotic. It is used to treat certain kinds of bacterial infections. It will not work for colds, flu, or other viral infections.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take with food or on an empty stomach. Take your medicine at regular intervals. Do not take your medicine more often than directed. Take all of your medicine as directed even if you think your are better. Do not skip doses or stop your medicine early.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

This medicine may also interact with the following medications:

  • diet pills, stimulants or amphetamine-like drugs
  • medicines for allergies or colds like phenylpropanolamine, pseudoephedrine
  • medicines for blood pressure
  • medicines for depression, anxiety, or psychotic disturbances
  • St. John's wort

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not begin to improve or if you get new symptoms.

You will need to be on a special diet while taking this medicine. Ask your doctor or health care professional for a list of foods that you should try to avoid. This includes, but is not limited to, smoked or processed meats, aged cheeses, soy sauce, red wines and beer.

Do not treat diarrhea with over-the-counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if the diarrhea is severe and watery.

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