Drug Notebook

FDA Alerts

Special Alerts:

[Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.

Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fluoroquinolone, http://www.fda.gov/cder/drug/infopage/fluoroquinolones/default.htm, http://www.fda.gov/cder/drug/InfoSheets/HCP/fluoroquinolonesHCP.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01858.html.

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norfloxacin
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(nor FLOX a sin)

What is the most important information I should know about norfloxacin?

Do not use this medication if you are allergic to norfloxacin, or if you have problems with your tendons, or a history of tendon rupture while taking a medicine similar to norfloxacin, such as Avelox, Cipro, Floxin, Levaquin, Maxaquin, Tequin, Trovan, or Zagam. Take this medication for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Norfloxacin can make your skin more sensitive to sunlight and sunburn may result.

There are many other medicines that can interact with norfloxacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

It is important to drink several glasses of water each day while you are taking norfloxacin to protect your kidneys. Do not give this medication to anyone younger than 18 years old. Norfloxacin may interfere with bone development in growing children.

What is norfloxacin?

Norfloxacin is an antibiotic in a group of drugs called fluoroquinolones (flor-oh-KWIN-oh-lones). It fights bacteria in the body.

Norfloxacin is used to treat bacterial infections such as urinary tract infections, gonorrhea, and prostate infections.

Norfloxacin may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before taking norfloxacin?

Do not use this medication if you are allergic to norfloxacin, or if you have:

Before taking norfloxacin, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may not be able to use norfloxacin, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether norfloxacin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to anyone younger than 18 years old. Norfloxacin may interfere with bone development in growing children.

If you are being treated for gonorrhea, your doctor may want to test you to make sure you do not have another sexually transmitted disease called syphilis.

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