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.
Before taking ofloxacin, tell your doctor if you have kidney or liver disease, joint problems, myasthenia gravis, seizures or epilepsy, diabetes, low levels of potassium in your blood (hypokalemia), or a personal or family history of "Long QT syndrome."
Take ofloxacin with a full glass of water (8 ounces). Drink several extra glasses of fluid each day to prevent crystals from forming in the urine. Call your doctor at once if you have a serious side effect such as watery diarrhea, seizure, unusual thoughts or behavior, fast or pounding heartbeats, fainting, sudden pain or swelling near your joints, urinating less than usual, dark colored urine, jaundice (yellowing of the skin or eyes), or a severe blistering, peeling, and red skin rash. Avoid taking antacids, vitamin or mineral supplements, sucralfate (Carafate), or didanosine (Videx) powder or chewable tablets within 2 hours before or after you take ofloxacin. These other medicines can make ofloxacin much less effective when taken at the same time. Ofloxacin may cause swelling or tearing of a tendon (the fiber that connects bones to muscles in the body), especially in the Achilles' tendon of the heel. These effects may be more likely to occur if you are over 60, if you take an oral steroid medication, or if you have had a kidney, heart, or lung transplant. Stop taking ofloxacin and call your doctor at once if you have sudden pain, swelling, tenderness, stiffness, or movement problems in any of your joints. Rest the joint until you receive medical care or instructions. Do not share this medication with another person (especially a child), even if they have the same symptoms you have.Ofloxacin is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Ofloxacin fights bacteria in the body.
Ofloxacin is used to treat bacterial infections that cause bronchitis, pneumonia, chlamydia, gonorrhea, skin infections, urinary tract infections, and infections of the prostate.
Ofloxacin may also be used for other purposes not listed in this medication guide.
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