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Ofloxacin Oral

(oh floks' a sin)

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IMPORTANT WARNING:   Return to top

[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.

Why is this medication prescribed?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Ofloxacin is an antibiotic used to treat certain infections caused by bacteria, such as pneumonia; bronchitis; venereal disease (VD); and prostate, skin, and urinary tract infections. Antibiotics will not work for colds, flu, or other viral infections.

How should this medicine be used?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Ofloxacin comes as a tablet to take by mouth. It is usually taken with or without food every 12 hours (twice a day) for 3-10 days. Some infections may take up to 6 weeks or longer. To treat VD, a single dose is taken. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ofloxacin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

The tablets should be taken with a full glass of water.

Continue to take ofloxacin even if you feel well. Do not stop taking ofloxacin without talking to your doctor.

Other uses for this medicine   Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before taking ofloxacin,

What special dietary instructions should I follow?   Return to top

Drink at least eight full glasses of water or other liquid every day.

What should I do if I forget a dose?   Return to top

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Ofloxacin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

Ofloxacin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What storage conditions are needed for this medicine?   Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Keep away from light. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose   Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What other information should I know?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your response to ofloxacin.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking ofloxacin.

Do not let anyone else take your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the ofloxacin, call your doctor.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names   Return to top

  • Floxin®

Last Revised - 10/01/2006
Last Reviewed - 08/01/2007


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