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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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ciprofloxacin
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(sip roe FLOX a sin)

What is this medicine?

CIPROFLOXACIN is a quinolone 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:

  • child with joint problems
  • heart condition
  • kidney disease
  • liver disease
  • seizures disorder
  • an unusual or allergic reaction to ciprofloxacin, other antibiotics or medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. 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. You can take this medicine with food or on an empty stomach. It can be taken with a meal that contains dairy or calcium, but do not take it alone with a dairy product, like milk or yogurt or calcium-fortified juice. A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time. Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. 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: 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 improve. Do not treat diarrhea with over the counter products. Contact your doctor if you have diarrhea that lasts more than 2 days or if it is severe and watery. You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. This medicine can make you more sensitive to the sun. Keep out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths. Avoid antacids, aluminum, calcium, iron, magnesium, and zinc products for 6 hours before and 2 hours after taking a dose of this medicine.

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