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Ferrlecit®

Brand Name: Ferrlecit®
Active Ingredient:   sodium ferric gluconate complex in sucrose injection
Strength(s): 12.5mg/ml
Dosage Form(s):   intravenous injection
Company Name:    R & D Laboratories
Availability:         Prescription only
*Date Approved by FDA:   February 18, 1999
*Approval by FDA does not mean that a new drug will be immediately marketed and available to consumers at this time.




What is Ferrlecit used for?  Ferrlecit is used to treat iron deficiency anemia in patients on chronic hemodialysis who are receiving treatment to stimulate the production of red blood cells.

Who should not be treated with Ferrlecit? You should not be given Ferrlecit if you have an anemia that is not related to iron deficiency, or if you have iron overload.

Special Warnings with Ferrlecit:

  • Immediate allergic reactions to intravenous iron carbohydrate complexes can cause death. Preparation for appropriate resuscitation equipment is recommended.
  • Ferrlecit can cause a severe drop in blood pressure together with flushing, lightheadedness, weakness, fatigue, or severe pain in the chest, back or groin. Do not exceed recommended dosage levels. These reactions usually end within one or two hours.

General Precautions with Ferrlecit: 

  • Iron is not easily eliminated from the body, and its build up can be toxic. Certain medical conditions may make you more likely to develop iron overload. Your doctor will decide if Ferrlecit is right for you.
  • Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.
  • Ferrlecit contains benzyl alcohol and therefore should not be used in newborns.

What are some possible side effects of Ferrlecit? (This is NOT a complete list of side effects reported with Ferrlecit. Your health care provider can discuss with you a more complete list of side effects.)

  • Hypersensitivity reactions (see "Special Warnings")
  • Flushing and blood pressure drop (see "Special Warnings")

Other side effects may include:

  • Injection site reaction
  • Pain
  • Weakness
  • Headache
  • Abdominal pain
  • Fever
  • Feeling tired
  • Dizziness
  • Burning or prickling sensation
  • Shortness of breath
  • Diarrhea
  • Itching
  • Rash

For more detailed information about Ferrlecit, ask your health care provider.

http://www.fda.gov/cder/foi/label/1999/20955lbl.pdf    Link to Ferrlecit's Labeling 

Posted 4/6/99

 

Back to Drug Side Effects


source: FDA


last update: December 2004





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