"The US Food and Drug Administration (FDA) is ordering stricter warnings and contraindications for the anemia drug ferumoxytol (Ferumoxytol, AMAG Pharmaceuticals), stating that even with current warnings, there have been 79 anaphylactic r"...
(sodium ferric gluconate complex in sucrose) Injection
Ferrlecit® (sodium ferric gluconate complex in sucrose injection), an iron replacement product, is a stable macromolecular complex with an apparent molecular weight on gel chromatography of 289,000 – 440,000 daltons. The macromolecular complex is negatively charged at alkaline pH and is present in solution with sodium cations. The product has a deep red color indicative of ferric oxide linkages. The chemical name is D-Gluconic acid, iron (3+) sodium salt.
The structural formula is considered to be [NaFe2O3(C6H11O7)(C12H22O11)5]n≈200•
Each sterile, single-use ampule or vial of 5 mL of Ferrlecit for intravenous injection contains 62.5 mg (12.5 mg/mL) of elemental iron as the sodium salt of a ferric ion carbohydrate complex in an alkaline aqueous solution with approximately 20% sucrose w/v (195 mg/mL) in water for injection, pH 7.7 - 9.7.
Each mL contains 9 mg of benzyl alcohol as an inactive ingredient.
What are the possible side effects of sodium ferric gluconate complex (Ferrlecit, Nulecit)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives, sweating, vomiting; severe lower back pain; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- feeling like you might pass out;
- chest pain, trouble breathing;
- flushing (warmth, redness, or tingly feeling);
- fast or uneven heart rate; or
- dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears,...
Last reviewed on RxList: 8/31/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Ferrlecit Information
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