Sodium Ferric Gluconate Complex

Sodium Ferric Gluconate Complex

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Questions & Answers

Side Effects & Adverse Reactions

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Sodium ferric gluconate complex in sucrose injection is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy.

History

There is currently no drug history available for this drug.

Other Information

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)(C12H22011)5]n≈200• 

Each sterile, single-use vial of 5 mL of sodium ferric gluconate complex in sucrose injection 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.

Sodium Ferric Gluconate Complex Manufacturers


  • Watson Laboratories, Inc.
    Sodium Ferric Gluconate Complex Injection [Watson Laboratories, Inc.]

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