Sodium Ferric Gluconate Complex
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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
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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.
Sources
Sodium Ferric Gluconate Complex Manufacturers
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Watson Laboratories, Inc.
![Sodium Ferric Gluconate Complex Injection [Watson Laboratories, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Sodium Ferric Gluconate Complex | Watson Laboratories, Inc.
The dosage of sodium ferric gluconate complex in sucrose injection is expressed in terms of mg of elemental iron. Each 5 mL sterile, single-use vial contains 62.5 mg of elemental iron (12.5 mg/mL).
Do not mix sodium ferric gluconate complex in sucrose injection with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility of sodium ferric gluconate complex in sucrose injection with intravenous infusion vehicles other than 0.9% sodium chloride has not been evaluated. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. If diluted, use immediately.
Sodium ferric gluconate complex in sucrose injection treatment may be repeated if iron deficiency reoccurs.
2.1 Adult Dosage and AdministrationThe recommended dosage of sodium ferric gluconate complex in sucrose injection for the repletion treatment of iron deficiency in hemodialysis patients is 10 mL of sodium ferric gluconate complex in sucrose injection (125 mg of elemental iron). Sodium ferric gluconate complex in sucrose injection may be diluted in 100 mL of 0.9% sodium chloride administered by intravenous infusion over 1 hour per dialysis session. Sodium ferric gluconate complex in sucrose injection may also be administered undiluted as a slow intravenous injection (at a rate of up to 12.5 mg/min) per dialysis session. For repletion treatment most patients may require a cumulative dose of 1000 mg of elemental iron administered over 8 dialysis sessions. Sodium ferric gluconate complex in sucrose injection has been administered at sequential dialysis sessions by infusion or by slow intravenous injection during the dialysis session itself.
Data from sodium ferric gluconate complex in sucrose injection postmarketing spontaneous reports indicate that individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see Adverse Reactions (6.2)].
2.2 Pediatric Dosage and AdministrationThe recommended pediatric dosage of sodium ferric gluconate complex in sucrose injection for the repletion treatment of iron deficiency in hemodialysis patients is 0.12 mL/kg sodium ferric gluconate complex in sucrose injection (1.5 mg/kg of elemental iron) diluted in 25 mL 0.9% sodium chloride and administered by intravenous infusion over 1 hour per dialysis session. The maximum dosage should not exceed 125 mg per dose.
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