SODIUM FERRIC GLUCONATE

Absorption

Peak drug levels (Cmax) varied significantly by dosage and by rate of administration. Highest Cmax value is observed in the regimen in which 125 mg was administered in 7 minutes (19.0 mg/L).

Toxicity

The Ferrlecit iron complex is not dialyzable.
No data is available regarding overdose of Ferrlecit in humans. Excessive dosages of Ferrlecit may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer Ferrlecit to patients with iron overload [see Warnings and Precautions (5.3)].
Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see Adverse Reactions (6.2)].
Ferrlecit at elemental iron doses of 125 mg/kg, 78.8 mg/kg, 62.5 mg/kg, and 250 mg/kg caused deaths in mice, rats, rabbits, and dogs respectively. The major symptoms of acute toxicity were decreased activity, staggering, ataxia, increases in respiratory rate, tremors, and convulsions.

The Uses of SODIUM FERRIC GLUCONATE

Sodium ferric gluconate is hematinic used in the management of iron deficiency in hemodialysis patients for whom oral iron is insufficient.

Indications

Sodium ferric gluconate complex in sucrose injection is used to deplete the total body content of iron during iron deficiency anemia in patients aged 6 years and older with chronic kidney disease receiving hemodialysis and receiving supplemental epoetin therapy.

Background

Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 – 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate. It is used in adult and in pediatric patients over the age of 6 years with chronic kidney disease (CKD) receiving hemodialysis and receiving supplemental epoetin therapy.

Pharmacokinetics

Sodium ferric gluconate complex is an exogenous epoetin that acts to restore the body's content of iron, which is essential for normal hemoglobin synthesis, oxygen transport, and enzymatic processes. The complex increases red blood cell production and increased iron utilization.

Metabolism

Not Available