Sodium Ferric Gluconate Complex

Sodium Ferric Gluconate Complex Uses, Dosage, Side Effects, Food Interaction and all others data.

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.

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.

Sodium Ferric Gluconate Complex
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Sodium Ferric Gluconate Complex
Generic	Sodium ferric gluconate complex
Sodium ferric gluconate complex Other Names	Ferric sodium gluconate complex, Sodium ferric gluconate complex
Weight	12.5mg/ml,
Type	Intravenous Solution, Intravenous
Formula	C₆₆H₁₂₁Fe₂NaO₆₅
Weight	Average: 2089.309 Monoisotopic: 2088.47592
Protein binding	It is bind to transferrin, ferritin and hemoglobin.
Groups	Approved
Therapeutic Class
Manufacturer
Available Country	United States
Last Updated:	September 19, 2023 at 7:00 am

Uses

Sodium Ferric Gluconate Complex is an iron complex used 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.

Used to replete the total body content of iron during iron deficiency anemia in patients age 6 years and older with chronic kidney disease receiving hemodialysis and receiving supplemental epoetin therapy.

Sodium Ferric Gluconate Complex is also used to associated treatment for these conditions: Anemia, Iron Deficiency Anemia (IDA)

How Sodium Ferric Gluconate Complex works

The complex is endocytosed by macrophages of the reticuloendothelial system. Within an endosome of the macrophage , lysosome fuses with the endosome creating an acidic environment leading to the cleavage of the complex from iron. Iron is then incorporated in ferritin, transferrin or hemoglobin. Sodium ferric gluconate also normalizes RBC production by binding with hemoglobin

Toxicity

Overdosage of iron causes cardiovascular toxicity and hepatic necrosis. The lowest lethal dose (LDLo) following intravenous administration is 78.8mg/kg in rats and 250mg/kg in dogs. Adverse effects from sodium ferric gluconate therapy include hypersensitivity reactions, nausea, vomiting, diarrhea, pain, peripheral swelling and hypotension. Dosages in excess of iron needs may lead to accumulation of iron in iron storage sites and hemosiderosis.

Food Interaction

No interactions found.

Volume of Distribution

The initial volume of distribution is 6L which correlates well with the calculated blood volume.

Elimination Route

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).

Half Life

The terminal elimination half-life for drug bound iron was approximately 1 hour, with the value varying by dose but not by rate of administration. In adults, the shortest terminal elimination half-life of 0.825h occurs with the 62.5 mg/4 min dosing regimen and the longest value of 1.45h is achieved with 125 mg/7 min regimen. In pediatric patients, the half-life was 2 hours following administration of 1.5 mg/kg dose and 2.5 hours following administration of 3.0mg/kg dose.