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Sodium Ferric Gluconate Complex
Overview
What is Sodium Ferric Gluconate Complex?
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 [NaFeO(CHO)(CH0)5]
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.
What does Sodium Ferric Gluconate Complex look like?
What are the available doses of Sodium Ferric Gluconate Complex?
Sodium ferric gluconate complex in sucrose injection is supplied in a single use vial containing 62.5 mg of elemental iron in 5 mL. ()
What should I talk to my health care provider before I take Sodium Ferric Gluconate Complex?
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How should I use Sodium Ferric Gluconate Complex?
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.
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.
What interacts with Sodium Ferric Gluconate Complex?
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What are the warnings of Sodium Ferric Gluconate Complex?
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What are the precautions of Sodium Ferric Gluconate Complex?
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What are the side effects of Sodium Ferric Gluconate Complex?
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What should I look out for while using Sodium Ferric Gluconate Complex?
Known hypersensitivity to sodium ferric gluconate or any of its inactive components. ()
What might happen if I take too much Sodium Ferric Gluconate Complex?
The sodium ferric gluconate complex in sucrose injection iron complex is not dialyzable.
No data is available regarding overdose of sodium ferric gluconate complex in sucrose injection in humans. Excessive dosages of sodium ferric gluconate complex in sucrose injection may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Do not administer sodium ferric gluconate complex in sucrose injection to patients with iron overload [see
].
Individual doses exceeding 125 mg may be associated with a higher incidence and/or severity of adverse events [see
].
Sodium ferric gluconate complex in sucrose injection 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 the respiratory rate, tremor, and convulsions.
How should I store and handle Sodium Ferric Gluconate Complex?
Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.Keep vial in the outer carton in order to protect from light.DO NOT FREEZE. DO NOT SHAKE.Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.Keep vial in the outer carton in order to protect from light.DO NOT FREEZE. DO NOT SHAKE.Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) until time of use.Keep vial in the outer carton in order to protect from light.DO NOT FREEZE. DO NOT SHAKE.How Supplied NDC 0591-0149-87 Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials. Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.How Supplied NDC 0591-0149-87 Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials. Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.How Supplied NDC 0591-0149-87 Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials. Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.How Supplied NDC 0591-0149-87 Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials. Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.How Supplied NDC 0591-0149-87 Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials. Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.How Supplied NDC 0591-0149-87 Sodium ferric gluconate complex in sucrose injection is supplied in colorless glass vials. Each sterile, single-use vial contains 62.5 mg of elemental iron in 5 mL for intravenous use, packaged in cartons of 10 vials. Storage Store at 20 - 25°C (68 - 77°F); excursions permitted to 15 - 30°C (59 - 86°F). See USP Controlled Room Temperature. Do not freeze. Keep out of the reach of children.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Sodium ferric gluconate complex in sucrose injection is used to replete the body content of iron. Iron is critical for normal hemoglobin synthesis to maintain oxygen transport. Additionally, iron is necessary for metabolism and various enzymatic processes.
Non-Clinical Toxicology
Known hypersensitivity to sodium ferric gluconate or any of its inactive components. ()Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors
Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported in patients receiving sodium ferric gluconate complex in sucrose injection in post marketing experience. Patients may present with shock, clinically significant hypotension,
loss of consciousness, or collapse. Monitor patients for signs and symptoms of hypersensitivity during and after sodium ferric gluconate complex in sucrose injection administration for at least 30 minutes and until clinically stable following completion of the infusion. Only administer sodium ferric gluconate complex in sucrose injection when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions [see
].
In the single-dose, post-marketing, safety study one patient experienced a life-threatening hypersensitivity reaction (diaphoresis, nausea, vomiting, severe lower back pain, dyspnea, and wheezing for 20 minutes) following sodium ferric gluconate complex in sucrose injection administration. Among 1,097 patients who received sodium ferric gluconate complex in sucrose injection in this study, there were 9 patients (0.8%) who had an adverse reaction that, in the view of the investigator, precluded further sodium ferric gluconate complex in sucrose injection administration. These included one life-threatening reaction, six allergic reactions (pruritus x2, facial flushing, chills, dyspnea/chest pain, and rash), and two other reactions (hypotension and nausea). Another 2 patients experienced (0.2%) allergic reactions not deemed to represent drug intolerance (nausea/malaise and nausea/dizziness) following sodium ferric gluconate complex in sucrose injection administration.
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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