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Sodium Ferric Gluconate
Pronunciation: SOE-dee-um FER-ik GLOO-koe-nate
Class: Parenteral iron
- Injection, solution 12.5 mg/mL of elemental iron
Provides iron to replenish Hgb and depleted iron stores.
C max is 19 mg/L after a 125 mg dose.
Half-life is 0.85 to 1.45 h. Total Cl is 3.02 to 5.35 L/h.
Indications and Usage
Treatment of iron deficiency anemia in patients with chronic kidney disease receiving hemodialysis who are receiving supplemental erythropoietin.
Hypersensitivity to any component of the product.
Dosage and Administration
Dosage is expressed as mg of elemental iron.Adults and children older than 15 y
IV 125 mg/dose. Most patients require a minimum cumulative dose of 1 g over 8 dialysis sessions.Children and adolescents 6 to 15 y of age
IV 1.5 mg/kg/dose (max, 125 mg/dose).
- May be administered at sequential dialysis sessions by infusion or slow IV injection during the dialysis session. For adults, administer undiluted as a slow IV injection (up to 12.5 mg/min) or diluted in 100 mL of sodium chloride 0.9% and infused over 1 h. For children, dilute in 25 mL of sodium chloride 0.9% and administer over 1 h.
- Do not administer with other medications or add to parenteral nutrition solutions for IV infusion.
- Compatibility with IV infusion vehicles other than sodium chloride 0.9% has not been evaluated.
- Treatment may be repeated if iron deficiency recurs.
Store vials at 59° to 86°F. Protect from freezing. Use immediately after dilution.
Drug InteractionsOral iron preparations
May have reduced absorption.
Hypotension (35%); hypertension (23%); tachycardia (17%); syncope, thrombosis (6%); phlebitis, shock (postmarketing).
Headache (24%); dizziness (13%); asthenia (7%); fatigue, paresthesia (6%); convulsion, loss of consciousness, nervousness (postmarketing).
Pruritus (6%); pallor, skin discoloration (postmarketing).
Pharyngitis (9%); rhinitis (6%); abnormal vision, dysgeusia, hypoesthesia (postmarketing).
Diarrhea, nausea, vomiting (35%); abdominal pain (9%); anorexia (6%); dry mouth (postmarketing).
Abnormal erythrocytes (11%); hemorrhage (postmarketing).
Injection-site reactions (33%).
Hyperkalemia (6%); generalized edema (5%).
Leg cramps (10%); back pain (postmarketing).
Dyspnea (11%); coughing, upper respiratory tract infections (6%).
Cramps (25%); chest pain, pain (10%); infection (8%); fever (5%); allergic reaction, anaphylactic-type reactions, hypertonia (postmarketing).
Periodic monitoring of hematologic and iron parameters is required. Monitor patients for signs and symptoms of hypersensitivity during and after administration for at least 30 min and until clinically stable following completion of the infusion. Monitor patients for signs and symptoms of hypotension during and following infusion.
Category B .
Benzyl alcohol present in maternal serum is likely to cross into human milk, and may be orally absorbed by a breast-feeding infant. Exercise caution when administered to a breast-feeding woman.
Safety and efficacy are not established for children younger than 6 y.
Use with caution, usually starting at the low end of the dosing range, because of the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant diseases or other drug therapy.
Rare cases of serious hypersensitivity reactions have been reported.
This product contains benzyl alcohol and should not be used in premature infants and neonates.
Flushing and hypotension reactions
Associated with too rapid administration. Do not exceed 125 mg/h (2.1 mg/min).
Unwarranted therapy with parenteral iron will cause excess storage of iron and possibly cause iatrogenic hemosiderosis.
Hypotension associated with light-headedness, malaise, fatigue, weakness, or severe chest, back, flank, or groin pain has been reported. This reaction may or may not be associated with hypersensitivity and usually resolves within 1 to 2 h.
Accumulation of iron in iron storage sites, hemosiderosis.
- Explain name, dose, action, and potential adverse reactions of drug.
- Advise patients that medication will be prepared and administered by a health care provider during dialysis sessions and that medication will not be administered at home.
- Instruct patients to immediately inform health care provider if any of the following occur during or shortly after the administration of drug: light-headedness; weakness; anxiety; sweating; rapid heartbeat; shortness of breath or difficulty breathing; swelling of the throat; rash; itching; chest, back, flank, or groin pain.
- Caution patients not to take oral iron supplements while receiving IV iron.
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