Sodium Ferric Gluconate

Trade Names:
Ferrlecit
- Injection 62.5 mg per 5 mL (12.5 mg/mL) of elemental iron

Pharmacology

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Provides iron to replenish hemoglobin and depleted iron stores.

Indications and Usage

Treatment of iron deficiency anemia in patients undergoing chronic hemodialysis and supplemental erythropoietin.

Contraindications

All anemias not associated with iron deficiency; evidence of iron overload; hypersensitivity to any component of the product.

Dosage and Administration

Dosage is expressed as mg of elemental iron.

IV Iron Replacement Dose: 10 mL (iron 125 mg) diluted in 100 mL of sodium chloride 0.9%. Infuse over 1 h. Most patients require a minimum cumulative dose of 1 g over 8 sessions at sequential dialysis treatments.

IV Iron Replacement Dose: 0.12 mL/kg (elemental iron 1.5 mg/kg) diluted in 25 mL 0.9% sodium chloride and given by IV infusion over 1 h at 8 sequential dialysis sessions (max, 125 mg/dose).

Storage/Stability

Store ampules at controlled room temperature (59° to 86°F). Protect from freezing. Use immediately after dilution in saline.

Drug Interactions

May potentiate adverse reactions.

May have reduced absorption.

Incompatibility

Do not mix with other medications or add to parenteral nutrition solutions.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension (29%); hypertension (13%); syncope (6%); tachycardia (5%); angina pectoris; bradycardia; MI; pulmonary edema; vasodilation.

CNS

Dizziness (13%); fatigue, paresthesia (6%); agitation; malaise; nervousness; somnolence (postmarketing).

Dermatologic

Pruritus (6%); increased sweating; rash.

EENT

Abnormal vision; conjunctivitis; ear disorder.

GI

Diarrhea, nausea, vomiting (35%); anorexia; dry mouth; dyspepsia; eructation; flatulence; GI disorder; melena; rectal disorder (postmarketing).

Genitourinary

UTI.

Hematologic

Abnormal erythrocytes (11%); anemia; hemorrhage; leukocytosis; lymphadenopathy; sepsis (postmarketing).

Local

Injection-site reactions (33%).

Metabolic-Nutritional

Hyperkalemia (6%); generalized edema (5%); edema; hypervolemia; hypoglycemia; hypokalemia; leg edema; peripheral edema.

Musculoskeletal

Leg cramps (10%); arthralgia; myalgia.

Miscellaneous

Cramps (25%); chest pain, pain (10%); fever (5%); abscess; arm pain; back pain; chills; flu-like syndrome; hypersensitivity; hypertonia; infection; rigors (postmarketing).

Precautions

Pregnancy

Category B .

Lactation

Undetermined.

Children

Safety and efficacy are not established for children younger than 6 yr of age.

Elderly

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 concomitant diseases or other drug therapy.

Hypersensitivity

Rare cases of serious hypersensitivity reported.

Benzyl alcohol

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).

Hemosiderosis

Unwarranted therapy with parenteral iron will cause excess storage of iron and possibly cause exogenous hemosiderosis, especially in patients with hemoglobinopathies and other refractory anemias.

Hypotension

Hypotension associated with lightheadedness, malaise, fatigue, weakness, or severe chest, back, flank, or groin pain reported. This reaction has not been associated with hypersensitivity and usually resolves within 1 to 2 h.

Overdosage

Symptoms

Accumulation of iron in iron storage sites, abdominal pain, diarrhea, vomiting, pallor, cyanosis, lassitude, drowsiness, hyperventilation (caused by acidosis), CV collapse.

Patient Information

• Explain name, dose, action, and potential adverse reactions of drug.
• Advise patient that medication will be prepared and administered by health care provider during dialysis sessions and that medication will not be administered at home.
• Instruct patient to immediately inform health care provider if any of the following occur during, or shortly after the administration of drug: lightheadedness; weakness; anxiety; sweating; rapid heart beat; shortness of breath or difficulty breathing; swelling of the throat; rash; itching; chest, back, flank, or groin pain.
• Caution patient not to take oral iron supplements while receiving IV iron.

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