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ALERT: U.S. Boxed Warning
The FDA-approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling or www.fda.gov.
Pronunciation
(FER us GLOO koe nate)
U.S. Brand Names
Index Terms
Generic Available
Yes
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Prevention and treatment of iron-deficiency anemias
Pregnancy Considerations
It is recommended that pregnant women meet the dietary requirements of iron with diet and/or supplements in order to prevent adverse events associated with iron deficiency anemia in pregnancy. Treatment of iron deficiency anemia in pregnant women is the same as in nonpregnant women and in most cases, oral iron preparations may be used. Except in severe cases of maternal anemia, the fetus achieves normal iron stores regardless of maternal concentrations.
Lactation
Enters breast milk
Breast-Feeding Considerations
Iron is normally found in breast milk. Breast milk or iron fortified formulas generally provide enough iron to meet the recommended dietary requirements of infants. The amount of iron in breast milk is generally not influenced by maternal iron status.
Contraindications
Hypersensitivity to iron salts or any component of the formulation; hemochromatosis, hemolytic anemia
Warnings/Precautions
Boxed warnings:
• Iron toxicity: See “Concerns related to adverse effects” below.
Concerns related to adverse effects:
• Iron toxicity: [U.S. Boxed Warning]: Severe iron toxicity may occur in overdose, particularly when ingested by children; iron is a leading cause of fatal poisoning in children; store out of children's reach and in child-resistant containers.
Disease-related concerns:
• Gastrointestinal disease: Avoid in patients with peptic ulcer, enteritis, or ulcerative colitis.
Special populations:
• Blood transfusion recipients: Avoid in patients receiving frequent blood transfusions.
• Elderly: Anemia in the elderly is often caused by “anemia of chronic disease” or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the “anemia of chronic disease” is not secondary to iron deficiency but the inability of the reticuloendothelial system to reclaim available iron stores.
• Premature infants: Avoid use in premature infants until the vitamin E stores, deficient at birth, are replenished.
Other warnings/precautions:
• Duration of therapy: Administration of iron for >6 months should be avoided except in patients with continuous bleeding or menorrhagia.
Adverse Reactions
>10%: Gastrointestinal: Constipation, dark stools, nausea, stomach cramping, vomiting
1% to 10%:
Gastrointestinal: Diarrhea, heartburn, staining of teeth
Genitourinary: Discoloration of urine
<1%: Contact irritation
Drug Interactions
Antacids: May decrease the absorption of Iron Salts. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Iron Salts may decrease the absorption of Bisphosphonate Derivatives. Only oral iron salts are of concern. Exceptions: Pamidronate; Zoledronic Acid. Risk D: Consider therapy modification
Cefdinir: Iron Salts may decrease the serum concentration of Cefdinir. Red-appearing, non-bloody stools may also develop due to the formation of an insoluble iron-cefdinir complex. Management: Avoid concurrent cefdinir and oral iron when possible. Separating doses by several hours may minimize interaction. Iron-containing infant formulas do not appear to interact with cefdinir. Risk D: Consider therapy modification
Dimercaprol: May enhance the nephrotoxic effect of Iron Salts. Risk X: Avoid combination
Eltrombopag: Iron Salts may decrease the serum concentration of Eltrombopag. Management: Separate administration of eltrombopag and any orally administered polyvalent cation (e.g., iron-containing products) by at least 4 hours. Risk D: Consider therapy modification
H2-Antagonists: May decrease the absorption of Iron Salts. Risk C: Monitor therapy
Levodopa: Iron Salts may decrease the absorption of Levodopa. Only applies to oral iron preparations. Risk D: Consider therapy modification
Levothyroxine: Iron Salts may decrease the serum concentration of Levothyroxine. Management: Separate oral administration of iron salts and levothyroxine by at least 4 hours. Separation of doses is not required with parenterally administered iron salts or levothyroxine. Risk D: Consider therapy modification
Methyldopa: Iron Salts may decrease the absorption of Methyldopa. Only oral iron salts are of concern. Risk D: Consider therapy modification
Pancrelipase: May decrease the absorption of Iron Salts. Risk C: Monitor therapy
Penicillamine: Iron Salts may decrease the absorption of Penicillamine. Only oral iron salts are a concern. Risk D: Consider therapy modification
Phosphate Supplements: Iron Salts may decrease the absorption of Phosphate Supplements. Management: Administer oral phosphate supplements at least 1 hour before, or 2 hours after, oral iron salt administration. Risk D: Consider therapy modification
Proton Pump Inhibitors: May decrease the absorption of Iron Salts. Risk C: Monitor therapy
Quinolone Antibiotics: Iron Salts may decrease the absorption of Quinolone Antibiotics. Of concern only with oral administration of both agents. Risk D: Consider therapy modification
Tetracycline Derivatives: Iron Salts may decrease the absorption of Tetracycline Derivatives. Only a concern with orally administered products. Risk D: Consider therapy modification
Trientine: May decrease the serum concentration of Iron Salts. Iron Salts may decrease the serum concentration of Trientine. Management: Trientine manufacturer recommends avoiding concurrent administration with oral iron salts due to the risk for impaired GI absorption of both trientine and the iron salt. Short courses of iron may be used however separate administration by at least 2 hours Risk D: Consider therapy modification
Ethanol/Nutrition/Herb Interactions
Food: Cereals, dietary fiber, tea, coffee, eggs, and milk may decrease absorption.
Storage
Iron is a leading cause of fatal poisoning in children. Store out of children's reach and in child-resistant containers.
Mechanism of Action
Replaces iron found in hemoglobin, myoglobin, and enzymes; allows the transportation of oxygen via hemoglobin
Pharmacodynamics/Kinetics
Onset of action: Hematologic response: Oral: 3-10 days; peak reticulocytosis occurs in 5-10 days, and hemoglobin values increase in ?2-4 weeks
Dosage
Oral:
Dietary Reference Intake: Dose is RDA presented as elemental iron unless otherwise noted:
0-6 months: 0.27 mg/day (adequate intake)
7-12 months: 11 mg/day
1-3 years: 7 mg/day
4-8 years: 10 mg/day
9-13 years: 8 mg/day
14-18 years: Male: 11 mg/day; Female: 15 mg/day; Pregnant female: 27 mg/day; Lactating female: 10 mg/day
19-50 years: Male: 8 mg/day; Female: 18 mg/day; Pregnant female: 27 mg/day; Lactating female: 9 mg/day
?50 years: 8 mg/day
Dose expressed in terms of elemental iron:
Children:
Severe iron-deficiency anemia: 4-6 mg Fe/kg/day in 3 divided doses
Mild to moderate iron deficiency anemia: 3 mg Fe/kg/day in 1-2 divided doses
Prophylaxis: 1-2 mg Fe/kg/day
Adults:
Iron deficiency: 60 mg twice daily up to 60 mg 4 times/day
Prophylaxis: 60 mg/day
Administration: Oral
Administer 2 hours before or 4 hours after antacids. Administration of iron preparations to premature infants with vitamin E deficiency may cause increased red cell hemolysis and hemolytic anemia, therefore, vitamin E deficiency should be corrected if possible.
Monitoring Parameters
Serum iron, total iron binding capacity, reticulocyte count, hemoglobin
Reference Range
Therapeutic: Male: 75-175 mcg/dL (SI: 13.4-31.3 ?mol/L); Female: 65-165 mcg/dL (SI: 11.6-29.5 ?mol/L); serum iron level >300 mcg/dL usually requires treatment of overdose due to severe toxicity
Test Interactions
False-positive for blood in stool by the guaiac test
Dietary Considerations
Should be taken with water or juice on an empty stomach; may be administered with food to prevent irritation; however, not with cereals, dietary fiber, tea, coffee, eggs, or milk.
Elemental iron content of ferrous gluconate: 12%
Dietary sources of iron include beans, cereal (enriched), clams, beef, lentils, liver, oysters, shrimp, and turkey. Foods that enhance dietary absorption of iron include broccoli, grapefruit, orange juice, peppers and strawberries. Foods that decrease dietary absorption of iron include coffee, dairy products, soy products, spinach, and tea.
Patient Education
May color stool black. Take between meals for maximum absorption; take with food if GI upset occurs. Do not take with milk or antacids. Keep out of reach of children.
Geriatric Considerations
Anemia in the elderly is often caused by “anemia of chronic disease”, a result of aging changes in the bone marrow, or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the anemia is not secondary to iron deficiency but the inability of the reticuloendothelial system to use available iron stores. Timed release iron preparations should be avoided due to their erratic absorption. Products combined with a laxative or stool softener should not be used unless the need for the combination is demonstrated.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Staining of teeth. Do not prescribe tetracyclines simultaneously with iron since GI tract absorption of both tetracycline and iron may be inhibited.
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
None reported
Mental Health: Effects on Psychiatric Treatment
Constipation is common; concurrent use with psychotropic agents may increase the risk
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet: 246 mg [elemental iron 28 mg] [DSC]; 300 mg [elemental iron 34 mg] [DSC]; 325 mg [elemental iron 36 mg]
Fergon®: 240 mg [elemental iron 27 mg]
References
American College of Obstetricians and Gynecologists, “ACOG Practice Bulletin No. 95: Anemia in Pregnancy,” Obstet Gynecol, 2008, 112(1):201-7.
Baker WF Jr, “Iron Deficiency in Pregnancy, Obstetrics, and Gynecology,” Hematol Oncol Clin North Am, 2000, 14(5):1061-77.
“Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc.” Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine, National Academy of Sciences, Washington, DC: National Academy Press, 2000. Available at http://www.nap.edu.
Lipschitz DA, “The Anemia of Chronic Disease,” J Am Geriatr Soc, 1990, 38(11):1258-64.
Marx JJM, “Normal Iron Absorption and Decreased Red Cell Iron Uptake in the Aged,” Blood, 1979, 53:204-11.
“Nutrition During Lactation.” Subcommittee on Nutrition During Lactation, Committee on Nutritional Status During Pregnancy and Lactation, Food and Nutrition Board Institute of Medicine, National Academy of Sciences Washington, DC: National Academy Press, 1991. Available at http://www.nap.edu.
“Recommendations to Prevent and Control Iron Deficiency in the United States. Centers for Disease Control and Prevention,” MMWR Recomm Rep, 1998, 47(RR-3):1-29.
“Routine Iron Supplementation During Pregnancy. Review Article. US Preventive Services Task Force,” JAMA, 1993, 270(23):2848-54.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2009
Content last modified August 2009
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