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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 SUL fate)
Generic Available (U.S.)
Yes
Index Terms
Brand Names: U.S.
Brand Names: Canada
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:
• Pediatrics: See “Special Populations” below.
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. Avoid using doses >325 mg daily of ferrous sulfate, as this may increase potential for constipation, but not significantly increase absorption (Beers Criteria).
• Pediatrics: [U.S. Boxed Warning]: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this product out of the reach of children. In case of accidental overdose call the poison control center immediately.
• 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, epigastric pain, GI irritation, nausea, stomach cramping, vomiting
1% to 10%:
Gastrointestinal: Diarrhea, heartburn
Genitourinary: Discoloration of urine
Miscellaneous: Liquid preparations may temporarily stain the teeth
<1%: Contact irritation
Metabolism/Transport Effects
None known.
Drug Interactions
Antacids: May decrease the absorption of Iron Salts. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Iron Salts may decrease the serum concentration of Bisphosphonate Derivatives. Management: Avoid administration of oral iron supplements within: 2 hours before or after tiludronate/clodronate/etidronate; 60 minutes after oral ibandronate; or 30 minutes after alendronate/risedronate. 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
Deferiprone: Iron Salts may decrease the serum concentration of Deferiprone. Management: Separate administration of deferiprone and oral medications or supplements that contain polyvalent cations by at least 4 hours. 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 serum concentration of Levodopa. Only applies to oral iron preparations. Management: Consider separating doses of the agents by 2 or more hours to minimize the effects of this interaction. Monitor for decreased therapeutic effects of levodopa during concomitant therapy, particularly if doses cannot be separated. 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 serum concentration of Methyldopa. 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. Exceptions: Potassium Phosphate. 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: Iron Salts may decrease the serum concentration of Trientine. Trientine may decrease the serum concentration of Iron Salts. 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 other enzymes; allows the transportation of oxygen via hemoglobin
Pharmacodynamics/Kinetics
Onset of action: Hematologic response: Oral: ~3-10 days
Peak effect: Reticulocytosis: 5-10 days; hemoglobin increases within 2-4 weeks
Absorption: Iron is absorbed in the duodenum and upper jejunum; in persons with normal serum iron stores, 10% of an oral dose is absorbed; this is increased to 20% to 30% in persons with inadequate iron stores. Food and achlorhydria will decrease absorption
Protein binding: To transferrin
Excretion: Urine, sweat, sloughing of the intestinal mucosa, and menses
Dosage
Oral: Note: Multiple concentrations of ferrous sulfate oral liquid exist; close attention must be paid to the concentration when ordering and administering ferrous sulfate; incorrect selection or substitution of one ferrous sulfate liquid for another without proper dosage volume adjustment may result in serious over- or underdosing.
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: Males: 11 mg/day; Females: 15 mg/day; Pregnant females: 27 mg/day; Lactating females: 10 mg/day
19-50 years: Males: 8 mg/day; Females: 18 mg/day; Pregnant females: 27 mg/day; Lactating females: 9 mg/day
≥50 years: 8 mg/day
Children (dose expressed in terms of elemental iron):
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 up to a maximum of 15 mg/day
Adults (dose expressed in terms of ferrous sulfate):
Iron deficiency: 300 mg twice daily up to 300 mg 4 times/day or 250 mg (extended release) 1-2 times/day
Prophylaxis: 300 mg/day
Elderly: Lower doses (15-50 mg elemental iron/day) may have similar efficacy and less GI adverse events (eg, nausea, constipation) as compared to higher doses (eg, 150 mg elemental iron/day) (Rimon, 2005).
Administration: Oral
Should be taken with water or juice on an empty stomach; administer ferrous sulfate 2 hours prior to, or 4 hours after antacids
Monitoring Parameters
Serum iron, total iron binding capacity, reticulocyte count, hemoglobin
Reference Range
Serum iron:
Males: 75-175 mcg/dL (SI: 13.4-31.3 micromole/L)
Females: 65-165 mcg/dL (SI: 11.6-29.5 micromole/L)
Total iron binding capacity: 230-430 mcg/dL
Transferrin: 204-360 mg/dL
Percent transferrin saturation: 20% to 50%
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 iron salts in ferrous sulfate is 20% (ie, 300 mg ferrous sulfate is equivalent to 60 mg ferrous iron)
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. You may experience constipation, nausea, vomiting, abdominal pain, and other GI complaints.
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. This medication is considered to be potentially inappropriate in this patient population (Beers Criteria severity: Low, dosage dependent).
Dental Health: Effects on Dental Treatment
Do not prescribe tetracyclines simultaneously with iron since GI tract absorption of both tetracycline and iron may be inhibited. Liquid preparations may temporarily stain the teeth.
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
GI side effects are common; concomitant use with SSRIs, carbamazepine, valproic acid, and lithium may produce additive effects
Nursing: Physical Assessment/Monitoring
May cause GI irritation. Monitor GI function (observe for epigastric pain, nausea, dark stools, vomiting, stomach cramping, constipation).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Elixir, oral: 220 mg/5 mL (473 mL, 480 mL) [elemental iron 44 mg/5 mL]
Liquid, oral: 300 mg/5 mL (5 mL) [elemental iron ~60 mg/5 mL]
Liquid, oral [drops]: 75 mg/mL (50 mL) [elemental iron 15 mg/mL]; 75 mg/0.6 mL (50 mL [DSC]) [elemental iron 15 mg/0.6 mL]
Fer-In-Sol®: 75 mg/mL (50 mL) [gluten free; contains ethanol 0.2%, sodium bisulfite; elemental iron 15 mg/mL]
Fer-iron: 75 mg/mL (50 mL) [contains ethanol 0.2%, sodium bisulfite; lemon flavor; elemental iron 15 mg/mL]
Suspension, oral [drops]:
MyKidz Iron 10™: 75 mg/1.5 mL (118 mL) [dye free, ethanol free; contains propylene glycol, sodium 12 mg/1.5 mL; strawberry-banana flavor; elemental iron 15 mg/1.5 mL]
Tablet, oral: 324 mg [elemental iron 65 mg], 325 mg [elemental iron 65 mg]
Tablet, oral [exsiccated]:
Feosol®: 200 mg [elemental iron 65 mg]
Tablet, enteric coated, oral: 324 mg [elemental iron 65 mg], 325 mg [elemental iron 65 mg]
Tablet, extended release, oral: 140 mg [elemental iron 45 mg], 160 mg [DSC] [elemental iron 50 mg]
Tablet, slow release, oral: 160 mg [elemental iron 50 mg]
Slow FE®: 142 mg [elemental iron 45 mg]
Slow Release: 140 mg [elemental iron 45 mg]
Pricing: U.S. (www.drugstore.com)
Elixir (Ferrous Sulfate)
220 (44 Fe) mg/5 mL (480): $15.99
Solution (Fer-In-Sol)
75 (15 Fe) mg/mL (50): $18.99
Syrup (Ferrous Sulfate)
300 (60 Fe) mg/5 mL (500): $39.99
Tablet, controlled release (Slow Release Iron)
140 (45 Fe) mg (90): $17.99
Tablets (Ferrous Sulfate)
325 (65 Fe) mg (100): $11.99
325 (65 Fe) mg (1000): $30.04
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.
IOM (Institute of Medicine), Dietary Reference Intakes for Vitamin A, Vitamin K, Arsenic, Boron, Chromium, Copper, Iodine, Iron, Manganese, Molybdenum, Nickel, Silicon, Vanadium, and Zinc, Washington, DC: National Academy Press, 2001.
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.
Rimon E, Kagansky N, Kagansky M, et al, “Are We Giving Too Much Iron? Low-Dose Iron Therapy is Effective in Octogenarians,” Am J Med, 2005, 118(10):1142-7.
“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 March 2012
Content last modified March 2012
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