Iron Preparations, Oral (Monograph)
Brand names: Feosol, Feostat, Feratab, Fer-Gen-Sol, Fergon,
... show all 17 brands
Drug class: Iron Preparations
CAS number: 1332-96-3
Introduction
Ferrous fumarate, ferrous gluconate, ferrous sulfate, carbonyl iron, and polysaccharide-iron complex are used orally in the prevention and treatment of iron deficiency.a
Uses for Iron Preparations, Oral
Prevention and Treatment of Iron Deficiency
Prevention and treatment of iron deficiency.a Not indicated for treatment of anemia resulting from causes other than iron deficiency.a
Iron Preparations, Oral Dosage and Administration
Administration
Oral Administration
Administer orally between meals (e.g., 1 hour before or 2 hours after a meal).201 202 203
For patients who have difficulty tolerating oral iron supplements, administer smaller, more frequent doses; start with a lower dose and increase slowly to the target dose; try a different form or preparation; or take with or after mealsa or at bedtime.149
Dosage
Dosage expressed in terms of elemental iron. (See Table 1.)
Do not exceed recommended dosage.b
Carbonyl iron is elemental iron, not an iron salt.
Drug |
Elemental Iron |
---|---|
Ferric pyrophosphate |
120 mg/g |
Ferrous gluconate |
120 mg/g |
Ferrous sulfate |
200 mg/g |
Ferrous sulfate, dried |
300 mg/g |
Ferrous fumarate |
330 mg/g |
Ferrous carbonate, anhydrous |
480 mg/g |
Carbonyl iron |
1000 mg/g |
Pediatric Patients
Iron Deficiency Anemia
Prevention
OralPremature or low-birthweight infants: 2–4 mg/kg daily starting preferably at 1 month, but at least by 2 months, of age.a Do not exceed 15 mg daily.a
Normal full-term infants who are not breast-fed or are only partially breast-fed: 1 mg/kg daily, preferably as iron-fortified formula, starting at birth and continuing during the first year of life.109 133 Do not exceed 15 mg daily.a
Children ≥10 years of age who have begun their pubertal growth spurt may require daily iron supplementation of 2 or 5 mg daily in males or females, respectively.a
Based on the need to maintain a normal functional iron concentration but only minimal stores,188 RDA is the goal for dietary intake in individuals.c
Established for infants through 6 months of age based on the observed mean iron intake of infants fed principally human milk.188
Age |
RDA (mg/day) |
AI (mg/day) |
---|---|---|
Infants 0–6 months of age |
0.27 |
|
Infants 7–12 months of age |
11 |
|
Children 1–3 years of age |
7 |
|
Children 4–8 years of age |
10 |
|
Children 9–13 years of age |
8 |
|
Children 14–18 years of age |
Boys: 11 Girls: 15 |
Treatment
OralChildren: 3–6 mg/kg daily in 3 divided doses.a
If a satisfactory response is not noted after 3 weeks of oral iron therapy, consideration should be given to the possibilities of patient noncompliance, simultaneous blood loss, additional complicating factors, or incorrect diagnosis.a
Adults
Iron Deficiency Anemia
Prevention
OralRDA for healthy men of all ages (≥19 years of age) is 8 mg daily.188
RDA for healthy women 19–50 years of age is 18 mg daily, and RDA for healthy women ≥51 years of age is 8 mg daily.188
Treatment
OralUsual therapeutic dosage: 50–100 mg 3 times daily.a Smaller dosages (e.g., 60–120 mg daily) also recommended if patients are intolerant of oral iron, but the possibility that iron stores will be replenished at a slower rate should be considered.a
If a satisfactory response is not noted after 3 weeks of oral iron therapy, consider possibility of patient noncompliance, simultaneous blood loss, additional complicating factors, or incorrect diagnosis.a
Normal hemoglobin values usually obtained in 2 months unless blood loss continues.a In severe deficiencies, continue iron therapy for approximately 6 months.a
Special Populations
Renal Impairment
Iron Deficiency Anemia
Anemia of Chronic Renal Failure in Hemodialysis Patients Receiving Epoetin Alfa
OralChildren: 2–3 mg/kg daily in 2 or 3 divided doses.149
Adults: ≥200 mg daily in 2 or 3 divided doses.149
Pregnant Women
RDA for pregnant women 14–50 years of age is 27 mg daily.188
Lactating Women
RDA for lactating women 14–18 or 19–50 years of age is 10 or 9 mg daily, respectively.188
Cautions for Iron Preparations, Oral
Contraindications
Warnings/Precautions
Warnings
Children <12 years of age and pregnant or nursing women should consult a health professional before using iron-containing preparations.b
Accidental Overdose
Possible fatal poisoning in children <6 years of age;108 148 b keep iron-containing preparations out of reach of children.148 b
If accidental overdosage occurs, immediately contact a clinician or a poison control center.148 b
Sensitivity Reactions
Allergic Reactions
Possible allergic reactions (e.g., bronchial asthma) with Fergon 225-mg tablets, which contain the dye tartrazine (FD&C yellow No. 5).a Use with caution, particularly in patients sensitive to aspirin.a
Major Toxicities
Excess Iron Stores
Excess storage of iron with secondary hemochromatosis possible; not recommended for treatment of hemolytic anemias (unless an iron-deficient state also exists) or for patients receiving repeated blood transfusions.a
Do not administer for >6 months except in patients with continued bleeding, menorrhagia, or repeated pregnancies.a
General Precautions
Infectious Complications
Possible increased pathogenicity of certain microorganisms,134 138 139 140 including possible adverse effects on prognosis in HIV-infected individuals;138 139 not recommended for use in individuals without documented iron deficiency.138 139
Use of Fixed Combination
When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.
Specific Populations
Lactation
Distributed into milk.a
Common Adverse Effects
Constipation, diarrhea, dark stools, nausea, epigastric pain.a
Drug Interactions
Specific Drugs, Foods, and Laboratory Tests
Drug, Food, or Test |
Interaction |
Comment |
---|---|---|
Antacids or aluminum-containing phosphate binders |
May decrease iron absorptiona |
Administer these drugs as far apart as possiblea |
Calcium supplements |
Pharmacokinetic (decrease iron absorption) interactiona |
Administer at least 2 hours aparta |
Chloramphenicol |
Possible delayed response to iron therapya |
Avoid concomitant use a |
Food |
Iron absorption may be inhibited by polyphenols (e.g., from certain vegetables), tannins (e.g., from tea), phytates (e.g., from bran), and calcium (e.g., from dairy products)109 111 113 133 |
|
H2-receptor antagonists |
Increased gastric pH and possibly decreased GI absorption of oral iron preparations that depend on gastric acidity for dissolution and absorption192 193 194 195 196 197 198 |
Administer oral iron at least 1 hour prior to H2-receptor antagonists195 |
Iron, parenteral |
Iron toxicitya |
Concomitant use not recommendeda |
Methyldopa |
Pharmacokinetic (decreased oral absorption of methyldopa) and pharmacologic (decreased hypotensive effect) interactions106 |
Monitor BPa |
Penicillamine |
May decrease the cupruretic effect of penicillamine, probably by decreasing its absorptiona |
Administer at least 2 hours aparta |
Quinolone anti-infectives |
Pharmacokinetic interaction (iron may interfere with quinolone absorption)a |
Administer at least 2 hours aparta |
Tests for detection of occult blood in stools |
Possible false-positive results with guaiac testa |
Use a benzidine test insteada |
Tetracyclines |
Pharmacokinetic interaction (decreased oral absorption of both iron and tetracyclines)a |
Administer tetracycline 3 hours after or 2 hours before oral irona |
Thyroid agents |
Possible pharmacokinetic interaction (decreased thyroxine absorption)107 |
Administer at least 2 hours apart and monitor thyroid function107 |
Vitamin C |
Increased absorption of iron from GI tract (with >200 mg Vitamin C per 30 mg elemental iron)a |
Concomitant use may be of benefit, particularly in infantsa |
Iron Preparations, Oral Pharmacokinetics
Absorption
Bioavailability
Absorption dependent upon the form of iron administered (e.g., ferrous form more readily absorbed), the dose, degree of erythropoiesis, diet, and iron stores.a GI absorption of iron increases in iron-deficient individuals.109
Oral bioavailability of iron can vary from <1% to >50%,109 110 and the principal factor controlling GI iron absorption is the amount of iron stored in the body.109 111
Onset
Symptoms of anemia usually improve within a few days; normal hemoglobin values usually attained in 2 months unless blood loss continues.a
Food
Food decreases absorption of inorganic iron.a (See Food under Interactions.)
Distribution
Extent
Exists in humans almost exclusively complexed to protein or in heme molecules.a
Crosses the placenta and distributes into milk.a
Elimination
Metabolism
Occurs in a virtually closed system.a
Elimination Route
Most iron liberated by destruction of hemoglobin is conserved and reused by the body.a Blood loss greatly increases iron loss.a
Stability
Storage
Oral
Capsules, Solutions, Suspensions, Tablets
Room temperature (15–30°C).a Protect from excessive heat and moisture.a
Actions
-
Corrects erythropoietic abnormalities caused by a deficiency of iron.a
-
Does not stimulate erythropoiesis, nor does it correct hemoglobin disturbances not caused by iron deficiency.a
-
Risk of fatal poisoning in children <6 years of age;108 148 importance of keeping iron-containing products out of reach of children.148
-
Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.a
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.a
-
Importance of informing patients of other important precautionary information.a (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Suspension |
15 mg (of iron) per 1.25 mL |
Icar Pediatric |
Hawthorn |
Tablets |
45 mg (of iron) |
Feosol Caplets |
GlaxoSmithKline |
|
Tablets, chewable |
15 mg (of iron) |
Icar Pediatric |
Hawthorn |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Tablets |
200 mg (66 mg iron) |
Ircon |
Kenwood |
324 mg (106 mg iron)* |
Hemocyte |
US Pharmaceutical |
||
325 mg (107 mg iron)* |
Ferrous Fumarate Tablets |
CMC |
||
350 mg (115 mg iron) |
Nephro-Fer |
R&D Labs |
||
Tablets, chewable |
100 mg (33 mg iron) |
Feostat |
Forest |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Capsules, extended-release |
150 mg (50 mg iron) with Docusate Sodium 100 mg* |
Ferrous Fumarate with DSS Timed Capsules |
Vita-Rx |
Tablets, extended-release, film-coated |
150 mg (50 mg iron) with Docusate Sodium 100 mg |
Ferro-DSS Caplets |
Time-Caps |
|
Ferro-Sequels (with povidone) |
Inverness |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Bulk |
Powder |
|||
Oral |
Tablets |
225 mg (27 mg iron) |
Fergon (with tartrazine) |
Bayer |
Ferrous Gluconate Tablets |
IVAX |
|||
300 mg (35 mg iron) |
Ferrous Gluconate Tablets |
Upsher-Smith |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Bulk |
Powder |
|||
Oral |
Solution |
220 mg (44 mg iron) per 5 mL* |
Ferrous Sulfate Elixir |
Alpharma |
300 mg (60 mg iron) per 5 mL |
Ferrous Sulfate Solution |
Pharmaceutical Associates |
||
125 mg (25 mg iron) per mL* |
Fer-Gen-Sol Drops |
IVAX |
||
Fer-In-Sol Drops (with alcohol 0.02%) |
Mead Johnson |
|||
Tablets |
195 mg (39 mg iron)* |
Mol-Iron (with butylparaben and povidone) |
Schering-Plough |
|
300 mg (60 mg iron)* |
Feratab |
Upsher-Smith |
||
Tablets, enteric-coated |
325 mg (65 mg iron)* |
Ferrous Sulfate Tablets EC |
IVAX |
|
Tablets, film-coated |
325 mg (65 mg iron) |
Ferrous Sulfate Tablets |
United Research |
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Tablets |
200 mg (65 mg iron) |
Feosol |
GlaxoSmithKline |
Tablets, extended-release |
160 mg (50 mg iron) |
Slow FE |
Novartis |
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Oral |
Capsules |
150 mg (of iron) |
Ferrex-150 |
Breckenridge |
Fe-Tinic 150 |
Ethex |
|||
Hytinic |
Hyrex |
|||
Niferex-150 (with benzyl alcohol and parabens) |
Ther-Rx |
|||
Solution |
100 mg (of iron) per 5 mL |
Niferex Elixir (with alcohol 10%) |
Ther-Rx |
|
Tablets, film-coated |
50 mg (of iron) |
Niferex |
Ther-Rx |
AHFS DI Essentials™. © Copyright 2025, Selected Revisions October 23, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
References
Only references cited for selected revisions after 1984 are available electronically.
101. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press; 1998. (Prepublication copy uncorrected proofs.)
102. Polk RE, Healy DP, Sahai J et al. Effect of ferrous sulfate and multivitamins with zinc on absorption of ciprofloxacin in normal volunteers. Antimicrob Agents Chemother. 1989; 33:1841-4. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC172774/ https://pubmed.ncbi.nlm.nih.gov/2610494
103. Merck & Co Inc. Noroxin (norfloxacin precribing information. West Point, PA; 1993 May.
104. Polk RE. Drug-drug interactions with ciprofloxacin and other fluoroquinolones. Am J Med. 1989; 87(Suppl 5A):76S-81S. https://pubmed.ncbi.nlm.nih.gov/2686430
105. Janknegt R. Drug interactions with quinolones. J Antimicrob Chemother. 1990; 26(Suppl D):7-25. https://pubmed.ncbi.nlm.nih.gov/2286594
106. Campbell N, Paddock V, Sundaram R. Alteration of methyldopa absorption, metabolism, and blood pressure control caused by ferrous sulfate and ferrous gluconate. Clin Pharmacol Ther. 1988; 43:381-6. https://pubmed.ncbi.nlm.nih.gov/3356082
107. Campbell NRC, Hasinoff BB, Stalts H et al. Ferrous sulfate reduces thyroxine efficiency in patients with hypothyroidism. Ann Intern Med. 1992; 117:1010-3. https://pubmed.ncbi.nlm.nih.gov/1443969
108. Centers for Disease Control and Prevention. Toddler deaths resulting from ingestion of iron supplements—Los Angeles, 1992–1993. MMWR. 42:111-3.
109. Centers for Disease Control and Prevention. Recommendations to prevent and control iron deficiency in the United States. MMWR Morb Mortal Wkly Rep. 1998; 47(Suppl RR-3):1-29. https://www.cdc.gov/mmwr/PDF/rr/rr4703.pdf https://pubmed.ncbi.nlm.nih.gov/9450721
110. Halberg L. Bioavailability of dietary iron in man. Annu Per Nutr. 1981; 1:123-47.
111. Bothwell TH. Overview and mechanisms for iron regulation. Nutr Rev. 1995; 53:237-45. https://pubmed.ncbi.nlm.nih.gov/8577406
112. Allen LH. Pregnancy and iron deficiency: unresolved issues. Nutr Rev. 1997; 55:91-101. https://pubmed.ncbi.nlm.nih.gov/9197129
113. Siegenberg D, Baynes RD, Bothwell TH et al. Ascorbic acid prevents the dose-dependent inhibitory effects of polyphenols and phytates on nonheme-iron absorption. Am J Clin Nutr. 1994; 53:537-41.
114. Stoltzfus RJ, Chwaya HM, Tielsch JM et al. Epidemiology of iron deficiency anemia in Zanzibari schollchildren: the importance of hookworms. Am J Clin Nutr. 1997; 65:153-9. https://pubmed.ncbi.nlm.nih.gov/8988928
115. Pollitt E. Iron deficiency and cognitive function. Annu Rev Nutr. 1993; 13:521-37. https://pubmed.ncbi.nlm.nih.gov/8369157
116. Idjradinata P, Pollitt E. Reversal of developmental delays in iron-deficient anaemic infants treated with iron. Lancet. 1993; 341:1-4. https://pubmed.ncbi.nlm.nih.gov/7678046
117. Lozoff B, Jimenez E, Wolf AW. Long-term developmental outcome of infants with iron deficiency. N Engl J Med. 1991; 325:687-94. https://pubmed.ncbi.nlm.nih.gov/1870641
118. Goyer RA. Nutrition and metal toxicity. Am J Clin Nutr. 1995; 61(Suppl.):646-50S.
119. Li R, Chen X, Yan H et al. Functional consequences of iron supplementation in iron deficient female cotton mill worker in Beijing, China. Am J Clin Nutr. 1994; 59:908-13. https://pubmed.ncbi.nlm.nih.gov/8147338
120. Scholl TO, Hediger ML, Fischer RL et al. Anemia vs iron deficiency: increased risk of preterm delivery in a prospective study. Am J Clin Nutr. 1992; 55:985-8. https://pubmed.ncbi.nlm.nih.gov/1570808
121. Puolakka J, Jänne O, Pakarinen A et al. Serum ferritin as a measure of iron stores during and after normal pregnancy with and without iron supplements. Acta Obstet Gynecol Suppl. 1980; 65:43-51.
122. Taylor DJ, Mallen C, McDougall N et al. Effect of iron supplementation on serum ferritin levels during and after pregnancy. Br J Obstet Gynaecol. 1982; 89:1011-7. https://pubmed.ncbi.nlm.nih.gov/7171510
123. Hemminki E, Rimpelä U. A randomized comparison of routine versus selective iron supplementation during pregnancy. J Am Coll Nutr. 1991; 10:3-10. https://pubmed.ncbi.nlm.nih.gov/2010577
124. Hemminki E, Meriäinen J. Long-term follow-up of mothers and their infants in a randomized trial on iron prophylaxis during pregnancy. Am J Obstet Gynecol. 1995; 173:205-9. https://pubmed.ncbi.nlm.nih.gov/7631683
125. Looker AC, Dallman PR, Carroll MD et al. Prevalence of iron deficiency in the United States. JAMA. 1997; 277:973-6. https://pubmed.ncbi.nlm.nih.gov/9091669
126. Pizarro F, Yip R, Dallman PR et al. Iron Status with different infant feeding regimens: relevance to screening and prevention of iron deficiency. J Pediatr. 1991; 118:687-92. https://pubmed.ncbi.nlm.nih.gov/2019922
127. Walter T. Dallman PR, Pizarro F et al. Effectiveness of iron-fortified infant cereal in prevention of iron deficiency anemia. Pediatrics. 1993; 91:976-82. https://pubmed.ncbi.nlm.nih.gov/8474819
128. Pisacane A, De Vizia B, Valiente A et al. Iron status in breast-fed infants. J Pediatr. 1995; 127:429-31. https://pubmed.ncbi.nlm.nih.gov/7658275
129. Oski FA, Iron deficiency in infancy and childhood. N Engl J Med. 1993; 329:190-3.
130. Boutry M, Needlman R. Use of diet history in screening of iron deficiency. Pediatrics. 1996; 98:1138-42. https://pubmed.ncbi.nlm.nih.gov/8951266
131. Oski FA. Iron-fortified formulas and gastrointestinal symptoms in infants: a controlled study. Pediatrics. 1980; 66:168-70. https://pubmed.ncbi.nlm.nih.gov/7402800
132. Nelson SE, Ziegler EE, Copeland AM et al. Lack of adverse reactions to iron-fortified formula. Pediatrics. 1988; 81:360-4. https://pubmed.ncbi.nlm.nih.gov/3344179
133. American Academy of Pediatrics Committee on Nutrition. Pediatric nutrition handbook. 4th ed. Elk Groove Village, IL: American Academy of Pediatrics; 1998:233-46.
134. Jurado RL. Iron, infections, and anemia of inflammation. Clin Infect Dis. 1997; 25:888-95. https://pubmed.ncbi.nlm.nih.gov/9356804
135. Ashby D. Can iron supplementation improve congnitive functioning? Lancet. 1996; 348:973. Editorial.
136. Bruner AB, Jaffe A, Duggan AK et al. Randomized study of cognitive effects of iron supplementation in non-anaemic iron-deficient adolescent girls. Lancet. 1996; 348:992-6. https://pubmed.ncbi.nlm.nih.gov/8855856
137. Frewin R, Henson A, Provan D. Iron deficiency anemia. BMJ. 1997; 314:360-3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2125872/ https://pubmed.ncbi.nlm.nih.gov/9040336
138. Jacobus DP. Randomization to iron supplementation of patients with advanced human immunodeficiency virus disease—an inadvertent but controlled study with results important for patient care. J Infect Dis. 1996; 173:1044-5. https://pubmed.ncbi.nlm.nih.gov/8603950
139. Vildé JL, Salmon-Céron D. Randomization to iron supplementation of patients with advanced human immunodeficiency virus disease—an inadvertent but controlled study with results importannt for patient care. J Infect Dis. 1996; 173:1045. https://pubmed.ncbi.nlm.nih.gov/8603951
140. Weinberg GA. Iron and oxidative stress as a mechanism for the enhanced production of human immunodeficiency virus by alveolar macrophages from otherwise healthy cigarette smokers. J Clin Infect Dis. 1996; 173:1045-6.
141. Mooij PNM, Thomas CMG, Doesburg WH et al. The effects of oral contraceptives and multivitamin supplementation on serum ferritin and hematological parameters. Int J Clin Pharmacol Ther Toxicol. 1992; 30:57-62. https://pubmed.ncbi.nlm.nih.gov/1551747
142. Galloway R, McGuire J. Determinants of compliance with iron supplementation: supplies, side effects, or psychology? Soc Sci Med. 1994; 39:381-90.
143. Yu SM, Keppel KG, Singh GK et al. Preconceptional and prenatal multivitamin-mineral supplement use in the 1988 National Maternal and Infant Health Survey. Am J Public Health. 1996; 86:240-2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1380335/ https://pubmed.ncbi.nlm.nih.gov/8633743
144. Rockey DC, Cello JP. Evaluation of the gastrointestinal tract in patients with iron-deficiency anemia. N Engl J Med. 1993; 329:1691-5. https://pubmed.ncbi.nlm.nih.gov/8179652
145. Yip R, Dallman PR. The roles of inflammation and iron deficiency as causes of anemia. Am J Clin Nutr. 1988; 48:1295-300. https://pubmed.ncbi.nlm.nih.gov/3189219
146. Thomsen JK, Prien-Larson JC, Devantier A et al. Low dose iron supplementation does not cover the need for iron during pregnancy. Acta Obstet Gynecol Scand. 1993; 72:93-8. https://pubmed.ncbi.nlm.nih.gov/8383415
147. Witte DL, Crosby WH, Edwards CO et al. Hereditary hemochromatosis. Clin Chim Acta. 1996; 245:139-200. https://pubmed.ncbi.nlm.nih.gov/8867884
148. Food and Drug Administration. Iron-containing supplements and drugs: label warning statements and unit-dose packaging requirements. 21 CFR Parts 110, 111, 310. Final rule. [Docket Nos; 91P-0186, 93P-0306] Fed Regist. 1997; 62:2218-51.
149. National Kidney Foundation Study Group: NKF-DOQI clinical practice guidelines for the treatment of anemia of chronic renal failure. Am J Kidney Dis. 1997; 30(Suppl 3):S192-237.
150. Allegra V, Mengossi G, Vasile A. Iron deficiency in maintenance hemodialysis patients: assessment of diagnosis critieria and of three different iron treatments. Nephron. 1991; 57:175-82. https://pubmed.ncbi.nlm.nih.gov/1902285
151. Besarab A, Frinak S, Yee S. An indistinct balance: the safety and efficacy of parenteral iron therapy. J Am Soc Nephrol. 1999; 10:2029-43. https://pubmed.ncbi.nlm.nih.gov/10477157
152. Macdougall IC, Tucker B, Thompson J et al. A randomized controlled study of iron supplementation in patients treated with epoetin alfa. Kidney Int. 1996; 50:1694-9. https://pubmed.ncbi.nlm.nih.gov/8914038
153. Macdougall IC, Cavill I, Hulme B et al. Detection of functional iron deficiency during epoetin alfa treatment: a new approach. BMJ. 1992; 304:225-6. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1881474/ https://pubmed.ncbi.nlm.nih.gov/1739797
154. Schaefer RM, Schaefer L. Management of iron substitution during r-HuEPO therapy in chronic renal failure patients. Erythropoiesis. 1992; 3:71-5.
155. Schwenk MH, Halstenson CE. Recombinant human epoetin alfa. DICP. 1989; 23:528-36. https://pubmed.ncbi.nlm.nih.gov/2669369
156. Sinai-Trieman L, Salusky IB, Fine RN. Use of subcutaneous recombinant human epoetin alfa in children undergoing continuous cycling peritoneal dialysis. J Pediatr. 1989; 114:550-4. https://pubmed.ncbi.nlm.nih.gov/2926567
157. Schaefer PM, Kuerner B, Zech M et al. Treatment of the anemia of hemodialysis patients with recombinant human epoetin alfa. Int J Artif Organs. 1988; 11:249-54. https://pubmed.ncbi.nlm.nih.gov/3410565
158. Eschbach JW, Adamson JW. Recombinant human epoetin alfa: implications for nephrology. Am J Kidney Dis. 1988; 11:203-9. https://pubmed.ncbi.nlm.nih.gov/3278599
159. Kleinman KS, Schweitzer SU, Perdue ST et al. The use of recombinant human epoetin alfa in the correction of anemia in predialysis patients and its effects on renal function: a double blind placebo controlled trial. Abstracts on recombinant epoetin alfa from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:6. Abstract.
160. Casati S, Passerini P, Campise MR et al. Benefits and risks of protracted treatment with human recombinant epoetin alfa in patients having haemodialysis. BMJ. 1987; 295:1017-20. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1248067/ https://pubmed.ncbi.nlm.nih.gov/3120854
161. Eschbach JW, Kelly MR, Haley NR et al. Treatment of the anemia of progressive renal failure with recombinant human epoetin alfa. N Engl J Med. 1989; 321:158-63. https://pubmed.ncbi.nlm.nih.gov/2747747
162. Eschbach JW, Adamson JW. Correction of the anemia of hemodialysis (HD) patients with recombinant human epoetin alfa (r-HuEPO): results of multicenter study. Selected abstracts on recombinant epoetin alfa from the American Society of Nephrology 20th annual meeting, December 13-16, 1987, Washington, DC. Thorofare, NJ: Special Projects Network; 1988:9.
163. Eschbach JW, Abdulhadi MH, Browne JK et al. Recombinant human epoetin alfa in anemic patients with end-stage renal disease: results of a phase III multicenter clinical trial. Ann Intern Med. 1989; 111:992-1000. https://pubmed.ncbi.nlm.nih.gov/2688507
164. Flaharty KK, Grimm AM, Vlasses PH. Epoetin: recombinant human epoetin alfa. Clin Pharm. 1989; 8:769-82. https://pubmed.ncbi.nlm.nih.gov/2680241
165. Grutzmacher P, Bergmann M, Weinreich T et al. Beneficial and adverse effects of correction of anaemia by recombinant human epoetin alfa in patients on maintenance haemodialysis. Contrib Nephrol. 1988; 66:104-13. https://pubmed.ncbi.nlm.nih.gov/3292143
166. Macdougall IC, Hutton RD, Cavill I et al. Treating renal anemia with recombinant human epoetin alfa: practical guidelines and a clinical algorithm. Br Med J. 1990; 300:655-9.
167. Macdougall IC, Hutton RD, Cavill I et al. Poor response to treatment of renal anaemia with epoetin alfa corrected by iron given intravenously. BMJ. 1989; 299:157-8. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1837074/ https://pubmed.ncbi.nlm.nih.gov/2504356
168. Pollok M, Bommer J, Gurland HJ et al. Effects of recombinant human epoetin alfa treatment in end-stage renal failure patients: results of a multicenter phase II/III study. Contrib Nephrol. 1989; 76:201-11. https://pubmed.ncbi.nlm.nih.gov/2684523
169. Ortho Biotech Division. Procrit (epoetin alfa) prescribing information. Raritan, NJ; 1997 Feb.
170. Amgen, Inc. Epogen (epoetin alfa) prescribing information (dated 1996 Nov). In: Physicians’ desk reference. 52nd ed. Montvale, NJ: Medical Economics Company Inc; 1998:505-10.
171. Amgen, Thousand Oaks, CA: Personal communication regarding epoetin alfa monograph.
172. Eschbach JW, Egrie JC, Downing MR et al. Correction of the anemia of end-stage renal disease with recombinant human epoetin alfa: results of a combined phase I and II clinical trial. N Engl J Med. 1987; 316:73-78. https://pubmed.ncbi.nlm.nih.gov/3537801
173. Van Wyck DB, Stivelman J, Kirlin L et al. Predicting iron status in patients receiving epoetin alfa for dialysis- associated anemia. Abstracts on recombinant epoetin alfa from the American Society of Nephrology 21st annual meeting, San Antonio, TX, December 11-14, 1988. Thorofare, NJ: Special Projects Network; 1988:16. Abstract.
174. Klingemann HG. Clinical applications of recombinant human colony-stimulating factors. CMAJ. 1989; 140:137-42. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1268583/ https://pubmed.ncbi.nlm.nih.gov/2642725
175. Anon. Epoetin alfa for anemia. Med Lett Drugs Ther. 1989; 31:85-86. https://pubmed.ncbi.nlm.nih.gov/2671624
176. Macdougall IC, Cavill I, Davies ME et al. Subcutaneous recombinant epoetin alfa in the treatment of renal anaemia in CAPD patients. Contrib Nephrol. 1989; 76:219-26. https://pubmed.ncbi.nlm.nih.gov/2582780
177. Stone WJ, Graber SE, Krantz SB et al. Treatment of the anemia of predialysis patients with recombinant human epoetin alfa: a randomized, placebo-controlled trial. Am J Med Sci. 1988; 171-9. (IDIS 246785)
178. Mohini R. Clinical efficacy of recombinant human epoetin alfa in hemodialysis patients. Semin Nephrol. 1989; 9:16-21. https://pubmed.ncbi.nlm.nih.gov/2648516
179. Anon. Recombinant human epoetin alfa product approved for use in chronic renal failure. Clin Pharm. 1989; 8:531.
180. Kuhn K, Nonnast-Daniel B, Grutzmacher P et al. Analysis of initial resistance of erythropoiesis to treatment with recombinant human epoetin alfa. Contrib Nephrol. 1988; 66:94-103. https://pubmed.ncbi.nlm.nih.gov/3292152
181. Ad Hoc Committee for the National Kidney Foundation. Statement on clinical use of recombinant epoetin alfa in anemia of end-stage renal disease. Am J Kidney Dis. 1989; 14:163-9. https://pubmed.ncbi.nlm.nih.gov/2672796
182. Beresford CH. Epoetin alfa. New Zealand Med J. 1989; 102:185. https://pubmed.ncbi.nlm.nih.gov/2652007
183. Schein Pharmaceutical, Inc. and R&D Laboratories, Inc. Ferrlecit (sodium ferric gluconate) injection for intravenous use prescribing information. Florham Park, NJ; 1998.
184. Faich G, Strobos J. Sodium ferric gluconate in sucrose: safer intravenous iron therapy than iron dextrans. Am J Kidney Dis. 1999; 33(3): 464-70.
185. Nissenson AR. Achieving target hematocrit in dialysis patients: new concepts in iron management. Am J Kidney Dis. 1997; 30(6): 907-11. https://pubmed.ncbi.nlm.nih.gov/9398140
186. Fishbane S, Maesaka JK. Iron management in end-stage renal disease. Am J Kidney Dis. 1997; 29(3): 319-33. https://pubmed.ncbi.nlm.nih.gov/9041207
187. Hillman RS. Hematopoietic agents. In: Hardman JG, Limbird LE, Molinoff PB et al., eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 9th ed. New York: McGraw Hill Company; 1995:1311-40.
188. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. 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. (Prepublication copy uncorrected proofs.)
189. Gordeuk VR, Brittenham GM, Hughes M et al. High-dose carbonyl iron for iron deficiency anemia: a randomized double-blind trial. Am J Clin Nutr 1987: 46:1029-34.
190. Gordeuk VR, Brittenham GM, McLaren CE et al. Carbonyl iron therapy for iron deficiency anemia. Blood 1986:745-52.
191. GlaxoSmithKline. Feosol Caplets prescribing information. In: Huff BB, ed. Physicians’ desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:1717.
192. Esposito R. Cimetidine and iron-deficiency anaemia. Lancet. 1977; 2:1132.(letter) https://pubmed.ncbi.nlm.nih.gov/73039
193. Walan A, Strom M. Metabolic consequences of reduced gastric acidity. Scand J Gastroenterol. 1985;111:24-30.
194. Little DR. Ambulatory management of common forms of anemia. Am Fam Physician. 1999; 59:1598-1604. https://pubmed.ncbi.nlm.nih.gov/10193599
195. Iron salt interactions: histamine H2 antagonists. In: Tatro DS ed. Drug interaction facts. St. Louis, MO; Facts and Comparisons; 1997:421.
196. Wyeth-Ayerst. Protonix (pantoprazole) delayed-release tablets prescribing information. (dated 2002 Jul) In: PDR Electronic Library. http://pdrel.thomsonhc.com
197. AstraZeneca. Prilosec (omeprazole) delayed-release capsules prescribing information. Wilmington, DE. 2002 Jul.
198. Skoutakis VA, Joe RH, Hara DS. Comparative role of omeprazole in the treatment of gastroesophageal reflux disease. Ann Pharmacother. 1995; 29:1252-1262. https://pubmed.ncbi.nlm.nih.gov/8672831
201. Killip S, Bennett JM, Chambers MD. Iron deficiency anemia. Am Fam Physician. 2007; 75:671-8. https://pubmed.ncbi.nlm.nih.gov/17375513
202. US Food and Drug Administration. Avoid food-drug interactions: a guide from the National Consumers League and the US Food and Drug Administration. 2010 Oct 12. Available from FDA website. Accessed 2017 Oct 16.
203. Meda Consumer Health. Feosol: iron absorption. Accessed 2017 Oct 16. http://feosol.com/iron-absorption/
a. AHFS Drug Information. McEvoy GK, ed. Iron preparations, oral. Bethesda, MD: American Society of Health-System Pharmacists.
b. Feosol (carbonyl iron) caplets prescribing information. In: PDR.net [database online]. Montvale, NJ: Thomson Healthcare; 2004.
c. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes of the Food and Nutrition Board, Institute of Medicine, National Academy of Sciences. Dietary reference intakes for thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic acid, biotin, and choline. Washington, DC: National Academy Press; 1998. (Prepublication copy uncorrected proofs.)