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 meals^a 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.

Table 1. Approximate Elemental Iron Content of Various Oral Iron Preparationsa
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

Oral

Premature 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

Table 2. Recommended Dietary Allowance (RDA)/Adequate Intake (AI) of Iron for Pediatric Patients188
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

Oral

Children: 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

Oral

RDA 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

Oral

Usual 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

Oral

Children: 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

Primary hemochromatosis.^a
Peptic ulcer, regional enteritis, or ulcerative colitis.^a

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 absorption^a	Administer these drugs as far apart as possible^a
Calcium supplements	Pharmacokinetic (decrease iron absorption) interaction^a	Administer at least 2 hours apart^a
Chloramphenicol	Possible delayed response to iron therapy^a	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	Administer 1 hour before or 2 hours after a meal²⁰¹ ²⁰² ²⁰³
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 toxicity^a	Concomitant use not recommended^a
Methyldopa	Pharmacokinetic (decreased oral absorption of methyldopa) and pharmacologic (decreased hypotensive effect) interactions¹⁰⁶	Monitor BP^a
Penicillamine	May decrease the cupruretic effect of penicillamine, probably by decreasing its absorption^a	Administer at least 2 hours apart^a
Quinolone anti-infectives	Pharmacokinetic interaction (iron may interfere with quinolone absorption)^a	Administer at least 2 hours apart^a
Tests for detection of occult blood in stools	Possible false-positive results with guaiac test^a	Use a benzidine test instead^a
Tetracyclines	Pharmacokinetic interaction (decreased oral absorption of both iron and tetracyclines)^a	Administer tetracycline 3 hours after or 2 hours before oral iron^a
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 infants^a

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.

Carbonyl Iron
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

Ferrous Fumarate
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

Ferrous Fumarate Combinations
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

Ferrous Gluconate
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

Ferrous Sulfate
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

Ferrous Sulfate, Dried
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

Polysaccharide-iron Complex
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

References

Only references cited for selected revisions after 1984 are available electronically.

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