Iron Preparations, Oral (Monograph)

Brand names: Feosol, Feostat, Feratab, Fer-Gen-Sol, Fergon, ... show all 17 brands Fer-In-Sol, Ferrex, Ferrous Sulfate Tablets EC, Fe-Tinic, Hemocyte, Hytinic, Icar Pediatric, Ircon, Mol-Iron, Nephro-Fer, Niferex, Slow FE
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.

Uses for Iron Preparations, Oral

Prevention and Treatment of Iron Deficiency

Prevention and treatment of iron deficiency. Not indicated for treatment of anemia resulting from causes other than iron deficiency.

Iron Preparations, Oral Dosage and Administration

Administration

Oral Administration

Administer orally between meals (e.g., 1 hour before or 2 hours after a meal).

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 or at bedtime.

Dosage

Dosage expressed in terms of elemental iron. (See Table 1.)

Do not exceed recommended dosage.

Carbonyl iron is elemental iron, not an iron salt.

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. Do not exceed 15 mg daily.

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. Do not exceed 15 mg daily.

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.

Based on the need to maintain a normal functional iron concentration but only minimal stores, RDA is the goal for dietary intake in individuals.

Established for infants through 6 months of age based on the observed mean iron intake of infants fed principally human milk.

Treatment

Oral

Children: 3–6 mg/kg daily in 3 divided doses.

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.

Adults

Iron Deficiency Anemia

Prevention

Oral

RDA for healthy men of all ages (≥19 years of age) is 8 mg daily.

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.

Treatment

Oral

Usual therapeutic dosage: 50–100 mg 3 times daily. 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.

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.

Normal hemoglobin values usually obtained in 2 months unless blood loss continues. In severe deficiencies, continue iron therapy for approximately 6 months.

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.

Adults: ≥200 mg daily in 2 or 3 divided doses.

Pregnant Women

RDA for pregnant women 14–50 years of age is 27 mg daily.

Lactating Women

RDA for lactating women 14–18 or 19–50 years of age is 10 or 9 mg daily, respectively.

Cautions for Iron Preparations, Oral

Contraindications

• Primary hemochromatosis.

• Peptic ulcer, regional enteritis, or ulcerative colitis.

Warnings/Precautions

Warnings

Children <12 years of age and pregnant or nursing women should consult a health professional before using iron-containing preparations.

Accidental Overdose

Possible fatal poisoning in children <6 years of age; keep iron-containing preparations out of reach of children.

If accidental overdosage occurs, immediately contact a clinician or a poison control center.

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). Use with caution, particularly in patients sensitive to aspirin.

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.

Do not administer for >6 months except in patients with continued bleeding, menorrhagia, or repeated pregnancies.

General Precautions

Infectious Complications

Possible increased pathogenicity of certain microorganisms, including possible adverse effects on prognosis in HIV-infected individuals; not recommended for use in individuals without documented iron deficiency.

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.

Common Adverse Effects

Constipation, diarrhea, dark stools, nausea, epigastric pain.

Drug Interactions

Specific Drugs, Foods, and Laboratory Tests

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. GI absorption of iron increases in iron-deficient individuals.

Oral bioavailability of iron can vary from <1% to >50%, and the principal factor controlling GI iron absorption is the amount of iron stored in the body.

Onset

Symptoms of anemia usually improve within a few days; normal hemoglobin values usually attained in 2 months unless blood loss continues.

Food

Food decreases absorption of inorganic iron. (See Food under Interactions.)

Distribution

Extent

Exists in humans almost exclusively complexed to protein or in heme molecules.

Crosses the placenta and distributes into milk.

Elimination

Metabolism

Occurs in a virtually closed system.

Elimination Route

Most iron liberated by destruction of hemoglobin is conserved and reused by the body. Blood loss greatly increases iron loss.

Stability

Storage

Oral

Capsules, Solutions, Suspensions, Tablets

Room temperature (15–30°C). Protect from excessive heat and moisture.

Actions

• Corrects erythropoietic abnormalities caused by a deficiency of iron.

• Does not stimulate erythropoiesis, nor does it correct hemoglobin disturbances not caused by iron deficiency.

• Risk of fatal poisoning in children <6 years of age; importance of keeping iron-containing products out of reach of children.

• Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.

• Importance of informing patients of other important precautionary information. (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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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