Iron Preparations, Oral

Administration

Oral Administration

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

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.

Pediatric Patients

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.

Established for infants through 6 months of age based on the observed mean iron intake of infants fed principally human milk.188

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

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

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

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

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

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

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 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

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

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Distributed into milk.a

Common Adverse Effects

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

Storage

Oral

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

• 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

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

Oral iron preparations are also commercially available in combination with vitamins and minerals and oral contraceptives.