Prevention and treatment of iron deficiency. Not indicated for treatment of anemia resulting from causes other than iron deficiency.
Dosage and Administration
Administration
Oral Administration
Administer orally between meals (e.g., 2 hours before or 1 hour 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.
Table 1. Approximate Elemental Iron Content of Various Oral Iron Preparations
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.
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.
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)
Administer 2 hours before or 1 hour after a meal
H2-receptor antagonists
Increased gastric pH and possibly decreased GI absorption of oral iron preparations that depend on gastric acidity for dissolution and absorption
Administer oral iron at least 1 hour prior to H2-receptor antagonists
Increased absorption of iron from GI tract (with >200 mg Vitamin C per 30 mg elemental iron)
Concomitant use may be of benefit, particularly in infants
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.
Advice to Patients
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.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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