Iron Preparations, Oral Monograph for Professionals - Drugs.com

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# Iron Preparations, Oral

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.

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. 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.

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.

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.

## Interactions for Iron Preparations, Oral

### Specific Drugs, Foods, and Laboratory Tests

Drug, Food, or Test | Interaction | Comment
--- | --- | ---
Antacids or aluminum-containing phosphate binders | May decrease iron absorption | Administer these drugs as far apart as possible
Calcium supplements | Pharmacokinetic (decrease iron absorption) interaction | Administer at least 2 hours apart
Chloramphenicol | Possible delayed response to iron therapy | Avoid concomitant use
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) | Administer 1 hour before or 2 hours 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
Iron, parenteral | Iron toxicity | Concomitant use not recommended
Methyldopa | Pharmacokinetic (decreased oral absorption of methyldopa) and pharmacologic (decreased hypotensive effect) interactions | Monitor BP
Penicillamine | May decrease the cupruretic effect of penicillamine, probably by decreasing its absorption | Administer at least 2 hours apart
Quinolone anti-infectives | Pharmacokinetic interaction (iron may interfere with quinolone absorption) | Administer at least 2 hours apart
Tests for detection of occult blood in stools | Possible false-positive results with guaiac test | Use a benzidine test instead
Tetracyclines | Pharmacokinetic interaction (decreased oral absorption of both iron and tetracyclines) | Administer tetracycline 3 hours after or 2 hours before oral iron
Thyroid agents | Possible pharmacokinetic interaction (decreased thyroxine absorption) | Administer at least 2 hours apart and monitor thyroid function
Vitamin C | 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

## 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.

## 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.

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, United Research
|  | 300 mg (35 mg iron) | Ferrous Gluconate Tablets | Upsher-Smith
|  | 320 mg (37 mg iron)* |  |
|  | 325 mg (38 mg iron)* |  |

* 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, IVAX, United Research
|  | 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
|  | 325 mg (65 mg iron)* |  |
| Tablets, enteric-coated | 325 mg (65 mg iron)* | Ferrous Sulfate Tablets EC | IVAX, Paddock
| Tablets, film-coated | 325 mg (65 mg iron) | Ferrous Sulfate Tablets | United Research

Ferrous Sulfate, Dried
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer
--- | --- | --- | --- | ---
Oral | Capsules | 190 mg (60 mg iron) |  |
| 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

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

AHFS DI Essentials™. © Copyright 2023, Selected Revisions October 23, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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