Iron Products

Pronunciation: EYE-urn
Class: Iron product

Trade Names

EzFe 200
- Capsules, oral iron 200 mg as polysaccharide iron complex

Femiron
- Tablets, oral 63 mg (iron 20 mg) as ferrous fumarate

Feosol
- Tablets, oral 200 mg (iron 65 mg) as ferrous sulfate, dried
- Tablets, oral 225 mg (iron 45 mg) as carbonyl iron

Fer-In-Sol
- Drops 75 mg (iron 15 mg) as ferrous sulfate

Fer-Iron
- Drops 75 mg in 1 mL (15 mg in 1 mL) as ferrous sulfate

Ferate
- Tablets, oral 240 mg (iron 27 mg) as ferrous gluconate

Fergon
- Tablets, oral 240 mg (iron 27 mg) as ferrous gluconate

Ferretts
- Tablets, oral 325 mg (iron 106 mg) as ferrous fumarate

Ferrex 150
- Capsules, oral Iron 150 mg as polysaccharide iron complex

Ferrimin 150
- Tablets, oral 150 mg as ferrous fumarate

Ferrocite
- Tablets, oral 324 mg (iron 106 mg) as ferrous fumarate

Ferro-Sequels
- Tablets, controlled release, oral 50 mg as ferrous fumarate

Ferrous Aspartate
- Tablets, oral 112 mg (iron 18 mg)

Ferrous Fumarate
- Tablets, oral 29 mg
- Tablets, oral 90 mg

Ferrous gluconate
- Tablets, oral 324 mg (iron 38 mg)
- Tablets, oral 325 mg (iron 36 mg)
- Tablets, oral 325 mg (iron 37.5 mg)
- Tablets, oral 246 mg (iron 38 mg)

Ferrous sulfate
- Tablets, delayed release, oral 325 mg (iron 65 mg)
- Tablets, enteric coated, oral 325 mg (iron 65 mg)
- Tablets, oral 27 mg
- Tablets, oral 28 mg
- Tablets, oral 83 mg
- Tablets, oral 90 mg (iron 18 mg)
- Tablets, oral 134 mg
- Tablets, oral 325 mg (iron 65 mg)
- Tablets, ER, oral 140 mg (iron 45 mg)
- Tablets, controlled release, oral 140 mg (iron 45 mg)
- Elixir, oral 220 mg/5 mL (iron 44 mg/5 mL)
- Syrup, oral 300 mg (iron 60 mg)/5 mL
- Solution, concentrate 75 mg (iron 15 mg)/0.6 mL

Ferrousul
- Tablets, oral 325 mg (iron 65 mg) as ferrous sulfate

Hemocyte
- Tablets, oral 324 mg (iron 106 mg) as ferrous fumarate

Icar
- Suspension 15 mg/1.25 mL as carbonyl iron
- Tablets, chewable, oral 15 mg as carbonyl iron

iFerex 150
- Capsules, oral Iron 150 mg as polysaccharide iron complex

Leader Iron
- Tablets, ER, oral 160 mg (iron 50 mg) as ferrous sulfate, exsiccated
- Tablets, oral 240 mg (iron 27 mg) as ferrous gluconate

Myferon 150
- Capsules, oral 150 mg as polysaccharide iron complex

Nu-Iron 150
- Capsules, oral Iron 150 mg as polysaccharide iron complex

Poly-Iron 150
- Capsules, oral Iron 150 mg as polysaccharide iron complex

Slow Fe
- Tablets, slow-release, oral 142 mg (45 mg iron) as ferrous sulfate, dried
- Tablets, slow release, oral 160 mg (50 mg iron) as ferrous sulfate, dried

Wee Care
- Suspension 15 mg/1.25 mL as carbonyl iron

Apo-Ferrous Gluconate (Canada)
Apo-Ferrous Sulfate (Canada)
Ferodan (Canada)
Palafer (Canada)

Pharmacology

Iron is a major factor in oxygen transport and an essential mineral component of hemoglobin, myoglobin, and several enzymes.

Pharmacokinetics

Absorption

Primary site of absorption is the duodenum and upper jejunum. Food decreases absorption at least 50%.

Elimination

Daily loss of iron from urine, sweat, and sloughing of intestinal mucosal cells equals approximately 0.5 to 1 mg in healthy men and approximately 1 to 2 mg in menstruating women.

Indications and Usage

Prevention and treatment of iron deficiency and iron-deficiency anemias.

Unlabeled Uses

Use with epoetin to ensure hematologic response to epoetin.

Contraindications

Hypersensitivity to any ingredient; hemosiderosis, hemolytic anemia, hemochromatosis.

Dosage and Administration

Stated dose is for elemental iron. Dosage must be calculated based on salt form. Ferrous sulfate is 20% elemental iron. Ferrous sulfate, exsiccated, is approximately 32% elemental iron. Ferrous gluconate is approximately 12% elemental iron. Ferrous fumarate is 33% elemental iron.

Iron Replacement Therapy in Deficiency States
Adults

PO 150 to 300 mg/day in 3 divided doses. Alternatively, 60 mg 2 to 4 times daily may lessen GI effects.

Children

PO 3 to 6 mg/kg/day in 1 to 3 divided doses.

Premature Infants

PO 2 to 4 mg/kg/day in 1 to 2 divided doses.

Prevention of Iron Deficiency
Adults

PO 60 mg/day in 1 to 2 divided doses.

Children

PO 1 to 2 mg/kg/day in 1 to 3 divided doses (max, 15 mg/day).

Premature Infants

PO 2 mg/kg/day in 1 to 3 divided doses (max, 15 mg/day).

RDA
Men 19 y and older

PO 8 mg/day.

Adolescent boys 14 to 18 y of age

PO 11 mg/day.

Boys 9 to 13 y of age

PO 8 mg/day.

Women 50 y and older

PO 8 mg/day.

Women 19 to 50 y of age

PO 18 mg/day.

Adolescent girls 14 to 18 y of age

PO 15 mg/day.

Girls 9 to 13 y of age

PO 8 mg/day.

Children 4 to 8 y of age

PO 10 mg/day.

Children 1 to 3 y of age

PO 7 mg/day.

Children 7 to 12 mo of age

PO 11 mg/day.

Pregnancy

PO 27 mg/day.

Lactation

19 y and older: PO 9 mg/day.

18 y and younger: PO 10 mg/day.

Iron Supplementation (Pregnancy)

PO 15 to 30 mg/day should meet the daily requirements for last 2 trimesters.

Dietary Supplement
Adults and children 12 y and older

PO 27 to 130 mg/day or as directed by health care provider.

Children younger than 12 y

PO As directed by health care provider.

General Advice

• Discomfort, such as nausea, may be minimized by taking with food.
• Multiple salt forms (eg, sulfate, gluconate, fumarate) containing different amounts of elemental iron are available. Ensure proper salt form is being used and doses are determined as elemental iron.
• Separate administration of iron supplements and antacids, diary products, or antibiotics by at least 2 h.
• Administer 1 h before or 2 h after a meal. Administer in divided doses if GI upset occurs. If GI upset does not resolve with divided-dose administration, administer each dose with food.
• Advise patient receiving enteric-coated or timed-release tablets to swallow tablets whole and not to crush, chew, break, or split.
• Measure prescribed dose of elixir using dosing syringe, dosing spoon, or dosing cup. To reduce risk of temporary staining of teeth, dilute prescribed dose of elixir with water or juice and have patient drink directly or through a straw. Do not dilute elixir with milk or wine-based vehicles.
• Measure prescribed dose of iron supplement drops using calibrated dropper. Administer directly into mouth with dropper or mix with water or juice.
• Shake suspension well before measuring dose. Measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or dosing cup.
• Do not exceed recommended dosage.

Storage/Stability

Store between 59° and 86°F. Protect from excessive heat and moisture. Protect elixir and drops from freezing.

Drug Interactions

Acetohydroxamic acid, antacids, calcium salts, food (eg, eggs, milk), H ₂ antagonists, proton pump inhibitors

Iron absorption may be decreased.

Ascorbic acid

May increase iron absorption.

Captopril

Coadministration within 2 h may promote formation of inactive captopril disulfide dimmer.

Cefdinir

Absorption of cefdinir may be decreased. Administer cefdinir 2 h before or after iron.

Chloramphenicol

May increase serum iron concentrations.

Digestive enzymes

Serum iron response to oral iron may be decreased.

Levodopa

Effects of levodopa may be decreased.

Levothyroxine

Efficacy of levothyroxine may be reduced.

Methyldopa, mycophenolate mofetil, penicillamine, quinolones

Absorption may be decreased by iron.

Tetracyclines

Absorption of both drugs may be decreased. Do not administer within 2 h of each other.

Trientine

Absorption of both drugs may be decreased.

Adverse Reactions

GI

Anorexia, constipation, dark stool, diarrhea, irritation, nausea, vomiting.

Miscellaneous

Teeth staining with liquid formulation.

Precautions

Monitor Ensure Hgb, Hct, reticulocyte count, and bilirubin are determined before starting therapy and periodically thereafter during prolonged treatment. Periodically review therapy to determine if it needs to be continued without change or if a dose change is indicated.

Pregnancy

Category A .

Tartrazine Sensitivity

Some products contain tartrazine, which may cause allergic-type reactions in susceptible individuals.

Sulfite Sensitivity

Some products contain sulfites, which may cause allergic-type reactions in susceptible individuals.

GI effects

Discomfort, such as constipation, diarrhea, gas, indigestion, nausea, and vomiting, may be minimized by taking with food. Monitor patient for GI adverse reactions.

Overdosage

Symptoms

Abdominal pain, acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrhosis, hypotension, hypothermia, lethargy, nausea, pulmonary edema, pyloric or antral stenosis, shock, tarry stool, weak/rapid pulse, vomiting.

Patient Information

• Advise patient dose may be changed periodically to obtain max benefit and minimize adverse reactions.
• Caution patient receiving iron supplements in conjunction with epoetin therapy that failure to take the iron supplement as prescribed may interfere with the beneficial effects of epoetin. Caution patient not to change the dose of, or stop taking, the iron supplement unless advised by health care provider.
• Caution patient or caregiver who is considering self-treatment of a suspected anemic state to seek medical advice before beginning treatment. Advise patient that other conditions could mimic an anemic state and using iron supplements could be harmful if taken when not clearly needed.
• Caution patient each iron product has specific dosing instructions, to read package label before using, and not to exceed dose or frequency of administration instructions unless advised differently by health care provider.
• Caution patient or caregiver multiple salt forms (eg, sulfate, gluconate, fumarate) containing different amounts of elemental iron are available and to check product label when purchasing replacement iron supplements to ensure proper salt form is being used and doses are the same based on elemental iron content.
• Advise patient with sulfite or tartrazine sensitivity to carefully read inactive ingredients listed on package to identify iron supplement that contains sulfites and/or tartrazine. Advise patients to avoid those products and consult with pharmacist if they have any questions or are not sure about the contents of the product.
• Advise patient to take on an empty stomach 1 h before or 2 h after a meal.
• Advise patient to take in divided doses if GI upset occurs with single dose. If GI upset does not resolve with divided-dose administration, advise patient to take each dose with food.
• Instruct patient who also is taking antacids, tetracycline antibiotics, or fluoroquinolone antibiotics to separate administration of iron supplement by at least 2 h.
• Advise patient using enteric-coated or timed-release tablets to swallow tablets whole and not to crush, chew, cut, or split the tablet.
• Advise patient using elixir to measure prescribed dose of elixir using dosing syringe, dosing spoon, or dosing cup. To reduce risk of temporary staining of teeth, advise patient to dilute prescribed dose of elixir with water or juice and drink directly or through a straw. Caution patient not to dilute elixir with milk or wine-based vehicles.
• Advise patient or caregiver using iron supplement drops to measure prescribed dose using calibrated dropper and to administer directly into mouth with dropper or mix with water or juice. Inform parent or caregiver that when iron-containing drops are given to infants, the membrane covering the teeth may darken; this is normal and of no consequence.
• Advise patient using suspension to shake suspension well before measuring dose and to measure and administer prescribed dose of suspension using dosing syringe, dosing spoon, or dosing cup.
• Advise patient or caregiver iron supplements may cause the stools to turn black and this is normal and of no consequence.
• Advise patient or caregiver stomach pain, constipation, diarrhea, stomach irritation, nausea, and vomiting are the most common adverse reactions. Instruct patient to notify health care provider if any occur and are intolerable.
• Caution parent or caregiver accidental overdose of iron-containing products is a leading cause of fatal poisoning in children and to take precautions to keep iron-containing products out of the reach of children.

Copyright © 2009 Wolters Kluwer Health.