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Pronunciation:

(FER us SUL fate)

U.S. Brand Names:

Feosol® [OTC]; Feratab® [OTC]; Fer-Gen-Sol [OTC]; Fer-In-Sol® [OTC]; Fer-Iron® [OTC]; Slow FE® [OTC]

Synonyms:

FeSO4; Iron Sulfate

Generic Available:

Yes

Canadian Brand Names:

Apo-Ferrous Sulfate®; Fer-In-Sol®; Ferodan™

Use:

Prevention and treatment of iron-deficiency anemias

Pregnancy Risk Factor:

A

Contraindications:

Hypersensitivity to iron salts or any component of the formulation; hemochromatosis, hemolytic anemia

Warnings/Precautions:

Administration of iron for >6 months should be avoided except in patients with continued bleeding, menorrhagia, or repeated pregnancies; avoid in patients with peptic ulcer, enteritis, or ulcerative colitis. Anemia in the elderly is often caused by "anemia of chronic disease" or associated with inflammation rather than blood loss. Iron stores are usually normal or increased, with a serum ferritin >50 ng/mL and a decreased total iron binding capacity. Hence, the "anemia of chronic disease" is not secondary to iron deficiency but the inability of the reticuloendothelial system to reclaim available iron stores.

Adverse Reactions:

>10%: Gastrointestinal: GI irritation, epigastric pain, nausea, dark stools, vomiting, stomach cramping, constipation

1% to 10%:

Gastrointestinal: Heartburn, diarrhea

Genitourinary: Discoloration of urine

Miscellaneous: Liquid preparations may temporarily stain the teeth

<1%: Contact irritation

Overdosage/Toxicology:

Symptoms of overdose include acute GI irritation; erosion of GI mucosa, hepatic and renal impairment, coma, hematemesis, lethargy, acidosis

Following treatment for fluid losses, metabolic acidosis, and shock, a severe iron overdose may be treated with deferoxamine. Deferoxamine may be administered I.V. (80 mg/kg over 24 hours) or I.M. (40-90 mg/kg every 8 hours). Usual toxic dose of elemental iron: 35 mg/kg.

Drug Interactions:

Antacids and H2 blockers (cimetidine): Concurrent administration may decrease iron absorption.

Chloramphenicol: Response to iron therapy may be delayed.

Levodopa, methyldopa, penicillamine: Iron may decrease absorption when given at the same time.

Quinolones: Absorption may be decreased due to formation of a ferric ion-quinolone complex

Tetracyclines: Absorption of oral preparation of iron and tetracyclines are decreased when both of these drugs are given together

Vitamin C: Concurrent administration of 200 mg vitamin C per 30 mg elemental iron increases absorption of oral iron.

Ethanol/Nutrition/Herb Interactions:

Food: Cereals, dietary fiber, tea, coffee, eggs, and milk may decrease absorption.

Mechanism of Action:

Replaces iron, found in hemoglobin, myoglobin, and other enzymes; allows the transportation of oxygen via hemoglobin

Pharmacodynamics/Kinetics:

Onset of action: Hematologic response: Oral: ~3-10 days

Peak effect: Reticulocytosis: 5-10 days; hemoglobin increases within 2-4 weeks

Absorption: Iron is absorbed in the duodenum and upper jejunum; in persons with normal serum iron stores, 10% of an oral dose is absorbed; this is increased to 20% to 30% in persons with inadequate iron stores. Food and achlorhydria will decrease absorption

Protein binding: To transferrin

Excretion: Urine, sweat, sloughing of the intestinal mucosa, and menses

Dosage:

Oral:

Children (dose expressed in terms of elemental iron):

Severe iron-deficiency anemia: 4-6 mg Fe/kg/day in 3 divided doses

Mild to moderate iron deficiency anemia: 3 mg Fe/kg/day in 1-2 divided doses

Prophylaxis: 1-2 mg Fe/kg/day up to a maximum of 15 mg/day

Adults (dose expressed in terms of ferrous sulfate):

Iron deficiency: 300 mg twice daily up to 300 mg 4 times/day or 250 mg (extended release) 1-2 times/day

Prophylaxis: 300 mg/day

Administration:

Administer ferrous sulfate 2 hours prior to, or 4 hours after antacids

Monitoring Parameters:

Serum iron, total iron binding capacity, reticulocyte count, hemoglobin

Reference Range:

Serum iron:

Male: 75-175 mcg/dL (SI: 13.4-31.3 mol/L)

Female: 65-165 mcg/dL (SI: 11.6-29.5 mol/L)

Total iron binding capacity: 230-430 mcg/dL

Transferrin: 204-360 mg/dL

Percent transferrin saturation: 20% to 50%

Test Interactions:

False-positive for blood in stool by the guaiac test

Dietary Considerations:

Should be taken with water or juice on an empty stomach; may be administered with food to prevent irritation; however, not with cereals, dietary fiber, tea, coffee, eggs, or milk.

Elemental iron content of iron salts in ferrous sulfate is 20% (ie, 300 mg ferrous sulfate is equivalent to 60 mg ferrous iron)

Patient Education:

May color stool black. Take between meals for maximum absorption; take with food if GI upset occurs. Do not take with milk or antacids. Keep out of reach of children.

Dental Health: Effects on Dental Treatment:

Do not prescribe tetracyclines simultaneously with iron since GI tract absorption of both tetracycline and iron may be inhibited. Liquid preparations may temporarily stain the teeth.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Elixir: 220 mg/5 mL (480 mL) [elemental iron 44 mg/5 mL; contains alcohol]

Liquid, oral drops: 75 mg/0.6 mL (50 mL) [elemental iron 15 mg/0.6 mL]

Fer-Gen-Sol: 75 mg/0.6 mL (50 mL) [elemental iron 15 mg/0.6 mL]

Fer-In-Sol®: 75 mg/0.6 mL (50 mL) [elemental iron 15 mg/0.6 mL; contains alcohol 0.2% and sodium bisulfite]

Fer-Iron: 75 mg/0.6 mL (50 mL) [elemental iron 15 mg/0.6 mL]

Tablet: 324 mg [elemental iron 65 mg]; 325 mg [elemental iron 65 mg]

Feratab®: 300 mg [elemental iron 60 mg]

Tablet, exsiccated (Feosol®): 200 mg [elemental iron 65 mg]

Tablet, exsiccated, timed release (Slow FE®): 160 mg [elemental iron 50 mg]

International Brand Names:

Aktiferrin® (AT, CH, CZ, DE, HU, RU); Apo-Ferrous Sulfate® (CA); ARI® (BD); Ceferro® (DE); Duroferon® (FI, NO, SE); Dyaferon® (BD); Eisendragees-ratiopharm® (DE, PL); Eisensulfat Lomapharm® (DE); Eisensulfat Stada® (DE); Eryfer® (DE); Eurofer® (AR); Factofer® (AR); Femas® (JP); Femeton® (BD); Feospan® (GB, HK, IE, SG); Feoton® (BD); Fer-in-Sol® (AR, BR); Fer-In-Sol® (CA); Fer-in-Sol® (CL, CR, GT, HN, IE, PA, SV); Ferlea® (AR); Ferocin® (BD); Ferodan™ (CA); Fero-Gradumet® (BE, ES, LU, NL); Ferosol® (BD); Ferradren® (AR); Ferricol® (AR); Ferro Duretter® (DK); Ferrogamma® (DE); Ferroglobe® (BD); Ferroglobin® (BD); Ferrograd® (GB, IE); Ferro-Grad® (IT); Ferro-Gradumet® (AT, AU, CH, EG, HU, IL, JO, KW, LB); Ferrogradumet® (NZ); Ferro-Gradumet® (PL, PT, RO, SY); Ferro gradumet® (YU); FERROinfant® (DE); Ferromas® (AR); Ferrometion® (AR); Ferroplex "Era"® (DK); Ferroso Solfato® (IT); Ferrous Sulfate® (TR); Ferrum-Quarz-Kapseln® (AT); Fesofor® (ZA); Fesyrup® (BD); Haemofer® (RU); Haemoprotect® (DE); H&auml;matopan® (DE); Hemobion® (MX); Hemofer Prolongatum® (BG, PL); Hierro Fabra® (AR); Hierro Lafedar® (AR); Iberol® (AR, BR, CL); Infa-Tardyferon® (AT); Ironfer® (BR); Kendural® (DE); Lom-Sulfato Ferroso® (BR); Oroferon® (TR); Plastufer® (DE); Resoferon® (MT, PL, RO); Retafer® (FI, HR, RO, SI); Siderblut® (AR); Slow-Fe® (GB, IL); Sorbifer® (HK); Sulfato Ferroso® (CL); Tardyferon® (AT, CH, CZ, DE, ES, FR, HU, LU, PL, RO, RU); Venofer® (DK, NO, SE); Viron® (BD); Vitaferro Kapseln® (DE)

References

Lipschitz DA, "The Anemia of Chronic Disease,"J Am Geriatr Soc, 1990, 38(11):1258-64.

Marx JJM, "Normal Iron Absorption and Decreased Red Cell Iron Uptake in the Aged,"Blood, 1979, 53:204-11.

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