Iron Supplements (Systemic)

This monograph includes information on the following:

1) Ferrous Fumarate
2) Ferrous Gluconate
3) Ferrous Sulfate
4) Iron Dextran
5) Iron-Polysaccharide  
6) Iron Sorbitol  *
7) Iron Sucrose  
8) Sodium Ferric Gluconate

VA CLASSIFICATION
Primary: TN401

Commonly used brand name(s): Apo-Ferrous Gluconate2; Apo-Ferrous Sulfate3; DexFerrum4; DexIron4; Femiron1; Feosol Caplets3; Feosol Tablets3; Feostat1; Feostat Drops1; Fer-In-Sol Drops3; Fer-In-Sol Syrup3; Fer-Iron Drops3; Fer-gen-sol3; Feratab3; Fergon2; Fero-Gradumet3; Ferodan Infant Drops3; Ferodan Syrup3; Ferospace3; Ferra-TD3; Ferralet2; Ferralet Slow Release2; Ferralyn Lanacaps3; Ferretts1; Ferrlecit8; Fertinic2; Fumasorb1; Fumerin1; Hemocyte1; Hytinic5; InFeD4; Ircon1; Jectofer6; Mol-Iron3; Neo-Fer1; Nephro-Fer1; Niferex5; Niferex-1505; Novofumar1; Nu-Iron5; Nu-Iron 1505; Palafer1; Simron2; Slow Fe3; Span-FF1; Venofer7.

Other commonly used names are:

• Ferric hydroxide sucrose complex [Iron sucrose]


• Ferrous sulfate exsiccated [Ferrous Sulfate]


• Iron saccharate [Iron sucrose]


• Iron sucrose complex [Iron sucrose]


• Iron sugar [Iron sucrose]


• Saccharated ferric oxide [Iron sucrose]

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).

*Not commercially available in the U.S.

Not commercially available in Canada.



Category:


Antianemic—

nutritional supplement (mineral)—

Indications

Accepted

Iron deficiency anemia, hemodialysis-induced (treatment)—Sodium ferric gluconate complex injection and iron sucrose injection are indicated for the treatment of iron deficiency anemia in patients undergoing chronic hemodialysis who are receiving supplemental erythropoietin therapy. {148}{149}

Iron deficiency anemia (prophylaxis and treatment)—Iron supplements are indicated in the prevention and treatment of iron deficiency anemia, which may result from inadequate diet, malabsorption, pregnancy, rapid growth during childhood, and/or blood loss. {105}
—Iron dextran and iron sorbitol are recommended for patients in whom iron deficiency has been determined, only after the cause has been corrected, if possible, and only when oral administration has been found unsatisfactory or impossible. {01} {43} {105}

Note: The cause of iron deficiency states should always be determined, as it may relate to a serious condition. {105}

—Deficiency of iron may lead to fatigue, {105} shortness of breath, {105} decreased physical performance, impaired learning in children and adults, {04} {05} {09} {11} {76} {77} {103} {130} altered body temperature, and altered immune function. {10} {52} {53} {54}
—Requirements may be increased and/or supplementation may be necessary in the following persons or conditions (based on documented iron deficiency):

• Achlorhydria {31} {104} {105}


• Blood loss, excessive {55}


• Burns


• Gastrectomy {105}


• Hemodialysis {43}


• Hemorrhage {55}


• Infants—full-term infants after 4 months of age and {106} {107} preterm infants after 2 months of age, {55} especially those receiving breast milk or low-iron formulas {10} {127}


• Intestinal diseases—celiac, {55} Crohn's, {76} diarrhea, {104} inflammatory bowel disease, {81} {115} malabsorption {104}

—In addition, individuals with conditions that cause chronic blood loss (e.g., peptic ulcer, hemorrhoids, hookworms) may be at risk for iron deficiency anemia. {105}
—Some unusual diets (e.g., reducing diets that drastically restrict food selection) may not supply minimum daily requirements of iron. Supplementation may be necessary in patients receiving total parenteral nutrition (TPN) {116} {121} or undergoing rapid weight loss or in those with malnutrition, because of inadequate dietary intake.
—Recommended intakes for most vitamins and minerals are increased during pregnancy. Many physicians recommend that pregnant women receive multivitamin and mineral supplements, especially those pregnant women who do not consume an adequate diet and those in high-risk categories (i.e., women carrying more than one fetus, heavy cigarette smokers, and alcohol and drug abusers). However, taking excessive amounts of multivitamin and mineral supplements may be harmful to the mother and/or fetus and should be avoided. {56}
—Recommended intakes for most vitamins and most minerals are increased during breast-feeding. {10}
—Recommended intakes may be increased by the following medications: Antacids, {21} {23} {38} calcium supplements, {35} {36} epoetin, {48} {49} penicillamine, {22} trientine, {34} zinc supplements, {39} {40} {41} {42} and any medications that cause bleeding from the gastrointestinal tract. {60} {62} {63}


Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    Ferrous fumarate: 169.91 {113}
    Ferrous gluconate: 482.18 {113}
    Ferrous sulfate: 278.02 {113}
    Ferrous sulfate, dried: 151.91 {102}
    Iron sucrose: 34,000–60,000 daltons {149}.
    Sodium ferric gluconate: 289,000–440,000 daltons{148}


pH
    Iron sucrose: 10.5–11.1{149}.
    Sodium ferric gluconate: 7.7–9.7.

Mechanism of action/Effect:

Iron is an essential component in the physiological formation of hemoglobin, adequate amounts of which are necessary for effective erythropoiesis and the resultant oxygen transport capacity of the blood. A similar function is provided by iron in myoglobin production. Iron also serves as a cofactor of several essential enzymes, including cytochromes that are involved in electron transport. {57} {58} {60} Iron is necessary for catecholamine metabolism {58} {60} and the proper functioning of neutrophils. {54} {57} {58} {59}

Absorption:

Absorption is increased when iron stores are depleted or red blood cell production is increased. Conversely, high iron blood concentrations decrease absorption. {108}


Oral dosage forms:

When taken orally, in food or as a supplement, iron passes through the mucosal cells in the ferrous state and is bound with the protein transferrin. {60}

Iron-deficient individuals: 10 to 30% is absorbed, the amount being approximately proportional to the degree of deficiency. {104} {132} {134}

Non–iron-deficient individuals: Approximately 5 to 15% of ingested iron is absorbed. {132}

Absorption occurs principally in the duodenum and proximal jejunum. {61} {104}

Absorption is most efficient when iron is ingested in its ferrous rather than its ferric form, on an empty stomach. Gastric acid increases absorption by maintaining ferric iron in a soluble form. {104}

Twenty to 30% of heme iron is absorbed from the diet. {105} {133} Two to 10% of nonheme iron is absorbed from the diet, {134} and its absorption is affected by other foods ingested. {60} Ascorbic acid, as a supplement or in foods, {77} reduces ferric salts to the ferrous form and thus enhances the absorption of nonheme iron. {15} {51} Meat and other animal tissues also enhance the absorption of nonheme iron. {132} Certain foods and supplements, such as coffee, tea, milk, eggs, calcium, whole grains, and phosphorus, may inhibit nonheme iron absorption. {141}



Parenteral dosage forms:

Iron dextran: Iron dextran is absorbed from the injection site into the capillaries and lymphatic system. {11} The majority of the intramuscular injection is absorbed within 72 hours. {01} The remaining iron is absorbed in the following 3 to 4 weeks. {01} Evidence of a therapeutic response is observed in a few days as an increase in reticulocyte count. {06} The intravenous dose is available much more rapidly. {02}

Iron sorbitol: Iron sorbitol is absorbed directly into the bloodstream as well as via the lymphatic system. {43} Sixty-six percent of the intramuscular injection is absorbed within 3 hours. {43}


Distribution:

Oral dosage forms—Iron is transported in the body to bone marrow for red blood cell production in the iron-transferrin complex form.

Iron dextran—Iron dextran is removed from the plasma by cells of the reticuloendothelial system and dissociated into iron and dextran. The released iron is immediately bound to protein moieties to form hemosiderin or ferritin or, to a lesser extent, transferrin. {11} The protein-bound iron eventually replenishes the depleted iron stores and is incorporated into hemoglobin.

Iron sucrose—Iron sucrose is removed from the plasma by cells of the reticuloendothelial system and dissociated into iron and sucrose.{149} The apparent volume of distribution (Vol D) of iron sucrose at steady-state is 7.9 L{149}

Sodium ferric gluconate—In pharmacokinetic studies, approximately 80% of drug-bound iron is delivered to transferrin as a mononuclear ionic iron species within 24 hours of administration in each dosage regimen. Direct movement of iron from sodium ferric gluconate to transferrin was not observed. The initial volume of distribution was 6 L.{148}

Protein binding:

Very high (90% or more).

Hemoglobin—High.

Myoglobin, enzymes, and transferrin—Low.

Ferritin and hemosiderin—Low.


Storage

Iron is stored as ferritin or hemosiderin, {104} primarily in hepatocytes and in the reticuloendothelial system, with some storage in muscle. {60}

Half-life:

Ferrous sulfate—6 hours. {61}

Iron dextran, intravenously administered—5 to more than 20 hours. However, half-life values do not represent clearance of iron from the body. {01}

Iron sucrose—6 hours.{149}

Sodium ferric gluconate—Approximately 1 hour.{148}

Time to peak concentration:

Iron sorbitol—2 hours. {43}

Elimination:
    No physiological system of elimination exists for iron, and it can accumulate in the body to toxic amounts; however, small amounts are lost daily in the shedding of skin, hair, and nails; and in feces, perspiration, breast milk (1.1 to 1.4 mg per day){151}{152}, menstrual blood, and urine. {14}


Average daily loss of iron for healthy adults is—
         Males: 1 mg per day. {14}
        Postmenopausal females: 1 mg per day. {14}
        Healthy premenopausal adult females: 1.5 to 2 mg per day. {60}



Iron sorbitol—
        30% of dose excreted in urine in 24 hours. {43}



Iron sucrose—
        5% of the iron excreted in urine in 24 hours.{149}



In dialysis—
        Less than 1% of the iron component of sodium ferric gluconate complex in vitro can be dialyzed through membranes with pore sizes 12,000 to 14,000 daltons over a period of 270 minutes.{148}



Precautions to Consider

Carcinogenicity/Tumorigenicity

For iron dextran—Tumors at the injection site have been reported in humans who had previously received intramuscular injections of iron-carbohydrate complexes. However, the actual risk of such tumors is unknown because of the long latency period between injection and appearance of a tumor. Animal studies have shown the production of sarcoma in rodents injected repeatedly at the same site with large doses of iron-carbohydrate complexes. However, the rodent tumors were a different type than those reported in humans. {01}

For iron sorbitol—There was no evidence of lymphatic obstruction or tumors at the injection site in mice receiving iron sorbitol subcutaneously at doses of 1 mg a week for seven months. {43}

For iron sucrose—Long-term carcinogenicity studies in animals have not been performed.{149}

For sodium ferric gluconate—Long-term carcinogenicity studies in animals have not been performed {148}.

Mutagenicity

For iron sucrose—There was no evidence of mutagenicity in the Ames test, mouse lymphoma cell forward mutation test, human lymphocyte chromosome aberration test, or the mouse micronucleus test.{149}

For sodium ferric gluconate—There was no evidence of mutagenicity in the Ames test and the rat micronucleus test. Sodium ferric gluconate produced a clastogenic effect in an in vitro chromosomal aberration assay in Chinese hamster ovary cells.{148}

Pregnancy/Reproduction
Fertility—

For iron sucrose

Intravenous doses up to 15 mg iron per kg of body weight (mg/kg) per day (1.2 times the recommended maximum human dose on a body surface area basis) did not result in any effects on fertility or reproductive performance in male or female rats.{149}



For sodium ferric gluconate

Studies to assess the effects on fertility were not performed.{148}


Pregnancy—

For ferrous fumarate, ferrous gluconate, ferrous sulfate, and iron-polysaccharide

In the first trimester of pregnancy, adequate iron intake is usually obtained from a proper diet; however, in the second and third trimesters, when iron deficiency is more prevalent because of greatly increased requirements, iron supplements may be recommended. However, some clinicians prefer to evaluate the patient before giving routine iron supplementation. {117} {118}

Studies in humans have not been done, and problems in humans have not been documented with intake of normal daily recommended amounts.

Studies in animals have not been done.



For iron dextran

Iron dextran crosses the placenta. Studies in humans have not been done. {01}

Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses three times the maximum human dose. {01}

FDA Pregnancy Category C.



For iron sucrose

Studies in humans have not been done. Studies in rats and rabbits at doses of 13 mg/kg/day (0.5 times the recommended human dose on a body surface area (BSA) basis and 1 time the recommended human dose on a BSA basis, respectively) have shown no evidence of fetal harm.{149}

FDA Pregnancy Category B.{149}



For iron sorbitol

Although no adequate and well-controlled studies have been done in humans, there have been a few reports of abortion after use of iron sorbitol in early pregnancy. Use is not recommended in the first 3 to 4 months of pregnancy. {43}


Studies in animals have not been done. {43}



For sodium ferric gluconate

Adequate and well-controlled studies in humans have not been done. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus{148}.

Sodium ferric gluconate was not teratogenic in mice and rats at doses of 300 milligram per square meter of body surface area (mg/m 2) per day and 120 mg/m2 per day (1.3 and 3.4 times the recommended human dose), respectively.{148}

FDA Pregnancy Category B.


Breast-feeding


For ferrous fumarate, ferrous gluconate, ferrous sulfate, and iron-polysaccharide :

Problems in humans have not been documented with intake of normal daily recommended amounts. {01}



For iron dextran:

Only traces of unmetabolized iron dextran are distributed into breast milk. {01}



For iron sucrose:

It is not known whether this drug is distributed into human breast milk. However, it has been shown to distribute into the milk of rats. Because many drugs are distributed into human milk, caution should be exercised when this drug is administered to a nursing woman.{149}



For sodium ferric gluconate:

It is not known whether this drug is distributed into human milk. Because many drugs are distributed into human milk, caution should be exercised when this drug is administered to a nursing woman{148}.


Pediatrics

The American Academy of Pediatrics recommends that iron supplementation (as iron-fortified formula or cereal or as iron-containing drops) {127} be given to preterm infants after 2 months of age and to full-term infants after 4 months of age, whether breast or formula fed. {106}

Problems in pediatrics have not been documented with intake of normal daily recommended amounts. Iron dextran is not normally given to infants under 4 months of age. {20} There have been reports from other countries of increased gram-negative sepsis in neonates given iron dextran, probably due to Escherichia coli , after intramuscular injection. {01}

No information is available on the relationship of age to the effects of sodium ferric gluconate in the pediatric population. Safety and efficacy have not been established. The sodium ferric gluconate complex in sucrose injection contains benzyl alcohol and therefore should not be used in neonates {148}.

No information is available on the relationship of age to the effects of iron sucrose in the pediatric population. Safety and efficacy have not been established. {149}.


Geriatrics


Problems in geriatrics have not been documented with intake of normal daily recommended amounts. Some geriatric patients may require a larger than usual daily ingestion of bioavailable {77} iron to correct an iron deficiency, because their ability to absorb iron has been diminished by reduced gastric secretions and achlorhydria.

Appropriate studies on the relationship of age to the effects of iron sucrose and sodium ferric gluconate have not been performed in the geriatric population. However, no geriatrics-specific problems have been documented to date. In general, dose selection for an elderly patient should be cautious , usually starting at the low end of the dosing range{148}.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following, depending on the amount present, may also interact with this iron supplement.

» Acetohydroxamic acid{07}    (iron, and possibly other heavy metals, when taken orally, are chelated by acetohydroxamic acid; this may result in reduced intestinal absorption of both acetohydroxamic acid and oral iron supplements; if iron therapy is indicated during treatment with acetohydroxamic acid, parenteral administration of iron is recommended {07})


Alcohol    (concurrent use with ferric iron for a prolonged period may result in toxicity since absorption and hepatic storage of iron are increased, especially if alcohol usage is high {37} {61})


» Antacids or{21}{23}{38}
Calcium supplements (calcium carbonate or phosphate) or{35}{36}
Coffee or{50}{61}
Eggs or{46}
Foods or medications containing bicarbonates,{108} carbonates,{120} oxalates,{108} or phosphates or{60}{104}{129}
Milk or milk products or{31}
Tea containing tannic acid or{31}
Whole-grain breads and cereals (contain phytic acid) and dietary fiber{31}{47}{61}    (concurrent use with iron may {78} decrease iron absorption because of the formation of less soluble or insoluble complexes; iron supplements should not be taken within 1 hour before or 2 hours after ingestion of any of the above)


Cimetidine    (the decrease in gastric acid caused by cimetidine may decrease the absorption of nonheme iron; concurrent use with iron supplements is not recommended; iron supplements should be taken at least 2 hours before or after cimetidine {82} {83} {84})


Deferoxamine, and possibly other chelating agents    (deferoxamine chelates iron and is used in the treatment of iron overdose and other iron overload conditions; iron may be necessary in patients receiving other chelating agents; however, it should be given at least 2 hours after the chelating agent {79})


» Dimercaprol{23}{32}    (concurrent administration of medicinal iron with dimercaprol results in the formation of a toxic complex; if iron deficiency is present, its treatment should be postponed until therapy with dimercaprol has been discontinued for at least 24 hours; severe iron deficiency anemia occurring during dimercaprol therapy should be managed with blood transfusion)


» Etidronate{33}    (concurrent use may prevent absorption of oral etidronate; patients should be advised to avoid using iron supplements within 2 hours of etidronate)


» Fluoroquinolones    (iron may reduce absorption of fluoroquinolones by chelation, resulting in lower serum and urine concentrations of fluoroquinolones; fluoroquinolones should be taken at least 2 hours before or 2 hours after iron supplements {12} {13} {44} {45} {100} {131})


Pancreatin or{21}
Pancrelipase{21}    (concurrent use of these medications with iron supplements may decrease iron absorption)


Penicillamine{19}{22} or
Trientine{34}    (concurrent use with iron supplements may decrease the therapeutic effects of these medications; if necessary, iron may be administered in short courses, but a period of 2 hours should elapse between administration of penicillamine or trientine and iron)


» Tetracyclines, oral{21}{23}{38}    (concurrent use with iron reduces absorbability and resultant therapeutic effects of oral tetracyclines; patients should be advised to take iron supplements 2 hours after tetracycline)


Zinc supplements, oral    (large doses of iron supplements have been found to inhibit the intestinal absorption of zinc; {39} {40} {41} {42} this may be a problem in individuals taking commercial multivitamin-mineral preparations or infant formulas that have a high iron-to-zinc ratio; {40} {42} however, most firms in the U.S. have reformulated their products; zinc supplements should be taken at least 2 hours after iron supplements)



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results
For all iron supplements
Iron concentrations, serum    (caution in interpretation of serum iron values in blood samples drawn within 1 to 2 weeks of administration of large doses of iron dextran and within 4 hours of oral iron {79})


Orthotolidine test    (presence of iron may give false-positive results {119} {144})


Technetium Tc 99m–labeled phosphates and phosphonates    (iron supplements may cause a decrease in bone uptake of technetium Tc 99m-labeled phosphates and phosphonates because of iron overload; bone scans with Tc 99m diphosphonate, taken 1 to 6 days after intramuscular iron dextran administration, may show dense areas of activity in the buttock, following the contour of the iliac crest {01} {109})


Tumor and/or abscess imaging with Ga-67 gallium citrate    (iron supplements may cause a decrease in tumor and/or abscess uptake of Ga-67 gallium citrate due to competition for the same binding sites {109} {110})

For ferrous sulfate only (in addition to those laboratory value alterations listed above)
Glucose oxidase tests    (presence of ferrous sulfate may give false-negative results {64})

With physiology/laboratory test values
Occult blood in stools    (may be obscured by black coloration of iron in stool {143})


Serum discoloration    (large doses of iron dextran have been reported to impart a brown color to serum in blood drawn 4 hours after intravenous administration {01})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:
» Hemochromatosis or{16}
» Hemosiderosis{16}    (existing iron overload may be increased)


» Other anemic conditions, unless accompanied by iron deficiency (some conditions, such as hemolytic anemia or thalassemia, may cause excess storage of iron){14}{43}
» Porphyria cutanea tarda    (may be caused by hepatic accumulation of iron, as in iron overload {104} {122} {123} {124})


Risk-benefit should be considered when the following medical problems exist
Alcoholism, active or in remission    (alcohol may increase absorption and hepatic storage of iron and increase iron toxicity {37} {61})


Allergies or{01}
Asthma{01}    (increased risk of hypersensitivity reactions with parenteral administration)


Cardiovascular disease    (may be exacerbated by possible adverse reactions caused by administration of iron dextran {01} {140})


Hepatitis or hepatic function impairment or{01}{43}
Kidney disease, acute, infectious{01}    (may cause an accumulation of iron)


Intestinal tract inflammatory conditions, such as enteritis, colitis, diverticulitis, and ulcerative colitis or{15}
Peptic ulcer{17}{43}    (may be exacerbated with oral iron dosage forms)


Rheumatoid arthritis    (acute exacerbation of joint pain and swelling following intravenous administration of parenteral iron {01})


Sensitivity to iron
» Caution is recommended also in patients receiving repeated blood transfusions because the addition of high erythrocytic iron content may produce iron overload.{01}

Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):

Ferritin concentrations, serum and{01}
Iron concentrations, serum{01}    (determinations are recommended when deemed necessary to recognize and prevent hemosiderosis and progressive accumulation of iron in patients with chronic renal failure, {119} Hodgkin's disease, or rheumatoid arthritis, or in patients receiving large doses of iron dextran; patients on chronic renal dialysis may not show a valid correlation of serum iron ferritin with body iron stores while receiving iron dextran {01})


Hemoglobin and hematocrit determinations and{01}{16}
Reticulocyte counts{16}    (suggested at 3-week intervals for the first 2 months of therapy; recommended a few days after parenteral administration to determine therapeutic response; if there has not been at least a 1-gram-per-100-mL rise in hemoglobin within 2 weeks of initiation of iron dextran therapy, a review of the diagnosis of iron deficiency anemia may be necessary)


Total iron binding capacity (TIBC) or{01}
Transferrin, percentage saturation of{01}    (some clinicians recommend monthly determinations {80} during parenteral iron administration; however, while transferrin saturation may reflect a depletion of stored iron, it is less sensitive to changes in iron stores than serum ferritin {65}; some clinicians recommend that TIBC and/or transferrin be monitored only in the case of suspected iron overload {77} {79})




Side/Adverse Effects

Note: Stools commonly become dark green or {72} black when iron preparations are taken orally. This is caused by the presence of unabsorbed iron and is harmless. {120}However, bleeding in the gastrointestinal tract may also cause black stools of a sticky consistency, often accompanied by other symptoms such as red streaks in the stool, cramping, soreness, or sharp pains in the stomach or abdominal region. Medical attention is needed for proper evaluation of the cause.
The parenteral administration of iron has resulted in anaphylactic reactions that, on rare occasions, have been fatal. Such reactions occur within the first several minutes of administration and have been characterized by sudden onset of respiratory difficulties and/or cardiovascular collapse. {01} Therefore, the parenteral form of drug should should be administered only when resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available{150}. {01} {69} {77}

The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence more frequent
Oral use only
    
Abdominal or stomach pain, cramping, or soreness {17} {114} {120}

Parenteral use only
    
Allergic reaction {148}{43}{114}{148}(skin rash or hives; swelling of mouth or throat; trouble in breathing )
    
backache , flank, groin, {148}or muscle pain
    
chills
    
dizziness {43}{114}{148}
    
fever with increased sweating {114}
    
headache {149}
    
metallic taste {43}
    
nausea or vomiting {43}{114}{148}
    
numbness, pain, or tingling of hands or feet
    
chest pain
    
hypotension (dizziness or fainting){148}{149}
    
fast heartbeat
    
flushing or redness of skin —with excessive rate of intravenous administration {43}
    
pain and redness or sores at intramuscular injection site {43}
    
redness at intravenous injection site {43} {114}

Note: Backache or muscle pain, chills, dizziness {43}, fever with increased sweating, headache, metallic taste {14} {43}, nausea or vomiting, {43} or numbness, pain, or tingling of hands or feet due to delayed reaction, with recommended doses; onset may be in 24 to 48 hours after administration and subsides in 3 to 7 days. {01} {114}
Hypotension may be related to the rate of administration and the total dose given.{149}



Incidence less frequent or rare
Oral use only
    
Contact irritation (chest or throat pain, especially when swallowing ; stools containing fresh or digested blood)
Note: Contact irritation due to contact with ulcerous areas or high concentration of iron in one area resulting from improper release from dosage form or delayed passage of dosage form through alimentary tract.



Parenteral use only
    
Diplopia (double vision)
    
malaise (general unwell feeling)
    
weakness —without feeling dizzy or faint
{148}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent {17} {120}
Oral use only
    
Constipation
    
diarrhea
    
nausea
    
vomiting

Parenteral use only
    
Brown discoloration of skin —usually fading within several weeks or months {43} {81}
    
leg cramps {149}


Incidence less frequent
Oral use only {17}
    
Darkened urine (iron sulfide formation following large doses )
    
staining of teeth —with liquid dosage forms

Oral and parenteral use only
    
Heartburn {148}






Overdose

Note: Acute toxicity, with symptoms ranging from vomiting to coma, {70} has been reported with ingestion of 200 to 250 mg per kg of body weight (mg/kg) of ferrous sulfate in adults {10} and 20 mg/kg of elemental iron in children. {70} There have been no reports of chronic iron toxicity in individuals who do not have genetic defects that increase iron absorption. {10} {138}

For specific information on the agents used in the management of iron overdose, see    • Deferoxamine (Systemic) monograph;
   • Ipecac (Oral-Local) monograph; and/or
   • Sodium Bicarbonate (Systemic) monograph.


For more information on the management of overdose or unintentional ingestion, contact a poison control center (see Poison Control Center Listing ).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Acute effects
Early symptoms of acute iron toxicity
Oral use only
    
Diarrhea, sometimes containing blood {17}{66}
    
fever {66}
    
nausea, severe {17}{66}{68}
    
stomach pain or cramping, sharp {17}{66}{68}
    
vomiting, severe, sometimes containing blood {17} {66} {68}
Note: Early symptoms may not be evident for up to 60 minutes or longer; if overdose is suspected, emergency room treatment should not be delayed for evidence of symptoms, but should begin immediately. {66}
Early signs may also include increased blood glucose and leukocytosis. {66}
A latency period lasting from 2 to about 48 hours after ingestion may occur between the 2 symptomatic phases. During this time, the patient may appear to improve clinically. {03}



Parenteral use only
    
Abdominal pain
    
diarrhea
    
vomiting


Late symptoms of acute iron toxicity
Oral and parenteral use
    
Bluish-colored lips, fingernails, palms of hands
    
drowsiness
    
pale, clammy skin {68}
    
seizures
    
shallow and rapid breathing — due to acidosis
    
unusual tiredness or weakness
    
weak and fast heartbeat

Note: Late signs may also include metabolic acidosis, {67} {68} hypotension, {67} hypoglycemia, {66} hepatic injury or failure, {66} {125} cardiovascular collapse, and gastrointestinal scarring {67} {68} {126}.





For treatment of acute overdose
Overdose of iron by any route may be fatal, and immediate treatment is essential. Overdoses of ingested iron can be fatal, especially in small children. Serious poisoning may result in small children from ingestion of 3 or 4 ferrous sulfate tablets (200 mg of elemental iron). {70}

Acute overdose of iron requires immediate medical treatment that should be completed as soon as possible following ingestion. {120}

After one hour, excessive systemic absorption of iron and possible erosion of stomach {126} and intestinal tissues complicate evacuative and supportive procedures.

Transport of patient to emergency room should not be delayed. If syrup of ipecac has been administered, emesis may require up to 30 minutes or even a repeat dose. However, patient transport must not wait for emetic effect.

Overdose symptoms may be delayed (10 to 60 minutes or longer) because of many intervening factors such as the iron salt taken, amount of food in stomach, and size of dose.


To decrease absorption (after oral ingestion):
Inducing emesis with syrup of ipecac or lavaging with sodium bicarbonate if patient is comatose or having convulsions may be used, depending on the patient's condition. {70}

If intact radiopaque tablets are visualized on x-ray, repeating lavage may be necessary. {70}



Monitoring :
Laboratory studies on heparinized blood should include serum iron, hemoglobin, hematocrit, electrolytes, blood gases and blood glucose {06}, total iron-binding capacity (TIBC), complete blood count, blood type, and cross-match. {70}

Serum iron determinations should be repeated. Serum drawn early (within 2 hours of ingestion) may have artificially high concentrations of iron. Peak serum concentrations are reached about 6 hours after ingestion. {70} However, achievement of peak serum concentrations is delayed if the iron was in extended-release form, if the patient had a significant amount of food in his/her stomach, and if the dose of iron was large. {18}



Specific treatment:
Fluid and electrolyte balance must be maintained. {18} Acidosis may be corrected with intravenous sodium bicarbonate.

Antidote—Deferoxamine, administered slowly, intravenously or intramuscularly, is used in more severe iron toxicity, when symptoms are other than minimal vomiting or diarrhea. Deferoxamine chelates iron to form a red soluble ferric complex (ferrioxamine) that is excreted in the urine. {18} {70} Children with a history of ingesting > 40 mg of elemental iron per kg of body weight, or if serum iron determinations and TIBC are not available, should receive an intramuscular test dose of deferoxamine, regardless of symptoms. If the urine turns an orange-rose (vin rosé) color, deferoxamine should be continued intravenously. However, a negative test dose does not rule out iron toxicity, since false negative tests have been reported with deferoxamine. {71} When results of serum iron determinations and TIBC are available, dosing should continue, if necessary.

Avoid deferoxamine in patients who have developed renal failure.

Dialysis is of no value in removing serum iron alone, but may be used to increase excretion of the iron-deferoxamine complex, and is indicated in the presence of anuria or oliguria. {18} {70}

Exchange transfusion may be successful. {08} {18}

Whole bowel irrigation is being used by some clinicians, {137} {138} but is not standard practice. {139}

Sodium ferric gluconate complex is not dialyzable{148}.



Supportive care:
Patient must be observed for a minimum of 24 hours after becoming asymptomatic. Delayed effects may include shock and severe gastrointestinal bleeding {02} (24 to 48 hours), and gastrointestinal obstruction (weeks to months). Residual damage may be ruled out with liver and upper gastrointestinal studies.

Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.



Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Iron Supplements (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Description of use
Description should include function in body, signs of deficiency, and conditions that may cause deficiency


Importance of diet
Importance of proper nutrition; supplement may be needed because of inadequate dietary intake

Best dietary sources of iron

Recommended daily intake for iron

Before using this dietary supplement
»   Conditions affecting use, especially:
Sensitivity to iron
Other medications, especially acetohydroxamic acid, antacids, dimercaprol, etidronate, fluoroquinolones, or oral tetracyclines
Other medical problems, especially hemochromatosis, hemosiderosis, other anemic conditions, prophyria cutanea tarda, or repeated blood transfusions

Proper use of this dietary supplement

» Proper dosing
Taking on empty stomach 1 hour before or 2 hours after meals; or with food to lessen possibility of stomach upset

Taking with water or fruit juice, a full glass (240 mL) for adults, 1/2 glass (120 mL) for children

Use of parenteral form reserved in patients where the indications have been clearly established and laboratory results confirm an iron deficient state not amenable to oral iron therapy.

Following health care professional's directions if dietary supplement was prescribed

Following manufacturer's package directions on nonprescription (OTC) iron

For preventing, reducing, or removing iron stains on teeth
Diluting liquid forms in water or fruit juice

Using drinking tube or straw

Placing dropper doses well back on tongue

Brushing teeth with baking soda or hydrogen peroxide 3%
Skipping missed dose; going back to regular schedule; not doubling doses

» Proper storage

Precautions while using this dietary supplement
Taking iron supplements 1 hour before or 2 hours after eating dairy products, eggs, coffee, tea, whole-grain breads and cereals, antacids, or calcium supplements

Not taking iron supplements orally if receiving iron by injection

Avoiding regular use of large amounts of iron supplements several times daily for more than 6 months unless approved by health care professional

Extended-release dosage forms may not release iron properly; checking with health care professional if stools are not black during therapy

Keeping iron preparations out of the reach of children. Keeping syrup of ipecac readily available in case ordered for emergency

Keeping telephone numbers of poison control center, nearest hospital emergency room, and doctor readily available

» Suspected overdose: Immediately contacting physician, poison control center, or emergency room; following any instructions given on phone; not delaying emergency treatment; taking container of iron medicine to emergency room


Side/adverse effects
Parenteral use of this medication may lead to anaphylactic reactions; not administering unless resuscitation techniques and treatment of anaphylactic and anaphylactoid shock are readily available.

Iron supplements cause black stools, which may be alarming to patient although medically insignificant; checking with physician if black stools occur with other symptoms of internal blood loss

Signs of potential side effects, especially abdominal or stomach pain , cramping, or soreness, allergic reaction, backache, flank, groin, or muscle pain, chills, dizziness, fever with increased sweating, headache, metallic taste, nausea or vomiting, numbness, pain, or tingling of hands or feet, chest pain, hypotension, fast heartbeat, flushing or redness of skin, pain and redness or sores at intramuscular injection site, redness at intravenous injection site, contact irritation in alimentary tract, diplopia, malaise, or weakness


General Dosing Information
The elemental iron content of iron salts is as follows: {60} {70}

Iron Salt
% Elemental Iron
Ferrous fumarate
Ferrous 33
Ferrous gluconate
Ferrous 11.6
Ferrous sulfate
Ferrous 20
Ferrous sulfate, dried
Ferrous
Iron dextran
Ferric *
Iron-polysaccharide
Ferric *
Iron sucrose
Ferric
Sodium ferric gluconate   Ferric
* Variable, depending on product.


Noncompliance is a major factor in slow therapeutic results, especially in patients requiring prolonged treatment. {128}

In healthy adult males, there are approximately 50 mg per kg of body weight (mg/kg) of iron and 14 to 18 grams of hemoglobin per 100 mL of whole blood. {14}

In healthy adult females, there are approximately 35 mg/kg of iron and 12 to 16 grams of hemoglobin per 100 mL of whole blood.

The hemoglobin concentration of an iron-deficient patient usually reaches normal parameters after iron therapy of 1 or 2 months, but the plasma iron concentration often requires 3 to 6 months of therapy to reflect the normalization of body iron stores. {14}

The American Academy of Pediatrics recommends that breast-fed preterm infants 2 months of age and older receive 2 to 3 mg/kg a day of elemental iron in the form of ferrous sulfate. {127} Full-term infants 4 months of age and older should receive 1 mg/kg a day of elemental iron, preferably from iron-fortified formula or cereal. {127}

Concurrent use of ascorbic acid with iron in proper ratio is thought to enhance iron absorption by maintaining ferrous salts in the reduced state and by reducing ferric salts to the more absorbable ferrous form; {51} the suggested ratio is over 200 mg of ascorbic acid to 30 mg of elemental iron. {15}

Diet/Nutrition
Absorption of iron is most effective when the iron is ingested on an empty stomach; taking it with food will lessen absorption but will also lessen the chance of gastrointestinal irritation. {17} {105}

Taking iron supplements 1 hour before or 2 hours after eating dairy products, eggs, coffee, tea, or whole-grain breads and cereals will prevent the formation of less soluble or insoluble complexes, which decrease iron absorption. {31} {61}

Recommended dietary intakes for iron are defined differently worldwide.

Iron dextran injection should only be used by patients in whom indications have been clearly established and laboratory investigations confirm an iron deficient state not amenable to oral iron therapy.{150}



For U.S.:
The Recommended Dietary Allowances (RDAs) for vitamins and minerals are determined by the Food and Nutrition Board of the National Research Council and are intended to provide adequate nutrition in most healthy persons under usual environmental stresses. In addition, a different designation may be used by the FDA for food and dietary supplement labeling purposes, such as Daily Value (DV). DVs replace the previous labeling terminology United States Recommended Daily Allowances (USRDAs).



For Canada:
Recommended Nutrient Intakes (RNIs) for vitamins, minerals, and protein are determined by Health and Welfare Canada and provide recommended amounts of a specific nutrient while minimizing the risk of chronic diseases.

Daily recommended intakes for elemental iron are generally defined as follows: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
6–10
0.3–6
4 to 6 years of age
10
8
7 to 10 years of age
10
8–10
Adolescent and adult males
10
8–10
Adolescent and adult females
10–15
8–13
Pregnant females
30
17–22
Breast-feeding females
15
8–13


The best dietary source of iron is lean red meat. Chicken, turkey, and fish are less important sources of iron. {77} Foods rich in vitamin C (e.g., citrus fruits and fresh vegetables) and heme iron–containing foods (such as found in meats) enhance nonheme iron absorption from cereals, beans, and other vegetables. {26} Foods containing phytates, oxalates, fiber, and calcium may inhibit the absorption of nonheme iron. {77} In food preparation, additional iron may be added through cooking in iron pots. {60}


For treatment of allergic reaction
Treatment may include the following:

   • Administering epinephrine subcutaneously or intramuscularly. The usual adult dose for acute allergic (anaphylactic) reactions is 0.5 mL of a 1:1000 (1 mg/mL) solution (500 mcg of epinephrine base). {69}
   • Isoproterenol or similar beta-agonists may be required in patients taking beta-blockers because of an inadequate response to epinephrine. {01}

FERROUS FUMARATE

Summary of Differences
General dosing information: Contains 33% elemental ferrous iron. {09}


Oral Dosage Forms

FERROUS FUMARATE CAPSULES

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
10
8–10
Adolescent and adult females
10–15
8–13
Pregnant females
30
17–22
Breast-feeding females
15
8–13


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


300 mg (100 mg of elemental iron) (OTC) [Neo-Fer] [Palafer{153}]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of accidental overdose, especially in children, and need for immediate medical aid.



FERROUS FUMARATE EXTENDED-RELEASE CAPSULES

Usual adult and adolescent dose
See Ferrous Fumarate Capsules.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


325 mg (106 mg of elemental iron) (OTC) [Span-FF (sucrose )]{86}

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow capsules whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of accidental overdose, especially in children, and need for immediate medical aid.



FERROUS FUMARATE ORAL SOLUTION

Usual adult and adolescent dose
See Ferrous Fumarate Capsules.

Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
6–10
0.3–6
4 to 6 years of age
10
8
7 to 10 years of age
10
8–10


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Strength(s) usually available
U.S.—


45 mg (15 mg of elemental iron) per 0.6 mL (OTC) [Feostat Drops]

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Protect from freezing.
   • Keep out of reach of children.

Note: Explain dosage measurement; provide dropper or other dose-measuring device if indicated.
Explain dilution requirements.
Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS FUMARATE ORAL SUSPENSION

Usual adult and adolescent dose
See Ferrous Fumarate Capsules.

Usual pediatric dose
See Ferrous Fumarate Oral Solution.

Strength(s) usually available
U.S.—


100 mg (33 mg of elemental iron) per 5 mL (OTC) [Feostat]

Canada—


300 mg (100 mg of elemental iron) per 5 mL (OTC) [Palafer{153}]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Shake well before using.
   • Protect from freezing.
   • Keep out of reach of children.

Note: Explain dosage measurement; provide dropper or other dose-measuring device if indicated.
Explain dilution requirements.
Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS FUMARATE TABLETS USP

Usual adult and adolescent dose
See Ferrous Fumarate Capsules.

Usual pediatric dose
See Ferrous Fumarate Oral Solution.

Strength(s) usually available
U.S.—


63 mg (20 mg of elemental iron) (OTC) [Femiron]


195 mg (64 mg of elemental iron) (OTC) [Fumerin]


200 mg (66 mg of elemental iron) (OTC) [Fumasorb] [Ircon{89}]


300 mg (99 mg of elemental iron) (OTC)[Generic]


325 mg (106 mg of elemental iron) (OTC) [Ferretts{147}] [Hemocyte][Generic]


350 mg (115 mg of elemental iron) (OTC) [Nephro-Fer{86}]

Canada—


200 mg (66 mg of elemental iron) (OTC) [Novofumar (sucrose )]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of accidental overdose, especially in children, and need for immediate medical aid.



FERROUS FUMARATE CHEWABLE TABLETS

Usual adult and adolescent dose
See Ferrous Fumarate Capsules.

Usual pediatric dose
See Ferrous Fumarate Oral Solution.

Strength(s) usually available
U.S.—


100 mg (33 mg of elemental iron) (OTC) [Feostat]

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Chew well before swallowing.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of accidental overdose, especially in children, and need for immediate medical aid.



FERROUS GLUCONATE

Summary of Differences
General dosing information: Contains 11.6% elemental ferrous iron. {09}


Oral Dosage Forms

FERROUS GLUCONATE CAPSULES USP

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
10
8–10
Adolescent and adult females
10–15
8–13
Pregnant females
30
17–22
Breast-feeding females
15
8–13


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
6–10
0.3–6
4 to 6 years of age
10
8
7 to 10 years of age
10
8–10


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Strength(s) usually available
U.S.—


86 mg (10 mg of elemental iron) (OTC) [Simron (not USP )]

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS GLUCONATE ELIXIR USP

Usual adult and adolescent dose
See Ferrous Gluconate Capsules USP.

Usual pediatric dose
See Ferrous Gluconate Capsules USP.

Strength(s) usually available
U.S.—


300 mg (34 {88} mg of elemental iron) per 5 mL (OTC) [Fergon (alcohol 7%)][Generic]{24}{90}{92}

Canada—
Not commercially available.

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight, light-resistant container. Protect from freezing.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS GLUCONATE SYRUP

Usual adult and adolescent dose
See Ferrous Gluconate Capsules USP.

Usual pediatric dose
See Ferrous Gluconate Capsules USP.

Strength(s) usually available
U.S.—
Not commercially available.

Canada—


300 mg (35 mg of elemental iron) per 5 mL (OTC) [Fertinic]

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from light. Protect from freezing.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS GLUCONATE TABLETS USP

Usual adult and adolescent dose
See Ferrous Gluconate Capsules USP.

Usual pediatric dose
See Ferrous Gluconate Capsules USP.

Strength(s) usually available
U.S.—


300 mg (34 {88} mg of elemental iron) (OTC)[Generic]


320 mg (37 mg of elemental iron) (OTC) [Fergon (not USP )] [Ferralet]


325 mg (38 {88} mg of elemental iron) (OTC)[Generic]

Canada—


300 mg (35 mg of elemental iron) (OTC) [Apo-Ferrous Gluconate{153}] [Fertinic][Generic]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS GLUCONATE EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
See Ferrous Gluconate Capsules USP.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


320 mg (37 mg of elemental iron) (OTC) [Ferralet Slow Release{88}]

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE

Summary of Differences
Precautions: Laboratory value alterations—Ferrous sulfate may give false-negative results for glucose oxidase tests.

General dosing information: Contains 20% of elemental ferrous iron (dried ferrous sulfate contains approximately 32% of elemental iron). {09}


Oral Dosage Forms

FERROUS SULFATE CAPSULES

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
10
8–10
Adolescent and adult females
10–15
8–13
Pregnant females
30
17–22
Breast-feeding females
15
8–13


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
6–10
0.3–6
4 to 6 years of age
10
8
7 to 10 years of age
10
8–10


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Strength(s) usually available
U.S.—


250 mg (50 mg of elemental iron) (OTC) [Ferospace][Generic]{94}

Canada—
Not commercially available.

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE (DRIED)CAPSULES

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
See Ferrous Sulfate Capsules.

Strength(s) usually available
U.S.—

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow capsules whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE (DRIED)EXTENDED-RELEASE CAPSULES

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


150 mg (30 mg of elemental iron) (OTC)[Generic]


250 mg (50 mg of elemental iron) (OTC) [Ferralyn Lanacaps] [Ferra-TD][Generic]

Canada—
Not commercially available.

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a well-closed container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow capsules whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE ORAL SOLUTION USP

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
See Ferrous Sulfate Capsules.

Strength(s) usually available
U.S.—


220 mg (44 mg of elemental iron) per 5 mL (OTC)[Generic]

Canada—
Not commercially available.

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer. Protect from freezing.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE SYRUP USP

Note: The oral solution is sometimes known as concentrate, drops, or syrup.


Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
See Ferrous Sulfate Capsules.

Strength(s) usually available
U.S.—


75 mg (15 mg of elemental iron) per 0.6 mL (OTC) [Fer-gen-sol ( alcohol 0.2%)] [Fer-In-Sol Drops (alcohol 0.2% v/v)][Generic]{94}


90 mg (18 mg of elemental iron) per 5 mL (OTC) [Fer-In-Sol Syrup ( alcohol 5% {94})]


125 mg (25 mg of elemental iron) per mL (OTC) [Fer-Iron Drops][Generic]{94}


300 mg (60 mg elemental iron) {90} per 5 mL[Generic]{96}

Canada—


75 mg (15 mg of elemental iron) per mL (OTC) [Fer-In-Sol Drops ( alcohol 1.6%) (sodium < 1 0.1 mg){153}] [Ferodan Infant Drops{153}]


150 mg (30 mg of elemental iron) per 5 mL (OTC) [Fer-In-Sol Syrup ( sodium < 7.5 mg){153}] [Ferodan Syrup{153}]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from light. Protect from freezing.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE TABLETS USP

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
See Ferrous Sulfate Capsules.

Strength(s) usually available
U.S.—


195 mg (39 mg of elemental iron) (OTC) [Mol-Iron (sucrose )]


225 mg (45 mg of elemental iron) (OTC) [Feosol Caplets ( lactose) (sorbitol){154}]


300 mg (60 mg of elemental iron) (OTC) [Feratab{94}][Generic]{94}


325 mg (65 mg of elemental iron) (OTC)[Generic]

Canada—


300 mg (60 mg of elemental iron) (OTC) [Apo-Ferrous Sulfate{153}]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Swallow tablets whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE(DRIED)TABLETS USP

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
See Ferrous Sulfate Capsules.

Strength(s) usually available
U.S.—


200 mg, dried (65 mg of elemental iron) (OTC) [Feosol Tablets ( sorbitol){154}]

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Swallow tablets whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE DELAYED-RELEASE TABLETS

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


325 mg (approximately 65 mg of elemental iron) (OTC)[Generic]

Canada—


300 mg (60 mg of elemental iron) (OTC)[Generic]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow tablets whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



FERROUS SULFATE EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


325 mg (65 mg elemental iron) {91} (OTC)[Generic]{97}


525 mg (105 mg of elemental iron) (OTC) [Fero-Gradumet]

Canada—
Not commercially available.

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow tablets whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.


Additional information:
Products utilize a plastic matrix that may appear intact in the stool.


FERROUS SULFATE(DRIED)EXTENDED-RELEASE TABLETS

Usual adult and adolescent dose
See Ferrous Sulfate Capsules.

Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


160 mg, dried (50 mg of elemental iron) (OTC) [Slow Fe ( lactose) ( wax matrix)]

Canada—


160 mg, dried (50 mg of elemental iron) (OTC) [Slow Fe ( lactose) ( wax matrix)]

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), in a tight container, unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow tablets whole.
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.


Additional information:
Products utilize a porous wax matrix that may appear intact in the stool.


IRON DEXTRAN

Summary of Differences
General dosing information: Contains elemental ferric form of iron.


Additional Dosing Information
Oral iron must be discontinued before the administration of parenteral iron. {43}

Epinephrine should be immediately available during injection of iron dextran, especially in patients with allergies or asthma. {01}

Overdose with iron dextran produces no acute toxicity. However, excessive doses beyond the amounts required for restoration of hemoglobin and replenishment of iron stores may result in hemosiderosis. Excess iron may also increase a patient's susceptibility to infection, especially Yersinia enterocolitica . {74}

Factors contributing to the formula for determining dosages for patients with iron deficiency include:

• Blood volume—7.0% of body weight


• Normal hemoglobin (males and females)—

• 15 kg (33 lb) or less: 12 grams/deciliter (dL)


• Over 15 kg (33 lb): 14.8 grams/dL



• Iron content of hemoglobin—0.34%


• Body weight {05}


Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of iron dextran, and returns to baseline after about 3 weeks. {01}
For intravenous injection



• Iron dextran is administered undiluted and injected slowly at a rate not exceeding 1 mL per minute. However, some clinicians recommend that the calculated dose of iron dextran for the patient be added to 500 mL of dextrose 5% and infused over 4 to 5 hours, after a test infusion of 10 drops per minute for 10 minutes. {85}


• The manufacturer does not recommend that iron dextran be mixed with other medications or added to parenteral nutrition solutions for intravenous infusion; however, iron dextran is added to total parenteral nutrition solutions in current medical practice. {27} {28} {29} {30} Iron dextran should not be added to total nutrient admixtures (TNA) because it has been reported to affect lipid emulsion stability. {20} {111} {112}
For intramuscular injection

   • Iron dextran should be injected only into the muscle mass of the upper outer quadrant of the buttock. It should never be injected into the arm or other exposed areas. {01}
   • Deep injection with a 2- to 3-inch, 19- or 20-gauge needle is recommended. {01}
   • If the patient is standing during administration of iron dextran, body weight should be on the leg opposite to the injection site. {01}
   • If the patient is lying down during administration of iron dextran, he/she should be in a lateral position with injection site uppermost. {01}
   • A Z-track technique (displacement of the skin laterally prior to injection) is recommended to avoid injection or leakage into subcutaneous tissue. {01}
Test dose—An intramuscular or intravenous test dose of 25 mg (elemental iron) should be given to all patients before receiving their first therapeutic dose. {69} Although anaphylactic reactions may be evident within the first few minutes after injection, one hour or longer should elapse before the initial therapeutic dose. The intramuscular test dose should be administered in the same injection site and by the same technique as the therapeutic dose. {01}

If no adverse reactions are observed after the test dose, the daily dose of iron dextran may be given according to the following schedule until the total calculated amount has been reached:

• For infants up to 5 kg of body weight—25 mg (elemental iron) {01}


• For children under 10 kg—50 mg (elemental iron) {01}


• Other patients—100 mg (elemental iron) {01}



Parenteral Dosage Forms

IRON DEXTRAN INJECTION USP

Usual adult and adolescent dose
Deficiency (treatment)
To restore hemoglobin and replenish iron stores: Intravenous or intramuscular, the dosage being determined by the following dosage table: {01}

Patient
Weight

Total Iron Dextran Requirement (mL) *

Based on Observed Hemoglobin (grams/dL) of:

lb
kg
3
4
5
6
7
8
9
10
11
5
3
3
3
3
2
2
2
2
22
10
7
6
6
5
5
4
4
3
33
15
10
9
9
8
7
7
6
5
44
20
16
15
14
13
12
11
10
9
55
25
20
18
17
16
15
14
13
12
66
30
23
22
21
19
18
17
15
14
77
35
27
26
24
23
21
20
18
17
88
40
31
29
28
26
24
22
21
19
99
45
35
33
31
29
27
25
23
21
110
50
39
37
35
32
30
28
26
24
121
55
43
41
38
36
33
31
28
26
132
60
47
44
42
39
36
34
31
28
143
65
51
48
45
42
39
36
34
31
154
70
55
52
49
45
42
39
36
33
165
75
59
55
52
49
45
42
39
35
176
80
63
59
55
52
48
45
41
38
187
85
66
63
59
55
51
48
44
40
198
90
70
66
62
58
54
50
46
42
209
95
74
70
66
62
57
53
49
45
220
100
78
74
69
65
60
56
52
47
231
105
82
77
73
68
63
59
54
50
242
110
86
81
76
71
67
62
57
52
253
115
90
85
80
75
70
64
59
54
264
120
94
88
83
78
73
67
62
57
* Dosage calculations based on a normal adult hemoglobin of 14.8 grams per dL for patients weighing more than 15 kg (33 pounds) and on hemoglobin of 12 grams/dL for patients weighing 15 kg (33 pounds) or less than or equal to 15 kg (33 pounds). {01}

To calculate the total amount of iron dextran (mL) required to restore hemoglobin and to replenish iron stores in adults and children weighing over 15 kg (33 pounds), when LBW = lean body weight in kg and H = hemoglobin in grams/ dL: {13}

   • Iron dextran (mL) = 0.0442 (Desired H - Observed H) × LBW + (0.26 × LBW)
   • The dosage table above is not to be used for simple iron replacement from periodic blood loss in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) or patients on renal hemodialysis. {01}
To replace the equivalent amount of iron represented in blood loss (based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron)—Intramuscular or intravenous, the total iron requirement to be determined as follows: {01}

   • Replacement iron (mg) = Blood loss (mL) × hematocrit. {01}
   • To calculate dose in mL of iron dextran injection, divide result by 50. {01}


Usual pediatric dose
Deficiency (treatment)
To restore hemoglobin and replenish iron stores: Intravenous or intramuscular, the dosage being determined by the following dosage table: {01}

Patient
Weight

Total Iron Dextran Requirement (mL) *

Based on Observed Hemoglobin (grams/dL) of:

lb
kg
3
4
5
6
7
8
9
10
11
5
3
3
3
3
2
2
2
2
22
10
7
6
6
5
5
4
4
3
33
15
10
9
9
8
7
7
6
5
44
20
16
15
14
13
12
11
10
9
55
25
20
18
17
16
15
14
13
12
66
30
23
22
21
19
18
17
15
14
77
35
27
26
24
23
21
20
18
17
88
40
31
29
28
26
24
22
21
19
99
45
35
33
31
29
27
25
23
21
110
50
39
37
35
32
30
28
26
24
121
55
43
41
38
36
33
31
28
26
132
60
47
44
42
39
36
34
31
28
143
65
51
48
45
42
39
36
34
31
154
70
55
52
49
45
42
39
36
33
165
75
59
55
52
49
45
42
39
35
176
80
63
59
55
52
48
45
41
38
187
85
66
63
59
55
51
48
44
40
198
90
70
66
62
58
54
50
46
42
209
95
74
70
66
62
57
53
49
45
220
100
78
74
69
65
60
56
52
47
231
105
82
77
73
68
63
59
54
50
242
110
86
81
76
71
67
62
57
52
253
115
90
85
80
75
70
64
59
54
264
120
94
88
83
78
73
67
62
57
* Dosage calculations based on a normal adult hemoglobin of 14.8 grams per dL for patients weighing more than 15 kg (33 pounds) and on hemoglobin of 12 grams/dL for patients weighing less than or equal to 15 kg. {01}


Note: To calculate the total amount of iron dextran (mL) required to restore hemoglobin and to replenish iron stores in children weighing between 5 and 15 kg (11 and 33 pounds), when W = body weight in kg and H = hemoglobin in grams/dL: {01}    • Iron dextran (mL) = 0.0442 (Desired H - Observed H) × W + (0.26 × W)
   • The dosage table above is not to be used for simple iron replacement from periodic blood loss in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) or patients on renal hemodialysis. {01}




Strength(s) usually available
U.S.—


50 mg (elemental ferric iron) per mL (Rx) [DexFerrum{146}] [InFeD]

Canada—


50 mg (elemental ferric iron) per mL (Rx) [DexIron{153}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing.

Incompatibilities:
Addition of iron dextran to blood for transfusion is not recommended. {20} Iron dextran has been reported to affect lipid emulsion stability in certain total nutrient admixture (TNA) formulations. {20} {111} {112}

Additional information:
Vehicle in iron dextran injection is 0.9% sodium chloride injection. {20}


IRON-POLYSACCHARIDE

Summary of Differences
General dosing information: Contains elemental ferric form of iron.


Additional Dosing Information
Strengths of products expressed in terms of elemental iron content only.


Oral Dosage Forms

IRON-POLYSACCHARIDE CAPSULES

Usual adult and adolescent dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Adolescent and adult males
10
8–10
Adolescent and adult females
10–15
8–13
Pregnant females
30
17–22
Breast-feeding females
15
8–13


Deficiency (treatment)
Treatment dose is individualized based on severity of deficiency.


Usual pediatric dose
Dosage form is not recommended for use in children.

Strength(s) usually available
U.S.—


150 mg (elemental ferric iron) (OTC) [Hytinic] [Niferex-150{154}] [Nu-Iron 150]

Canada—
Not commercially available.

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



IRON-POLYSACCHARIDE ORAL SOLUTION

Usual adult and adolescent dose
See Iron-Polysaccharide Capsules.

Usual pediatric dose
Deficiency (prophylaxis)
Oral, amount based on normal daily recommended intakes of elemental iron: {10} {101}

Persons
U.S.
(mg)
Canada
(mg)
Infants and children
Birth to 3 years of age
6–10
0.3–6
4 to 6 years of age
10
8
7 to 10 years of age
10
8–10


Deficiency (treatment)
Treatment dose is individualized by prescriber based on severity of deficiency.


Strength(s) usually available
U.S.—


100 mg (elemental ferric iron) per 5 mL (OTC) [Niferex ( alcohol 10%) (sorbitol){154}] [Nu-Iron (alcohol 10%)]

Canada—
Not commercially available.

Note: The strength of these iron preparations may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container. Protect from freezing.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.
When indicated by dosage, include a calibrated liquid-measuring device and explain use.



IRON-POLYSACCHARIDE TABLETS

Usual adult and adolescent dose
See Iron-Polysaccharide Capsules.

Usual pediatric dose
See Iron-Polysaccharide Oral Solution.

Strength(s) usually available
U.S.—


50 mg (elemental ferric iron) (OTC) [Niferex{154}]

Canada—
Not commercially available.

Note: The strength of this iron preparation may exceed the dosage range recommended by USP DI Advisory Panels based on the amount necessary to meet normal nutritional needs.


Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a tight container.

Auxiliary labeling:
   • Keep out of reach of children.

Note: Caution patients about toxic effects of overdose, especially in children, and need for immediate medical aid.



IRON SORBITOL

Summary of Differences
General dosing information: Contains elemental ferric form of iron.


Additional Dosing Information
Oral iron must be discontinued before the administration of parenteral iron. {43}
For intramuscular injection

   • Iron sorbitol should be injected only into the muscle mass of the upper outer quadrant of the buttock. It should never be injected into the arm or other exposed areas. {43}
   • Deep injection with a 2- to 3-inch, 19- or 20-gauge needle is recommended. {43}
   • If the patient is standing during administration of iron sorbitol, body weight should be on the leg opposite to the injection site. {43}
   • If the patient is lying down during administration of iron sorbitol, he/she should be in a lateral position with injection site uppermost. {43}
   • A Z-track technique (displacement of the skin laterally prior to injection) is recommended to avoid injection or leakage into subcutaneous tissue. {43}


Parenteral Dosage Forms

IRON SORBITOL INJECTION

Usual adult and adolescent dose
Deficiency (treatment)
To restore hemoglobin and replenish iron stores: Intramuscular, the daily dosage is determined based on 1.5 mg of elemental iron per kg of body weight. The calculated daily dose may be administered daily or every other day until hemoglobin values are normal. {43}
To increase hemoglobin by 1 gram per 100 mL: Intramuscular administration of 200 mg elemental iron for women and 250 mg for men is necessary. To replenish iron stores, an additional 250 to 1000 mg of elemental iron is needed. {43}

Note: Some clinicians recommend that iron sorbitol injection be given in divided doses of 50 mg per week because larger doses are painful to the patient. {81}



Usual adult prescribing limits
100 mg per day. {43}

Usual pediatric dose
Deficiency (treatment)
To restore hemoglobin and replenish iron stores: Intramuscular, the daily dosage is determined based on 1.5 mg of elemental iron per kg of body weight. The calculated daily dose may be administered daily or every other day until hemoglobin values are normal. {43}

Note: Some clinicians recommend that iron sorbitol injection be given in doses of 50 mg per week because larger doses are painful to the patient. {81}



Strength(s) usually available
U.S.—
Not commercially available.

Canada—


50 mg (elemental ferric iron) per mL (Rx) [Jectofer{153}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.


IRON SUCROSE

Summary of Differences


Indications:
Used to treat hemodialysis-induced iron deficiency anemia in chronic dialysis patients receiving supplemental erythropoietin therapy{149}.



General dosing information:
Contains elemental ferric form of iron.{149}



Additional dosing information:
Dosage is expressed in terms of elemental iron.{149}

Rate of administration for slow injection should not exceed 1 mL (20 mg) per minute. {149} Infusion dose should be diluted in a maximum of 100 mL of 0.9% sodium chloride for injection and infused over at least 15 minutes.{149}



Parenteral Dosage Forms

IRON SUCROSE INJECTION

Usual adult dose
Deficiency (treatment)
Intravenous, by slow injection or infusion, 5 mL (100 mg elemental iron) one to three times a week. For infusion into the dialysis line, diluted in a maximum of 100 mL of 0.9% sodium chloride for injection and infused over at least 15 minutes. For slow injection, directly into the dialysis line at a rate of 1 ml (20 mg) per minute over 5 minutes.{149}


Note: Most patients will require a minimum cumulative dose of 1 gram of elemental iron, administered over 10 sequential dialysis sessions, to achieve a favorable hemoglobin or hematocrit response. Patients may continue to require therapy with intravenous iron supplementation at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit, and laboratory parameters of iron storage within acceptable limits{149}.


Usual adult prescribing limits
100 mg per injection.{149}

Usual pediatric dose
Safety and efficacy have not been established.{149}

Usual geriatric dose
See Usual adult dose

Strength(s) usually available
U.S.—


20 mg (elemental iron) per mL (Rx) [Venofer (sucrose approximately 30% w/v){154}]

Canada—
Not commercially available.

Packaging and storage:
Store at 25 °C (77 °F), excursions permitted to 15°- 30° C (59°- 86° F). Protect from freezing.{149}

Stability:
Use immediately after dilution in saline{149}. Discard any unused portion.{149}

Incompatibilities:
Do not mix iron sucrose with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility with intravenous infusion vehicles other than 0.9% sodium chloride for injection has not been evaluated{149}.


SODIUM FERRIC GLUCONATE COMPLEX

Summary of Differences


Indications:
Used to treat hemodialysis-induced iron deficiency anemia{148}.



General dosing information:
A stable macromolecular complex, free of ferrous iron and dextran polysaccharides. Deep red in color, indicative of ferric oxide linkages.



Additional Dosing Information
Test dose—Before initiating therapeutic doses, administration of a test dose of 2 mL (25 mg of elemental iron) is recommended. This test dose should be diluted in 50 mL of 0.9% sodium chloride for injection and administered over 60 minutes. {148}

Dosage is expressed in terms of mg of elemental iron.{148}

Rate of intravenous infusion should not exceed 2.1 mg per minute due to possible flushing and hypotension (resolves in one to two hours).{148}


Parenteral Dosage Forms

SODIUM FERRIC GLUCONATE COMPLEX INJECTION

Usual adult dose
Deficiency (treatment)
Intravenous, 10 mL (125 mg of elemental iron) diluted in 100 mL of 0.9% sodium chloride for injection, administered over 1 hour or undiluted at a rate of up to 12.5 mg per minute.{148}

Note: Most patients will require a minimum cumulative dose of 1 gram of elemental iron administered over 8 sessions at sequential dialysis treatments, to achieve a favorable hemoglobin or hematocrit response. Patients may continue to require therapy with intravenous iron supplementation at the lowest dose necessary to maintain target levels of hemoglobin, hematocrit and laboratory parameters of iron storage within acceptable limits{148}.
Sodium ferric gluconate has been administered at sequential dialysis sessions by infusion during the dialysis session itself{148}.



Usual pediatric dose
Safety and efficacy have not been established{148}.

Injection dosage form contains benzyl alcohol and should not be used in neonates{148}.

Strength(s) usually available
U.S.—


12.5 mg (elemental iron) per mL (Rx) [Ferrlecit (benzyl alcohol 9 mg) (sucrose approximately 20% w/v){154}]

Canada—
Not commercially available.

Packaging and storage:
Store at 20 to 25°C (68 to 77°F), with excursions permitted between 15 and 30°C (59 and 86°F){148}.

Stability:
Use immediately after dilution in saline{148}.

Incompatibilities:
Do not mix sodium ferric gluconate with other medications, or add to parenteral nutrition solutions for intravenous infusion. The compatibility with intravenous infusion vehicles other than 0.9% sodium chloride for injection has not been evaluated{148}.



Revised: 12/20/2001



References
  1. Iron dextran product information (InFeD, Schein—US), Rec 4/94, Rev 10/94.
  1. Panel comment, 1986.
  1. Rowe PC, editor. The Harriet Lane handbook. A manual for pediatric house officers. 11th ed. Chicago: Year Book Medical Publishers, Inc., 1987: 167-8.
  1. Lozoff B, Brittenham G, Wolf A, et al. Iron deficiency anemia and iron therapy effects on infant development test performance. Pediatrics 1987; 79(6): 981-95.
  1. Lozoff B, Jimenez E, Wolfe A. Long-term developmental outcome of infants with iron deficiency. N Engl J Med 1991: 325(10): 687-94.
  1. Manufacturer comment, 1987.
  1. Lithostat product information (Mission—US), Original.
  1. Panel consensus, 1991.
  1. Idjradinata P, Pollitt E. Reversal of developmental anaemic infants treated with iron. Lancet 1993; 341: 1-4.
  1. National Research Council. Recommended dietary allowances. 10th ed. Washington DC: National Academy Press, 1989: 195-205.
  1. Pollitt E, Leibel R. Iron deficiency and behavior. J Pediatr 1976: 88: 372.
  1. Campbell N, Kara M, Hasinoff B, et al. Norfloxacin interaction with antacids and minerals. Br J Clin Pharmacol 1992; 33(1): 115-6.
  1. Cabarga M, Navario A, Gandarillas C, et al. Effects of two cations on gastrointestinal absorption of ofloxacin. Antimicrob Agents Chemother 1991; 35(10): 2102-5.
  1. McEvoy GK, editor. AHFS Drug information 90. Bethesda, MD: American Society of Hospital Pharmacists, 1990: 714-8.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1988: 62-4.
  1. Knoben J, Anderson P. Handbook of clinical drug data. 6th ed. Hamilton IL: Drug Intelligence Publications, Inc: 61.
  1. Ferrous sulfate product information (Slow Fe, Ciba-Geigy—Canada), Rec 7/87, Rev 1/84.
  1. Dreisbach RH, Robertson WO. Handbook of poisoning: Prevention, diagnosis, & treatment. 12th ed. Norwalk CT: Appleton & Lange, 1987: 449-51.
  1. Osman M, Patel R, Schuna A, et al. Reduction in oral penicillamine absorption by food, antacid, and ferrous sulfate. Clin Pharmacol Ther 1983; 33(4): 465-70.
  1. Trissel LA. ASHP handbook on injectable drugs. 5th ed. Bethesda MD: American Society of Hospital Pharmacists, 1988: 388.
  1. Hansten PD, Horn JR. Drug interactions. 6th ed. Philadelphia: Lea & Febiger, 1989: 382.
  1. Cuprimine product information (MSD—US), Rec 10/88, Rev 5/87.
  1. Ferrous fumarate product information (Palafer, Beecham—Canada), Rev 3/89, Rec 6/89.
  1. Ferrous gluconate product label (Fergon, Winthrop), Rec 2/89.
  1. AMA Drug evaluations. 6th ed. Chicago: American Medical Association, September 1986: 581-4.
  1. Panel comment, 1991.
  1. Panel comment, 1991.
  1. Panel comment, 1991.
  1. Norton J, Peters M, Wesley R, et al. Iron supplementation of total parenteral nutrition—a prospective study. JPEN J Parenter Enteral Nutr 1983; 7(5): 457-61.
  1. Porter K, Blackburn G, Bistrian B. Safety of iron dextran in total parenteral nutrition: a case report. J Am Coll Nutr 1988; 7(2): 107-10.
  1. Roe D. Diet and drug interactions. New York: AVI Press, 1989: 15-7.
  1. BAL in Oil product information (Becton Dickinson—US), Rec 6/90, Rev 3/88.
  1. Didronel product information (Norwich Eaton—US), Rec 6/88, Rev 4/3/89.
  1. Syprine product information (MSD—US), Rev 3/89, Rec 11/89.
  1. Hallberg L, Brune M, Erlandsson M, et al. Calcium: effect of different amounts on nonheme- and heme-iron absorption in humans. Am J Clin Nutr 1991; 53: 112-9.
  1. Cook J, Dassenko S, Whittaker P. Calcium supplementation effect on iron absorption. Am J Clin Nutr 1991; 53: 106-11.
  1. Lieber C. The influence of alcohol on nutritional status. Nutr Rev 1988; 46(7): 241-54.
  1. D'Arcy P, McElnay J. Drug-antacid interactions assessment of clinical importance. DICP 1987; 21: 607-17.
  1. Valberg L, Flanagan P, Chamberlain M. Effects of iron, tin, and copper on zinc absorption in humans. Am J Clin Nutr 1984; 40: 536-41.
  1. Sandstead H. Trace elements interactions. J Lab Clin Med 1981; 98(4): 457-62.
  1. Solomons N, Pineda O, Viteri F, Sandstead H. Studies on the bioavailability of zinc in humans: mechanism of the intestinal interaction of nonheme iron and zinc. J Nutr 1983; 113: 337-49.
  1. Solomons N, Jacob R. Studies on the bioavailability of zinc in humans: effects of heme and nonheme iron on the absorption of zinc. Am J Clin Nutr 1981; 34: 475-82.
  1. Iron sorbitol product information (Jectofer, Astra—Canada), Rev 3/93, Rec 9/93.
  1. Brouwers J, Van der Kam H, Sytsma J, Proost J. Decreased ciprofloxacin absorption with concomitant administration of ferrous fumerate. Pharm Weekbl Sci 1990; 12(5): 182-3.
  1. Polk R, Healy D, Sahai J, et al. Effect of ferrous sulfate and multivitamins with zinc on absorption of ciprofloxacin in normal volunteers. Antimicrob Agents Chemother 1989; 33(11): 1841-4.
  1. Cook J, Monsen E. Food iron absorption in human subjects. III. Comparison of the effect of animal proteins on nonheme iron absorption. Am J Clin Nutr 1979; 29: 859-67.
  1. Hallberg L. Wheat fiber, phytates and iron absorption. Scand J Gastroenterol 1987; 129(suppl): 73-9.
  1. Schwenk M, Halstenson C. Recombinant human erythropoietin. DICP 1989; 23: 528-35.
  1. Epoetin alpha product information (Amgen—US), Rev 12/90.
  1. Morck T, Lynch S, Cook J. Inhibition of food iron absorption by coffee. Am J Clin Nutr 1983; 37(3): 416-20.
  1. Siegenberg D, Baynes R, Bothwell T, et al. Ascorbic acid prevents dose-dependent inhibitory effects of polyphenols and phytates on nonheme iron absorption. Am J Clin Nutr 1991; 53: 537-41.
  1. Dallman P. Manifestations of iron deficiency. Semin Hematol 1982; 19(1): 19-30.
  1. Finch C, Cook J. Iron deficiency. Am J Clin Nutr 1984; 39: 471-7.
  1. Herchberg S, Galan P. Biochemical effects of iron deprivation. Acta Paediatr Scand 1989; 361(suppl): 63-70.
  1. Arthur C, Isbister J. Iron deficiency: misunderstood, misdiagnosed and mistreated. Drugs 1987; 33: 171-82.
  1. Committee on Nutritional Status during Pregnancy, National Academy of Sciences. Washington DC: National Academy Press, 1990: 1-23.
  1. Woods S, DeMarco T, Friedland M. Iron metabolism. Am J Gastroenterol 1990; 85(1): 1-8.
  1. Dallman P. Biochemical basis for the manifestations of iron deficiency. Annu Rev Nutr 1986; 6: 13-40.
  1. Babior B. The respiratory burst of phagocytes. J Clin Invest 1984; 73: 599-601.
  1. Gilman AG, Rall TW, Nies AS, Taylor P, editors. Goodman and Gilman's the pharmacological basis of therapeutics. 8th ed. New York: Pergamon Press, 1990: 1308-18.
  1. Harju E. Clinical pharmacokinetics of iron preparations. Clin Pharmacokinet 1989; 17(2): 69-89.
  1. Matsui M, Rozovski S. Drug-nutrient interactions. Clin Ther 1982; 4(6): 423-40.
  1. Murray J, Healy M. Drug-mineral interactions: a new responsibility for the hospital dietitian. J Am Diet Assoc 1991; 91: 66-70, 73.
  1. Gossel T. Diabetes home testing: urine glucose and ketones. U.S. Pharmacist 1987, April: 52-62.
  1. Cook J. Clinical evaluation of iron deficiency. Semin Hematol 1982; 19(1): 6-18.
  1. Am Academy of Pediatrics. Handbook of common poisonings in children. 2nd ed. 75-9.
  1. Johns Hopkins Hospital, The Harriet Lane Handbook. 8th ed.
  1. Banner W, Tong T. Iron poisoning. Pediatr Tox 1986; 33(2): 393-409.
  1. Kumpf V, Holland E. Parenteral iron dextran therapy. DICP 1990; 24: 162-6.
  1. Ellenhorn MJ, Barceloux DG. Medical toxicology. Diagnosis and treatment of human poisoning. New York: Elsevier, 1988: 1023-30.
  1. Panel comment on Deferoxamine monograph, 1991.
  1. Reviewer comment, 1990.
  1. Pediatric Dosage Handbook, APhA, 1980.
  1. Leighton P, MacSween H. Yersinia hepatic abscesses subsequent to long-term iron therapy. JAMA 1987; 257(7): 964-5.
  1. Iron-polysacchride product information (Niferex, Central Pharm—US), Rec 7/91, Rev 12/90.
  1. Panel comment, 1991.
  1. Panel comment, 1991.
  1. Panel comments 1991.
  1. Panel comment, 1991.
  1. Panel comment, 1991.
  1. Panel comment, 1991.
  1. Skikne B, Lynch S, Cook J. Role of gastric acid in food iron absorption. Gastroenterology 1981; 81: 1068-71.
  1. Aymard J, Aymard B, Wetter P, et al. Haematological adverse effects of histamine h 2-receptor antagonists. Med Toxicol 1988; 3: 430-48.
  1. Panel consensus, 1991.
  1. Panel comments, 1991.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1992 Jan: 66.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 899.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1992 Jan: 65.
  1. Per phone call (Roberts—US), 10/13/93.
  1. Per phone call to Roxanne 10/19/94.
  1. Per phone call to Health Vitamin 10/19/94.
  1. Per phone call (Liquipharm—US), 10/13/93.
  1. Per phone call (Novopharm—Canada), 10/13/93.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1992 Jan: 64.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 453.
  1. Red book 1993. Montvale, NJ: Medical Economics Data, 1993: 248.
  1. Per phone call (Health Vitamin—US), 10/14/93.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 85.
  1. Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 28th ed. Ottawa: Canadian Pharmaceutical Association, 1993: 953.
  1. Lihto P, Kivisto K, Neuvonen P. The effect of ferrous sulphate on the absorption of norfloxacin, ciprofloxacin and ofloxacin. Br J Clin Pharmacol 1994; 37(1): 82-5.
  1. Health and Welfare Canada. Nutrition recommendations, the report of the scientific committee. Ottawa Canada: Canadian Government Publishing Centre, 1990: 11-5.
  1. The United States pharmacopeia. The national formulary. USP 23nd revision (January 1, 1995). NF 18th ed (January 1, 1995). Rockville, MD: The United States Pharmacopeial Convention, Inc., 1995: 660.
  1. Walter T, de Androca I, Chaderd P. Iron deficiency anemia: adverse affects of infant psychomotor development. Pediatrics 1989; 84(1): 7-16.
  1. Wilson JD, Braunwald E, Isselbacher KJ, Petersdorf RG, Martin JB, Fauci AS, Root RK, editors. Harrison's principles of internal medicine. 12th ed. New York: McGraw-Hill, Inc., 1991: 1518-23, 1833-4.
  1. Wyngaarden J, Smith L, editors. Cecil's textbook of medicine. 18th ed. Philadelphia: W.B. Saunders, 1988: 892-8.
  1. Committee on Nutrition, American Academy of Pediatrics. Pediatric nutrition handbook. 2nd ed. Elk Grove Village, IL: American Academy of Pediatrics, 1985: 41, 216.
  1. Calvo E, Galendo A, Aspres N. Iron status in exclusively breast-fed infant. Pediatrics 1992; 90(3): 375-9.
  1. Linder M, editor. Nutritional biochemistry and metabolism with clinical applications. New York: Elsevier, 1991: 146-7.
  1. Hladik W, Saha G, Study K. Essentials of nuclear medicine science. Baltimore: Williams & Wilkins, 1987: 193, 213.
  1. Reviewer comment, 1994.
  1. Vaughan L, Small C, Plunkett V. Incompatibility of iron dextran and a total nutrient admixture. Am J Hosp Pharm 1990; 47: 1745-6.
  1. Orr M, Vaughan L, Small C. Effect of varying iron dextran concentrations on the emulsion stability of a total nutrient admixture. Pharmacotherapy 1991; 11(3): 282.
  1. Fleeger CA, editor. USAN 1994. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1993: 283-4.
  1. Adverse drug reactions advisory committee, Australian drug evaluation committee. Take care with iron dextran. Australian adverse drug reactions bulletin 1991; 10(3): 2.
  1. Halpin T, Bertino J, Rothstein F, et al. Iron-deficiency anemia in childhood inflammatory bowel disease: treatment with intravenous iron-dextran. JPEN J Parenter Enteral Nutr 1982; 6(1): 9-11.
  1. Reed M, Bertino J, Halpin T. Use of intravenous iron dextran injection in children receiving total parenteral nutrition. Am J Dis Child 1981; 135: 829-31.
  1. U.S. preventive services task force. Routine iron supplementation during pregnancy. JAMA 1993; 270(23): 2846-54.
  1. McElhatton P, Roberts J, Sullivan F. The consequences of iron overdose and its treatment with desferrioxamine in pregnancy. Hum Exp Toxicol 1991; 10: 251-9.
  1. Jacobs D, editor. Laboratory test handbook. 2nd ed. Baltimore, MD: Williams & Wilkins, 1993: 234-5.
  1. American Pharmaceutical Association. Handbook of nonprescription drugs. 10th ed. Washington DC: American Pharmaceutical Association, 1993: 307.
  1. Norton J, Peters M, Wesley R, et al. Iron supplementation of total parenteral nutrition: a prospective study. J Parenter Enteral Nutr 1983; 7(5): 457-61.
  1. Rakel RE, editor. Conn's current therapy 1992. Philadelphia: W.B. Saunders Company, 1992: 392-3.
  1. Panelist comment, 1994.
  1. Williams W, Beutler E, Erslev A, et al, editors. Hematology. 4th ed. New York: McGraw-Hill, 1990: 730-3.
  1. Gleason W, deMello D, deCastro F, et al. Acute hepatic failure in severe iron poisoning. J Pediatr 1979; 95(1): 138-40.
  1. Gezerik W, Schmaman A, Chappell J. Corrosive gastritis as a result of ferrous sulphate ingestion. S Afr Med J 1980; 57: 151-4.
  1. Committee on Nutrition, American Academy of Pediatrics. Iron supplementation for infants. Pediatrics 1976; 58(5): 765-8.
  1. Schnultink W, van der Ree M, Matulessi P, et al. Low compliance with an iron-supplementation program: a study among pregnant women in Jakarta, Indonesia. Am J Clin Nutr 1993; 57: 135-9.
  1. Panelists comments, 1994.
  1. Tucker D, Sandstead H, Penland J, et al. Iron status and brain function: serum ferritin levels associated with asymmetries of cortical electrophysiology and cognitive performance. Am J Clin Nutr 1984; 39: 105-13.
  1. Lehto P, Kivisto K. Different effects of products containing metal ions on the absorption of lomefloxacin. Clin Pharmacol Ther 1994; 56: 477-82.
  1. Hallberg L, Rossander-Hulten L. Iron requirements in menstruating women. Am J Clin Nutr 1991; 54: 1047-58.
  1. Panelists comments, 1994.
  1. Panelist comment, 1994.
  1. Panelist comment, 1994.
  1. Panelists comments, 1994.
  1. Tenenbein M. Whole bowel irrigation in iron poisoning. J Pediatr 1987; 111(1): 142-5.
  1. Bock R, Tenenbein M. Whole bowel irrigation for iron overdose. Ann Emerg Med 1987; 16(1): 137-8.
  1. Panelists comments, 1995.
  1. Reviewer comment, 1995.
  1. Panelist comment, 1995.
  1. Panelist comment, 1995.
  1. Panelist comment, 1995.
  1. Lipton L, Kreiser J. False-positive stool occult blood tests caused by iron preparations. Gastroenterology 1982; 83: 860-3.
  1. DexIron package insert (American Regent—Canada), Rev 4/96, Rec 5/97.
  1. DexFerrum package insert (American Regent—US), Rev 6/96, Rec 5/97.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1996 Dec: 830.
  1. Product Information: Ferrlecit®, sodium ferric gluconate complex in sucrose injection. WatsonPharmaceutical, Inc., Morristown, NJ, USA, June 2001.
  1. Product Information: Venofer®, iron sucrose. Vifor International, St.Gallen, Switzerland (PI Issued 11/2000) reviewed 11/2000.
  1. Product Information: INFeD®, iron dextran injection, USP. Schein Pharmaceuticals Inc., Flornam Park, NJ (PI issued 02/2001) reviewed 12/2001
  1. Expert Committee comment, 01/24/02.
  1. Green R, Charlton R, Seftel H, et al. Body iron excretion in man: a collaborative study. Am J Med 1968; 45(3): 336-53.
  1. Repchinsky C, editor. CPS Compendium of pharmaceuticals and specialities. 36th ed. Ottawa: Canadian Pharmacists Association, 2001: 110, 565-6, 769, 1154.
  1. PDR Physicians' desk reference. 56th ed. 2002. Montvale, NJ: Medical Economics Company, 2002: 580, 1717, 3386-8.
Hide
(web5)