Iron dextran is used parenterally to treat iron-deficiency anemia. Iron dextran consists of a complex of ferric oxyhydroxide with dextrans of 5000-7000 daltons. Because fatalities have occurred with the parenteral use, iron dextran is usually reserved for iron-deficient patients unable to take or intolerant to oral iron preparations. Parenteral iron produces therapeutic responses similar to those of oral iron. One advantage of parenteral iron is that iron stores are rapidly repleted, which may take months to achieve with oral iron therapy. Iron dextran was approved by the FDA prior to 1982.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
NOTE: Serum iron, hemoglobin and hematocrit should be evaluated prior to iron therapy and at regular intervals during therapy. Ferritin and transferrin are also recommended monitoring parameters.
Route-Specific Administration
Injectable Administration
-INFeD: INFeD is administered by intramuscular or intravenous injection. Before administering therapeutic doses, a test dose of 25 mg (0.5 mL) should be given. Give INFeD test doses gradually over at least 30 seconds. Observe the patient for at least 1 hour after test dose administration. Because anaphylactic reactions are known to occur after uneventful test doses, test doses before subsequent doses should be considered.
-DexFerrum: DexFerrum is administered by intravenous injection only. Before administering therapeutic doses, a test dose of 25 mg (0.5 mL) should be given. Give DexFerrum test doses gradually over at least 5 minutes. Observe the patient for at least 1 hour after test dose administration. Because anaphylactic reactions are known to occur after uneventful test doses, test doses before subsequent doses should be considered.
-DO NOT mix iron dextran with other medications.
-Do not add therapeutic doses of iron dextran to total parenteral nutrition (TPN) solutions; iron dextran may destabilize the mixture or cause the cracking of the TPN emulsion.
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit.
Intravenous Administration
Slow intermittent intravenous (IV) injection:
NOTE: Each 1 mL of iron dextran injection contains 50 mg of elemental iron.
-No dilution necessary.
-Inject via slow IV at a gradual rate not to exceed 50 mg (1 mL) per minute for adults; take care to inject dosage very slowly in children and infants.
-There are limits to the volume of iron dextran that may be injected IV undiluted per 24 hours based on patient age and weight; see dosage guidelines.
Total Dose Intravenous Infusion :
-Iron dextran is not FDA-approved to be administered as a total dose infusion.
-Dilute the total calculated dose (see Dosage) in 250 to 1000 mL of 0.9% sodium chloride injection. 5% dextrose injection may be used for dilution; however, use of 5% dextrose injection for iron dextran dilution has been associated with a higher incidence of local pain and phlebitis upon administration.
-A test dose should be administered before the administration of the therapeutic dose.
-If test dose is uneventful after 1 hour of observation, then infuse the remaining dose over 4 to 6 hours (usually no faster than 2 to 6 mg/min). Once the infusion is completed, flush vein with NS injection.
Intramuscular Administration
NOTE: Each 1 mL of iron dextran injection contains 50 mg of elemental iron.
-No dilution necessary.
-To avoid staining of subcutaneous tissue, use the Z-track technique of injection.
-There are limits to the volume of iron dextran that may be injected IM per 24 hours based on patient age and weight; see dosage guidelines.
-Inject deeply into the upper outer quadrant of the buttock (gluteus maximus) only using a 2- or 3-inch, 19- or 20-gauge needle. DO NOT USE THE DELTOID MUSCLE OR OTHER EXPOSED AREAS. If the patient is standing, inject iron dextran into the buttock opposite the weight-bearing leg. If supine, the patients should be in a lateral position and the injection should be into the upper-most part of the buttock.
Patients who receive parenteral iron, rarely, if ever, develop hemochromatosis unless a genetic predisposition to the disorder is also present. Hemochromatosis results in aberrations of iron absorption, metabolism and storage; iron accumulates in the body and excess iron deposition occurs in the parenchymal tissues. With hemochromatosis, the liver becomes enlarged, and skin discoloration, specifically a bronze hue, occurs. Pancreatic dysfunction, diabetes mellitus, cardiac failure, liver failure and other tissue disorders may occur secondary to hemochromatosis.
Central nervous system effects which may occur iron dextran therapy include headache, transient paresthesias, weakness, dizziness, faintness, syncope, unresponsiveness, disorientation (confusion), numbness, and seizures.
Cardiovascular adverse effects associated with iron dextran administration include chest pain (unspecified) or tightness, cardiac arrest, shock, hypotension, hypertension, tachycardia, bradycardia, flushing, and cardiac arrhythmias. Flushing and hypotension may occur when the drug is administered too rapidly intravenously.
Iron dextran therapy may expose latent folic acid deficiency. Leukocytosis may occur and is frequently associated with fever.
Gastrointestinal effects produced by iron dextran include abdominal pain, nausea, vomiting, diarrhea, metallic taste in the mouth, and altered taste (dysgeusia).
Injection site reaction may occur following intramuscular administration of iron dextran. Local reactions may include soreness or pain, inflammation, sterile abscesses, skin necrosis, skin atrophy, fibrosis, cellulitis, edema, and persistent brown staining of the skin and/or the underlying tissue (skin discoloration). Intravenous injection of iron dextran may cause phlebitis or venospasm.
Serious hypersensitivity reactions or anaphylaxis, including fatal reactions, have occurred with iron dextran therapy. Fetal adverse reactions, including fetal bradycardia, have been associated with maternal hypersensitivity reactions, especially during the second and third trimester of pregnancy. These reactions can occur with either IM or IV administration and are usually apparent within minutes of administration. These reactions are characterized by sudden onset of dyspnea and/or anaphylactic shock. Hypersensitivity reactions also include urticaria, pruritus, arthralgia, myalgia, and fever. Other dermatological reactions include rash, purpura, and cyanosis. Angioedema has been reported with another parenteral iron product, sodium ferric gluconate complex (Ferrlecit). Administer iron dextran only when resuscitation techniques and treatment for anaphylactoid reactions are readily available.
Iron is not easily eliminated from the body and acute overdose may result in toxicity. Overdosage of iron dextran, per the manufacturer, is unlikely to cause any acute manifestations. Iron overload, which can occur after long-term use of iron dextran, may cause exogenous hemosiderosis. Hemosiderosis is the result of deposition of hemosiderin, an iron-containing pigment, in the tissues of the liver and spleen. Hemosiderosis has primarily been reported in dialysis patients who receive long-term iron dextran treatment. Periodic monitoring of serum ferritin levels may be helpful in recognizing a progressive accumulation of iron resulting from impaired iron uptake from the reticuloendothelial system.
Adverse reactions associated with iron dextran therapy include malaise, diaphoresis, respiratory arrest, dyspnea, wheezing, bronchospasm, chills, shivering, lymphadenopathy, and hematuria. Lymphadenopathy is generally confined to the inguinal area and occurs with intramuscular administration. Two patients have been reported to have significant pulmonary edema following IV infusion of iron dextran, which responded promptly to treatment of anaphylaxis.
Parenteral iron dextran therapy is associated with a risk of serious hypersensitivity reactions or anaphylaxis. Iron dextran should only be used in patients with a clear and confirmed need for parenteral iron therapy. Iron dextran is contraindicated in patients with iron dextran hypersensitivity. Fatal anaphylactoid reactions have occurred during the parenteral administration of iron dextran. These reactions have been characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. A test dose should be given prior to administration of the initial therapeutic dose. Reactions are usually evident within a few minutes of administration; however, observe patients for at least 1 hour after the administration of the test dose before administering the remainder of the therapeutic dose. Fatal reactions have occurred following the test dose of iron dextran and also have occurred after other doses when the test dose was tolerated. Monitor patients for signs and symptoms of anaphylactoid reactions during all iron dextran administrations. Patients with a history of drug allergy may be at increased risk for anaphylactoid reactions. Furthermore, concomitant use of angiotensin-converting enzyme inhibitors may increase the risk for serious reactions to iron dextran. Serious anaphylactoid reactions require appropriate resuscitative measures. Facilities for cardiopulmonary resuscitation and personnel trained in the detection and treatment of anaphylactoid reactions must be available during administration. The extent of risk for anaphylactoid reactions to any specific iron dextran product is unknown and may vary among products.
Patients with a significant history of allergies (e.g., atopy), asthma, or other inflammatory conditions appear to be susceptible to experiencing adverse effects from iron dextran treatment. Parenteral administration of iron dextran may exacerbate joint pain and swelling in patients with rheumatoid arthritis, ankylosing spondylitis, or systemic lupus erythematosus (SLE).
Cardiovascular adverse effects may also occur with iron dextran therapy, and do not necessarily indicate hypersensitivity. Flushing and hypotension are more common following rapid intravenous administration; do not exceed recommended IV infusion rates. Patients with preexisting cardiac disease may have exacerbation of cardiovascular symptoms if adverse effects occur following iron dextran administration.
Iron dextran is contraindicated for use in patients with anemia not associated with iron deficiency. Do not administer iron dextran to patients with evidence of iron overload (e.g., patients with hemochromatosis). Unnecessary or prolonged administration of iron may lead to iron overload and consequently the possibility of exogenous hemosiderosis. Patients with hemoglobinopathy and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias are at particular risk for such iron overload. The type of anemia and the underlying cause or causes should be determined before starting therapy with parenteral iron dextran. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause(s) should be corrected, if possible. Patients receiving exogenous iron therapy require periodic monitoring of hematologic and hematinic parameters (i.e., hemoglobin, hematocrit, serum ferritin, and transferrin saturation) to avoid iron overload.
Hemosiderosis secondary to long-term iron dextran treatment has primarily been reported in patients with renal failure receiving dialysis. Periodic monitoring of serum ferritin levels may be helpful in recognizing a progressive accumulation of iron resulting from impaired iron uptake from the reticuloendothelial system in patients with renal failure. The contribution of iron to infectious processes is unclear, but iron dextran should not be administered during the acute phase of infectious renal disease (manufacturer's information).
Some patients with chronic hepatic disease may also have hemochromatosis or moderate iron overload in hepatic tissues. The liver is one of the main storage sites for iron, and advanced chronic liver disease may result in excess storage iron in the liver. Use iron dextran with caution in patients with hepatic disease.
Use of iron dextran in infants younger than 4 months of age and neonates is not recommended; there have been reports from other countries of an increased incidence of gram-negative sepsis (e.g., E. coli sepsis) in infants receiving iron dextran. Administration of iron dextran to premature infants/neonates can increase the risk of developing hemolytic anemia because these infants may have a low vitamin E serum concentration. In general, iron supplementation should not begin in premature infants until adequate vitamin E is supplied in the diet; human breast milk and modern infant formulas usually supply adequate dietary vitamin E.
Fetal adverse reactions, including fetal bradycardia, have been associated with maternal hypersensitivity reactions to parenteral iron products, especially during the second and third trimester of pregnancy. There are no adequate and well-controlled studies of iron dextran in pregnant women. Administer iron dextran during pregnancy only if the potential benefit outweighs the potential risk to the fetus. Various human and animal studies have demonstrated inconclusive results regarding the ability of iron dextran to cross the placenta; it appears some iron does reach the fetus, but the form in which it crosses the placenta is not clear. Iron dextran has been shown to be teratogenic and embryocidal in animals (mice, rats, rabbits, dogs, and monkeys) when given in doses approximately 3 times the maximum human dose. No consistent adverse fetal effects were observed in non-iron deficient animals at doses of 50 mg iron/kg or less. Fetal and maternal toxicity has been reported in monkeys receiving a total dose of 90 mg iron/kg administered over a 14-day period. Similar effects were observed in mice and rats after administration of a single 125 mg iron/kg dose. Fetal abnormalities were also observed in rats and dogs at doses of 250 mg iron/kg or higher.
While iron is excreted into breast-milk, the iron content of breast milk is not readily affected by the iron content of the maternal diet or the maternal serum iron level. Therefore, the therapeutic prescription use of iron is usually compatible with breast-feeding if the lactating mother needs treatment for iron deficiency. However, trace amounts of unmetabolized iron dextran are excreted in breast milk. According to FDA-approved labeling, caution should be exercised if iron dextran is administered to a nursing mother. Potential alternatives include iron salts, polysaccharide-iron complex, and iron sucrose. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Laboratory test interference may occur with iron dextran therapy. Specifically, the drug may cause falsely elevated concentrations of serum bilirubin and falsely decreased concentrations of serum calcium. Additionally, the drug may affect bone scans. Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of iron dextran. Bone scans with 99m Tc-labeled bone-seeking agents, in the presence of high serum ferritin concentrations or following iron dextran infusions, have been reported to show a reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation.
For the treatment of iron-deficiency anemia in patients in whom oral iron administration is unsatisfactory or impossible:
NOTE: The dose of iron dextran is expressed in mg of elemental iron. Each mL contains 50 mg of elemental iron.
-for the treatment of iron-deficiency anemia due to causes other than blood loss:
NOTE: The formula is based on hemoglobin (Hb) expressed as g/dL and lean body weight (LBW) in kg or actual body weight (ABW) in kg if the actual body weight is less than LBW or for children 15 kg or less.
Intramuscular or Intravenous dosage:
Adults: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 100 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = [0.0442 x (desired Hb - observed Hb) x LBW] + (0.26 x LBW). Use actual body weight if less than lean body weight. Each mL of iron dextran contains 50 mg of elemental iron. Max: 100 mg/day.
Children and Adolescents weighing more than 15 kg: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 100 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = [0.0442 x (desired Hb - observed Hb) x LBW] + (0.26 x LBW). Use actual body weight if less than lean body weight. Each mL of iron dextran contains 50 mg of elemental iron. Max: 100 mg/day.
Infants and Children 4 months and older weighing 10 to 15 kg: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 100 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = [0.0442 x (desired Hb - observed Hb) x ABW] + (0.26 x ABW). Each mL of iron dextran contains 50 mg of elemental iron. Max: 100 mg/day.
Infants and Children 4 months and older weighing 5 to 9.9 kg: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 50 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = [0.0442 x (desired Hb - observed Hb) x ABW] + (0.26 x ABW). Each mL of iron dextran contains 50 mg of elemental iron. Max: 50 mg/day.
Infants 4 months and older weighing less than 5 kg: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 25 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = [0.0442 x (desired Hb - observed Hb) x ABW] + (0.26 x ABW). Each mL of iron dextran contains 50 mg of elemental iron. Max: 25 mg/day.
-for the treatment of iron-deficiency anemia due to blood loss:
Intramuscular or Intravenous dosage:
Adults: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 100 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = blood loss (mL) x hematocrit (expressed as a decimal fraction) x 0.02. Each mL of iron dextran contains 50 mg of elemental iron. Max: 100 mg/day.
Infants, Children, and Adolescents 4 months and older weighing 10 kg or more: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 100 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = blood loss (mL) x hematocrit (expressed as a decimal fraction) x 0.02. Each mL of iron dextran contains 50 mg of elemental iron. Max: 100 mg/day.
Infants and Children 4 months and older weighing 5 to 9.9 kg: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 50 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = blood loss (mL) x hematocrit (expressed as a decimal fraction) x 0.02. Each mL of iron dextran contains 50 mg of elemental iron. Max: 50 mg/day.
Infants 4 months and older weighing less than 5 kg: 25 mg IV or IM as a test dose 1 hour or more before first therapeutic dose, then 25 mg IV or IM once daily until the calculated total dose has been reached. Total iron dextran dose in mL = blood loss (mL) x hematocrit (expressed as a decimal fraction) x 0.02. Each mL of iron dextran contains 50 mg of elemental iron. Max: 25 mg/day.
For the treatment of anemia of prematurity*:
Intravenous dosage:
Premature Neonates: 1 mg/kg/day IV added to total parenteral nutrition (TPN) has been used in very low birth weight premature neonates (n = 26 with birth weight 1,005 +/- 302 g and gestational age 28 +/- 2.3 weeks in 1 study and n = 28 with birth weight 662 +/- 14 g and gestational age 24.7 +/- 0.3 weeks in a second study). Some patients received epoetin in conjunction with parenteral iron. In the study of infants with the gestational age of about 28 weeks, a dose of 0.2 mg/day IV added to the TPN was not a sufficient amount of iron. The authors concluded that 1 mg/kg/day IV added to the TPN would more closely maintain iron balance. Alternatively, a weekly dose of 5 mg/kg IV added to TPN and administered over 24 hours or diluted in several milliliters of normal saline or 10% dextrose in water and infused over 4 to 6 hours also has been used in low birth weight neonates.
Therapeutic Drug Monitoring:
-Serum iron, hemoglobin, and hematocrit should be evaluated prior to iron therapy and at regular intervals during therapy. Ferritin, transferrin, total iron binding capacity, and percent saturation of transferrin are also recommended monitoring parameters.
-Serum iron concentrations, especially measured by colorimetric assays, may not be meaningful for 3 weeks following iron dextran administration.
-Examination of the bone marrow for iron stores may also not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells.
-Serum ferritin peaks approximately 7 to 9 days after an IV dose of iron dextran and slowly returns to baseline after approximately 3 weeks.
Maximum Dosage Limits:
Total dosage with iron dextran must be individualized according to the patients age, weight, and the degree of the iron-deficiency anemia. Excess accumulation may occur if iron therapy is continued after the correction of the deficiency. The following are generally accepted limits in the treatment of iron-deficient patients.
-Adults
100 mg/day IV or IM. See individual dosage if using total dose IV infusion methods.
-Geriatric
100 mg/day IV or IM. See individual dosage if using total dose IV infusion methods.
-Adolescents
100 mg/day IV or IM. See individual dosage if using total dose IV infusion methods.
-Children
10 kg or more: 100 mg/day IV or IM. See individual dosage if using total dose IV infusion methods.
5 to 9.9 kg: 50 mg/day IV or IM.
-Infants
4 months and older (weight 5 to 9.9 kg): 50 mg/day IV or IM.
4 months and older (weight less than 5 kg): 25 mg/day IV or IM.
1 to 3 months: Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Patients with hepatic disease should receive iron dextran with caution. The liver is one of the main storage sites for iron, and some patients with chronic liver disease may have excessive iron storage. Specific guidelines for dosage adjustments in hepatic impairment are not available.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Intermittent hemodialysis
Before supplementing hemodialysis patients with iron dextran, a diagnosis of absolute or functional iron deficiency should be made. Follow recommended dosage. Iron dextran is not hemodialyzable.
*non-FDA-approved indication
Amlodipine; Benazepril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Angiotensin-converting enzyme inhibitors: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Benazepril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Benazepril; Hydrochlorothiazide, HCTZ: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Captopril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Captopril; Hydrochlorothiazide, HCTZ: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Dimercaprol: (Major) Avoid concomitant use of dimercaprol and products containing iron. Dimercaprol forms toxic-chelates with iron which increases the risk for nephrotoxicity and other adverse effects.
Enalapril, Enalaprilat: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Enalapril; Hydrochlorothiazide, HCTZ: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Ferric Maltol: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Fosinopril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Fosinopril; Hydrochlorothiazide, HCTZ: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Hydrochlorothiazide, HCTZ; Moexipril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Iron Salts: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Iron Salts: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Iron: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Levonorgestrel; Ethinyl Estradiol; Ferrous Bisglycinate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Levonorgestrel; Ethinyl Estradiol; Ferrous Fumarate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Lisinopril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Lisinopril; Hydrochlorothiazide, HCTZ: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Moexipril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Norethindrone Acetate; Ethinyl Estradiol; Ferrous fumarate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Norethindrone; Ethinyl Estradiol; Ferrous fumarate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Perindopril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Perindopril; Amlodipine: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Quinapril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Quinapril; Hydrochlorothiazide, HCTZ: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Ramipril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Sodium Ferric Gluconate Complex; ferric pyrophosphate citrate: (Major) Parenteral iron formulas are generally only indicated for use in patients with documented iron deficiency in whom oral administration is either impossible or unsatisfactory. In general, do not administer parenteral iron concomitantly with other iron preparations (e.g., other parenteral iron products or oral iron supplements). Parenteral iron preparations (e.g., iron dextran; iron sucrose, sucroferric oxyhydroxide; sodium ferric gluconate complex; ferric carboxymaltose; ferumoxytol) may reduce the absorption of concomitantly administered oral iron preparations. Oral iron supplementation should be discontinued before parenteral administration of iron. Too much iron can be toxic, and iron is not easily eliminated from the body.
Trandolapril: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Trandolapril; Verapamil: (Moderate) The concomitant use of angiotensin-converting enzyme inhibitors (ACE inhibitors) with iron dextran may increase the risk for anaphylactic-type reactions. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. Patients should be monitored for signs and symptoms of anaphylactic-type reactions during all iron dextran administrations.
Trientine: (Major) In general, oral mineral supplements should not be given since they may block the oral absorption of trientine. However, iron deficiency may develop, especially in children and menstruating or pregnant women, or as a result of the low copper diet recommended for Wilson's disease. If necessary, iron may be given in short courses, but since iron and trientine each inhibit oral absorption of the other, 2 hours should elapse between administration of trientine and iron doses.
Normal erythropoiesis is dependent on the concentration of iron and erythropoietin available in the plasma. Administration of iron does not stimulate the production of red blood cells, nor does it correct abnormalities not caused by iron deficiency. A therapeutic response to treatment with iron products is dependent on the patient's ability to absorb and use the iron, and it is influenced by the cause of the deficiency as well as other illnesses that can affect normal erythropoiesis.
There is some concern that intravenously administered iron is not used appropriately by the body. Both animal and human data indicate that the bulk of intravenous iron is sequestered in the reticuloendothelial system (i.e., liver, spleen), and little is available to the iron-deficient bone marrow.
Pharmacokinetics:
Iron dextran is administered intramuscularly or intravenously. Approximately 60% of an injected dose is absorbed within 3 days and up to 90% within 1-3 weeks. Subcutaneous injection results in slow absorption and staining of subcutaneous tissue. Distribution of iron dextran following intramuscular or intravenous injection involves uptake by reticuloendothelial cells of the liver, spleen, and bone marrow. Uptake by these cells occurs at a rate of about 10-20 mg per hour. Iron crosses the placenta, and pregnancy increases iron-intake requirements. Once taken into reticuloendothelial cells, the iron from the iron dextran complex is separated and added to the body's total iron stores. Ferric iron is then gradually released into the plasma where it combines rapidly with transferrin.
Transferrin delivers iron to specific receptors for deposit, where it is either incorporated into hemoglobin or oxidized and stored in combination with apoferritin as ferritin. Transferrin eventually becomes available for reuse. There is no destructive metabolism of iron because it takes place in a closed system. In normal, healthy adults, some daily loss of iron occurs through normal skin, hair, and nail loss, and GI losses.
-Route-Specific Pharmacokinetics
Intramuscular Route
Following intramuscular injection of iron dextran, the drug is slowly absorbed in two stages primarily through the lymphatic system. The first stage involves an inflammatory reaction at the site of injection which aids the passage of the drug into the lymphatic system. In the second stage, macrophages ingest the iron dextran and enter the lymphatic system and eventually the blood.
Subcutaneous Route
Subcutaneous injection of iron dextran results in slow absorption and staining of subcutaneous tissue.
-Special Populations
Gender Differences
Men have about twice the amount of stored iron than women. Menstruating women have an increased loss as do other persons with loss of blood.