INFeD

Injectable Iron Supplements
Iron Supplements

 
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.

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.

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 [26236]:
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.

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.

seizures / Delayed / Incidence not known
bradycardia / Rapid / Incidence not known
cardiac arrest / Early / Incidence not known
skin necrosis / Early / Incidence not known
skin atrophy / Delayed / Incidence not known
serious hypersensitivity reactions or anaphylaxis / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
cyanosis / Early / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known
pulmonary edema / Early / Incidence not known
bronchospasm / Rapid / Incidence not known
respiratory arrest / Rapid / Incidence not known

confusion / Early / Incidence not known
hypertension / Early / Incidence not known
chest pain (unspecified) / Early / Incidence not known
hypotension / Rapid / Incidence not known
phlebitis / Rapid / Incidence not known
edema / Delayed / Incidence not known
hemosiderosis / Delayed / Incidence not known
hematuria / Delayed / Incidence not known
lymphadenopathy / Delayed / Incidence not known
dyspnea / Early / Incidence not known
wheezing / Rapid / Incidence not known

weakness / Early / Incidence not known
headache / Early / Incidence not known
syncope / Early / Incidence not known
paresthesias / Delayed / Incidence not known
dizziness / Early / Incidence not known
flushing / Rapid / Incidence not known
fever / Early / Incidence not known
leukocytosis / Delayed / Incidence not known
vomiting / Early / Incidence not known
abdominal pain / Early / Incidence not known
metallic taste / Early / Incidence not known
diarrhea / Early / Incidence not known
nausea / Early / Incidence not known
dysgeusia / Early / Incidence not known
injection site reaction / Rapid / Incidence not known
skin discoloration / Delayed / Incidence not known
pruritus / Rapid / Incidence not known
rash / Early / Incidence not known
purpura / Delayed / Incidence not known
myalgia / Early / Incidence not known
urticaria / Rapid / Incidence not known
arthralgia / Delayed / Incidence not known
diaphoresis / Early / Incidence not known
chills / Rapid / Incidence not known
malaise / Early / Incidence not known

INFeD

Rx

Parenteral iron supplement of ferric oxyhydroxide complexed with dextrans; rapidly repletes iron stores in deficiency from anemia or blood loss; sometimes associated with severe hypersensitivity.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

†Indicates off-label use

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.

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.

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: (Contraindicated) Dimercaprol forms toxic chelates with iron. These dimercaprol-iron complexes are more toxic than the metal alone, especially to the kidneys. Do not administer iron during dimercaprol treatment. Therapy with iron should generally be delayed until 24 hours after the cessation of dimercaprol therapy.
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.
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: (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.
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.
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.

INFeD Intramuscular Inj Sol: 1mL, 50mg
INFeD Intravenous Inj Sol: 1mL, 50mg

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.

100 mg/day IV or IM. See individual dosage if using total dose IV infusion methods.

100 mg/day IV or IM. See individual dosage if using total dose IV infusion methods.

100 mg/day IV or IM. See individual dosage if using total dose IV infusion methods.

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.

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.

Safety and efficacy have not been established.

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.

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.

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 injection of iron dextran results in slow absorption and staining of subcutaneous tissue.

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.[42291]

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.[42291] 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.