Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Each mL contains the equivalent of 50 mg of elemental iron as an iron dextran complex , approximately 0. The pH of the solution is between 4. General: After intramuscular injection, iron dextran is absorbed from the injection site into the capillaries and the lymphatic system.
|Published (Last):||21 October 2004|
|PDF File Size:||9.16 Mb|
|ePub File Size:||12.66 Mb|
|Price:||Free* [*Free Regsitration Required]|
Send the page " " to a friend, relative, colleague or yourself. We do not record any personal information entered above.
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. Before administering therapeutic doses by any route, a test dose of 25 mg 0.
Observe patient for at least 1 hour after test dose administration. Because anaphylactic reactions are known to occur after uneventful test doses, subsequent test doses should be considered. Before administering therapeutic doses by any route, a test dose of of iron dextran should be given by the route and method of administration for which therapeutic doses are to be administered.
Consult specialized references for amount of test dose to be given. While the manufacturer recommends 25 mg 0. Use actual body weight if less than lean body weight. A value of If test dose uneventful, give the remainder of the total dose as mg elemental iron per day IM or IV until the total calculated dose is given. A value of 12 may be used as a target normal hemoglobin. If test dose uneventful, give the remainder of the total dose as 50 mg of elemental iron per day IM or slow IV until the total calculated dose is given.
If test dose uneventful, give the remainder of the total dose as 25 mg of elemental iron per day IM or slow IV until the total calculated dose needed given. If test dose uneventful, infuse the remainder of the total calculated dose IV over 2 to 6 hours. If test dose uneventful, give the remainder of the total dose as mg of elemental iron per day IM or slow IV until the total calculated dose is given.
If test dose uneventful, give the remainder of the total dose as 50 mg of iron dextran per day IM or slow IV until the total calculated dose is given. If test dose uneventful, give the remainder of the total dose as 25 mg of iron dextran per day IM or slow IV until the total calculated dose see equation is given. If test dose uneventful, infuse the remainder of the total calculated dose see equation IV over 2 to 6 hours.
NOTE: Patients who require parenteral nutrition for a limited period of time and who are not iron-deficient do not need parenteral iron supplementation. The use of iron dextran to prevent iron deficiency in patients requiring long-term parenteral nutrition support is controversial; some experts advocate the use of iron to treat a deficiency if it occurs vs.
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. If test dose uneventful, doses of 1. 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. 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. See individual dosage if using total dose IV infusion methods. 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. 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. Before administering therapeutic doses, a test dose of 25 mg 0. 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. Give DexFerrum test doses gradually over at least 5 minutes. DO NOT mix iron dextran with other medications.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. 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. Dilute the total calculated dose see Dosage in to mL of 0. A test dose should be administered before the administration of the therapeutic dose. Once the infusion is completed, flush vein with NS injection.
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, or gauge needle. 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. 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. 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. 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. 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.
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. 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.
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.
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.
Iron dextran (INFeD)