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Iron Dextran
Overview
What is INFeD?
INFeD (Iron Dextran Injection USP) is a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use.
Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. The pH of the solution is between 5.2 and 6.5.
Therapeutic Class: Hematinic
What does INFeD look like?
What are the available doses of INFeD?
Sorry No records found.
What should I talk to my health care provider before I take INFeD?
Sorry No records found
How should I use INFeD?
Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.
Oral iron should be discontinued prior to administration of INFeD.
What interacts with INFeD?
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What are the warnings of INFeD?
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What are the precautions of INFeD?
Sorry No Records found
What are the side effects of INFeD?
Sorry No records found
What should I look out for while using INFeD?
Hypersensitivity to the product. All anemias not associated with iron deficiency.
Risk for Anaphylactic-type Reactions:
Anaphylactic-type reactions, including fatalities have followed the parenteral administration of iron dextran. Always have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Prior to the first therapeutic dose, administer a test INFeD dose of 0.5 mL. (See .) Although reactions are usually evident within a few minutes, observe patients for at least one hour before administering the therapeutic dose. During all INFeD administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.
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. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products.
Iron dextran products differ in chemical characteristics and may differ in clinical effects. Iron dextran products are not clinically interchangeable.
Delayed Reactions:
Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse effects. The adverse effects frequently are delayed (1-2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. The onset is usually 24-48 hours after administration and symptoms generally subside within 3-4 days. The etiology of these reactions is not known. The potential for a delayed reaction must be considered when estimating the risk/benefit of treatment.
The maximum daily dose should not exceed 2 mL undiluted iron dextran.
Risk in Patients with Underlying Conditions:
INFeD should be used with extreme care in patients with serious impairment of liver function. It should not be used during the acute phase of infectious kidney disease.
Adverse reactions experienced following administration of INFeD may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease.
Carcinogenesis:
A risk of carcinogenesis may attend the intramuscular injection of iron-carbohydrate complexes. Such complexes have been found under experimental conditions to produce sarcoma when large doses or small doses injected repeatedly at the same site were given to rats, mice, and rabbits, and possibly in hamsters.
The long latent period between the injection of a potential carcinogen and the appearance of a tumor makes it impossible to measure accurately the risk in man. There have, however, been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes.
What might happen if I take too much INFeD?
Overdosage with iron dextran is unlikely to be associated with any acute manifestations. Dosages of iron dextran in excess of the requirements for restoration of hemoglobin and replenishment of iron stores may lead to hemosiderosis. Periodic monitoring of serum ferritin levels may be helpful in recognizing a deleterious progressive accumulation of iron resulting from impaired uptake of iron from the reticuloendothelial system in concurrent medical conditions such as chronic renal failure, Hodgkins disease, and rheumatoid arthritis. The LD
of iron dextran is not less than 500 mg/kg in the mouse.
How should I store and handle INFeD?
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Do not refrigerate.Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Do not refrigerate.INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 ( ).Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].Rx OnlyINFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 ( ).Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].Rx OnlyINFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 ( ).Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].Rx OnlyINFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 ( ).Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].Rx OnlyINFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 ( ).Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].Rx OnlyINFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 ( ).Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].Rx OnlyINFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 ( ).Store at 20 -25°C (68 -77°F) [See USP Controlled Room Temperature].Rx Only
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
General:
Dextran, a polyglucose, is either metabolized or excreted. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran.
The major portion of intramuscular injections of iron dextran is absorbed within 72 hours; most of the remaining iron is absorbed over the ensuing 3 to 4 weeks.
Various studies involving intravenously administered Fe iron dextran to iron deficient subjects, some of whom had coexisting diseases, have yielded half-life values ranging from 5 hours to more than 20 hours. The 5-hour value was determined for Fe iron dextran from a study that used laboratory methods to separate the circulating Fe iron dextran from the transferrin-bound Fe. The 20-hour value reflects a half-life determined by measuring total Fe, both circulating and bound. It should be understood that these half-life values do not represent clearance of iron from the body. Iron is not easily eliminated from the body and accumulation of iron can be toxic.
In vitro
Non-Clinical Toxicology
Hypersensitivity to the product. All anemias not associated with iron deficiency.Risk for Anaphylactic-type Reactions:
Anaphylactic-type reactions, including fatalities have followed the parenteral administration of iron dextran. Always have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Prior to the first therapeutic dose, administer a test INFeD dose of 0.5 mL. (See .) Although reactions are usually evident within a few minutes, observe patients for at least one hour before administering the therapeutic dose. During all INFeD administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Use INFeD only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy.
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. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products.
Iron dextran products differ in chemical characteristics and may differ in clinical effects. Iron dextran products are not clinically interchangeable.
Delayed Reactions:
Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse effects. The adverse effects frequently are delayed (1-2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. The onset is usually 24-48 hours after administration and symptoms generally subside within 3-4 days. The etiology of these reactions is not known. The potential for a delayed reaction must be considered when estimating the risk/benefit of treatment.
The maximum daily dose should not exceed 2 mL undiluted iron dextran.
Risk in Patients with Underlying Conditions:
INFeD should be used with extreme care in patients with serious impairment of liver function. It should not be used during the acute phase of infectious kidney disease.
Adverse reactions experienced following administration of INFeD may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease.
Carcinogenesis:
A risk of carcinogenesis may attend the intramuscular injection of iron-carbohydrate complexes. Such complexes have been found under experimental conditions to produce sarcoma when large doses or small doses injected repeatedly at the same site were given to rats, mice, and rabbits, and possibly in hamsters.
The long latent period between the injection of a potential carcinogen and the appearance of a tumor makes it impossible to measure accurately the risk in man. There have, however, been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes.
Although the pressor activity of desmopressin acetate is very low compared with the antidiuretic activity, use of doses as large as 0.3 mcg/kg of desmopressin acetate with other pressor agents should be done only with careful patient monitoring. The concomitant administration of drugs that may increase the risk of water intoxication with hyponatremia, (e.g., tricyclic antidepressants, selective serotonin re-uptake inhibitors, chlorpromazine, opiate analgesics, NSAIDs, lamotrigine and carbamazepine) should be performed with caution.
Desmopressin acetate has been used with epsilon aminocaproic acid without adverse effects.
Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias.
INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Therefore, administer a test dose prior to the first therapeutic dose of INFeD. (See and .)
Epinephrine should be immediately available in the event of acute hypersensitivity reactions. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.) Patients using beta-blocking agents may not respond adequately to epinephrine. Isoproterenol or similar beta-agonist agents may be required in these patients.
Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD.
Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to
Severe/Fatal:
Cardiovascular:
Dermatologic:
Gastrointestinal:
Hematologic/lymphatic:
Musculoskeletal/soft tissue: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis - See ), myalgia; backache; sterile abscess, atrophy/fibrosis (intramuscular injection site); brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites; cellulitis; swelling; inflammation; local phlebitis at or near intravenous injection site.
Neurologic:
Respiratory:
Urologic:
Delayed reactions:
Miscellaneous:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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