Iron dextran

153.917

1346.576050

618-390-1

146177|57631

DTXSID1031464

Dark brown, slightly viscous solution

83

0.00000

solution

greater than 200° F (NTP, 1992)

H2O: soluble ;Completely miscible with 0.9% sodium chloride injection.

Conditions for safe storage, including any incompatibilities: Keep container tightly closed in a dry and well-ventilated place. Containers which are opened must be carefully resealed and kept upright to prevent leakage.

LD50 i.v. in mice: 2240 mg Fe/kg (Beliles)

pH = 5.2-6.5

Dark-brown colloidal solution in saline

No rapid reaction with air. No rapid reaction with water.

Non-Redox-Active Inorganic Compounds

IRON DEXTRAN is unstable at a pH of 5 and decomposes at 149-158° F. It may be sensitive to prolonged exposure to air. (NTP, 1992)

NONH for all modes of transport

40-42/43-43-45

23-26-36/37/39-45-36-36/37-53

NI2200000

Xn,T

Complex is unstable at pH 5; it does not undergo autoxidation at ambient temp, but this does occur at 65-70 deg C.

P201-P280-P308 + P313

H317-H350

SRP: Expired or waste pharmaceuticals shall carefully take into consideration applicable DEA, EPA, and FDA regulations. It is not appropriate to dispose by flushing the pharmaceutical down the toilet or discarding to trash. If possible return the pharmaceutical to the manufacturer for proper disposal being careful to properly label and securely package the material. Alternatively, the waste pharmaceutical shall be labeled, securely packaged and transported by a state licensed medical waste contractor to dispose by burial in a licensed hazardous or toxic waste landfill or incinerator.|SRP: Wastewater from contaminant suppression, cleaning of protective clothing/equipment, or contaminated sites should be contained and evaluated for subject chemical or decomposition product concentrations. Concentrations shall be lower than applicable environmental discharge or disposal criteria. Alternatively, pretreatment and/or discharge to a permitted wastewater treatment facility is acceptable only after review by the governing authority and assurance that "pass through" violations will not occur. Due consideration shall be given to remediation worker exposure (inhalation, dermal and ingestion) as well as fate during treatment, transfer and disposal. If it is not practicable to manage the chemical in this fashion, it must be evaluated in accordance with EPA 40 CFR Part 261, specifically Subpart B, in order to determine the appropriate local, state and federal requirements for disposal.|PRECAUTIONS FOR "CARCINOGENS": There is no universal method of disposal that has been proved satisfactory for all carcinogenic compounds & specific methods of chem destruction ... published have not been tested on all kinds of carcinogen-containing waste. ... summary of avail methods & recommendations ... /given/ must be treated as guide only. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": ... Incineration may be only feasible method for disposal of contaminated laboratory waste from biological expt. However, not all incinerators are suitable for this purpose. The most efficient type ... is probably the gas-fired type, in which a first-stage combustion with a less than stoichiometric air:fuel ratio is followed by a second stage with excess air. Some ... are designed to accept ... aqueous & organic-solvent solutions, otherwise it is necessary ... to absorb soln onto suitable combustible material, such as sawdust. Alternatively, chem destruction may be used, esp when small quantities ... are to be destroyed in laboratory. /Chemical Carcinogens/|For more Disposal Methods (Complete) data for IRON DEXTRAN (8 total), please visit the HSDB record page.

The Approved Drug Products with Therapeutic Equivalence Evaluations identifies currently marketed prescription drug products, including iron dextran, approved on the basis of safety and effectiveness by FDA under sections 505 of the Federal Food, Drug, and Cosmetic Act.|Oral dosage form new animal drug: iron dextran oral suspension. ... Indications for use: For the prevention of iron deficiency anemia in baby pigs. ... Limitations: Treat each pig within 24 hours of farrowing.|Dextrans used as a general purpose food additive in animal drugs, feeds, and related products is generally recognized as safe when used in accordance with good manufacturing or feeding practice. /Dextrans of average molecular weight below 100,000/|The Generic Animal Drug and Patent Restoration act requires that each sponsor of an approved animal drug must submit to the FDA certain information regarding patents held for the animal drug or its method of use. The Act requires that this information, as well as a list of all animal drug products approved for safety and effectiveness, be made available to the public. Iron dextran is included on this list.

National Toxicology Program. Thirteenth Report on Carcinogens (2014). The Report on Carcinogens is an informational scientific and public health document that identifies and discusses substances (including agents, mixtures, or exposure circumstances) that may pose a carcinogenic hazard to human health. Iron Dextran (9004-66-4) is listed in as reasonably anticipated to be a human carcinogen.[Available from, as of July 21, 2015: http://ntp.niehs.nih.gov/pubhealth/roc/roc13/index.html]

This chemical is combustible. (NTP, 1992)

|Danger|H317 (100%): May cause an allergic skin reaction [Warning Sensitization, Skin]|P201, P202, P261, P272, P280, P281, P302+P352, P308+P313, P321, P333+P313, P363, P405, and P501|Aggregated GHS information provided by 91 companies from 2 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.|Warning|H302 (100%): Harmful if swallowed [Warning Acute toxicity, oral]|P264, P270, P280, P301+P312, P302+P352, P305+P351+P338, P321, P330, P332+P313, P337+P313, P362, and P501|Aggregated GHS information provided by 31 companies from 2 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.|H317: May cause an allergic skin reaction [Warning Sensitization, Skin]|H302: Harmful if swallowed [Warning Acute toxicity, oral]|P201, P202, P264, P270, P281, P301+P312, P308+P313, P330, P405, and P501

SMALL SPILLS AND LEAKAGE: If you spill this chemical, FIRST REMOVE ALL SOURCES OF IGNITION. Then, use absorbent paper to pick up all liquid spill material. Seal the absorbent paper, as well as any of your clothing which may be contaminated, in a vapor-tight plastic bag for eventual disposal. Wash any surfaces you may have contaminated with a soap and water solution. Do not reenter the contaminated area until the Safety Officer (or other responsible person) has verified that the area has been properly cleaned. STORAGE PRECAUTIONS: You should keep this material in a tightly closed container under an inert atmosphere, and store it at refrigerated temperatures. STORE AWAY FROM SOURCES OF IGNITION. (NTP, 1992)

RECOMMENDED RESPIRATOR: Where the neat test chemical is weighed and diluted, wear a NIOSH-approved half face respirator equipped with an organic vapor/acid gas cartridge (specific for organic vapors, HCl, acid gas and SO2) with a dust/mist filter. (NTP, 1992)|Skin protection: Handle with gloves.|Eye/face protection: Face shield and safety glasses. Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).|PRECAUTIONS FOR "CARCINOGENS": ... Dispensers of liq detergent /should be available./ ... Safety pipettes should be used for all pipetting. ... In animal laboratory, personnel should ... wear protective suits (preferably disposable, one-piece & close-fitting at ankles & wrists), gloves, hair covering & overshoes. ... In chemical laboratory, gloves & gowns should always be worn ... however, gloves should not be assumed to provide full protection. Carefully fitted masks or respirators may be necessary when working with particulates or gases, & disposable plastic aprons might provide addnl protection. ... Gowns ... /should be/ of distinctive color, this is a reminder that they are not to be worn outside the laboratory. /Chemical Carcinogens/|Respiratory protection: Where risk assessment shows air-purifying respirators are appropriate use a full-face respirator with multipurpose combination (US) or type ABEK (EN 14387) respirator cartridges as a backup to engineering controls. If the respirator is the sole means of protection, use a full-face supplied air respirator. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).|Body Protection: Complete suit protecting against chemicals. The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.

Advice for firefighters: Wear self contained breathing apparatus for fire fighting if necessary.|Suitable extinguishing media: Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.

Accidental Release Measures. Personal precautions, protective equipment and emergency procedures: Use personal protective equipment. Avoid breathing vapors, mist or gas. Ensure adequate ventilation. Evacuate personnel to safe areas. Environmental precautions: Prevent further leakage or spillage if safe to do so. Do not let product enter drains. Methods and materials for containment and cleaning up: Soak up with inert absorbent material and dispose of as hazardous waste. Keep in suitable, closed containers for disposal.|PRECAUTIONS FOR "CARCINOGENS": A high-efficiency particulate arrestor (HEPA) or charcoal filters can be used to minimize amt of carcinogen in exhausted air ventilated safety cabinets, lab hoods, glove boxes or animal rooms ... Filter housing that is designed so that used filters can be transferred into plastic bag without contaminating maintenance staff is avail commercially. Filters should be placed in plastic bags immediately after removal ... The plastic bag should be sealed immediately ... The sealed bag should be labelled properly ... Waste liquids ... should be placed or collected in proper containers for disposal. The lid should be secured & the bottles properly labelled. Once filled, bottles should be placed in plastic bag, so that outer surface ... is not contaminated ... The plastic bag should also be sealed & labelled. ... Broken glassware ... should be decontaminated by solvent extraction, by chemical destruction, or in specially designed incinerators. /Chemical Carcinogens/

SRP: Local exhaust ventilation should be applied wherever there is an incidence of point source emissions or dispersion of regulated contaminants in the work area. Ventilation control of the contaminant as close to its point of generation is both the most economical and safest method to minimize personnel exposure to airborne contaminants. Ensure that the local ventilation moves the contaminant away from the worker.|SRP: Contaminated protective clothing should be segregated in a manner such that there is no direct personal contact by personnel who handle, dispose, or clean the clothing. The completeness of the cleaning procedures should be considered before the decontaminated protective clothing is returned for reuse by the workers. Contaminated clothing should not be taken home at the end of shift, but should remain at employee's place of work for cleaning.|PRECAUTIONS FOR "CARCINOGENS": Smoking, drinking, eating, storage of food or of food & beverage containers or utensils, & the application of cosmetics should be prohibited in any laboratory. All personnel should remove gloves, if worn, after completion of procedures in which carcinogens have been used. They should ... wash ... hands, preferably using dispensers of liq detergent, & rinse ... thoroughly. Consideration should be given to appropriate methods for cleaning the skin, depending on nature of the contaminant. No standard procedure can be recommended, but the use of organic solvents should be avoided. Safety pipettes should be used for all pipetting. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": In animal laboratory, personnel should remove their outdoor clothes & wear protective suits (preferably disposable, one-piece & close-fitting at ankles & wrists), gloves, hair covering & overshoes. ... clothing should be changed daily but ... discarded immediately if obvious contamination occurs ... /also,/ workers should shower immediately. In chemical laboratory, gloves & gowns should always be worn ... however, gloves should not be assumed to provide full protection. Carefully fitted masks or respirators may be necessary when working with particulates or gases, & disposable plastic aprons might provide addnl protection. If gowns are of distinctive color, this is a reminder that they should not be worn outside of lab. /Chemical Carcinogens/|For more Preventive Measures (Complete) data for IRON DEXTRAN (13 total), please visit the HSDB record page.

PRECAUTIONS FOR "CARCINOGENS": Procurement ... of unduly large amt ... should be avoided. To avoid spilling, carcinogens should be transported in securely sealed glass bottles or ampoules, which should themselves be placed inside strong screw-cap or snap-top container that will not open when dropped & will resist attack from the carcinogen. Both bottle & the outside container should be appropriately labelled. ... National post offices, railway companies, road haulage companies & airlines have regulations governing transport of hazardous materials. These authorities should be consulted before ... material is shipped. /Chemical Carcinogens/|PRECAUTIONS FOR "CARCINOGENS": When no regulations exist, the following procedure must be adopted. The carcinogen should be enclosed in a securely sealed, watertight container (primary container), which should be enclosed in a second, unbreakable, leakproof container that will withstand chem attack from the carcinogen (secondary container). The space between primary & secondary container should be filled with absorbent material, which would withstand chem attack from the carcinogen & is sufficient to absorb the entire contents of the primary container in the event of breakage or leakage. Each secondary container should then be enclosed in a strong outer box. The space between the secondary container & the outer box should be filled with an appropriate quantity of shock-absorbent material. Sender should use fastest & most secure form of transport & notify recipient of its departure. If parcel is not received when expected, carrier should be informed so that immediate effort can be made to find it. Traffic schedules should be consulted to avoid ... arrival on weekend or holiday ... /Chemical Carcinogens/

IDENTIFICATION AND USE: Iron dextran is a dark brown, slightly viscous solution. Intravenous or intramuscular injection of iron dextran is indicated for treatment of patients with documented iron deficiency in which oral administration is unsatisfactory or impossible. HUMAN EXPOSURE AND TOXICITY: 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, Hodgkin's disease, and rheumatoid arthritis. Anaphylactic or anaphylactoid reactions to iron dextran, including fatal anaphylaxis, have been reported. These reactions occur most frequently within the first several minutes of administration and are generally characterized by sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, and cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse. The manufacturers state that concomitant use of angiotensin-converting enzyme (ACE) inhibitors may increase the risk for reactions to iron dextran. Acute hypersensitivity reactions to iron dextran have been estimated to occur in 0.2-3% of patients. These reactions have been reported after administration of uneventful test doses of iron dextran as well as after therapeutic doses of the drug. Although it has been suggested that severe systemic reactions, including anaphylactoid reactions, are more common following IV rather than IM administration of iron dextran, the risk of severe systemic reactions following IV or IM administration has not been directly compared and there appears to be no well-substantiated evidence of a difference in the frequency of anaphylactoid reactions following either route of administration. ANIMAL STUDIES: Rats treated with iron dextran by intramuscular injection at a total dose of 100 mg of iron/kg in divided doses over a 12-week period exhibited no drug-related abnormalities. At ten times this dose, 1000 mg of iron/kg, treated rats had enlarged livers and spleens compared to control rats. Iron dextran is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals. Three male and three female rabbits were given 28 once-weekly im injections of 2 mL iron-dextran starting at 6 months of age and were observed for up to four years after the first injection. Two developed pleomorphic sarcoma at 39 and 48 months after the first injection, and 1 of the sarcomas metastasized to the lungs. No distant primary tumors were seen. Rats were given repeated im injections over 4 months (totaling 1250 mg iron in males and 800 mg iron in females). Local sarcomas, several of which were transplantable, developed in 13/18 rats between 8 and 10 months after the first injection of iron-dextran. In another study, researchers found 41 sarcomas, 6 histiocytomas and 1 epithelioma at the injection site in 70/95 mice that survived from 6 to 18 months after the start of a course of once-weekly sc doses of 0.2 or 0.3 mL of iron-dextran from 11 wk to 7.5 months. Mice injected with dextran only developed no tumors. When a single sc doses of iron dextran equivalent to 25-2500 mg/kg bw of trivalent iron were given to groups mice of different numbers (6 to 44 males and 8 to 60 females), altogether three local tumors (1 sarcoma, 2 unspecified) developed in 3 females (1/53 on 500 mg/kg, 1/10 on 1000 mg/kg and 1/8 on 2500 mg/kg). However, an increase in the incidence of distant tumors was noted only in females (61/137 test females versus 13/60 control females), and two-thirds of these tumors were of lymphoreticular origin. Intravenous injection of three doses of 50 mg iron/kg (total dose 150 mg Fe/kg) as iron dextran into rabbits late in pregnancy (days 26, 28 and 30 of gestation) reduced the weight gain of the dams and increased fetal mortality. Three doses of 20 mg Fe/kg also increased fetal mortality, while three doses of 5 mg Fe/kg were without effect. In the rat four i.v. doses of 200 mg Fe/kg as iron dextran on days 17, 18, 19, and 20 of gestation (total dose 800 mg Fe/kg) produced tremors, reduced body weight gain, and reduced food consumption in the dams. The growth and survival of the offspring were adversely influenced by these effects on the dam. No iron-induced pathology was evident in the offspring of either rabbits or rats after 14 and 18 weeks, respectively.

Female F344 rats received an i.p. injection of iron-dextran (600 mg Fe/kg) and then after 1 week were fed a diet containing 0.02% hexachlorobenzene (HCB) for up to 65 weeks. All rats (8/8) which received HCB after iron overload developed multiple hepatic nodules whereas only 3/8 rats administered HCB alone had nodules (average of one per positive liver). These hyperplastic regions were depleted of iron and were often positive for gamma-glutamyl transpeptidase (GGT) and glutathione S-transferase P (GST-P). Telangiectasis and peliosis were prominent features in the lesions. Short-term experiments (5-15 weeks of iron/HCB treatments) showed that GGT and GST-P were induced early in the neoplastic process but not in discrete focal areas. Iron alone also caused some induction of these enzymes. Some cells with induced GST-P in either short or long term experiments also stained positively for this enzyme in the nucleus. Studies of cytochrome P450 mediated activities showed that at 5 and 15 weeks HCB had induced EROD (an estimate of CYP1A1), PROD (CYP2B1 activity) and BROD activities (CYP2B1 but also other isoenzymes). Under the influence of iron overload EROD was significantly depressed from HCB alone, but not the others or cytochrome P450 reductase. Cytosolic glutathione S-transferase activities were also induced by HCB, but, unlike microsomal EROD, preloading with iron enhanced the effects. In contrast, although cytosolic diaphorase activity was induced by HCB, this response was depressed in combination with iron. Glutathione peroxidase (with H2O2 as substrate) was depressed by both iron and HCB.|Acute administration of dl-cysteine, a reactive oxygen species scavenger, completely abrogated the effects of iron loading on thrombus formation, suggesting that iron accelerated thrombosis through a pro-oxidant mechanism.|Doxorubicin (DOX) is known to induce serious cardiotoxicity, which is believed to be mediated by oxidative stress and complex interactions with iron. However, the relationship between iron and DOX-induced cardiotoxicity remains controversial and the role of iron chelation therapy to prevent cardiotoxicity is called into question. Firstly, we evaluated in vitro the effects of DOX in combination with dextran-iron on cell viability in cultured H9c2 cardiomyocytes and EMT-6 cancer cells. Secondly, we used an in vivo murine model of iron overloading (IO) in which male C57BL/6 mice received a daily intra-peritoneal injection of dextran-iron (15 mg/kg) for 3 weeks (D0-D20) and then (D21) a single sub-lethal intra-peritoneal injection of 6 mg/kg of DOX. While DOX significantly decreased cell viability in EMT-6 and H9c2, pretreatment with dextran-iron (125-1000 ug/mL) in combination with DOX, paradoxically limited cytotoxicity in H9c2 and increased it in EMT-6. In mice, IO alone resulted in cardiac hypertrophy (+22%) and up-regulation of brain natriuretic peptide and beta-myosin heavy-chain (beta-MHC) expression, as well as an increase in cardiac nitro-oxidative stress revealed by electron spin resonance spectroscopy. In DOX-treated mice, there was a significant decrease in left-ventricular ejection fraction (LVEF) and an up-regulation of cardiac beta-MHC and atrial natriuretic peptide (ANP) expression. However, prior IO did not exacerbate the DOX-induced fall in LVEF and there was no increase in ANP expression. IO did not impair the capacity of DOX to decrease cancer cell viability and could even prevent some aspects of DOX cardiotoxicity in cardiomyocytes and in mice.

LD50 Mouse iv 2,240 mg iron/kg|LD50 Rat ip 3 g (Fe)/kg|LD50 Mouse oral 1 g (Fe)/kg

Extreme caution should also be used in administering the drug IV in patients with rheumatoid arthritis, since IV administration may cause fever and exacerbation or reactivation of joint pain and swelling in these patients; the possibility of an increased risk of delayed reactions (e.g., arthralgia, myalgia, fever) should also be considered in patients with other inflammatory diseases (e.g., ankylosing spondylitis, lupus erythematosus).|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.|Iron dextran should not be used during the acute phase of infectious renal disease. The drug is contraindicated in patients with any anemia other than iron deficiency anemia and in patients who are hypersensitive to iron dextran.

This substance is a synthetic commercial product ... .

NIOSH (NOES Survey 1981-1983) has statistically estimated that 1,157 workers (573 of these are female) were potentially exposed to iron dextran in the US(1). Occupational exposure to iron dextran may occur through inhalation and dermal contact with this compound at workplaces where iron dextran is produced or used. Exposure to iron dextran among the general population may be limited to those administered the drug(SRC).

Hematinics|/CLINICAL TRIALS/ ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. The Web site is maintained by the National Library of Medicine (NLM) and the National Institutes of Health (NIH). Each ClinicalTrials.gov record presents summary information about a study protocol and includes the following: Disease or condition; Intervention (for example, the medical product, behavior, or procedure being studied); Title, description, and design of the study; Requirements for participation (eligibility criteria); Locations where the study is being conducted; Contact information for the study locations; and Links to relevant information on other health Web sites, such as NLM's MedlinePlus for patient health information and PubMed for citations and abstracts for scholarly articles in the field of medicine. Iron dextran is included in the database.|Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible. /Included in US product labeling/|MEDICATION (VET): Nutritional factor (parenteral). Used in iron deficiency anemia, chiefly in pigs.|For more Therapeutic Uses (Complete) data for IRON DEXTRAN (8 total), please visit the HSDB record page.

/BOXED WARNING/ WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS. Anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during INFeD administration. Administer a test INFeD dose prior to the first therapeutic dose. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic INFeD dose. During all INFeD administrations, observe for signs or symptoms of anaphylactic-type reactions. Fatal reactions have followed the test dose of iron dextran injection. Fatal reactions 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. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to INFeD.|Abdominal pain, dyspepsia, nausea, vomiting, diarrhea, metallic taste in the mouth, altered taste, and transient loss of taste perception have occurred in patients receiving iron dextran.|Anaphylactic or anaphylactoid reactions to iron dextran, including fatal anaphylaxis, have been reported. These reactions occur most frequently within the first several minutes of administration and are generally characterized by sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse. The manufacturers state that concomitant use of angiotensin-converting enzyme (ACE) inhibitors may increase the risk for reactions to iron dextran. The level of risk for anaphylactic-type reactions following exposure to specific iron dextran preparations is not known and may vary. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; the manufacturers state that such preparations are not clinically interchangeable. Acute hypersensitivity reactions to iron dextran have been estimated to occur in 0.2-3% of patients. These reactions have been reported after administration of uneventful test doses of iron dextran as well as after therapeutic doses of the drug. Although it has been suggested that severe systemic reactions, including anaphylactoid reactions, are more common following IV rather than IM administration of iron dextran, the risk of severe systemic reactions following IV or IM administration has not been directly compared and there appears to be no well-substantiated evidence of a difference in the frequency of anaphylactoid reactions following either route of administration.|Large IV doses of iron dextran, such as those used in total-dose infusions, may be associated with an increased frequency of adverse effects, especially delayed (1-2 days) reactions manifested by arthralgia, backache, myalgia, adenopathy, moderate to high fever, backache, chills, dizziness, headache, malaise, nausea, and/or vomiting. The onset of these adverse effects is usually 24-48 hours after administration of the drug, and the effects generally subside within 3-4 days. Delayed adverse effects have also occurred following IM administration and usually subsided within 3-7 days. The etiology of delayed adverse effects is not known, but the symptom complex resembles that of a serum sickness reaction. Patients with rheumatoid arthritis and possibly other inflammatory diseases (e.g., ankylosing spondylitis, lupus erythematosus) may be at particular risk for delayed reactions. IV administration of iron dextran has caused fever and exacerbation or reactivation of joint pain and swelling in patients with rheumatoid arthritis; in addition, exacerbation of ankylosing spondylitis in one patient and arthralgia, myalgia, erythema nodosum, and fever in a patient with lupus erythematosus have been reported. Such exacerbations of underlying inflammatory conditions may respond to nonsteroidal anti-inflammatory agent (NSAIA) therapy and may be prevented with corticosteroid pretreatment.|For more Drug Warnings (Complete) data for IRON DEXTRAN (21 total), please visit the HSDB record page.

Agents which improve the quality of the blood, increasing the hemoglobin level and the number of erythrocytes. They are used in the treatment of anemias. (See all compounds classified as Hematinics.)

Following intramuscular administration, iron dextran is absorbed from the site of injection primarily through the lymphatic system. Absorption takes place in two stages. Approximately 60% of the dose or iron dextran inected is absorbed within 72 hours of administration. Ninety percent of the dose is absorbed in the second, slower, phase lasting approximately 1 to 3 weeks in duration. The remaining 10% of the dose is gradually absorbed over a period of several months or longer.|Following IM or IV injection, iron dextran is gradually cleared from plasma by reticuloendothelial cells of liver, spleen, and bone marrow. Results of several studies indicate that /a/ variable portion of IV dose... may be stored in unusable form in bone marrow.|In vitro studies have shown that removal of iron dextran by dialysis is negligible.|/MILK/ Traces of unmetabolized iron dextran are excreted in human milk.|For more Absorption, Distribution and Excretion (Complete) data for IRON DEXTRAN (6 total), please visit the HSDB record page.

Dextran, a polyglucose, is either metabolized or excreted. Only traces of unmetabolized iron dextran are excreted in the urine, bile or feces.

After intravenous injection of 2 mL of DexIron (100 mg iron) to renal dialysis patients ... the average half-life of iron dextran in serum was 58.9 hours, ranging from 9.4 to 87.4 hours in 20 patients.|Various studies involving intravenously administered (59)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 (59)Fe iron dextran from a study that used laboratory methods to separate the circulating (59)Fe iron dextran from the transferrin-bound (59)Fe. The 20-hour value reflects a half-life determined by measuring total (59)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.

... Circulating iron dextran is removed from the plasma by cells of the reticuloendothelial system, which split the complex into its components of iron and dextran. The iron is immediately bound to the available protein moieties to form hemosiderin or ferritin, the physiological forms of iron, or to a lesser extent to transferrin. This iron which is subject to physiological control replenishes hemoglobin and depleted iron stores.|... The toxicity of iron in biological systems is believed to be attributed to its ability to catalyze the generation of oxygen-free radicals. In the current investigation, the dose-dependent effects of chronic iron-loading on heart tissue concentrations of iron, glutathione peroxidase (GPx) activity, free-radical production, and cardiac dysfunction were investigated in a murine model of iron-overload cardiomyopathy. It was shown that chronic iron-overload results in dose-dependent (a) increases in myocardial iron burden, (b) decreases in the protective antioxidant enzyme GPx activity, (c) increased free-radical production, and (d) increased mortality. These findings show that the mechanism of iron-induced heart dysfunction involves in part free radical-mediated processes.

SYMPTOMS: The symptoms associated with exposure to this compound are headaches, vomiting, and dizziness. (NTP, 1992)

EYES: First check the victim for contact lenses and remove if present. Flush victim's eyes with water or normal saline solution for 20 to 30 minutes while simultaneously calling a hospital or poison control center. Do not put any ointments, oils, or medication in the victim's eyes without specific instructions from a physician. IMMEDIATELY transport the victim after flushing eyes to a hospital even if no symptoms (such as redness or irritation) develop. SKIN: IMMEDIATELY flood affected skin with water while removing and isolating all contaminated clothing. Gently wash all affected skin areas thoroughly with soap and water. If symptoms such as redness or irritation develop, IMMEDIATELY call a physician and be prepared to transport the victim to a hospital for treatment. INHALATION: IMMEDIATELY leave the contaminated area; take deep breaths of fresh air. IMMEDIATELY call a physician and be prepared to transport the victim to a hospital even if no symptoms (such as wheezing, coughing, shortness of breath, or burning in the mouth, throat, or chest) develop. Provide proper respiratory protection to rescuers entering an unknown atmosphere. Whenever possible, Self-Contained Breathing Apparatus (SCBA) should be used; if not available, use a level of protection greater than or equal to that advised under Protective Clothing. INGESTION: Some heavy metals are VERY TOXIC POISONS, especially if their salts are very soluble in water (e.g., lead, chromium, mercury, bismuth, osmium, and arsenic). IMMEDIATELY call a hospital or poison control center and locate activated charcoal, egg whites, or milk in case the medical advisor recommends administering one of them. Also locate Ipecac syrup or a glass of salt water in case the medical advisor recommends inducing vomiting. Usually, this is NOT RECOMMENDED outside of a physician's care. If advice from a physician is not readily available and the victim is conscious and not convulsing, give the victim a glass of activated charcoal slurry in water or, if this is not available, a glass of milk, or beaten egg whites and IMMEDIATELY transport victim to a hospital. If the victim is convulsing or unconscious, do not give anything by mouth, assure that the victim's airway is open and lay the victim on his/her side with the head lower than the body. DO NOT INDUCE VOMITING. IMMEDIATELY transport the victim to a hospital. OTHER: Since this chemical is a known or suspected carcinogen you should contact a physician for advice regarding the possible long term health effects and potential recommendation for medical monitoring. Recommendations from the physician will depend upon the specific compound, its chemical, physical and toxicity properties, the exposure level, length of exposure, and the route of exposure. (NTP, 1992)

/SRP:/ Immediate first aid: Ensure that adequate decontamination has been carried out. If patient is not breathing, start artificial respiration, preferably with a demand valve resuscitator, bag-valve-mask device, or pocket mask, as trained. Perform CPR if necessary. Immediately flush contaminated eyes with gently flowing water. Do not induce vomiting. If vomiting occurs, lean patient forward or place on the left side (head-down position, if possible) to maintain an open airway and prevent aspiration. Keep patient quiet and maintain normal body temperature. Obtain medical attention. /Poisons A and B/|/SRP:/ Basic treatment: Establish a patent airway (oropharyngeal or nasopharyngeal airway, if needed). Suction if necessary. Watch for signs of respiratory insufficiency and assist ventilations if needed. Administer oxygen by nonrebreather mask at 10 to 15 L/min. Monitor for pulmonary edema and treat if necessary ... . Monitor for shock and treat if necessary ... . Anticipate seizures and treat if necessary ... . For eye contamination, flush eyes immediately with water. Irrigate each eye continuously with 0.9% saline (NS) during transport ... . Do not use emetics. For ingestion, rinse mouth and administer 5 mL/kg up to 200 mL of water for dilution if the patient can swallow, has a strong gag reflex, and does not drool ... . Cover skin burns with dry sterile dressings after decontamination ... . /Poisons A and B/|/SRP:/ Advanced treatment: Consider orotracheal or nasotracheal intubation for airway control in the patient who is unconscious, has severe pulmonary edema, or is in severe respiratory distress. Positive-pressure ventilation techniques with a bag valve mask device may be beneficial. Consider drug therapy for pulmonary edema ... . Consider administering a beta agonist such as albuterol for severe bronchospasm ... . Monitor cardiac rhythm and treat arrhythmias as necessary ... . Start IV administration of D5W TKO /SRP: "To keep open", minimal flow rate/. Use 0.9% saline (NS) or lactated Ringer's (LR) if signs of hypovolemia are present. For hypotension with signs of hypovolemia, administer fluid cautiously. Watch for signs of fluid overload ... . Treat seizures with diazepam or lorazepam ... . Use proparacaine hydrochloride to assist eye irrigation ... . /Poisons A and B/

/SIGNS AND SYMPTOMS/ Anaphylactic or anaphylactoid reactions to iron dextran, including fatal anaphylaxis, have been reported. These reactions occur most frequently within the first several minutes of administration and are generally characterized by sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse. The manufacturers state that concomitant use of angiotensin-converting enzyme (ACE) inhibitors may increase the risk for reactions to iron dextran. The level of risk for anaphylactic-type reactions following exposure to specific iron dextran preparations is not known and may vary. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; the manufacturers state that such preparations are not clinically interchangeable. Acute hypersensitivity reactions to iron dextran have been estimated to occur in 0.2-3% of patients. These reactions have been reported after administration of uneventful test doses of iron dextran as well as after therapeutic doses of the drug. Although it has been suggested that severe systemic reactions, including anaphylactoid reactions, are more common following IV rather than IM administration of iron dextran, the risk of severe systemic reactions following IV or IM administration has not been directly compared and there appears to be no well-substantiated evidence of a difference in the frequency of anaphylactoid reactions following either route of administration.|/SIGNS AND SYMPTOMS/ 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.|/CASE REPORTS/ ...Only one case of cancer has been reported as possible complication. 74-yr-old woman developed at site of injection an undifferentiated soft tissue sarcoma, 3 yr after receiving 6 inoculations (100 mg each) of iron-dextran for blood-loss anemia.|/CASE REPORTS/ A case is presented in which a 57-yr-old man experienced a false decrease in total serum calcium concentration and elevation in serum phosphorus concentration after an iv injection of 500 mg iron dextran (Infed) infused over 6 hr. It was noted that the total calcium concentration, which had been stable before iron dextran administration, decreased to 6.4 mg/dL about 8 hr after the infusion. The patient was given an iv infusion of 1 g calcium chloride. A total calcium concentration 22 hr later of 7.9 mg/dL was almost back to previous values.|For more Human Toxicity Excerpts (Complete) data for IRON DEXTRAN (7 total), please visit the HSDB record page.

Dexferrum

Essentially 100% as a hematinic

Iron Dextran Injection, USP (50 mg Elemental Iron/mL) 1 mL, 2 ml Single-Dose Vials: Dexiron|Table: Iron Dextran Preparations [Table#5164]

Sulfuric acid, iron salt (1:?): ACTIVE

Method: AOAC 977.30; Procedure: spectrophotometric method; Analyte: iron dextran; Matrix: drugs; Detection Limit: not provided.

Human Drugs -> FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) -> Active Ingredients