Iron-dextran 9004-66-4 wiki

1. Names and Identifiers

: 1.1 Name; Iron-dextran; 1.2 Synonyms; AlphaRedisol fe-dextran fenate ferdex100 Ferric hydroxide dextran complex ferricdextran ferridextran ferrodextran ferroglucin ferroglukin75 Hydroxocobalamin MFCD00081553; View all

1.3 CAS No.: 9004-66-4

1.4 CID: 105075

1.5 EINECS(EC#): 202-785-7

1.6 Molecular Formula: FeH2O4S (isomer)

1.7 Inchi: InChI=1S/Fe.H2O4S/c;1-5(2,3)4/h;(H2,1,2,3,4)

1.8 InChIkey: MVZXTUSAYBWAAM-UHFFFAOYSA-N

1.9 Canonical Smiles: [Fe].[H]OS(=O)(=O)O[H]

1.10 Isomers Smiles: OS(=O)(=O)O.[Fe]

2. Properties

2.1 Boiling point: 330°Cat760mmHg

2.1 Flash Point: greater than 200° F (NTP, 1992)

2.1 Precise Quality: 1346.576050

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

2.2 Appearance: solution

2.3 Carcinogenicity: Iron dextran complex is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals. Iron-dextran Preparation Products And Raw materials Preparation Products

2.4 Chemical Properties: Light to dark brown powder. Colloidal suspension of an iron-dextran complex in water. pH 5.2-6.5.

2.5 Color/Form: Dark brown slightly viscous liquid

2.6 PH: pH = 5.2-6.5

2.7 Physical: PHYSICAL DESCRIPTION: Dark reddish-brown liquid. Colloidal suspension of an iron;-dextran; complex in water;. pH 5.2-6.5.

2.8 Water Solubility: extremely soluble

2.9 Stability: Complex is unstable @ pH 5; it does not undergo autoxidation @ ambient temperature, but this does occur @ 65-70 C. Expiration date of 5 yr following date of mfr.

2.10 StorageTemp: Room Temperature

2.11 Toxicity Summary: 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.; View all

3. Use and Manufacturing

3.1 GHS Classification: Signal: Danger
GHS Hazard Statements
Aggregated GHS information provided by 59 companies from 2 notifications to the ECHA C&L Inventory. Each notification may be associated with multiple companies.

H317 (100%): May cause an allergic skin reaction [Warning Sensitization, Skin]
H350 (98.31%): May cause cancer [Danger Carcinogenicity]

Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown.

Precautionary Statement Codes
P201, P202, P261, P272, P280, P281, P302+P352, P308+P313, P321, P333+P313, P363, P405, and P501; View all

3.2 History: The therapeutic value of colloidal iron preparations was first reported in the 1950's by London and Twigg. Numerous attempts have been made to improve these iron preparations Thus dextran ([h] 0.05) is first heated with alkali, and is then neutralized in the presence of ferric chloride solution. Studies on this product have revealed that each particle consists of a central iron core, approximately 3nm diameter, surrounded by a dextran sheath of approximately 13nm diameter. The complex is visualized as a particle formed by a protective sheath of dextran attached by terminal metasaccharinic acid units to a b-FeOOH core. A solution of this complex containing 5% iron and 20% dextran (Imferon ™ ) is suitable for intramuscular and intravenous injection for treating iron deficiency anemia. The product is currently used widely for treating anemia in new-born piglets.The use of these preparations has been re-examined in humans and a dramatic rise in hemoglobin was reported following intravenous infusion. The solution is best administered together with glucose solutions.; View all

3.3 Methods of Manufacturing: To an aqueous solution of partially depolymerized dextran; (intrinsic viscosity 0.04-0.07) is added a solution of alkali and a solution of a ferric; salt. The mixture is heated, then cooled to room temperature, clarified by centrifugation, and the solution dialyzed against running water;. After concentrating to the required iron; content, the solution is filtered, ampuled, and sterilized by autoclaving.

3.4 Usage: Hematinic.

4. Safety and Handling

4.1 Symbol: GHS07, GHS08

4.1 Hazard Codes: Xn,T

4.1 Signal Word: Danger

4.1 Risk Statements: 40-42/43-43-45

4.1 Safety Statements: 23-26-36/37/39-45-36-36/37-53

4.1 Exposure Standards and Regulations: The Approved Drug Products with Therapeutic Equivalence Evaluations List identifies currently marketed prescription drug products, incl 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: Prevention of iron deficiency anemia in baby pigs. ... Limitations: Treat each pig within 24 hours of farrowing. Administer 1.8 milliliters orally by automatic dose dispenser.
Implantation or injectable dosage form new animal drugs. Iron dextran complex injection. ... Used in baby pigs ... for the prevention of anemia due to iron deficiency... /and/ for the treatment of anemia due to iron deficiency.
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/; View all

4.2 Fire Hazard: Iron-dextran is combustible.

4.3 Other Preventative Measures: 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.
SRP: Contaminated protective clothing should be segregated in such a manner so that there is no direct personal contact by personnel who handle, dispose, or clean the clothing. Quality assurance to ascertain the completeness of the cleaning procedures should be implemented before the decontaminated protective clothing is returned for reuse by the workers. Contaminated clothing should not be taken home at end of shift, but should remain at employee's place of work for cleaning.
SRP: The scientific literature for the use of contact lenses in industry is conflicting. The benefit or detrimental effects of wearing contact lenses depend not only upon the substance, but also on factors including the form of the substance, characteristics and duration of the exposure, the uses of other eye protection equipment, and the hygiene of the lenses. However, there may be individual substances whose irritating or corrosive properties are such that the wearing of contact lenses would be harmful to the eye. In those specific cases, contact lenses should not be worn. In any event, the usual eye protection equipment should be worn even when contact lenses are in place.
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/
PRECAUTIONS FOR "CARCINOGENS": ... Operations connected with synth & purification ... should be carried out under well-ventilated hood. Analytical procedures ... should be carried out with care & vapors evolved during ... procedures should be removed. ... Expert advice should be obtained before existing fume cupboards are used ... & when new fume cupboards are installed. It is desirable that there be means for decreasing the rate of air extraction, so that carcinogenic powders can be handled without ... powder being blown around the hood. Glove boxes should be kept under negative air pressure. Air changes should be adequate, so that concn of vapors of volatile carcinogens will not occur. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": Vertical laminar-flow biological safety cabinets may be used for containment of in vitro procedures ... provided that the exhaust air flow is sufficient to provide an inward air flow at the face opening of the cabinet, & contaminated air plenums that are under positive pressure are leak-tight. Horizontal laminar-flow hoods or safety cabinets, where filtered air is blown across the working area towards the operator, should never be used ... Each cabinet or fume cupboard to be used ... should be tested before work is begun (eg, with fume bomb) & label fixed to it, giving date of test & avg air-flow measured. This test should be repeated periodically & after any structural changes. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": Principles that apply to chem or biochem lab also apply to microbiological & cell-culture labs ... Special consideration should be given to route of admin. ... Safest method of administering volatile carcinogen is by injection of a soln. Admin by topical application, gavage, or intratracheal instillation should be performed under hood. If chem will be exhaled, animals should be kept under hood during this period. Inhalation exposure requires special equipment. ... unless specifically required, routes of admin other than in the diet should be used. Mixing of carcinogen in diet should be carried out in sealed mixers under fume hood, from which the exhaust is fitted with an efficient particulate filter. Techniques for cleaning mixer & hood should be devised before expt begun. When mixing diets, special protective clothing &, possibly, respirators may be required. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": When ... admin in diet or applied to skin, animals should be kept in cages with solid bottoms & sides & fitted with a filter top. When volatile carcinogens are given, filter tops should not be used. Cages which have been used to house animals that received carcinogens should be decontaminated. Cage-cleaning facilities should be installed in area in which carcinogens are being used, to avoid moving of ... contaminated /cages/. It is difficult to ensure that cages are decontaminated, & monitoring methods are necessary. Situations may exist in which the use of disposable cages should be recommended, depending on type & amt of carcinogen & efficiency with which it can be removed. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": To eliminate risk that ... contamination in lab could build up during conduct of expt, periodic checks should be carried out on lab atmospheres, surfaces, such as walls, floors & benches, & ... interior of fume hoods & airducts. As well as regular monitoring, check must be carried out after cleaning-up of spillage. Sensitive methods are required when testing lab atmospheres. ... Methods ... should ... where possible, be simple & sensitive. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": Rooms in which obvious contamination has occurred, such as spillage, should be decontaminated by lab personnel engaged in expt. Design of expt should ... avoid contamination of permanent equipment. ... Procedures should ensure that maintenance workers are not exposed to carcinogens. ... Particular care should be taken to avoid contamination of drains or ventilation ducts. In cleaning labs, procedures should be used which do not produce aerosols or dispersal of dust, ie, wet mop or vacuum cleaner equipped with high-efficiency particulate filter on exhaust, which are avail commercially, should be used. Sweeping, brushing & use of dry dusters or mops should be prohibited. Grossly contaminated cleaning materials should not be re-used ... If gowns or towels are contaminated, they should not be sent to laundry, but ... decontaminated or burnt, to avoid any hazard to laundry personnel. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": Doors leading into areas where carcinogens are used ... should be marked distinctively with appropriate labels. Access ... limited to persons involved in expt. ... A prominently displayed notice should give the name of the Scientific Investigator or other person who can advise in an emergency & who can inform others (such as firemen) on the handling of carcinogenic substances. /Chemical Carcinogens/
All ... /iron/ preparations should be kept in child-proof bottles. /Iron preparations/; View all

4.4 Hazard Declaration: H317-H350

4.4 Cleanup Methods: 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/; View all

4.5 DisposalMethods: [40 CFR 240-280, 300-306, 702-799 (7/1/2004)] Generators of waste (equal to or greater than 100 kg/mo) containing this contaminant, EPA hazardous waste number U139, must conform with USEPA regulations in storage, transportation, treatment and disposal of waste.
Generators of waste (equal to or greater than 100 kg/mo) containing this contaminant, EPA hazardous waste number U139, must conform with USEPA regulations in storage, transportation, treatment and disposal of waste.
A poor candidate for incineration.
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/
PRECAUTIONS FOR "CARCINOGENS": HEPA (high-efficiency particulate arrestor) filters ... can be disposed of by incineration. For spent charcoal filters, the adsorbed material can be stripped off at high temp & carcinogenic wastes generated by this treatment conducted to & burned in an incinerator. ... LIQUID WASTE: ... Disposal should be carried out by incineration at temp that ... ensure complete combustion. SOLID WASTE: Carcasses of lab animals, cage litter & misc solid wastes ... should be disposed of by incineration at temp high enough to ensure destruction of chem carcinogens or their metabolites. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": ... Small quantities of ... some carcinogens can be destroyed using chem reactions ... but no general rules can be given. ... As a general technique ... treatment with sodium dichromate in strong sulfuric acid can be used. The time necessary for destruction ... is seldom known ... but 1-2 days is generally considered sufficient when freshly prepd reagent is used. ... Carcinogens that are easily oxidizable can be destroyed with milder oxidative agents, such as saturated soln of potassium permanganate in acetone, which appears to be a suitable agent for destruction of hydrazines or of compounds containing isolated carbon-carbon double bonds. Concn or 50% aqueous sodium hypochlorite can also be used as an oxidizing agent. /Chemical Carcinogens/
PRECAUTIONS FOR "CARCINOGENS": Carcinogens that are alkylating, arylating or acylating agents per se can be destroyed by reaction with appropriate nucleophiles, such as water, hydroxyl ions, ammonia, thiols & thiosulfate. The reactivity of various alkylating agents varies greatly ... & is also influenced by sol of agent in the reaction medium. To facilitate the complete reaction, it is suggested that the agents be dissolved in ethanol or similar solvents. ... No method should be applied ... until it has been thoroughly tested for its effectiveness & safety on material to be inactivated. For example, in case of destruction of alkylating agents, it is possible to detect residual compounds by reaction with 4(4-nitrobenzyl)-pyridine. /Chemical Carcinogens/; View all

4.6 RIDADR: NONH for all modes of transport

4.6 Caution Statement: P201-P280-P308 + P313

4.6 Formulations/Preparations: Iron dextran is avail in 10 mL vials containing 0.5% phenol for im use & in 2 & 5 mL ampuls for im or iv admin.
Iron dextran injection, USP (Infed, Dexderrum), is parenteral preparation in general use in United States. It is a colloidal solution of ferric oxyhydroxide complexed with polymerized dextran (molecular weight approx 180,000), resulting in a dark brown viscous liquid,containing 50 mg/mL of elemental iron.
Iron-dextran complex: A complex of ferric hydroxide with dextrans of average molecular weight 5000-7500 ... A typical product contains 5% (w/v) iron & 20% (w/v) dextran, molecular weight 6500-7600.
Commercial hydrogenated form is also marketed as implant with vitamin B12 ("rubrafer").
Parenteral: Injection, for IV or IM use, equivalent to iron 50 mg/mL, DexFerrum (American Regent), INFeD (Watson).

4.7 WGK Germany: -

4.7 RTECS: NI2200000

4.7 Protective Equipment and Clothing: If inhaled, iron is a local irritant to the lung and gastrointestinal tract. /Iron compounds/

4.8 Reactivities and Incompatibilities: Iron dextran has been reported to be physically incompatible with oxytetracycline and with sulfadiazine sodium in iv ifusions

4.9 Report

The Iron-dextran complex is?a complex of ferric oxyhydroxide with dextrans of 5000 to 7000 daltons in a viscous solution containing 50 mg/ml of iron. With the CAS registry number 9004-66-4,?it is also named as Ferric dextran.?The classification codes are?Drug / Therapeutic Agent;?Hematinic;?Hematinics;?Hematologic Agents;?Human Data;?Reproductive Effect;?Tumor data. It is?dark reddish-brown liquid?which is soluble in hot water, soluble in ethanol and other organic solvents. Additionally, Iron-dextran is combustible, unstable at a pH of 5 and decomposes at 149-158° F.?It may be sensitive to prolonged exposure to air. The symptoms associated with exposure to Iron-dextran are headaches, vomiting, and dizziness. When not being used, product containers should be kept sealed and stored in a cool, dry place.

Uses of Iron-dextran complex: It is supplied as a parenteral preparation and is used as a hematinic. Furthermore, it used for the prevention and treatment of iron deficiency anemia of Pigs and other livestock, promoting growth and development.

When you are using this chemical, please be cautious about it as the following:
It may cause sensitization by inhalation and skin contact, so people should not breathe vapour.?In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.?If you want to contact this product, you must wear suitable protective clothing, gloves and eye/face protection.?In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)

The following are the toxicity data which has been tested.

Organism	Test Type	Route	Reported Dose (Normalized Dose)	Effect	Source
mouse	LD	intramuscular	> 450mg(Fe)/kg (450mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 10, Pg. 375, 1955.
mouse	LD50	intravenous	460mg(Fe)/kg (460mg/kg)	?	Acta Poloniae Pharmaceutica. For English translation, see APPFAR. Vol. 18, Pg. 149, 1961.
mouse	LD50	oral	1gm(Fe)/kg (1000mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 24, Pg. 352, 1965.
rabbit	LD	intramuscular	> 690mg(Fe)/kg (690mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 10, Pg. 375, 1955.
rabbit	LDLo	intravenous	500mg(Fe)/kg (500mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 10, Pg. 375, 1955.
rat	LD50	intraperitoneal	3gm(Fe)/kg (3000mg/kg)	?	Toxicology and Applied Pharmacology. Vol. 18, Pg. 185, 1971.
rat	LDLo	intramuscular	1617mg(Fe)/kg (1617mg/kg)	?	Acta Veterinaria Vol. 29, Pg. 21, 1979.

View all

4.10 Skin, Eye, and Respiratory Irritations: If inhaled, iron is a local irritant to the lung and gastrointestinal tract. /Iron compounds/

4.11 Specification

The Iron-dextran complex is?a complex of ferric oxyhydroxide with dextrans of 5000 to 7000 daltons in a viscous solution containing 50 mg/ml of iron. With the CAS registry number 9004-66-4,?it is also named as Ferric dextran.?The classification codes are?Drug / Therapeutic Agent;?Hematinic;?Hematinics;?Hematologic Agents;?Human Data;?Reproductive Effect;?Tumor data. It is?dark reddish-brown liquid?which is soluble in hot water, soluble in ethanol and other organic solvents. Additionally, Iron-dextran is combustible, unstable at a pH of 5 and decomposes at 149-158° F.?It may be sensitive to prolonged exposure to air. The symptoms associated with exposure to Iron-dextran are headaches, vomiting, and dizziness. When not being used, product containers should be kept sealed and stored in a cool, dry place.

Uses of Iron-dextran complex: It is supplied as a parenteral preparation and is used as a hematinic. Furthermore, it used for the prevention and treatment of iron deficiency anemia of Pigs and other livestock, promoting growth and development.

When you are using this chemical, please be cautious about it as the following:
It may cause sensitization by inhalation and skin contact, so people should not breathe vapour.?In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.?If you want to contact this product, you must wear suitable protective clothing, gloves and eye/face protection.?In case of accident or if you feel unwell, seek medical advice immediately (show the label whenever possible.)

The following are the toxicity data which has been tested.

Organism	Test Type	Route	Reported Dose (Normalized Dose)	Effect	Source
mouse	LD	intramuscular	> 450mg(Fe)/kg (450mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 10, Pg. 375, 1955.
mouse	LD50	intravenous	460mg(Fe)/kg (460mg/kg)	?	Acta Poloniae Pharmaceutica. For English translation, see APPFAR. Vol. 18, Pg. 149, 1961.
mouse	LD50	oral	1gm(Fe)/kg (1000mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 24, Pg. 352, 1965.
rabbit	LD	intramuscular	> 690mg(Fe)/kg (690mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 10, Pg. 375, 1955.
rabbit	LDLo	intravenous	500mg(Fe)/kg (500mg/kg)	?	British Journal of Pharmacology and Chemotherapy. Vol. 10, Pg. 375, 1955.
rat	LD50	intraperitoneal	3gm(Fe)/kg (3000mg/kg)	?	Toxicology and Applied Pharmacology. Vol. 18, Pg. 185, 1971.
rat	LDLo	intramuscular	1617mg(Fe)/kg (1617mg/kg)	?	Acta Veterinaria Vol. 29, Pg. 21, 1979.

View all

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

5. Other Information

5.0 Description: Iron dextran is a dark brown, slightly viscous liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Iron Dextran is used for the treatment of patients with documented iron deficiency in which oral administration is unsatisfactory or impossible. It is supplied as a parenteral preparation and is used as a hematinic. (Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed, p1292)
Iron-Dextran is for the parenteral treatment of iron-deficiency anemia in humans and baby pigs. Can be used as a reagent.

5.1 Chemical Properties: Light to dark brown powder. Colloidal suspension of an iron-dextran complex in water. pH 5.2-6.5.

5.2 History: The therapeutic value of colloidal iron preparations was first reported in the 1950's by London and Twigg. Numerous attempts have been made to improve these iron preparations Thus dextran ([h] 0.05) is first heated with alkali, and is then neutralized in the presence of ferric chloride solution. Studies on this product have revealed that each particle consists of a central iron core, approximately 3nm diameter, surrounded by a dextran sheath of approximately 13nm diameter. The complex is visualized as a particle formed by a protective sheath of dextran attached by terminal metasaccharinic acid units to a b-FeOOH core. A solution of this complex containing 5% iron and 20% dextran (Imferon ? ) is suitable for intramuscular and intravenous injection for treating iron deficiency anemia. The product is currently used widely for treating anemia in new-born piglets.
The use of these preparations has been re-examined in humans and a dramatic rise in hemoglobin was reported following intravenous infusion. The solution is best administered together with glucose solutions.; View all

5.3 Uses: Hematinic.

5.4 Uses: Iron-Dextran (ferric hydroxide dextran complex) may be used as an intravenous iron delivery preparation. Iron-Dextran may be used to induce iron-overload to study its effects and preventative measures.

5.5 Brand name: Dexferrum (Luitpold); Infed (Wat son); Proferdex (New River).

5.6 Reactivity Profile: Iron-dextran is unstable at a pH of 5 and decomposes at 149-158° F. Iron-dextran may be sensitive to prolonged exposure to air.

5.7 Health Hazard: SYMPTOMS: The symptoms associated with exposure to Iron-dextran are headaches, vomiting, and dizziness.

5.8 Fire Hazard: Iron-dextran is combustible.

5.9 Clinical Use: Prophylaxis of iron deficiency anaemia (when oral treatment is ineffective or contraindicated)

Treatment of iron deficiency during ESA therapy especially if serum ferritin is very low (<50 nanograms/mL)

5.10 Drug interactions: Potentially hazardous interactions with other drugs
Dimercaprol: avoid concomitant use.
Oral iron: reduced absorption of oral iron

5.11 Carcinogenicity: Iron dextran complex is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals.

5.12 Metabolism: After intravenous infusion, iron dextran is taken up by the cells of the reticuloendothelial cells, particularly in the liver and spleen. The reticuloendothelial cells gradually separate iron from the iron-dextran complex. Most absorbed iron is bound to transferrin and transported to the bone marrow where it is incorporated into haemoglobin; the remainder is contained within the storage forms, ferritin or haemosiderin, or as myoglobin, with smaller amounts occurring in haem-containing enzymes or in plasma bound to transferrin.
Only very small amounts of iron are excreted as the majority released after the destruction of the haemoglobin molecule is re-used.

6. Computational chemical data

Molecular Weight: 153.92348g/mol
Molecular Formula: FeH₂O₄S
Compound Is Canonicalized: True
XLogP3-AA: null
Exact Mass: 153.902315
Monoisotopic Mass: 153.902315
Complexity: 81.3
Rotatable Bond Count: 0
Hydrogen Bond Donor Count: 2
Hydrogen Bond Acceptor Count: 4
Topological Polar Surface Area: 83
Heavy Atom Count: 6
Defined Atom Stereocenter Count: 0
Undefined Atom Stereocenter Count: 0
Defined Bond Stereocenter Count: 0
Undefined Bond Stereocenter Count: 0
Isotope Atom Count: 0
Covalently-Bonded Unit Count: 2
CACTVS Substructure Key Fingerprint: AAADcQAAOABAAAAgAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAACAAAAAAAAAAAAAAAAIAAAAAAADAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA==

7. Question & Answer

What are the precautions for using Iron-dextran tablets? Nov 21 2022
The use of Iron-dextran tablets can effectively improve iron-deficiency anemia. However, there are some precautions that need to be taken into account to ensure safety and effectiveness during medicat..
What is Iron-dextran Injection and how is it used? Oct 19 2022
Iron-dextran Injection is a sterile colloidal solution of Iron-dextran. The iron content (Fe) should be within 95.0% to 105.0% of the labeled amount. Description This product is a dark brown colloidal..
What are the medicinal values of Iron-dextran? Aug 05 2022
Iron-dextran is the main component of Iron-dextran oral solution, which has excellent effects in improving symptoms of chronic bleeding or malnutrition. Taking it orally directly is very powerful, but..
What are the usage methods of Iron-dextran injection? Sep 02 2019
People's living conditions are improving, and basic needs are being met. Diseases caused by malnutrition, such as anemia, are also decreasing in clinical practice. However, further research has found ..

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