Protect from light. 1986;17(1):1-10. doi: 10.1007/BF00299858. Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. . This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. 1 0 obj Administer the test dose at a gradual rate over at least 30 seconds into the buttock. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. (See Sensitivity Testing under Dosage and Administration.) Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). 0000004233 00000 n Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. General Each days dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients. Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. 0000011305 00000 n Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. [s Parenteral iron dextran therapy: a review. Therefore, administration of subsequent test doses during therapy should be considered. Do not administer Infed to patients with evidence of iron overload. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. DOSAGE FORMS AND STRENGTHS VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials. F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' DailyMed - INFED- iron dextran injection Epinephrine should be immediately available. . Advise patients to immediately report any symptoms of hypersensitivity that develop during and following Infed administration such as arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting [see Warnings and Precautions (5.1)]. J Pain Palliat Care Pharmacother. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. 0000039715 00000 n 4. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the bodys total iron stores. l Sm3G.E7=" r7/[^;q|= Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Federal government websites often end in .gov or .mil. HOW SUPPLIED PubMed PMID: 23981803. Manifested as sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse; have resuscitation equipment and personnel trained in detection and treatment of anaphylactic-type reactions readily available during iron dextran administration. Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. $ To calculate a patient's weight in kg when lbs are known: Otherwise, the total dose may be calculated using the formula below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin for children with body weight of 15 kg (33 lbs) or less is 12 g/dL.]. 0000024030 00000 n Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. a. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. Carcinogenesis The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. <> These half-life values do not represent clearance of iron from the body. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Question patients regarding any prior history of reactions to parenteral iron products. % The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. INFeD may be used alone or with other medications. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. 5. . 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. Advise patients with pre-existing cardiovascular disease and rheumatoid arthritis that Infed administration may exacerbate symptoms and to contact their healthcare provider if any symptoms occur [see Warnings and Precautions (5.3)]. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. Available for Android and iOS devices. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. There are two preparations of IV iron available; IV iron sucrose (Venofer) given as divided dosages, and low molecular weight iron dextran (CosmoFer) this can be given as divided dose or as a total dose infusion (CosmoFer may also be given intramuscularly). Infed is a registered trademark of Allergan Sales, LLC. The stability of injectable medications after reconstitution is presented. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). CAS number: 9004-66-4. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. 2 DOSAGE AND ADMINISTRATION Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv Please enable it to take advantage of the complete set of features! Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. PDF Vaccines with Diluents: How to Use Them - immunize.org FOIA Bookshelf Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. . 0000004693 00000 n 0000035692 00000 n Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. 0000007316 00000 n Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. . There have been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes. Each monograph contains stability data, administration guidelines, and methods of preparation. Infed: Package Insert / Prescribing Information - Drugs.com Administer the test dose at a gradual rate over at least 30 seconds. Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. 0000047340 00000 n Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Infed (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Drug interactions involving Infed have not been studied. INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas - and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. . Bone scans with 99m Tc-labeled bone seeking agents, in the presence of high serum ferritin levels or following Infed infusions, have been reported to show reduction of bony uptake, marked renal activity, and excessive blood pool and soft tissue accumulation. 1995; 26(2):327-330. Fatal anaphylactic reactions are possible. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. PDF SCIENTIFIC DISCUSSION - European Medicines Agency 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. %PDF-1.3 % m$K~*&S)j5-Df"F d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? ],kI#tp. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Initial U.S. Approval: 1974 AHFS DI Essentials. Oxford University Press is a department of the University of Oxford. Infed (Iron Dextran): Uses, Dosage, Side Effects, Interactions - RxList Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. TRW3xs6's;W2YK8AAv4Qo~S ONW>dVN--sFhQe@ 0{7;;vmG+zW%Rmhh_}m?rjnY'0_i' C?U"-DA('[ PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan Thank you for submitting a comment on this article. Calculate the Infed dose based upon Table 1 and formulas below. PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. Dosage form: injection It should be understood that these half-life values do not represent clearance of iron from the body. During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. For information on systemic interactions resulting from concomitant use, see Interactions. 0000003347 00000 n Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. (See Cautions.). Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Trace amounts of unmetabolized iron dextran are present in human milk. Copyright 1993-2021 Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Written by ASHP. 0000008617 00000 n INFeD, Dexferrum (iron dextran complex) dosing, indications - Medscape PDF INFeD See full prescribing information for complete boxed warning xb```f``= @Q#3108-. 0000003224 00000 n All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. Anemias not associated with iron deficiency. Hypersensitivity Reactions Risk of developing potentially life-threatening anaphylactic reactions. The molecular weights of INFeD and DexFerrum are 165,000 and 267,000 daltons, respectively. Therefore, administration of subsequent test doses during therapy should be considered. 0000001797 00000 n Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. 1985;14(2):83-95. doi: 10.1007/BF00434343. a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. Dilution Iron Dextran (imferon ) - GlobalRPH Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE May increase risk for anaphylaxis with concomitant use, Bone scans using imaging agents labeled with technetium Tc 99m (diphosphonate), Dense, crescentic areas of activity along the contour of the iliac crest, visualized 16 days after IM administration of iron dextran, Possible reduced bone uptake, marked renal activity, and excessive blood pool and soft tissue accumulation, Therapeutic duplication; increased risk for iron toxicity, Serum iron determinations (especially colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran, Serum ferritin concentrations peak approximately 79 days following an IV iron dextran dose and slowly return to baseline over a period of about 3 weeks, Bone marrow examination for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells, May cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium, Prolonged partial thromboplastin time following IV administration of iron dextran when the blood sample for the test is mixed with anticoagulant citrate dextrose solution but not sodium citrate solution, Blood typing and cross-matching unaffected. Stability of injectable medications after reconstitution To avoid injection or leakage into subcutaneous tissue, use Z-track injection technique (i.e., firmly push aside subcutaneous tissue over the site of injection before inserting the needle). Accessibility The Summary of Product Characteristics (SmPC) recommends reconstituting a 1 g vial with 20 mL of water for injection (WFI), then diluting it in 100 mL of saline solution. %%EOF Do Not Copy, Distribute or otherwise Disseminate without express permission. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. Hilleman DE, McEvoy GK, Bailey RT Jr, Reich J. Hosp Pharm. 0000002041 00000 n Indian J Anaesth. .0.34% . The site is secure. The https:// ensures that you are connecting to the This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. After slow IV injection (given over 30 seconds for INFeD or 5 minutes for Dexferrum) or IM injection (INFeD) of 25 mg of iron (0.5 mL), observe for 1 hour for sensitivity reactions (see Anaphylaxis under Cautions) before administering the remaining portion of the initial dose. HHS Vulnerability Disclosure, Help Clinical Considerations Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). In doses 500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours. 0000005917 00000 n 0000006695 00000 n This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 1972;9:94-98. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. Hatton RC, Portales IT, Finlay A, Ross EA. For solution and drug compatibility information, see Compatibility under Stability. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates.