Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. ],kI#tp. Possible increased incidence of adverse effects, especially delayed reactions, associated with large IV doses of iron dextran, such as those used in total-dose infusions. Watson Pharma, Inc. 0000009066 00000 n 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)]. . . An official website of the United States government. Fetal/Neonatal Adverse Reactions Based on: Desired Hb = the target Hb in g/dl. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. Epinephrine should be immediately available. 5.4 Iron Overload INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response. 3 0 obj National Library of Medicine . Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Would you like email updates of new search results? The 5 hour value was determined for 59Fe iron dextran from a study that used laboratory methods to separate the circulating 59Fe iron dextran from the transferrin bound 59Fe. Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells. the 6 time points after injection.15 A 94-subject rater-blinded randomized control study of EDP action potentials compared toxin used within 2 hours, 72 hours, 1, 2, 3, or 4 weeks after reconstitution; at 1 week after injection, the point of maximum effect, there was no difference in quantitative paralysis . An official website of the United States government. Stability of injectable medications after reconstitution . endstream endobj 57 0 obj<> endobj 58 0 obj<>stream Brand and Other Names: INFeD, Dexferrum Classes: Iron Products Dosing & Uses AdultPediatric Dosage Forms & Strengths injectable solution 50mg (Fe)/mL Iron-deficiency Anemia 25-100 mg IV or deep. Advise patients with history of significant allergies and/or asthma to inform their healthcare provider as the risk of hypersensitivity reactions may be increased [see Warnings and Precautions (5.3)]. Before The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. 0000037333 00000 n The pH of the solution is between 4.5 to 7.0. 34 55 (See Anaphylaxis under Cautions.) 0000010118 00000 n Br Med J (Clin Res Ed). Metabolism The https:// ensures that you are connecting to the H|TMs6Wu*Q6i\l.` 0000004098 00000 n Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: 0000007617 00000 n official website and that any information you provide is encrypted %PDF-1.3 The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). government site. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Each days dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients. Elimination Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given. (See PRECAUTIONS: General.) A current package insert for the iron dextran product being used should always be reviewed, since these package inserts are periodically updated, and the product is currently made by more than one manufacturer. *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. The half-life of free iron in the plasma circulation is approximately 5 hours. 0000014709 00000 n INFeD may be used alone or with other medications. (See Cautions.). Use with caution in patients with a history of clinically important allergies and/or asthma. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 7.1 Drug/Laboratory Test Interactions Risk Summary Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` Please check for further notifications by email. (5.3). Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. INFeD preparation: Administer by deep IM injection using a 2- or 3-inch, 19- or 20-gauge needle into the upper outer quadrant of the buttock only. 0000004693 00000 n Risk of developing potentially life-threatening anaphylactic reactions. Four of the seven dilute solutions were stable after two months of storage. Ferentino, Italy 03013, Distributed By: For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet 0000001396 00000 n Animal Data 12.2 Pharmacodynamics Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). Discontinue oral iron therapy prior to initiation of iron dextran therapy. 0000010567 00000 n Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of Infed. Bonnie E. Kirschenbaum, M.S., Clifton J. Latiolais, Sc.D., Stability of injectable medications after reconstitution, American Journal of Hospital Pharmacy, Volume 33, Issue 8, 1 August 1976, Pages 767791, https://doi.org/10.1093/ajhp/33.8.767. If patient is standing, administer IM injection in buttock of the leg opposite the patients weight-bearing leg; if supine, place patient in a lateral position with the injection site uppermost. Patients with Renal Impairment The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron: Replacement iron (in mg) = Blood loss (in mL) x hematocrit, Example: Blood loss of 500 mL with 20% hematocrit. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). 0000011042 00000 n Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Infed (iron dextran injection), for intravenous or intramuscular use 0000003091 00000 n Dextran, a polyglucose, is either metabolized or excreted. Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 2025C; excursions permitted to 1530C. . Systemic exposure to iron dextran may be increased. PLEASE READ THE. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Unauthorized use of these marks is strictly prohibited. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. <> Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. 0000000016 00000 n 1-800-678-1605, Manufactured By: Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. Please enable it to take advantage of the complete set of features! . Increased Risk of Toxicity in Patients with Underlying Conditions Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. Careers. ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. General 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. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. 0000008504 00000 n Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli. 0000046285 00000 n Advise the patient to consult a healthcare provider before taking any other iron containing products as this may cause serious side effects [see Warnings and Precautions (5.4)]. In iron-deficient patients with coexistent end-stage renal disease and other clinical problems, the serum elimination half-life of iron averaged 58.9 hours (range: 9.487.4 hours) following IV administration of iron dextran. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. . 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. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU endobj 5 0 obj I. [2:/T6*cz1"Jk&n#n[[TU Available for Android and iOS devices. (5.1) There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Each monograph contains stability data, administration guidelines, and methods of preparation. 0000007316 00000 n The amount of vancomycin to treat an adult infection is superior to 1 g and so the volume administered can be higher than 100 mL. 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. . 0000032198 00000 n Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? endstream endobj 35 0 obj<> endobj 36 0 obj<> endobj 37 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 38 0 obj<> endobj 39 0 obj<> endobj 40 0 obj<> endobj 41 0 obj<> endobj 42 0 obj<> endobj 43 0 obj[/ICCBased 66 0 R] endobj 44 0 obj<> endobj 45 0 obj<>stream Recommended formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL) for calculating total dosage of iron dextran injection (in mL): Use the following formula to calculate required total dosage of iron dextran injection (in mL): Infants weighing <5 kg (11 lbs): Maximum daily dosage is 25 mg of iron. 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. Advise pregnant persons of the potential risk to the fetus. These half-life values do not represent clearance of iron from the body. 0000001877 00000 n Excess storage of iron and a syndrome similar to hemosiderosis possible when used for anemia not attributable to iron deficiency (e.g., those with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias). Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Known hypersensitivity to iron dextran or any ingredient in the formulation. tran [6]. 0000012898 00000 n Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss. PDF Storage and Reuse of Reconstituted Neuromodulators 2 DOSAGE AND ADMINISTRATION Bethesda, MD 20894, Web Policies Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. (Normal Hb for Children 15 kg or less is 12 g/dl). 5.2 Delayed Reactions Copyright 2021 GlobalRPH - Web Development by, IV Dilutions Medication Reference and Infusion Guidelines, Renal dosing for healthcare professionals, HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy. Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. 4. endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream 06\ zp#2j)kS \(nd+?5R
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