0000005561 00000 n General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation. Curr Opin Clin Nutr Metab Care. (See Boxed Warning.) INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. In iron-deficient patients, reticulocytosis may begin by the 4th day following an IV infusion of the total calculated dose of iron dextran and reaches a maximum by about the 10th day. government site. This site needs JavaScript to work properly. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. %%EOF IV Iron Dextran Infusion Protocol | MedStar Health Brand names: Dexferrum, INFeD Do Not Copy, Distribute or otherwise Disseminate without express permission. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. <> (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! (See DOSAGE AND ADMINISTRATION: Administration. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Available as iron dextran; dosage expressed in terms of elemental iron. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. (See PRECAUTIONS: General.) PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer Before Ferentino, Italy 03013, Distributed By: W = body weight in kg Abstract. FOIA PMC All rights reserved. 0000036781 00000 n trailer . 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. . Cancer Chemother Pharmacol. If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. Epinephrine should be immediately available. 0000008737 00000 n Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Four of the seven dilute solutions were stable after two months of storage. 2.2 Recommended Dosage for Iron Deficiency Anemia If there is no reaction after 1 hour continue. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. 0000035692 00000 n The https:// ensures that you are connecting to the III. 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 to oral iron. J Parenter Sci Technol. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated. Discontinue oral iron therapy prior to initiation of iron dextran therapy. Such reactions may be immediate or delayed. . All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D The total volume of Infed required for the treatment of iron deficiency anemia is determined from Table 1 or the appropriate formula listed [see Dosage and Administration (2.2)]. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. 15 kg (33 lbs) or less . endstream endobj 55 0 obj<> endobj 56 0 obj<>stream Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. I. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Assay methods, adriamycin and the other antitumour antibiotics. This revision is an update of: Latiolais CJ, Shoup LK and Thur MP: Stability of drugs after reconstitution, Am J Hosp Pharm 24:667-691 (Dec) 1967. 0000011305 00000 n In patients with CKD receiving an ESA, administer sufficient iron to maintain selected targets of iron therapy (i.e., transferrin saturation and serum ferritin concentrations); periodically monitor these iron indices and use results (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy. 0000031965 00000 n Stability of aminophylline injection in three parenteral nutrient solutions. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. . INFeD (IRON DEXTRAN COMPLEX) INJECTION SDS EFFECTIVE DATE: SEPTEMBER 24, 2018 PAGE 1 OF 8 SAFETY DATA SHEET Prepared to U.S. OSHA, CMA, ANSI, Canadian WHMIS Standards, European Union CLP EC 1272/2008 and the Global Harmonization Standard 1. 0000026302 00000 n Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Trace amounts of unmetabolized iron dextran are present in human milk. 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)]. Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. [See USP Controlled Room Temperature]. Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* Alternatively, the total dose may be calculated using the formulas below: Adults and Children over 15 kg (33 lbs) Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW) Based on: HHS Vulnerability Disclosure, Help Infed is a registered trademark of Allergan Sales, LLC. Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. . . 0000003708 00000 n 5. <> Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. The etiology of these reactions is not known. Iron dextran is a During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. Medically reviewed by Drugs.com on Oct 25, 2022. 0000007316 00000 n . Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. 8.4 Pediatric Use official website and that any information you provide is encrypted tran [6]. In doses 500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours. Question patients regarding any prior history of reactions to parenteral iron products. After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. Bookshelf David McAuley, Pharm.D. Sv MeSH Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. 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. $ Protect from light. Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (14.8 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). 8.1 Pregnancy Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. Drug class: Iron products. 4. Hatton RC, Portales IT, Finlay A, Ross EA. . Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. crobiological stability and recovery of the active drug after dilution or reconstitution should be evaluated during drug development to provide healthcare professionals with the necessary information about in-use stability. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. National Library of Medicine This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000001396 00000 n 0000047340 00000 n 0000001071 00000 n P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU Cancer Chemother Pharmacol. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. All Rights Reserved. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. 0000026943 00000 n endstream endobj 46 0 obj<>stream Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 1 0 obj In vitro studies have shown that removal of iron dextran by dialysis is negligible. Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. !m Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. PMC Disclaimer. sharing sensitive information, make sure youre on a federal . Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ Administer the test dose at a gradual rate over at least 30 seconds into the buttock. 0000011536 00000 n I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl INFeD (iron dextran injection), for intravenous or . endstream endobj 57 0 obj<> endobj 58 0 obj<>stream <> 0000002275 00000 n Removal of Iron Dextran by Hemodialysis: An In Vitro Study. 0000010759 00000 n Based on: Desired Hb = the target Hb in g/dl. Please enable it to take advantage of the complete set of features! 2.4 Administration (5.1) Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Based on: Desired Hb = the target Hb in g/dl. Elimination Anemias not associated with iron deficiency. (See Cautions.). The total volume of Infed required for the treatment of iron replacement for blood loss is determined from an appropriate formula listed [see Dosage and Administration (2.3)]. Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. J Pediatr Pharmacol Ther. Would you like email updates of new search results? LBW = Lean body weight in kg [A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.]

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