All rights reserved. Sv National Library of Medicine . 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. Absorption [s The stability of injectable medications after reconstitution is presented. Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The half-life of total iron, including both circulating and bound, is approximately 20 hours. 0000010759 00000 n Use the following formula to calculate required total iron dextran dosage in mL: 0.02 blood loss (in mL) hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL). INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02). Quantitative estimates of the individuals periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose. %%EOF J Pediatr Pharmacol Ther. 0000002696 00000 n The site is secure. (See DOSAGE AND ADMINISTRATION: Administration. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. 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. TRW3xs6's;W2YK8AAv4Qo~S ONW>dVN--sFhQe@ 0{7;;vmG+zW%Rmhh_}m?rjnY'0_i' C?U"-DA('[ <> ], Observed Hb = the patients current hemoglobin in g/dL. Women's Bond NFT Collection . 0000003686 00000 n sharing sensitive information, make sure youre on a federal To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Y-site compatibility of medications with parenteral nutrition. Iron storage parameters may improve prior to hematologic parameters. . Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. .12.0 g/dl, c. Iron content of hemoglobin . Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. A subsidiary of Watson Pharmaceuticals, Inc. 5 If reconstituted vaccine is not used immediately or comes in a multidose vial, be sure to clearly mark the vial with the date and time the vaccine was reconstituted, maintain the product at 2-8C (36-46F); do not freeze, and use only within the time indicated on chart above. This site complies with the HONcode standard for trust- worthy health information: verify here. 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.] Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. 5. Initial U.S. Approval: 1974 Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. equivalent to 50 mg of elemental iron per 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. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ .0.34% Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Last updated on Dec 1, 2022. Increased Risk of Toxicity in Patients with Underlying Conditions %PDF-1.3 It should not be used during the acute phase of infectious kidney disease. Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. Advise patients to consult their healthcare provider should they start to show symptoms of acute kidney infection as Infed should not be used [see Warnings and Precautions (5.3)]. 1986 Jul-Aug;40(4):142-63. Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the bodys total iron stores. 5.4 Iron Overload Distribution Take precautions to be prepared to treat potential allergic reactions. . Allergan USA, Inc. 2001;5(1):75-7. Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. The half-life of free iron in the plasma circulation is approximately 5 hours. . Each monograph contains stability data, administration guidelines, and methods of preparation. Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. Available for Android and iOS devices. Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as Infed) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. INFeD may be used alone or with other medications. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. Abstract. The test dose should be administered in the same recommended test site and by the same technique as described in the last paragraph of this section. INDICATIONS AND USAGE: Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: >who have intolerance to oral iron or have had unsatisfactory response to oral iron; Specific Populations The following information about each drug is given in tabular format: drug to be reconstituted and size of package; recommended route(s) of administration; recommended diluent, quantity to be used and resultant concentration; stability after initial dilution; and stability after further dilution; and stability of frozen antibiotics. . . Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. Clipboard, Search History, and several other advanced features are temporarily unavailable. Elimination (See Iron, oral under Interactions.). Administer a test Infed dose prior to the first therapeutic dose. . Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 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. <> Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. INFeD (iron dextran injection), for intravenous or . official website and that any information you provide is encrypted 88 0 obj<>stream . In mice, rats, rabbits, and possibly hamsters, it has been demonstrated that these complexes may produce sarcoma following repeated administration of large or small doses of iron-carbohydrate complexes at a single injection site. AHFS DI Essentials. Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. If diluted, administer by IV infusion [off-label] over 16 hours. The total amount of INFeD in mL required to treat the anemia and replenish iron stores may be approximated as follows: Adults and Children over 15 kg (33 lbs): See Dosage Table. 1984 Mar;19(3):202, 207, 211-3. The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. 0000035692 00000 n For solution and drug compatibility information, see Compatibility under Stability. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. . 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. If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. Cancer Chemother Pharmacol. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. <<7815BA97DDE94C498B4A3154474182CA>]>> (See Anaphylaxis under Cautions.) 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. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. . Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 0000005019 00000 n Watson Pharma, Inc. endobj Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl 0000002072 00000 n The maximum daily dose of Infed should not exceed 2 mL. 0000002441 00000 n 5 0 obj '* 8600 Rockville Pike Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli. To avoid injection or leakage into subcutaneous tissue, use Z-track injection technique (i.e., firmly push aside subcutaneous tissue over the site of injection before inserting the needle). This site needs JavaScript to work properly. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. MeSH Children weighing 515 kg (1133 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (12 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). Assay methods, adriamycin and the other antitumour antibiotics. Written by ASHP. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. 6Ee^2+G8"c+TepPRb d_@ 0000010567 00000 n 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. 0000006734 00000 n Therefore, administration of subsequent test doses during therapy should be considered. Data (See PRECAUTIONS: General.) This site complies with the HONcode standard for trust- worthy health information: verify here. Careers. 0000039715 00000 n . Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH 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. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Risk Summary Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Your comment will be reviewed and published at the journal's discretion. The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. Copyright 2021 GlobalRPH - Web Development by, The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. 8600 Rockville Pike The .gov means its official. III. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. Normal hemoglobin (males and females) BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , 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)]. Clipboard, Search History, and several other advanced features are temporarily unavailable. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition mixtures. Alternatively, the total dose may be calculated using the formulas below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin (males and females) for body weight over 15 kg (33 lbs) is 14.8 g/dL. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. 0000003913 00000 n The product should be further diluted in a suitable diluent prior to infusion. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. a. 0000011042 00000 n 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.]. The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. 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. 0000014709 00000 n Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. 3. Such reactions may be immediate or delayed. . 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. endobj . . . Pregnancy We comply with the HONcode standard for trustworthy health information. II. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. The stability of injectable medications after reconstitution is presented. David McAuley, Pharm.D. Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. 0000013099 00000 n Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. <> 2.2 Recommended Dosage for Iron Deficiency Anemia Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. The etiology of these reactions is not known. 0000001071 00000 n Observed Hb = the patients current hemoglobin in g/dl. Protect from light. Risk of developing potentially life-threatening anaphylactic reactions. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Distributed into breast milk, but only as trace amounts of unmetabolized iron dextran. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. 0000005691 00000 n Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. startxref 2 DOSAGE AND ADMINISTRATION Oxford University Press is a department of the University of Oxford. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. Continue Infed until hemoglobin is within the normal range and iron stores are replete. HR0~ Carcinogenesis The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Ferentino, Italy 03013, Distributed By: Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. 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. (Normal Hb for Children 15 kg or less is 12 g/dl). 0000032198 00000 n 0000010118 00000 n The easiest-to-prepare dilute solution (iron dextran, benzyl alcohol, and sterile water for injection) was stable for three months; stability was greater when refrigerated. Generic name: iron dextran . Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Available as iron dextran; dosage expressed in terms of elemental iron. trailer Should be administered by qualified individuals with ready access to resuscitation equipment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction (e.g., epinephrine, or isoproterenol in patients receiving -adrenergic blocking agents). Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. J Pain Palliat Care Pharmacother. All Rights Reserved. Total iron and free ferrous ion content of the preparations were measured for: (1) the dilute solutions at monthly intervals after up to three months of storage at room temperature and under refrigeration and (2) the parenteral nutrient solutions after 18 hours of storage at room temperature. Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin). Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Following administration of Infed, circulating iron dextran is split by the cells of the reticuloendothelial system into its components of iron and dextran. . 06\ zp#2j)kS \(nd+?5R Do Not Copy, Distribute or otherwise Disseminate without express permission. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. *Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs). Isoproterenol or similar beta-agonist agents may be required in these patients. Do not freeze. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). Patients with Renal Impairment 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 0 $]: Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. 0000007617 00000 n . WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Based on: Desired Hb = the target Hb in g/dl. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. xb```f``= @Q#3108-. 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.
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