infed stability after reconstitution infed stability after reconstitution

Iron Dextran Monograph for Professionals - Drugs.com 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)]. Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ 8.4 Pediatric Use Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. [Progress in drug technology in the years 1968 and 1969]. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). All Rights Reserved. Increased Risk of Toxicity in Patients with Underlying Conditions If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Last updated on Dec 1, 2022. endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream Oral iron should be discontinued prior to administration of INFeD. 0000004693 00000 n Four of the seven dilute solutions were stable after two months of storage. During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. %PDF-1.3 0000001071 00000 n 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). 0000009983 00000 n INFeD (iron dextran injection), for intravenous or . 0000026747 00000 n Stability of injectable medications after reconstitution Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. 12.2 Pharmacodynamics Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. 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. 0000032198 00000 n <> 4 0 obj To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. CONTRAINDICATIONS trailer 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)]. 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. Medically reviewed by Drugs.com on Oct 25, 2022. INFeD, Dexferrum (iron dextran complex) dosing, indications - Medscape Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{ wQ&vYAv6bUd`l!k3X*4V. 0000035990 00000 n 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). National Library of Medicine Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. 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 III. Therefore, administration of subsequent test doses during therapy should be considered. Bethesda, MD 20894, Web Policies II. Disclaimer. The https:// ensures that you are connecting to the Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). 0000004715 00000 n Risk of developing potentially life-threatening anaphylactic reactions. 0000046285 00000 n Brand names: Dexferrum, INFeD Administer test dose prior to first therapeutic dose. 7.1 Drug/Laboratory Test Interactions 0000002644 00000 n 0000010118 00000 n It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 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. %PDF-1.3 % For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet, For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet. Curr Opin Clin Nutr Metab Care. It should be recognized that iron storage may lag behind the appearance of normal blood morphology. IV Iron Dextran Infusion Protocol | MedStar Health Watson Pharma, Inc. PDF SCIENTIFIC DISCUSSION - European Medicines Agency 4. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Prior to the first intravenous Infed therapeutic dose, administer an intravenous test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. Prior to the first intramuscular Infed therapeutic dose, administer an intramuscular test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. Discontinue oral iron therapy prior to initiation of iron dextran therapy. endobj Absorption The maximum daily dose of INFeD should not exceed 2 mL. It is not known if INFeD is safe and effective in children younger than 4 months of age. 0000006673 00000 n Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. If there is no reaction after 1 hour continue. Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. PDF Storage and Reuse of Reconstituted Neuromodulators Medical Communications The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. Do not exceed a total daily dose of 2 mL undiluted Infed. 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. The site is secure. 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. 3 0 obj endstream endobj 46 0 obj<>stream and transmitted securely. .65 mL/kg of body weight, b. Evaluation of the stability of vancomycin solutions at concentrations HHS Vulnerability Disclosure, Help 0000024030 00000 n Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. 4. ],kI#tp. J Pain Palliat Care Pharmacother. The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. Administer only in a setting where resuscitation equipment and medications are available. 0000003686 00000 n 16.1 How Supplied Therefore, administration of subsequent test doses during therapy should be considered. For information on systemic interactions resulting from concomitant use, see Interactions. 0000004233 00000 n Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. 0000008737 00000 n 0000047340 00000 n over 15 kg (33 lbs) . 0000027226 00000 n (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! The animals used in these tests were not iron deficient. (See Anaphylaxis under Cautions.) 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 . HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> .14.8 g/dl Bookshelf (See PRECAUTIONS: General.) Use with caution in patients with a history of clinically important allergies and/or asthma. 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. *Qp"Q!J Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. Your comment will be reviewed and published at the journal's discretion. (See PRECAUTIONS: General.) 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. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Please enable it to take advantage of the complete set of features! If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. 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. Drug class: Iron products. Abstract. Patients with Renal Impairment Dilution Iron Dextran (imferon ) - GlobalRPH Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. . Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. 4GWVI~p`1x_7G|_Wz/ev5%b[~?w>ZG/*p%\/??w~=+ |O?~po>u|.@uM=Nvm_~~>\.%>?_mk+mp_{"ly"Y{JlqgIl#Y!Y@osLu]Mt=xx? 0000039715 00000 n )U!$5X3/9 ($5EO1'G!X! Based on: Desired Hb = the target Hb in g/dl. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. Dextran, a polyglucose, is either metabolized or excreted. 0000001877 00000 n Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. Disclaimer. Federal government websites often end in .gov or .mil. 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. 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. Systemic exposure to iron dextran may be increased. Copyright 1993-2021 Specific Populations Bullock L, Parks RB, Lampasona V, Mullins RE. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. 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. Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Based on: Desired Hb = the target Hb in g/dl. Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. (Normal Hb for Children 15 kg or less is 12 g/dl). PMC Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. official website and that any information you provide is encrypted Factors contributing to the formula are shown below. Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Trace amounts of unmetabolized iron dextran are present in human milk. 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. Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. HdTr0+(R^ Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. Patheon Italia S.p.A. Int J Pharm Compd. . p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 . 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. TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE PDF INFeD See full prescribing information for complete boxed warning American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. 88 0 obj<>stream A test dose of 25 mg infused over 5 minutes should be given. used within 6 hours after reconstitution.If RZV is stored after reconstitution, store at recommended storage conditions and reagitate prior to administration. Stability of aminophylline injection in three parenteral nutrient solutions. Various studies involving intravenously administered 59Fe iron dextran to iron deficient subjects, some of whom had coexisting disease, have yielded half-life values ranging from 5 hours to more than 20 hours. 0000007595 00000 n 0000012318 00000 n 3. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Crosses the placenta and small amounts of iron apparently reach the fetus. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. endstream endobj 57 0 obj<> endobj 58 0 obj<>stream WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS 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. . 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. The stability of injectable medications after reconstitution is presented. 0000037333 00000 n 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. MeSH Do not freeze. Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. . 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; 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 Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy. 0000009088 00000 n Accessibility (See Special Populations under Pharmacokinetics.). 0000007617 00000 n Postreconstitution Stability of Amoxicillin-Clavulanic Acid Suspensions Administer the test dose at a gradual rate over at least 30 seconds. Copyright 2023, Selected Revisions November 4, 2013. Dilute iron dextran formulation for addition to parenteral nutrient Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' General considerations, the nitrosoureas and alkylating agents. Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. . . 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. The .gov means its official. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet . Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. 0000002275 00000 n Serious hypersensitivity reactions, including anaphylactic-type reactions, some of which have been life-threatening and fatal, have been reported following the parenteral administration of iron dextran products, including Infed. Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. 12.1 Mechanism of Action W = body weight in kg %%EOF 5 0 obj 1972;9:94-98. 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. hO4,qv(8p]4SXs?_k^ '4["G!@` \ Generic name: iron dextran Calculate the Infed dose based upon Table 1 and formulas below. 0000008504 00000 n 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. The stability of injectable medications after reconstitution is presented. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. . Would you like email updates of new search results? The stability of injectable medications after reconstitution is presented. xref We comply with the HONcode standard for trustworthy health information. 0000010005 00000 n Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. startxref PDF INFeD (IRON DEXTRAN INJECTION USP) Rx only Revised: September 2020 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. REFERENCES Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. *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). It should not be used during the acute phase of infectious kidney disease. 0000009538 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). . . Cancer Chemother Pharmacol. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. 34 55 Infed is a registered trademark of Allergan Sales, LLC. 2025C; excursions permitted to 1530C. Morristown, NJ 07962 USA. Iron Overload No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. . In doses 500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours. 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.