Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. 0000003091 00000 n Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. 2.2 Recommended Dosage for Iron Deficiency Anemia . Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. 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)]. Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis. . 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. I. 0000005691 00000 n 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. Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Unable to load your collection due to an error, Unable to load your delegates due to an error. . 1-800-678-1605, Manufactured By: The animals used in these tests were not iron deficient. Disease-Associated Maternal and/or Embryo/Fetal Risk If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. 0000005917 00000 n Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. <> Observed Hb = the patients current hemoglobin in g/dl. Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. 8.2 Lactation 2009;23(3):223-30. doi: 10.1080/15360280903098382. HOW SUPPLIED 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)]. 0000002041 00000 n Normal hemoglobin (males and females) Abstract. 0000002294 00000 n The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic Assess baseline hematologic (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin) to monitor response to therapy. A test dose of 25 mg infused over 5 minutes should be given. 12.2 Pharmacodynamics The site is secure. Excretion . Pregnancy 0000002275 00000 n w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , . Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. HdTr0+(R^ Cancer Chemother Pharmacol. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. . Blood volume . Available for Android and iOS devices. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. endstream endobj 55 0 obj<> endobj 56 0 obj<>stream Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. Please enable it to take advantage of the complete set of features! Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. (5.1) 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. Question patients regarding any prior history of reactions to parenteral iron products. N}F( 9N(i{:%NISD;%NIS*T1 0000003224 00000 n Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. %%EOF Do Not Copy, Distribute or otherwise Disseminate without express permission. II. 2 0 obj Hb```f`` l,/`"`FOB/r7}UL xref (See Anaphylaxis under Cautions.) 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. Importance of informing patients of other important precautionary information. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. 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. 2 DOSAGE AND ADMINISTRATION 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. This site complies with the HONcode standard for trust- worthy health information: verify here. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Gaithersburg, MD: Genzyme; August 2018. Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. . % INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. 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). Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. Factors contributing to the formula are shown below. . 0000035692 00000 n Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Continue Infed until hemoglobin is within the normal range and iron stores are replete. . (See Iron, oral under Interactions.). 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. This site complies with the HONcode standard for trust- worthy health information: verify here. All Rights Reserved. ~q`C34&rAd oG Iron Overload l Sm3G.E7=" r7/[^;q|= F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' Metabolism Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK 1972;9:94-98. 16.2 Stability and Storage . Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU 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. 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. 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. fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ 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. 5.1 Hypersensitivity Reactions An official website of the United States government. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias. 16.1 How Supplied 0000007617 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 0000001797 00000 n HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy, Parenteral iron treatment should be administered only when, Milliliter Requirement of INFeD Based On Observed. 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. 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 is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. Thank you for submitting a comment on this article. Administer only in a setting where resuscitation equipment and medications are available. National Library of Medicine Initial U.S. Approval: 1974 (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: This antibiotic is active against Gram-positive aerobic and anaerobic bacteria1 2 and is commonly used in hospitals to treat serious infections.3 4 Vancomycin has slow bactericidal time-dependent activity and can be administered by continuous or . 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. Risk Summary . 88 0 obj<>stream The maximum daily dose of INFeD should not exceed 2 mL. AHFS DI Essentials. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. Data Systemic exposure to iron dextran may be increased. 0000039715 00000 n p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 4 0 obj Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. . 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. 0000006673 00000 n . Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. 0000012898 00000 n Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: Oral iron should be discontinued prior to administration of INFeD. 0000010005 00000 n 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. Bookshelf Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. %PDF-1.4 % Removal of Iron Dextran by Hemodialysis: An In Vitro Study. H|TMs6Wu*Q6i\l.` HdTn0D Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). Known hypersensitivity to iron dextran or any ingredient in the formulation. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. <> The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. PubMed PMID: 23981803. 2.4 Administration INFeD (IRON DEXTRAN COMPLEX) INJECTION SDS EFFECTIVE DATE: SEPTEMBER 24, 2018 PAGE 1 OF 8 SAFETY DATA SHEET Prepared to U.S. OSHA, CMA, ANSI, Canadian WHMIS Standards, European Union CLP EC 1272/2008 and the Global Harmonization Standard 1. V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Attached to this memorandum is a copy of a package insert for iron dextran (Infed). Sv 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. . Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. 3 0 obj 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. . trailer << /Size 254 /Info 216 0 R /Root 219 0 R /Prev 331519 /ID[<618a70ff49b482af49be42cc5de1ac5d><4f4e9802b6496a1513efa6cfdffb7212>] >> startxref 0 %%EOF 219 0 obj << /Type /Catalog /Pages 213 0 R /Metadata 217 0 R /PageLabels 211 0 R >> endobj 252 0 obj << /S 769 /T 901 /L 982 /Filter /FlateDecode /Length 253 0 R >> stream . For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Clinical Considerations 0000009371 00000 n ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. 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). endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream 0000006734 00000 n Fatal reactions have also occurred in situations where the test dose was tolerated. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. (See Anaphylaxis under Cautions.) Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Infed (iron dextran injection), for intravenous or intramuscular use . Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Distribution Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. Stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition mixtures. 0000018000 00000 n Written by ASHP. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. 0000002441 00000 n Trace amounts of unmetabolized iron dextran are present in human milk. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. . 5.3 Increased Risk of Toxicity in Patients with Underlying Conditions Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. 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. .0.34% Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. Bethesda, MD 20894, Web Policies Package insert / product label Four of the seven dilute solutions were stable after two months of storage. Copyright 2023, Selected Revisions November 4, 2013. Discontinue oral iron therapy prior to initiation of iron dextran therapy. 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). During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. 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. Cancer Chemother Pharmacol. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. endobj 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? !m Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. JLdddd0]`kig?yLm[}6:|Mm-g;b%&?,X,|&Y_}:|!'l%B%e]oJ\}v8l="[;`_#3B]v4ysnp6p3oQd+j_07(+g_Co;haE+1bk+|e>inBko686Jf?2o_>qfETmP@5(C7b$;HvqW!Vb(FNz& This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). . 0000010855 00000 n Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. The following information about each drug is given in tabular format: drug to be reconstituted and size of package; recommended route(s) of administration; recommended diluent, quantity to be used and resultant concentration; stability after initial dilution; and stability after further dilution; and stability of frozen antibiotics. Based on: Desired Hb = the target Hb in g/dl. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. Clipboard, Search History, and several other advanced features are temporarily unavailable. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). 34 55 Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site. . m$K~*&S)j5-Df"F d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? 0000002019 00000 n HHS Vulnerability Disclosure, Help (See Cautions.).
Shrimp Basket Birthday Specials,
Used Cars Birmingham, Al Under $2,000,
Articles I
