After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. . The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE Iron Overload Package insert / product label endobj 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. 0000037333 00000 n May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. Isoproterenol or similar beta-agonist agents may be required in these patients. The stability of injectable medications after reconstitution is presented. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Clipboard, Search History, and several other advanced features are temporarily unavailable. Dextran, a polyglucose, is either metabolized or excreted. 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. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. 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). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Carcinogenesis 0000008022 00000 n The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. 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. 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. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. %PDF-1.4 % Do Not Copy, Distribute or otherwise Disseminate without express permission. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Do not exceed a total daily dose of 2 mL undiluted Infed. I. Intravenous IV preparation and infusion guidelines - GlobalRPH HHS Vulnerability Disclosure, Help Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 1986;17(1):1-10. doi: 10.1007/BF00299858. 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. We comply with the HONcode standard for trustworthy health information. Oral and parenteral Iron Products - GlobalRPH xb```f``= @Q#3108-. Iron dextran is a Systemic exposure to iron dextran may be increased. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. [Progress in drug technology in the years 1968 and 1969]. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. 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. hO4,qv(8p]4SXs?_k^ '4["G!@` \ 0000035990 00000 n 0000030666 00000 n The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. This site complies with the HONcode standard for trust- worthy health information: verify here. The etiology of these reactions is not known. The molecular weights of INFeD and DexFerrum are 165,000 and 267,000 daltons, respectively. 2021 Allergan. 0000009983 00000 n 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 . H|TMs6Wu*Q6i\l.` Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. Federal government websites often end in .gov or .mil. Patients with Renal Impairment Iron storage parameters may improve prior to hematologic parameters. Specific Populations 3. The development and health benefits of breastfeeding should be considered along with the mothers clinical need for Infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. .65 mL/kg of body weight, b. Allergan USA, Inc. 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. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. 0000026747 00000 n Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. 0000009371 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 The site is secure. . 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. 0000013099 00000 n .14.8 g/dl Brand names: Dexferrum, INFeD 5.4 Iron Overload Increased Risk of Toxicity in Patients with Underlying Conditions Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Therefore, administration of subsequent test doses during therapy should be considered. 0000007595 00000 n Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. 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. If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. ~q`C34&rAd oG If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. 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. (See Boxed Warning.). INFeD (iron dextran injection), for intravenous or . Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. 0000001071 00000 n PDF HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPZELCA, periodically during Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 5 0 obj $ 0000008617 00000 n . J Pediatr Pharmacol Ther. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. %PDF-1.3 . In vitro studies have shown that removal of iron dextran by dialysis is negligible. The half-life of total iron, including both circulating and bound, is approximately 20 hours. 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. endstream endobj 47 0 obj<>stream If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). 0 If there is no reaction after 1 hour continue. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Each days dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients. . Dilution not recommended by manufacturers, but there have been reports of the total calculated dose of iron dextran being diluted in 2501000 mL of 0.9% sodium chloride injection for IV infusion [off-label]. (See DOSAGE AND ADMINISTRATION: Administration. 0000011536 00000 n Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. 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. Iron Dextran Monograph for Professionals - Drugs.com Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. 2.4 Administration Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. 0000010855 00000 n 0000008494 00000 n Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? . 0000040000 00000 n The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. 2.2 Recommended Dosage for Iron Deficiency Anemia Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Prior to the first intramuscular Infed therapeutic dose, administer an intramuscular test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. m$K~*&S)j5-Df"F d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? . Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. . Dosage 1972;9:94-98. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. Women's Bond NFT Collection HOW SUPPLIED AHFS DI Essentials. 0000003224 00000 n )U!$5X3/9 ($5EO1'G!X! w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V %%EOF .0.34% The https:// ensures that you are connecting to the 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. 16.1 How Supplied PMC 0000002803 00000 n Oxford University Press is a department of the University of Oxford. Administer test dose prior to first therapeutic dose. Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. 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)]. Fatal anaphylactic reactions are possible. The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. Before 88 0 obj<>stream . 0000004132 00000 n 0000003347 00000 n PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. *Qp"Q!J Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. 0000005917 00000 n J Pain Palliat Care Pharmacother. The stability of injectable medications after reconstitution is presented. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. 12.2 Pharmacodynamics INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Known hypersensitivity to iron dextran or any ingredient in the formulation. Stability of injectable medications after reconstitution Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Corrections in compilation of information on stability of injectable medications after reconstitution. Allergan Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. 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. 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; There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Bookshelf Elimination Generic name: iron dextran The adverse reactions are frequently delayed (1 to 2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. . To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. (See PRECAUTIONS: General.) 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.]. Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. Thank you for submitting a comment on this article. Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. 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. FLeQI!/r5=J aJp0s bEl$6uwK6).d>)bdJ6z!oGUayaZ`Z5$+=6mF2xzh[*'_L'T+Rbs VJlJ-2RSJrJIRSJxJ O))%Rs9PSJ~h]@?:4O~AQ@%{Ik@Ks1y,u?%s O))%\cy c ::y[%6b;+.:.=.7WKEbWd? (See Iron, oral under Interactions.). endstream endobj 46 0 obj<>stream F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' Disclaimer. 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)]. MeSH Available as iron dextran; dosage expressed in terms of elemental iron. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. 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. Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. N}F( 9N(i{:%NISD;%NIS*T1 0000001168 00000 n Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. (See PRECAUTIONS: General.) 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. 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). 4. PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan 0000031965 00000 n Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. . This site complies with the HONcode standard for trust- worthy health information: verify here. A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. HdTr0+(R^ If diluted, administer by IV infusion [off-label] over 16 hours. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. endobj . 0000005691 00000 n Available for Android and iOS devices. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, (See Cautions.). The .gov means its official. Cancer Chemother Pharmacol. . CAREFULLY BEFORE ACCESSING OR USING THIS SITE. x&q}2(33",Y &HS4) IE][5MA0A8eT?g_>^J37_/>O?'_koJ?DE>k/~fhFh-hiQv?}{spq8[vwVZinj4i ~q;+~F[f*]WR_Lk.U}2W%hv`kO?n7gC8V.WR'GB}Y2&?|l=FLf5Q*>nm{rDY_cVk|#sZa_&_~N#vjAjqe_5x?n'j_|WlYU2RW[KK/$ To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. 0000002986 00000 n 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. 0000001797 00000 n Gaithersburg, MD: Genzyme; August 2018. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. Administer the test dose at a gradual rate over at least 30 seconds. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. . 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. . Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. tran [6]. Medically reviewed by Drugs.com. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. LBW = Lean body weight in kg. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv 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 total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage). Distribution INFeD may be used alone or with other medications. 06\ zp#2j)kS \(nd+?5R xref 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). 0000005561 00000 n Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. [s BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , 0000010005 00000 n official website and that any information you provide is encrypted <> (See Anaphylaxis under Cautions.) 0000047340 00000 n 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. HHS Vulnerability Disclosure, Help 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. David McAuley, Pharm.D. Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. . Parenteral iron dextran therapy: a review. Bullock L, Parks RB, Lampasona V, Mullins RE. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. 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 . Four of the seven dilute solutions were stable after two months of storage. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 0000009066 00000 n Attached to this memorandum is a copy of a package insert for iron dextran (Infed). PMC 0000008504 00000 n 4 0 obj Would you like email updates of new search results? "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D 2 0 obj The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. II. 0000036781 00000 n W = body weight in kg . 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. All Rights Reserved. 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. II. 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. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates.
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