Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. 34 0 obj <> endobj Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation. . Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. 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. 0000002275 00000 n 0000047340 00000 n Iron dextran is a Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. 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. Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. Distribution 0000007617 00000 n Obstetric clinical pharmacy: A necessary birth of a new specialty, Sister Mary Louise Degenhart dies at 85 years, Infection risk and management strategies for patients with cirrhosis taking proton pump inhibitors, Cold chain experts look to future during latest ASHP forum, National trends in prescription drug expenditures and projections for 2023, ASHP National Surveys of Pharmacy Practice in Hospital Settings, Population Health Management Theme Issues, Practice Advancement Initiative Collection, Transitions of Care/Medication Reconciliation, Emergency Preparedness and Clinician Well-being, Author Instructions for Residents Edition, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 American Society of Health-System Pharmacists. Dilute iron dextran formulation for addition to parenteral nutrient Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. National Library of Medicine (See Boxed Warning.) REFERENCES Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan %PDF-1.3 % HR0~ xb```f``= @Q#3108-. . The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. 15 kg (33 lbs) or less . National Library of Medicine For information on systemic interactions resulting from concomitant use, see Interactions. Stability of injectable medications after reconstitution . 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. 0000003091 00000 n !m Stability of injectable medications after reconstitution 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. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Watson Pharma, Inc. . 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 reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. government site. Hb```f`` l,/`"`FOB/r7}UL 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. Factors contributing to the formula are shown below. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Infed: Package Insert / Prescribing Information - Drugs.com Advise patients that delayed reactions can occur and that these must be reported to their healthcare provider immediately [see Warnings and Precautions (5.2)]. 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. 0000002696 00000 n 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. DOSAGE FORMS AND STRENGTHS VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials. Iron storage parameters may improve prior to hematologic parameters. 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? Use with extreme caution in patients with serious impairment of hepatic function. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) 0000009371 00000 n 0000001396 00000 n 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. Discontinue administration of any iron-containing products prior to administration of Infed. If diluted, administer by IV infusion [off-label] over 16 hours. 8600 Rockville Pike Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. %PDF-1.3 Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. over 15 kg (33 lbs) . Clinical Considerations The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. 0000010005 00000 n COMMENTARY Biological parenteral products ar - American Society of (Normal Hb for Children 15 kg or less is 12 g/dl). Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet . PDF Significance of Reconstitution Time and Other Physical Parameters for (See Anaphylaxis under Cautions.) 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. hO4,qv(8p]4SXs?_k^ '4["G!@` \ Epinephrine should be immediately available. 0000037333 00000 n . 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. The pH of the solution is between 4.5 to 7.0. 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. Following administration of Infed, circulating iron dextran is split by the cells of the reticuloendothelial system into its components of iron and dextran. *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). The maximum daily dose of Infed should not exceed 2 mL. Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. (See Special Populations under Pharmacokinetics.). Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). N}F( 9N(i{:%NISD;%NIS*T1 Unauthorized use of these marks is strictly prohibited. 0000011042 00000 n 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. Anemia Associated with Chronic Renal Failure, Hypersensitivity Reactions [see Warnings and Precautions (5.1)], Delayed Reactions [see Warnings and Precautions (5.2)], Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions (5.3)], Iron Overload [see Warnings and Precautions (5.4)], Fetal bradycardia [see Use in Specific Populations (8.1)]. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: Generic name: iron dextran Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. 0000026943 00000 n Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. J Parenter Sci Technol. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. 5 0 obj PDF INFeD See full prescribing information for complete boxed warning Infed is a registered trademark of Allergan Sales, LLC. NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. 0000003396 00000 n 12.1 Mechanism of Action Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. 12.3 Pharmacokinetics Recommended formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL) for calculating total dosage of iron dextran injection (in mL): Use the following formula to calculate required total dosage of iron dextran injection (in mL): Infants weighing <5 kg (11 lbs): Maximum daily dosage is 25 mg of iron. 2009;23(3):223-30. doi: 10.1080/15360280903098382. 88 0 obj<>stream Disease-Associated Maternal and/or Embryo/Fetal Risk 0000003224 00000 n 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. 0000002041 00000 n . 6Ee^2+G8"c+TepPRb d_@ Clipboard, Search History, and several other advanced features are temporarily unavailable. Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (14.8 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). INFeD may be used alone or with other medications. 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? 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. Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. 3. Before To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. <> There are no data on the effects of iron dextran in breastfed infants or effects on milk production. This site needs JavaScript to work properly. 0000004715 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. sharing sensitive information, make sure youre on a federal 4. FOIA 3. 2.2 Recommended Dosage for Iron Deficiency Anemia 2. Do Not Copy, Distribute or otherwise Disseminate without express permission. %PDF-1.4 % RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T 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. Nephron. (See Boxed Warning.). endobj 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. Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream 0000011536 00000 n Fetal/Neonatal Adverse Reactions Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. 0000036781 00000 n We comply with the HONcode standard for trustworthy health information. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 The total volume of Infed required for the treatment of iron replacement for blood loss is determined from an appropriate formula listed [see Dosage and Administration (2.3)]. . . The following information about each drug is given in tabular format: drug to be reconstituted and size of package; recommended route(s) of administration; recommended diluent, quantity to be used and resultant concentration; stability after initial dilution; and stability after further dilution; and stability of frozen antibiotics. . Absorbed slowly from the site of IM injection, principally through the lymphatic system; 60% of an IM dose after 3 days, up to 90% after 13 weeks; and the remainder gradually absorbed over a period of several months or longer. This site complies with the HONcode standard for trust- worthy health information: verify here. 0000003913 00000 n Manifested as sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse; have resuscitation equipment and personnel trained in detection and treatment of anaphylactic-type reactions readily available during iron dextran administration. . Dosage form: injection official website and that any information you provide is encrypted 0000006734 00000 n MeSH . TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE 0000005561 00000 n Bethesda, MD 20894, Web Policies To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. . 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)]. Administer only in a setting where resuscitation equipment and medications are available. 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. NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. [2:/T6*cz1"Jk&n#n[[TU . 0000009983 00000 n 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.] a. I. Anemias not associated with iron deficiency. Evaluation of the stability of vancomycin solutions at concentrations Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. tran [6]. Therefore, administration of subsequent test doses during therapy should be considered. and transmitted securely. Careers. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Advise pregnant persons of the potential risk to the fetus. 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. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. II. Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. 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. <> 0000010118 00000 n 0000004098 00000 n [Progress in drug technology in the years 1968 and 1969]. The etiology of these reactions is not known. Trace amounts of unmetabolized iron dextran are present in human milk. The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. . 1-800-678-1605, Manufactured By: 0000002294 00000 n Sv After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. 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. Based on: Desired Hb = the target Hb in g/dl. Dextran, a polyglucose, is either metabolized or excreted. Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. <> These half-life values do not represent clearance of iron from the body. . A test dose of 25 mg infused over 5 minutes should be given. . 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. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. 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; Advise patients to immediately report any symptoms of hypersensitivity that develop during and following Infed administration such as arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting [see Warnings and Precautions (5.1)]. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. For all medical inquiries contact: Elimination 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. 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. Data Do Not Copy, Distribute or otherwise Disseminate without express permission. @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ Ling J, Gupta VD. The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. 2021 Allergan. .0.34% 0000031965 00000 n trailer startxref Available for Android and iOS devices. Brand names: Dexferrum, INFeD Observed Hb = the patients current hemoglobin in g/dl. JLdddd0]`kig?yLm[}6:|Mm-g;b%&?,X,|&Y_}:|!'l%B%e]oJ\}v8l="[;`_#3B]v4ysnp6p3oQd+j_07(+g_Co;haE+1bk+|e>inBko686Jf?2o_>qfETmP@5(C7b$;HvqW!Vb(FNz& Abstract. J Pediatr Pharmacol Ther. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. 0000027226 00000 n 8.1 Pregnancy Protect from light. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. Oral and parenteral Iron Products - GlobalRPH Do not exceed a total daily dose of 2 mL undiluted Infed. Would you like email updates of new search results? Hypersensitivity Reactions 0000002803 00000 n The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. Note: Patients using beta-blocking agents may not respond adequately to epinephrine. The https:// ensures that you are connecting to the 0000013099 00000 n 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)].
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