All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. Generic name: iron dextran This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. 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. xref 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. Do Not Copy, Distribute or otherwise Disseminate without express permission. infed stability after reconstitutionkneecap tattoo healing. 34 55 Patheon Italia S.p.A. Cancer Chemother Pharmacol. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. 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). For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Hilleman DE, McEvoy GK, Bailey RT Jr, Reich J. Hosp Pharm. Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. Dextran, a polyglucose, is either metabolized or excreted. Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. Your comment will be reviewed and published at the journal's discretion. 0000002644 00000 n If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. 4. (See Boxed Warning.) . Br Med J (Clin Res Ed). Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. 0 $]: This site needs JavaScript to work properly. General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation. This site complies with the HONcode standard for trust- worthy health information: verify here. Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. endstream endobj 57 0 obj<> endobj 58 0 obj<>stream 0000008737 00000 n 2.1 Important Pre-Treatment Information 0000030324 00000 n 0000002041 00000 n S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. 0000002803 00000 n Initial U.S. Approval: 1974 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. Last updated on Dec 1, 2022. Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. III. 0000008617 00000 n BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. 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. Cancer Chemother Pharmacol. During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? 5.2 Delayed Reactions Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. . 0000003913 00000 n <> General considerations, the nitrosoureas and alkylating agents. MeSH 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 . Fatal anaphylactic reactions are possible. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. [Progress in drug technology in the years 1968 and 1969]. 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). stream 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. m$K~*&S)j5-Df"F d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? 0000037333 00000 n Cancer Chemother Pharmacol. (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: 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. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, . To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Factors contributing to the formula are shown below. I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given. I. 0000024030 00000 n Obstetric clinical pharmacy: A necessary birth of a new specialty, Sister Mary Louise Degenhart dies at 85 years, Infection risk and management strategies for patients with cirrhosis taking proton pump inhibitors, Cold chain experts look to future during latest ASHP forum, National trends in prescription drug expenditures and projections for 2023, ASHP National Surveys of Pharmacy Practice in Hospital Settings, Population Health Management Theme Issues, Practice Advancement Initiative Collection, Transitions of Care/Medication Reconciliation, Emergency Preparedness and Clinician Well-being, Author Instructions for Residents Edition, Receive exclusive offers and updates from Oxford Academic, Copyright 2023 American Society of Health-System Pharmacists. ~q`C34&rAd oG (See PRECAUTIONS: General.) *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. 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. [2:/T6*cz1"Jk&n#n[[TU Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 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)]. The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. In iron-deficient patients with coexistent end-stage renal disease and other clinical problems, the serum elimination half-life of iron averaged 58.9 hours (range: 9.487.4 hours) following IV administration of iron dextran. 0000001877 00000 n During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK Anemia Associated with Chronic Renal Failure. 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). The https:// ensures that you are connecting to the 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. Four of the seven dilute solutions were stable after two months of storage. 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? . $ Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. 0000002918 00000 n Careers. 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). Metabolism and transmitted securely. . 0 Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 0000002294 00000 n . The stability of injectable medications after reconstitution is presented. 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. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. 2.4 Administration Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. Protect from light. 0000036781 00000 n 5. d. Hemoglobin deficit 3 0 obj 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. Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. 0000006734 00000 n 0000046285 00000 n A.YGtT~Ud!$8 d|Ey[9l]^Z.d,{Ah>=1LfC6= Lc3I`hOf2!*sXk!dPz9.UZJe|6xsd_nMS]UYG4@GCj_'8m$7$U |_6%$yf The site is secure. . Fatal reactions have been reported following the test dose of iron dextran injection. Curr Opin Clin Nutr Metab Care. Ferentino, Italy 03013, Distributed By: I. LBW = Lean body weight in kg. [See USP Controlled Room Temperature]. Following administration of Infed, circulating iron dextran is split by the cells of the reticuloendothelial system into its components of iron and dextran. 0000046691 00000 n Bookshelf 0000010759 00000 n The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. 12.2 Pharmacodynamics Discontinue administration of any iron-containing products prior to administration of Infed. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. Package insert / product label Increased Risk of Toxicity in Patients with Underlying Conditions 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]. . Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. Fatal reactions have also occurred in situations where the test dose was tolerated. 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. 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. Crosses the placenta and small amounts of iron apparently reach the fetus. Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. CAREFULLY BEFORE ACCESSING OR USING THIS SITE. 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. Use with caution in patients with a history of clinically important allergies and/or asthma. 0000005691 00000 n Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 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. We comply with the HONcode standard for trustworthy health information. endobj % 0000003396 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. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: 0000001396 00000 n An official website of the United States government. Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. Iron dextran is a 1-800-678-1605, Manufactured By: It should be understood that these half-life values do not represent clearance of iron from the body. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000011536 00000 n Available for Android and iOS devices. The .gov means its official. 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. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. endstream endobj 47 0 obj<>stream Federal government websites often end in .gov or .mil. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. For all medical inquiries contact: (5.1) BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. Stability of aminophylline injection in three parenteral nutrient solutions. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. 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 site is secure. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. Figure 1. Excretion Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. 0000009066 00000 n 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. HdTr0+(R^ (See Anaphylaxis under Cautions.) (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' Medically reviewed by Drugs.com. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. 12.3 Pharmacokinetics Administer only in a setting where resuscitation equipment and medications are available. 0000032198 00000 n 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. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. 4. <> Would you like email updates of new search results? 4. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU CAS number: 9004-66-4. An official website of the United States government. trailer The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. endobj Iron Overload 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. 1986;17(1):1-10. doi: 10.1007/BF00299858. Dosage form: injection Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. 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)]. INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02). 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. Absorption *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). Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 0000009538 00000 n ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) 1995; 26(2):327-330. . Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. 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. Medically reviewed by Drugs.com on Oct 25, 2022. Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. FOIA
If A Dog Drowns Will It Float,
How To Change Google Background On School Chromebook,
Buster Murdaugh Casino,
Track My Baggage Ethiopian Airlines,
Dr Fuhrman Covid Vaccine 2021,
Articles I