In vitro studies have shown that removal of iron dextran by dialysis is negligible. Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. Abstract. . 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 . 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). Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Use the following formula to calculate required total iron dextran dosage in mL: 0.02 blood loss (in mL) hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL). Continue Infed until hemoglobin is within the normal range and iron stores are replete. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. 0000002644 00000 n ],kI#tp. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. CAREFULLY BEFORE ACCESSING OR USING THIS SITE. Corrections in compilation of information on stability of injectable medications after reconstitution. J Pediatr Pharmacol Ther. %PDF-1.3 12.1 Mechanism of Action Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. . Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. 0000008022 00000 n sharing sensitive information, make sure youre on a federal (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! AHFS DI Essentials. 0000035990 00000 n The total volume of Infed required for the treatment of iron deficiency anemia is determined from Table 1 or the appropriate formula listed [see Dosage and Administration (2.2)]. 0000010877 00000 n 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. J Parenter Sci Technol. The half-life of total iron, including both circulating and bound, is approximately 20 hours. tran [6]. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. 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.] 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. Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. PubMed PMID: 23981803. Risk Summary 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. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. 0000006734 00000 n 8600 Rockville Pike Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. PDF Evaluation of the stability of vancomycin solutions at concentrations endobj Brand and Other Names: INFeD, Dexferrum Classes: Iron Products Dosing & Uses AdultPediatric Dosage Forms & Strengths injectable solution 50mg (Fe)/mL Iron-deficiency Anemia 25-100 mg IV or deep. These half-life values do not represent clearance of iron from the body. used within 6 hours after reconstitution.If RZV is stored after reconstitution, store at recommended storage conditions and reagitate prior to administration. MeSH Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. 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. 5.3 Increased Risk of Toxicity in Patients with Underlying Conditions Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. 0000012149 00000 n Each days dose should ordinarily not exceed 0.5 mL (25 mg of iron) for infants under 5 kg (11 lbs); 1.0 mL (50 mg of iron) for children under 10 kg (22 lbs); and 2.0 mL (100 mg of iron) for other patients. (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: Int J Pharm Compd. 0000002696 00000 n Drug class: Iron Preparations 0000004132 00000 n Y-site compatibility of medications with parenteral nutrition. The product should be further diluted in a suitable diluent prior to infusion. Use with extreme caution in patients with serious impairment of hepatic function. The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. 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. Your comment will be reviewed and published at the journal's discretion. Iron dextran is a 0000006673 00000 n (See Sensitivity Testing under Dosage and Administration.) KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Package insert / product label . *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH The https:// ensures that you are connecting to the Cancer Chemother Pharmacol. Each monograph contains stability data, administration guidelines, and methods of preparation. Last updated on Dec 1, 2022. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. 5.2 Delayed Reactions 0000024030 00000 n Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Administer the test dose at a gradual rate over at least 30 seconds into the buttock. Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Bookshelf The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. . fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ sharing sensitive information, make sure youre on a federal Known hypersensitivity to iron dextran or any ingredient in the formulation. Trace amounts of unmetabolized iron dextran are present in human milk. The maximum daily dose of INFeD should not exceed 2 mL. J Pediatr Pharmacol Ther. PDF INFeD (IRON DEXTRAN INJECTION USP) Rx only Revised: September 2020 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. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. For information on systemic interactions resulting from concomitant use, see Interactions. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. A test dose of 25 mg infused over 5 minutes should be given. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Use with caution in patients with a history of clinically important allergies and/or asthma. Importance of informing patients of other important precautionary information. 0000001797 00000 n The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. The stability of Meropenemreconstituted in solution is influenced by the following factors: Storage temperature: The drug is stable for longer time in solutions stored at 4 to 5C than in solutions stored at 21 to 26C. . Systemic exposure to iron dextran may be increased. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. David McAuley, Pharm.D. . Please enable it to take advantage of the complete set of features! 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. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. endstream endobj 35 0 obj<> endobj 36 0 obj<> endobj 37 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 38 0 obj<> endobj 39 0 obj<> endobj 40 0 obj<> endobj 41 0 obj<> endobj 42 0 obj<> endobj 43 0 obj[/ICCBased 66 0 R] endobj 44 0 obj<> endobj 45 0 obj<>stream Iron storage parameters may improve prior to hematologic parameters. (See Boxed Warning.). All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. Increased Risk of Toxicity in Patients with Underlying Conditions Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex. 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. Copyright 1993-2021 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). W = body weight in kg 12.2 Pharmacodynamics 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. 0000001877 00000 n 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. PDF SCIENTIFIC DISCUSSION - European Medicines Agency Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Delayed Reactions Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK Crosses the placenta and small amounts of iron apparently reach the fetus. If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. 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 SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. 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 . PDF HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPZELCA, periodically during 0000006695 00000 n The maximum daily dose of Infed should not exceed 2 mL. . Administer only in a setting where resuscitation equipment and medications are available. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. 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. Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. Patients with Renal Impairment .65 mL/kg of body weight, b. Calculate recommended total iron dextran dosage for treatment of iron deficiency anemia or iron replacement for blood loss from appropriate dosage formulas; these formulas are specific for each indication and are not interchangeable. F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU If diluted, administer by IV infusion [off-label] over 16 hours. a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) 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. This site complies with the HONcode standard for trust- worthy health information: verify here. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. . Do not exceed a total daily dose of 2 mL undiluted Infed. 15 kg (33 lbs) or less . Dosage official website and that any information you provide is encrypted Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. Calculate the Infed dose based upon Table 1 and formulas below. <> 0000003091 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 Women's Bond NFT Collection Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. (See Iron, oral under Interactions.). HOW SUPPLIED Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. Oral iron should be discontinued prior to administration of INFeD. LBW = Lean body weight in kg. 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. Accessibility 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. Excretion Available for Android and iOS devices. DailyMed - INFED- iron dextran injection [s 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. Iron Dextran Monograph for Professionals - Drugs.com Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Unauthorized use of these marks is strictly prohibited. . Discontinue administration of any iron-containing products prior to administration of Infed. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv endstream endobj 47 0 obj<>stream Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. . I. We comply with the HONcode standard for trustworthy health information. PDF Guidance for Addressing Shortages of Sterile Water for Injection and Brand names: Dexferrum, INFeD 8600 Rockville Pike Careers. 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.
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