Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. 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 . I. Total iron and free ferrous ion content of the preparations were measured for: (1) the dilute solutions at monthly intervals after up to three months of storage at room temperature and under refrigeration and (2) the parenteral nutrient solutions after 18 hours of storage at room temperature. Disclaimer. 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. (See Iron, oral under Interactions.). Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Administer only in a setting where resuscitation equipment and medications are available. 5.4 Iron Overload *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). 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). Would you like email updates of new search results? The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. This site needs JavaScript to work properly. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. Available for Android and iOS devices. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. Absorption 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. 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 Increased Risk of Toxicity in Patients with Underlying Conditions Bethesda, MD 20894, Web Policies w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V Elimination Observed Hb = the patients current hemoglobin in g/dl. 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. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. 0000008504 00000 n Pregnancy 8.2 Lactation The half-life of total iron, including both circulating and bound, is approximately 20 hours. 2025C; excursions permitted to 1530C. 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. 0000012898 00000 n PLEASE READ THE. 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). Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. 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.] Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb). Each monograph contains stability data, administration guidelines, and methods of preparation. 2 DOSAGE AND ADMINISTRATION Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. Gaithersburg, MD: Genzyme; August 2018. 8.1 Pregnancy The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. tran [6]. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. 0000002019 00000 n Medically reviewed by Drugs.com. . HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Infed is a registered trademark of Allergan Sales, LLC. 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. 2. We comply with the HONcode standard for trustworthy health information. 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. 0000000016 00000 n Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. (5.1) 0000009066 00000 n equivalent to 50 mg of elemental iron per mL. All Rights Reserved. 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 . 0000001396 00000 n Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Question patients regarding any prior history of reactions to parenteral iron products. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. A test dose of 25 mg infused over 5 minutes should be given. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. 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. . Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. Fetal/Neonatal Adverse Reactions Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. 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. a. Based on: Desired Hb = the target Hb in g/dl. 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. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Known hypersensitivity to iron dextran or any ingredient in the formulation. Advise pregnant persons of the potential risk to the fetus. 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. <> . Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. 0000039715 00000 n 0000046691 00000 n 0000011042 00000 n . INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Available as iron dextran; dosage expressed in terms of elemental iron. . 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. 2001;5(1):75-7. III. 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). Initial U.S. Approval: 1974 6Ee^2+G8"c+TepPRb d_@ Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. Blood volume . AHFS DI Essentials. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). 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). LBW = Lean body weight in kg. 4 0 obj Anemias not associated with iron deficiency. 0000002803 00000 n PMC Do Not Copy, Distribute or otherwise Disseminate without express permission. 0000018000 00000 n 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. Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. . . Curr Opin Clin Nutr Metab Care. 7.1 Drug/Laboratory Test Interactions crobiological stability and recovery of the active drug after dilution or reconstitution should be evaluated during drug development to provide healthcare professionals with the necessary information about in-use stability. Epinephrine should be immediately available. Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 0000046285 00000 n 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& Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. [2:/T6*cz1"Jk&n#n[[TU 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. Hypersensitivity Reactions The maximum daily dose of INFeD should not exceed 2 mL. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. 0000003913 00000 n endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream 0000026943 00000 n Administration All rights reserved. Unable to load your collection due to an error, Unable to load your delegates due to an error. . FOIA Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. 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)]. 0000001168 00000 n Medical Communications Thank you for submitting a comment on this article. Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. 0000008494 00000 n . Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. What are the possible side effects of INFeD? Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. sharing sensitive information, make sure youre on a federal 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)]. 1-800-678-1605, Manufactured By: 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. 06\ zp#2j)kS \(nd+?5R Indian J Anaesth. 0000002986 00000 n "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D 34 55 Accessibility 8600 Rockville Pike fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. 0000002275 00000 n David McAuley, Pharm.D. a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) . General ],kI#tp. 12.2 Pharmacodynamics It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. ], Observed Hb = the patients current hemoglobin in g/dL. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. 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. .12.0 g/dl, c. Iron content of hemoglobin . There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). 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. Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. Metabolism !m HdTr0+(R^ 0000002441 00000 n . 0000010567 00000 n . Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* Alternatively, the total dose may be calculated using the formulas below: Adults and Children over 15 kg (33 lbs) Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW) Based on: 0000007595 00000 n If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). Ling J, Gupta VD. 0000040000 00000 n Watson Pharma, Inc. After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. 2.4 Administration Distribution Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. . The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic Corrects the erythropoietic abnormalities that are due to a deficiency of iron. z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE 15 kg (33 lbs) or less . %PDF-1.4 % 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)]. 1995; 26(2):327-330. Iron dextran is a An official website of the United States government. HOW SUPPLIED 12.1 Mechanism of Action The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. Animal Data Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. MeSH The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. 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. The stability of injectable medications after reconstitution is presented. 1985;14(2):83-95. doi: 10.1007/BF00434343. INFeD should not normally be given in the first four months of life. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. 0000001797 00000 n Package insert / product label Allergan USA, Inc. endobj 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.

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