Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. 0000007595 00000 n Therefore, administration of subsequent test doses during therapy should be considered. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 0000012149 00000 n 5.4 Iron Overload The animals used in these tests were not iron deficient. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. ], Observed Hb = the patients current hemoglobin in g/dL. 0000011536 00000 n 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). Four of the seven dilute solutions were stable after two months of storage. Patients with Renal Impairment 88 0 obj<>stream %%EOF 3. . Epinephrine should be immediately available. and transmitted securely. Cancer Chemother Pharmacol. W = body weight in kg 0000003347 00000 n Iron storage parameters may improve prior to hematologic parameters. 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)]. .0.34% 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@> 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. 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. Question patients regarding any prior history of reactions to parenteral iron products. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Your comment will be reviewed and published at the journal's discretion. 4. Importance of informing patients of other important precautionary information. Cancer Chemother Pharmacol. 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 Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. . Carcinogenesis Stability of aminophylline injection in three parenteral nutrient solutions. 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]. Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. In vitro studies have shown that removal of iron dextran by dialysis is negligible. . 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. 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)]. Parenteral iron dextran therapy: a review. 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? . Watson Pharma, Inc. MeSH Known hypersensitivity to iron dextran or any ingredient in the formulation. 0000001797 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)]. 0000002441 00000 n Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. 0000004098 00000 n Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. 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. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. Iron Overload 8.2 Lactation Should be administered by qualified individuals with ready access to resuscitation equipment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction (e.g., epinephrine, or isoproterenol in patients receiving -adrenergic blocking agents). The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. . 34 0 obj <> endobj Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? Dosage form: injection 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{ wQ&vYAv6bUd`l!k3X*4V. 5.1 Hypersensitivity Reactions All rights reserved. endobj Use with extreme caution in patients with serious impairment of hepatic function. 06\ zp#2j)kS \(nd+?5R 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). [2:/T6*cz1"Jk&n#n[[TU 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. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. In patients with chronic kidney disease (CKD) on hemodialysis, IV iron superior to orally administered iron for increasing hemoglobin concentrations and/or minimizing dosage of an erythropoiesis-stimulating agent (ESA); the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines state that the IV route is preferred for iron administration in such patients. Infed is a registered trademark of Allergan Sales, LLC. 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 . Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. 3 0 obj Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. 0000005561 00000 n Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). 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). 0000003396 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 . 0000010567 00000 n 0000002294 00000 n The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. All Rights Reserved. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. 1985;14(2):83-95. doi: 10.1007/BF00434343. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. 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. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. Please check for further notifications by email. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V Copyright 2021 GlobalRPH - Web Development by, The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Curr Opin Clin Nutr Metab Care. 0000036781 00000 n Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. Hatton RC, Portales IT, Finlay A, Ross EA. 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. Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. 2001;5(1):75-7. Stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition mixtures. endobj 0000012898 00000 n Administer only in a setting where resuscitation equipment and medications are available. Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). 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. 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. II. Before Am J Kid Dis. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. The maximum daily dose of INFeD should not exceed 2 mL. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` official website and that any information you provide is encrypted Unable to load your collection due to an error, Unable to load your delegates due to an error. (See PRECAUTIONS: General.) Fatal anaphylactic reactions are possible. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. 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)]. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. J Pediatr Pharmacol Ther. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. 5. Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated. *Qp"Q!J 8.4 Pediatric Use Dosage 0000011305 00000 n 1989;23(4):197-207. doi: 10.1007/BF00451642. $ After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count. 1-800-678-1605, Manufactured By: 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. NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y 6Ee^2+G8"c+TepPRb d_@ (See Cautions.). 0000030324 00000 n infed stability after reconstitutionkneecap tattoo healing. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. hO4,qv(8p]4SXs?_k^ '4["G!@` \ Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. government site. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss 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. 0000002072 00000 n The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. startxref Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. 0000002696 00000 n and transmitted securely. 1986;17(1):1-10. doi: 10.1007/BF00299858. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 16.2 Stability and Storage Fetal/Neonatal Adverse Reactions J Pain Palliat Care Pharmacother. 0000009066 00000 n 0 $]: I. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. <<7815BA97DDE94C498B4A3154474182CA>]>> BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. It should be recognized that iron storage may lag behind the appearance of normal blood morphology. sharing sensitive information, make sure youre on a federal Therefore, administration of subsequent test doses during therapy should be considered. Protect from light. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. The stability of injectable medications after reconstitution is presented. This site complies with the HONcode standard for trust- worthy health information: verify here.
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