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 .
PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer Abstract. Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. %%EOF
An official website of the United States government. Such reactions may be immediate or delayed. 0000046285 00000 n
Gaithersburg, MD: Genzyme; August 2018. PMC equivalent to 50 mg of elemental iron per mL. Administer a test Infed dose prior to the first therapeutic dose. over 15 kg (33 lbs) . Absorption 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. Hb```f`` l,/`"`FOB/r7}UL This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. CONTRAINDICATIONS Crosses the placenta and small amounts of iron apparently reach the fetus. . Take precautions to be prepared to treat potential allergic reactions. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. 0000003913 00000 n
The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. Available for Android and iOS devices. 0000004098 00000 n
For information on systemic interactions resulting from concomitant use, see Interactions. )U!$5X3/9 ($5EO1'G!X! official website and that any information you provide is encrypted 5 0 obj 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. The pH of the solution is between 4.5 to 7.0. Unable to load your collection due to an error, Unable to load your delegates due to an error. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. All Rights Reserved. Dextran, a polyglucose, is either metabolized or excreted. 0000003396 00000 n
Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. 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?
Stability of injectable medications after reconstitution hO4,qv(8p]4SXs?_k^ '4["G!@` \
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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). The maximum daily dose of Infed should not exceed 2 mL. 1 INDICATIONS AND USAGE 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 . Metabolism Curr Opin Clin Nutr Metab Care. The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. startxref
Am J Kid Dis. The molecular weights of INFeD and DexFerrum are 165,000 and 267,000 daltons, respectively. Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. The product should be further diluted in a suitable diluent prior to infusion. Continue Infed until hemoglobin is within the normal range and iron stores are replete. Morristown, NJ 07962 USA. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet The stability of injectable medications after reconstitution is presented. 0000002275 00000 n
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Bethesda, MD 20894, Web Policies 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. J Pain Palliat Care Pharmacother. The stability of injectable medications after reconstitution is presented. Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. . ~q`C34&rAd oG
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). If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to Infed. HR0~ 0000011305 00000 n
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. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. 0000040000 00000 n
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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. 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). Clipboard, Search History, and several other advanced features are temporarily unavailable. BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ ,
Infed Dosage Guide - Drugs.com Observed Hb = the patients current hemoglobin in g/dl. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. 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)]. . 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.] The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. Please check for further notifications by email. Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. <> 0000009088 00000 n
Careers. Package insert / product label 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). Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). . Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. 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. National Library of Medicine Allergan USA, Inc.
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. . It should be understood that these half-life values do not represent clearance of iron from the body. Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. Iron storage parameters may improve prior to hematologic parameters. Each monograph contains stability data, administration guidelines, and methods of preparation. 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. I. 218 0 obj
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REFERENCES 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. 2.Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. 2. Do Not Copy, Distribute or otherwise Disseminate without express permission. 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). . BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. . Disease-Associated Maternal and/or Embryo/Fetal Risk 0000010855 00000 n