David McAuley, Pharm.D. 6Ee^2+G8"c+TepPRb d_@ Such blood losses may occur periodically in patients with hemorrhagic diatheses (familial telangiectasia; hemophilia; gastrointestinal bleeding) and on a repetitive basis from procedures such as renal hemodialysis. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. 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. Clipboard, Search History, and several other advanced features are temporarily unavailable. 0000006734 00000 n F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' 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. . 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. Federal government websites often end in .gov or .mil. Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. PDF Guidance for Addressing Shortages of Sterile Water for Injection and endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. 0000003708 00000 n 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)]. . 0000040000 00000 n INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli. trailer INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response. If there is no reaction after 1 hour continue. Trace amounts of unmetabolized iron dextran are present in human milk. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. . The stability of injectable medications after reconstitution is presented. 0000003224 00000 n The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic Discontinue administration of any iron-containing products prior to administration of Infed. Alternatively, the total dose may be calculated using the formulas below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin (males and females) for body weight over 15 kg (33 lbs) is 14.8 g/dL. and transmitted securely. <> Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. . WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. 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. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. 0000008617 00000 n A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. The half-life of free iron in the plasma circulation is approximately 5 hours. HdTr0+(R^ 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. II. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to Infed. 0000026747 00000 n Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. 0000039715 00000 n @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). 1 INDICATIONS AND USAGE INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response . Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 xb```f``= @Q#3108-. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. 3. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. 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. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. (See Sensitivity Testing under Dosage and Administration.) If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. . The pH of the solution is between 4.5 to 7.0. Medically reviewed by Drugs.com. Delayed Reactions Risk of developing potentially life-threatening anaphylactic reactions. A subsidiary of Watson Pharmaceuticals, Inc. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. 0000009538 00000 n 0000037133 00000 n 0000010567 00000 n 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). 5 0 obj Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. 8.1 Pregnancy Epinephrine should be immediately available. Iron dextran is a INFeD should not normally be given in the first four months of life. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. In mice, rats, rabbits, and possibly hamsters, it has been demonstrated that these complexes may produce sarcoma following repeated administration of large or small doses of iron-carbohydrate complexes at a single injection site. 12.3 Pharmacokinetics 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. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: endobj 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)]. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. The study suggests that addition of recommended daily doses of iron dextran to parenteral nutrient solutions creates no stability problems; however, further study of the effects of temperature, pH, light, and storage time are recommended. 12.1 Mechanism of Action 0000014709 00000 n 0000004233 00000 n The etiology of these reactions is not known. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. endstream endobj 55 0 obj<> endobj 56 0 obj<>stream Anemias not associated with iron deficiency. x&q}2(33",Y &HS4) IE][5MA0A8eT?g_>^J37_/>O?'_koJ?DE>k/~fhFh-hiQv?}{spq8[vwVZinj4i ~q;+~F[f*]WR_Lk.U}2W%hv`kO?n7gC8V.WR'GB}Y2&?|l=FLf5Q*>nm{rDY_cVk|#sZa_&_~N#vjAjqe_5x?n'j_|WlYU2RW[KK/$ Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells. Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Dilute iron dextran formulation for addition to parenteral nutrient 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. COMMENTARY Biological parenteral products ar - American Society of Infed (iron dextran injection), for intravenous or intramuscular use . 0000006673 00000 n All Rights Reserved. Y-site compatibility of medications with parenteral nutrition. III. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. [Progress in drug technology in the years 1968 and 1969]. Continue Infed until hemoglobin is within the normal range and iron stores are replete. CAREFULLY BEFORE ACCESSING OR USING THIS SITE. Dosage form: injection .12.0 g/dl, c. Iron content of hemoglobin . FOIA Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. Before . Bookshelf Carcinogenesis Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. 1989;23(4):197-207. doi: 10.1007/BF00451642. Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Such reactions may be immediate or delayed. . Administer test dose prior to first therapeutic dose. Br Med J (Clin Res Ed). Four of the seven dilute solutions were stable after two months of storage. 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. 0000026943 00000 n Disclaimer. Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. .0.34% 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Systemic exposure to iron dextran may be increased. The .gov means its official. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU 2. 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. 16.1 How Supplied IV Iron Dextran Infusion Protocol | MedStar Health Allergan 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@> 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). . 0 $]: Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. (5.1) NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. over 15 kg (33 lbs) . This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000047340 00000 n Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. Iron Dextran Monograph for Professionals - Drugs.com <> This site needs JavaScript to work properly. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. %%EOF Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. 0000002294 00000 n 3. Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. In patients with CKD receiving an ESA, administer sufficient iron to maintain selected targets of iron therapy (i.e., transferrin saturation and serum ferritin concentrations); periodically monitor these iron indices and use results (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. An official website of the United States government. e. Weight. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. 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.
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