This site complies with the HONcode standard for trust- worthy health information: verify here. 0000015331 00000 n Bullock L, Parks RB, Lampasona V, Mullins RE. TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE This revision is an update of: Latiolais CJ, Shoup LK and Thur MP: Stability of drugs after reconstitution, Am J Hosp Pharm 24:667-691 (Dec) 1967. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias. . 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)]. (5.1) government site. WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS 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 . Iron dextran is a The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. The maximum daily dose of INFeD should not exceed 2 mL. N}F( 9N(i{:%NISD;%NIS*T1 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. Systemic exposure to iron dextran may be increased. Do not administer Infed to patients with evidence of iron overload. 0000013156 00000 n (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. Pregnancy 0000007617 00000 n This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 0000006734 00000 n 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. For all medical inquiries contact: Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. 0000003746 00000 n Thank you for submitting a comment on this article. 5.2 Delayed Reactions Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. . Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. It should not be used during the acute phase of infectious kidney disease. . *Qp"Q!J 0000001168 00000 n @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ . 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. Absorption 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. Watson Pharma, Inc. LBW = Lean body weight in kg. 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). 0000030666 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. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. . 0000026302 00000 n INFeD (iron dextran injection), for intravenous or . (See DOSAGE AND ADMINISTRATION: Administration. The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. Question patients regarding any prior history of reactions to parenteral iron products. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. 0000010759 00000 n NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. 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. 3 0 obj % Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Infusion should then be stopped for 1 hour. Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. I. There are no data on the effects of iron dextran in breastfed infants or effects on milk production. official website and that any information you provide is encrypted Continue Infed until hemoglobin is within the normal range and iron stores are replete. In iron-deficient patients with coexistent end-stage renal disease and other clinical problems, the serum elimination half-life of iron averaged 58.9 hours (range: 9.487.4 hours) following IV administration of iron dextran. Please check for further notifications by email. ], Observed Hb = the patients current hemoglobin in g/dL. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. . Protect from light. . Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 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). 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. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. 0000002644 00000 n startxref 0000026943 00000 n Bonnie E. Kirschenbaum, M.S., Clifton J. Latiolais, Sc.D., Stability of injectable medications after reconstitution, American Journal of Hospital Pharmacy, Volume 33, Issue 8, 1 August 1976, Pages 767791, https://doi.org/10.1093/ajhp/33.8.767. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. Dextran, a polyglucose, is either metabolized or excreted. This site needs JavaScript to work properly. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. HR0~ 0000035990 00000 n 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. . 2025C; excursions permitted to 1530C. 2 DOSAGE AND ADMINISTRATION 0000040000 00000 n THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. . 0000039715 00000 n 0000008494 00000 n If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. Carcinogenesis Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. 4. 0000009066 00000 n Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. 0000006695 00000 n 0000009088 00000 n endstream endobj 47 0 obj<>stream A test dose of 25 mg infused over 5 minutes should be given. 2 0 obj 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. The molecular weights of INFeD and DexFerrum are 165,000 and 267,000 daltons, respectively. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Before 0000036781 00000 n For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet . Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. 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). Hatton RC, Portales IT, Finlay A, Ross EA. The stability of injectable medications after reconstitution is presented. During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. 0000004098 00000 n Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. 0000032198 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 Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. All rights reserved. Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. 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. HHS Vulnerability Disclosure, Help Infed (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. "3#$-Irc8x=B_}>_W@HqAP!I`H9+.@F.ix;i1E]"EOQ4E7M9$PB em$ Ie2} %+}hIIU}E+rS_OENx(tF_)@nRAtZn#JHg221^m+U|"vy ]yakuU Therefore, administration of subsequent test doses during therapy should be considered. <> Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. 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. The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: . . Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet, For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet. 0000005561 00000 n Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Discontinue oral iron therapy prior to initiation of iron dextran therapy. . endstream endobj 35 0 obj<> endobj 36 0 obj<> endobj 37 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 38 0 obj<> endobj 39 0 obj<> endobj 40 0 obj<> endobj 41 0 obj<> endobj 42 0 obj<> endobj 43 0 obj[/ICCBased 66 0 R] endobj 44 0 obj<> endobj 45 0 obj<>stream Absorbed slowly from the site of IM injection, principally through the lymphatic system; 60% of an IM dose after 3 days, up to 90% after 13 weeks; and the remainder gradually absorbed over a period of several months or longer. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. CAS number: 9004-66-4. 0000003396 00000 n Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. 8600 Rockville Pike Advise the patient to consult a healthcare provider before taking any other iron containing products as this may cause serious side effects [see Warnings and Precautions (5.4)]. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK Fatal reactions have been reported following the test dose of iron dextran injection. Dosage form: injection 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. 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). 0000031965 00000 n 0000002072 00000 n Animal Data 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.] (See PRECAUTIONS: General.) and transmitted securely. 0000007595 00000 n Careers. DOSAGE FORMS AND STRENGTHS VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. 2.4 Administration 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. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. 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. z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE 0000003224 00000 n 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` Copyright 2023, Selected Revisions November 4, 2013. 5 0 obj <<7815BA97DDE94C498B4A3154474182CA>]>> 0000011536 00000 n Patheon Italia S.p.A. 1985;14(2):83-95. doi: 10.1007/BF00434343. 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. Copyright 1993-2021 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. Please enable it to take advantage of the complete set of features! 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. 0000001797 00000 n Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. 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? 0000002909 00000 n Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. DOSAGE AND ADMINISTRATION Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. $ Ling J, Gupta VD. 0000009983 00000 n . 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. Advise patients to immediately report any symptoms of hypersensitivity that develop during and following Infed administration such as arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting [see Warnings and Precautions (5.1)]. 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. xb```f``= @Q#3108-. 0000002041 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). 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)]. INFeD should not normally be given in the first four months of life. The stability of injectable medications after reconstitution is presented. Allergan USA, Inc. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. 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. Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. 2001;5(1):75-7. . Clinical Considerations Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. Niemiec PW Jr, Vanderveen TW, Hohenwarter MW, Gadsden RH Sr. Bullock L, Fitzgerald JF, Glick MR, Parks RB, Schnabel JG, Hancock BG. Stability of aminophylline injection in three parenteral nutrient solutions. David McAuley, Pharm.D. 2009;23(3):223-30. doi: 10.1080/15360280903098382. The etiology of these reactions is not known. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. endstream endobj 57 0 obj<> endobj 58 0 obj<>stream S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. official website and that any information you provide is encrypted 5. Careers. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V 0000010567 00000 n