Drug interactions involving Infed have not been studied. @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ 06\ zp#2j)kS \(nd+?5R 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)]. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Infusion should then be stopped for 1 hour. 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). 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. INFeD should not normally be given in the first four months of life. 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. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. Gaithersburg, MD: Genzyme; August 2018. 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). PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan 0000040000 00000 n 0000002294 00000 n Recommended formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL) for calculating total dosage of iron dextran injection (in mL): Use the following formula to calculate required total dosage of iron dextran injection (in mL): Infants weighing <5 kg (11 lbs): Maximum daily dosage is 25 mg of iron. PDF Evaluation of the stability of vancomycin solutions at concentrations 0000002696 00000 n %PDF-1.4 % (See Anaphylaxis under Cautions.) Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. l Sm3G.E7=" r7/[^;q|= PDF SCIENTIFIC DISCUSSION - European Medicines Agency 0000004233 00000 n 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. e. Weight. Intravenous IV preparation and infusion guidelines - GlobalRPH 1984 Mar;19(3):202, 207, 211-3. Possible increased incidence of adverse effects, especially delayed reactions, associated with large IV doses of iron dextran, such as those used in total-dose infusions. Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. 0000046691 00000 n Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Parenteral iron dextran therapy: a review. 0000002441 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Disclaimer. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. Infed: Package Insert / Prescribing Information - Drugs.com There have been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes. 0000008022 00000 n startxref Abstract. sharing sensitive information, make sure youre on a federal J Pain Palliat Care Pharmacother. 4 0 obj It should be understood that these half-life values do not represent clearance of iron from the body. Medically reviewed by Drugs.com on Oct 25, 2022. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. 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. 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:/T6*cz1"Jk&n#n[[TU . Iron dextran is a 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. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. The Summary of Product Characteristics (SmPC) recommends reconstituting a 1 g vial with 20 mL of water for injection (WFI), then diluting it in 100 mL of saline solution. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. . official website and that any information you provide is encrypted This site complies with the HONcode standard for trust- worthy health information: verify here. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? 0000001071 00000 n Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. Elimination INFeD, Dexferrum (iron dextran complex) dosing, indications - Medscape <<7815BA97DDE94C498B4A3154474182CA>]>> 2009;23(3):223-30. doi: 10.1080/15360280903098382. 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. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. 1995; 26(2):327-330. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Written by ASHP. I. The half-life of free iron in the plasma circulation is approximately 5 hours. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. . Do not exceed a total daily dose of 2 mL undiluted Infed. Allergan Cancer Chemother Pharmacol. Available as iron dextran; dosage expressed in terms of elemental iron. Infed (Iron Dextran): Uses, Dosage, Side Effects, Interactions - RxList 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. SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream Curr Opin Clin Nutr Metab Care. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. 4. Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. 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. 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)]. The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. 12.3 Pharmacokinetics Delayed Reactions fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ National Library of Medicine Advise patients to immediately report any symptoms of hypersensitivity that develop during and following Infed administration such as arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting [see Warnings and Precautions (5.1)]. II. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. HlTM6(R;!$+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 the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). 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). 0000009088 00000 n 2.2 Recommended Dosage for Iron Deficiency Anemia Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. Y-site compatibility of medications with parenteral nutrition. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex. [See USP Controlled Room Temperature]. Protect from light. HdTr0+(R^ 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. Sv KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. d. Hemoglobin deficit INDICATIONS AND USAGE: Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: >who have intolerance to oral iron or have had unsatisfactory response to oral iron; 0000005669 00000 n The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl Int J Pharm Compd. If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Use the following formula to calculate required total iron dextran dosage in mL: 0.02 blood loss (in mL) hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL). 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). Such reactions may be immediate or delayed. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: Ling J, Gupta VD. endobj The https:// ensures that you are connecting to the Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. The site is secure. (See Iron, oral under Interactions.). HdTn0D (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! For solution and drug compatibility information, see Compatibility under Stability. (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: endstream endobj 46 0 obj<>stream The maximum daily dose of INFeD should not exceed 2 mL. 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 . 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 monograph contains stability data, administration guidelines, and methods of preparation. 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. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 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. Continue Infed until hemoglobin is within the normal range and iron stores are replete. We comply with the HONcode standard for trustworthy health information. 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. 0000005561 00000 n <> 3. The amount of vancomycin to treat an adult infection is superior to 1 g and so the volume administered can be higher than 100 mL. If there is no reaction after 1 hour continue. General Infed is a registered trademark of Allergan Sales, LLC. p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide, This PDF is available to Subscribers Only. Br Med J (Clin Res Ed). Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. 0000011536 00000 n Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. 4. 1972;9:94-98. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Administer test dose prior to first therapeutic dose. The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. Therefore, administration of subsequent test doses during therapy should be considered. INFeD (iron dextran injection), for intravenous or . Fatal reactions have been reported following the test dose of iron dextran injection. 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). 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. 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. used within 6 hours after reconstitution.If RZV is stored after reconstitution, store at recommended storage conditions and reagitate prior to administration. Calculate the Infed dose based upon Table 1 and formulas below. RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T 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. 0000003686 00000 n 0000003396 00000 n Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. A test dose of 25 mg infused over 5 minutes should be given. 2 DOSAGE AND ADMINISTRATION 0000035990 00000 n m$K~*&S)j5-Df"F d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? 16.2 Stability and Storage Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. . (5.1) . Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. PMC Madison, NJ 07940. . 0000014709 00000 n Federal government websites often end in .gov or .mil. FOIA Bullock L, Parks RB, Lampasona V, Mullins RE. This site needs JavaScript to work properly. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility HHS Vulnerability Disclosure, Help Please enable it to take advantage of the complete set of features! AHFS DI Essentials. 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: Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. PDF Storage and Reuse of Reconstituted Neuromodulators Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. 0000006673 00000 n ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. 0000037333 00000 n 0000036781 00000 n Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. Fetal/Neonatal Adverse Reactions . Based on: Desired Hb = the target Hb in g/dl. . Risk Summary Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. Iron Dextran Monograph for Professionals - Drugs.com Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. PDF Significance of Reconstitution Time and Other Physical Parameters for PMC Please check for further notifications by email. 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. 0 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. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. Epinephrine should be immediately available. I. Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. 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. PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. 0000026747 00000 n Oral and parenteral Iron Products - GlobalRPH In vitro studies have shown that removal of iron dextran by dialysis is negligible. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. 0000011042 00000 n Disclaimer. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. 0000015331 00000 n Bethesda, MD 20894, Web Policies . Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. 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 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. Last updated on Dec 1, 2022. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 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. 0000002918 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Anemia Associated with Chronic Renal Failure. 0000007617 00000 n PDF HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPZELCA, periodically during
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