infed stability after reconstitution

Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. 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. Based on: Desired Hb = the target Hb in g/dl. Federal government websites often end in .gov or .mil. If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. 5.1 Hypersensitivity Reactions Blood volume . "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D This site complies with the HONcode standard for trust- worthy health information: verify here. Nephron. If there is no reaction after 1 hour continue. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. 1-800-678-1605, Manufactured By: %PDF-1.3 % Administer test dose prior to first therapeutic dose. Dilution not recommended by manufacturers, but there have been reports of the total calculated dose of iron dextran being diluted in 2501000 mL of 0.9% sodium chloride injection for IV infusion [off-label]. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Excretion Bullock L, Parks RB, Lampasona V, Mullins RE. Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. 12.3 Pharmacokinetics INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. Medically reviewed by Drugs.com. Allergan Possible increased incidence of adverse effects, especially delayed reactions, associated with large IV doses of iron dextran, such as those used in total-dose infusions. INDICATIONS AND USAGE: Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: >who have intolerance to oral iron or have had unsatisfactory response to oral iron; rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! 2.Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. 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 . Your comment will be reviewed and published at the journal's discretion. FLeQI!/r5=J aJp0s bEl$6uwK6).d>)bdJ6z!oGUayaZ`Z5$+=6mF2xzh[*'_L'T+Rbs VJlJ-2RSJrJIRSJxJ O))%Rs9PSJ~h]@?:4O~AQ@%{Ik@Ks1y,u?%s O))%\cy c ::y[%6b;+.:.=.7WKEbWd? Distribution Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. ~q`C34&rAd oG 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. Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. HdTn0D 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. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. A.YGtT~Ud!$8 d|Ey[9l]^Z.d,{Ah>=1LfC6= Lc3I`hOf2!*sXk!dPz9.UZJe|6xsd_nMS]UYG4@GCj_'8m$7$U |_6%$yf This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Fatal reactions have also occurred in situations where the test dose was tolerated. A subsidiary of Watson Pharmaceuticals, Inc. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. 0000008617 00000 n Normal hemoglobin (males and females) J Pain Palliat Care Pharmacother. Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. 0000002441 00000 n J Pediatr Pharmacol Ther. . Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. <> The half-life of free iron in the plasma circulation is approximately 5 hours. Observed Hb = the patients current hemoglobin in g/dl. ],kI#tp. 0000004132 00000 n (Normal Hb for Children 15 kg or less is 12 g/dl). . Would you like email updates of new search results? Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. Note: Patients using beta-blocking agents may not respond adequately to epinephrine. 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. CONTRAINDICATIONS Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. Take precautions to be prepared to treat potential allergic reactions. 1 0 obj 0000003913 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. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Am J Kid Dis. 2009;23(3):223-30. doi: 10.1080/15360280903098382. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kD[email protected]>m231qSaLHh>` All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. FOIA Elimination Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. 0000008494 00000 n CAREFULLY BEFORE ACCESSING OR USING THIS SITE. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. All Rights Reserved. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Federal government websites often end in .gov or .mil. Cancer Chemother Pharmacol. Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. 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. Administer a test Infed dose prior to the first therapeutic dose. 0000009538 00000 n 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). Fatal anaphylactic reactions are possible. Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. "3#$-Irc8x=B_}>_W@HqAP!I`[email protected];i1E]"EOQ4E7M9$PB em$ Ie2} %+}hIIU}E+rS_OENx(tF_)@nRAtZn#JHg221^m+U|"vy ]yakuU Hatton RC, Portales IT, Finlay A, Ross EA. 0000047340 00000 n infed stability after reconstitution - womensbond.com Dosage The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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/$ . a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) endobj 0000035990 00000 n The maximum daily dose of INFeD should not exceed 2 mL. Iron storage parameters may improve prior to hematologic parameters. The stability of injectable medications after reconstitution is presented. 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). 2001;5(1):75-7. Infed (iron dextran injection), for intravenous or intramuscular use Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. The total volume of Infed required for the treatment of iron replacement for blood loss is determined from an appropriate formula listed [see Dosage and Administration (2.3)]. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. Accessibility Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. 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. . Each monograph contains stability data, administration guidelines, and methods of preparation. 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. There are no data on the effects of iron dextran in breastfed infants or effects on milk production. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. 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. 16.1 How Supplied 12.1 Mechanism of Action 0000026943 00000 n 218 0 obj << /Linearized 1 /O 220 /H [ 1168 873 ] /L 336009 /E 11783 /N 28 /T 331530 >> endobj xref 218 36 0000000016 00000 n MeSH Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. 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. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Data Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Patients with Renal Impairment hO4,qv(8p]4SXs?_k^ '4["G!@` \ KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Generic name: iron dextran 0000036574 00000 n Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: Corrections in compilation of information on stability of injectable medications after reconstitution. PDF Storage and Reuse of Reconstituted Neuromodulators P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU Please enable it to take advantage of the complete set of features! Perform periodic determinations of hematologic response (e.g., serum ferritin, blood hemoglobin concentration, hematocrit, and reticulocyte count) during the course of therapy. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. Parenteral Iron Therapy Options - Wiley Online Library General and transmitted securely. Copyright 2021 GlobalRPH - Web Development by, IV Dilutions Medication Reference and Infusion Guidelines, Renal dosing for healthcare professionals, HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy. 0000009066 00000 n . [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK . l Sm3G.E7=" r7/[^;q|= .65 mL/kg of body weight, b. 0000005917 00000 n 0000008504 00000 n Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. 2. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. Thank you for submitting a comment on this article. 0000001877 00000 n government site. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). (5.3). 0000010005 00000 n Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. . 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. 0000011305 00000 n The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. The site is secure. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. <> 0000007316 00000 n endstream endobj 46 0 obj<>stream !m . 3. 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. 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. 6Ee^2+G8"c+TepPRb d_@ HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv Corrects the erythropoietic abnormalities that are due to a deficiency of iron. 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). 3. (See Anaphylaxis under Cautions.) 0000018000 00000 n 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. Based on the above factors, individuals with normal hemoglobin levels will have approximately 33 mg of blood iron per kilogram of body weight (15 mg/lb). 4. Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. 0000026302 00000 n . The site is secure. Careers. Drug interactions involving Infed have not been studied. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V (See PRECAUTIONS: General.) 0000009983 00000 n Bethesda, MD 20894, Web Policies . crobiological stability and recovery of the active drug after dilution or reconstitution should be evaluated during drug development to provide healthcare professionals with the necessary information about in-use stability. 0000039715 00000 n used within 6 hours after reconstitution.If RZV is stored after reconstitution, store at recommended storage conditions and reagitate prior to administration. Postreconstitution Stability of Amoxicillin-Clavulanic Acid Suspensions %%EOF xb```f``= @Q#3108-. and transmitted securely. Drug class: Iron Preparations 2 DOSAGE AND ADMINISTRATION J Parenter Sci Technol. . 15 kg (33 lbs) or less . Discontinue administration of any iron-containing products prior to administration of Infed. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Calculate the Infed dose based upon Table 1 and formulas below. 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 $]: A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. In vitro studies have shown that removal of iron dextran by dialysis is negligible. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Quantitative estimates of the individuals periodic blood loss and hematocrit during the bleeding episode provide a convenient method for the calculation of the required iron dose. 1989;23(4):197-207. doi: 10.1007/BF00451642. . Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. 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. d. Hemoglobin deficit PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. Disease-Associated Maternal and/or Embryo/Fetal Risk % .12.0 g/dl, c. Iron content of hemoglobin . The pH of the solution is between 4.5 to 7.0. Do not freeze. Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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; 0000003224 00000 n 12.2 Pharmacodynamics 0000003708 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. 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. The https:// ensures that you are connecting to the Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. 1986;17(1):1-10. doi: 10.1007/BF00299858. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 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. 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. ], Observed Hb = the patients current hemoglobin in g/dL. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. PDF Significance of Reconstitution Time and Other Physical Parameters for Clipboard, Search History, and several other advanced features are temporarily unavailable. Y-site compatibility of medications with parenteral nutrition. Infed Dosage Guide - Drugs.com Drug class: Iron products. 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. . All rights reserved. Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Clipboard, Search History, and several other advanced features are temporarily unavailable. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. Please check for further notifications by email. Metabolism SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Ferentino, Italy 03013, Distributed By: I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Increased Risk of Toxicity in Patients with Underlying Conditions 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 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)]. HR0~ Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). PDF INFeD (IRON DEXTRAN INJECTION USP) Rx only Revised: September 2020 If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. Use with caution in patients with a history of clinically important allergies and/or asthma. 0000024030 00000 n Discontinue oral iron therapy prior to initiation of iron dextran therapy. endobj 0000001797 00000 n Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. 0000046691 00000 n Systemic exposure to iron dextran may be increased. 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. Administer the test dose at a gradual rate over at least 30 seconds. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Madison, NJ 07940. . Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. 3 0 obj Bethesda, MD 20894, Web Policies Stability of injectable medications after reconstitution 0000013099 00000 n 0000002019 00000 n Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). COMMENTARY Biological parenteral products ar - American Society of Before 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. 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.] In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Risk of developing potentially life-threatening anaphylactic reactions. Ling J, Gupta VD. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). To calculate a patient's weight in kg when lbs are known: Otherwise, the total dose may be calculated using the formula below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin for children with body weight of 15 kg (33 lbs) or less is 12 g/dL.]. . INFeD should not normally be given in the first four months of life. Cancer Chemother Pharmacol. . 0000012898 00000 n 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. Trace amounts of unmetabolized iron dextran are present in human milk.