government site. Infed (iron dextran injection), for intravenous or intramuscular use 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. CONTRAINDICATIONS The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. The maximum daily dose of Infed should not exceed 2 mL. 0000010877 00000 n Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. Data Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. W = body weight in kg 16.2 Stability and Storage 5.2 Delayed Reactions 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. Hb```f`` l,/`"`FOB/r7}UL The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. Medically reviewed by Drugs.com on Oct 25, 2022. 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. 0000011536 00000 n 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)]. 0000002072 00000 n Drug interactions involving Infed have not been studied. *Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs). [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK "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 8.2 Lactation Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer 0000002803 00000 n Importance of informing patients of other important precautionary information. 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. 2.2 Recommended Dosage for Iron Deficiency Anemia Blood volume . Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 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. Bookshelf 0000002041 00000 n Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. l Sm3G.E7=" r7/[^;q|= . 1989;23(4):197-207. doi: 10.1007/BF00451642. s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{ wQ&vYAv6bUd`l!k3X*4V. In doses 500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours. 0000002644 00000 n 0000036574 00000 n Iron Overload 8600 Rockville Pike 3. 0000008494 00000 n 5.1 Hypersensitivity Reactions Following administration of Infed, circulating iron dextran is split by the cells of the reticuloendothelial system into its components of iron and dextran. 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. 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 If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. 2021 Allergan. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. 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. INFeD belongs to a class of drugs called Iron Products. 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. DOSAGE AND ADMINISTRATION 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. Infusion should then be stopped for 1 hour. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. HR0~ Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. The stability of injectable medications after reconstitution is presented. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. 8600 Rockville Pike 0000036781 00000 n 0000001168 00000 n Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. I. Normal hemoglobin (males and females) American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. 0000031965 00000 n 0000009088 00000 n PDF INFeD (IRON DEXTRAN INJECTION USP) Rx only Revised: September 2020 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)]. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. . CAREFULLY BEFORE ACCESSING OR USING THIS SITE. Risk of developing potentially life-threatening anaphylactic reactions. Administer the test dose at a gradual rate over at least 30 seconds. Stability of injectable medications after reconstitution 0000001877 00000 n 0000004132 00000 n Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. Infed is a registered trademark of Allergan Sales, LLC. 0000046691 00000 n z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE Administer the test dose at a gradual rate over at least 30 seconds into the buttock. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Fetal/Neonatal Adverse Reactions 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. xb```f``= @Q#3108-. Advise pregnant persons of the potential risk to the fetus. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Please enable it to take advantage of the complete set of features! Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site. and transmitted securely. Corrections in compilation of information on stability of injectable medications after reconstitution. 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? Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. We comply with the HONcode standard for trustworthy health information. 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. 1985;14(2):83-95. doi: 10.1007/BF00434343. Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 0000032198 00000 n 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. Risk Summary All Rights Reserved. 0000004098 00000 n Available as iron dextran; dosage expressed in terms of elemental iron. If patient is standing, administer IM injection in buttock of the leg opposite the patients weight-bearing leg; if supine, place patient in a lateral position with the injection site uppermost. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. 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; 0000004233 00000 n )U!$5X3/9 ($5EO1'G!X! Iron Dextran Monograph for Professionals - Drugs.com 0000003396 00000 n Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH Cancer Chemother Pharmacol. Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as Infed) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. official website and that any information you provide is encrypted Prior to the first intramuscular Infed therapeutic dose, administer an intramuscular test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. . Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. Parenteral Iron Therapy Options - Wiley Online Library 5.4 Iron Overload Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. 0000013099 00000 n . 7.1 Drug/Laboratory Test Interactions (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! Use with caution in patients with a history of clinically important allergies and/or asthma. . . Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. A subsidiary of Watson Pharmaceuticals, Inc. @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ 0000046285 00000 n 0000009371 00000 n stream 2001;5(1):75-7. The maximum daily dose of INFeD should not exceed 2 mL. e. Weight. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. Hatton RC, Portales IT, Finlay A, Ross EA. J Parenter Sci Technol. rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! used within 6 hours after reconstitution.If RZV is stored after reconstitution, store at recommended storage conditions and reagitate prior to administration. 0000005917 00000 n INFeD should be injected only into the muscle mass of the upper outer quadrant of the buttock - never into the arm or other exposed areas - and should be injected deeply, with a 2-inch or 3-inch 19 or 20 gauge needle. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. All rights reserved. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 0000003347 00000 n The site is secure. The half-life of total iron, including both circulating and bound, is approximately 20 hours. 2009;23(3):223-30. doi: 10.1080/15360280903098382. 0000002909 00000 n Disclaimer. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. Specific Populations Therefore, administration of subsequent test doses during therapy should be considered. Observed Hb = the patients current hemoglobin in g/dl. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: 0000002986 00000 n Absorption Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). . The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. infed stability after reconstitutionkneecap tattoo healing. 0000035692 00000 n 5 If reconstituted vaccine is not used immediately or comes in a multidose vial, be sure to clearly mark the vial with the date and time the vaccine was reconstituted, maintain the product at 2-8C (36-46F); do not freeze, and use only within the time indicated on chart above.
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