Oral iron should be discontinued prior to administration of INFeD. 16.1 How Supplied To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. . III. 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. 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. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. INFeD (iron dextran injection), for intravenous or . . Use with extreme caution in patients with serious impairment of hepatic function. 0000007617 00000 n Am J Kid Dis. If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. (5.1) 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. Four of the seven dilute solutions were stable after two months of storage. Bullock L, Parks RB, Lampasona V, Mullins RE. Therefore, administration of subsequent test doses during therapy should be considered. 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). The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. 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. 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. 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. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. INFeD should be used with caution in individuals with histories of significant 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. "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D Increased Risk of Toxicity in Patients with Underlying Conditions . s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{ wQ&vYAv6bUd`l!k3X*4V. infed stability after reconstitutionkneecap tattoo healing. NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y 8600 Rockville Pike Crosses the placenta and small amounts of iron apparently reach the fetus. Drug class: Iron Preparations Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. Dilute iron dextran formulation for addition to parenteral nutrient The https:// ensures that you are connecting to the 5. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Unable to load your collection due to an error, Unable to load your delegates due to an error. Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. Clipboard, Search History, and several other advanced features are temporarily unavailable. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. 0000000016 00000 n An official website of the United States government. 0000024030 00000 n 0000009371 00000 n 0000006734 00000 n Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Copyright 2021 GlobalRPH - Web Development by, IV Dilutions Medication Reference and Infusion Guidelines, Renal dosing for healthcare professionals, HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy. Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ a. Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. 0000006673 00000 n It is not known if INFeD is safe and effective in children younger than 4 months of age. Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. 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. 0000002918 00000 n Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. . 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. 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. Your comment will be reviewed and published at the journal's discretion. (See Boxed Warning.) . PDF HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPZELCA, periodically during For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet Do Not Copy, Distribute or otherwise Disseminate without express permission. 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. I. 0000010567 00000 n 0000005019 00000 n 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. Administer only in a setting where resuscitation equipment and medications are available. 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? Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. 0000036574 00000 n 7.1 Drug/Laboratory Test Interactions 0000035990 00000 n Infusion should then be stopped for 1 hour. 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)]. 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). . 5.2 Delayed Reactions 0000037133 00000 n Each monograph contains stability data, administration guidelines, and methods of preparation. 0000030666 00000 n Federal government websites often end in .gov or .mil. Bookshelf 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). 2 DOSAGE AND ADMINISTRATION Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Stability of aminophylline injection in three parenteral nutrient solutions. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 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. Isoproterenol or similar beta-agonist agents may be required in these patients. 0000002696 00000 n Hypersensitivity Reactions [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK 2. The pH of the solution is between 4.5 to 7.0. Before Based on: Desired Hb = the target Hb in g/dl. . Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. Available for Android and iOS devices. Data David McAuley, Pharm.D. Would you like email updates of new search results? (See Anaphylaxis under Cautions.) Careers. 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 Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. 0000002644 00000 n Generic name: iron dextran Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. PDF 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE - Allergan PDF Vaccines with Diluents: How to Use Them - immunize.org 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. Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. Protect from light. p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 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. 2025C; excursions permitted to 1530C. Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. 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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. <> Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. Patheon Italia S.p.A. The etiology of these reactions is not known. . Do not exceed a total daily dose of 2 mL undiluted Infed. A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. 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. Trace amounts of unmetabolized iron dextran are present in human milk. . . Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. Advise patients that delayed reactions can occur and that these must be reported to their healthcare provider immediately [see Warnings and Precautions (5.2)]. Before Available as iron dextran; dosage expressed in terms of elemental iron. 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. (See PRECAUTIONS: General.) For information on systemic interactions resulting from concomitant use, see Interactions. Copyright 2023, Selected Revisions November 4, 2013. endobj Hb```f`` l,/`"`FOB/r7}UL 0000010118 00000 n Specific Populations 2.2 Recommended Dosage for Iron Deficiency Anemia During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. INFeD should not normally be given in the first four months of life. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V 4 0 obj Infed (iron dextran injection), for intravenous or intramuscular use To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss N}F( 9N(i{:%NISD;%NIS*T1 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.]. J Parenter Sci Technol. 0000013948 00000 n Women's Bond NFT Collection Dilution Iron Dextran (imferon ) - GlobalRPH COMMENTARY Biological parenteral products ar - American Society of 1972;9:94-98. 1984 Mar;19(3):202, 207, 211-3. 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. PDF Evaluation of the stability of vancomycin solutions at concentrations HdTr0+(R^ <> % 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. Morristown, NJ 07962 USA. 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. 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. Unable to load your collection due to an error, Unable to load your delegates due to an error. 0000009066 00000 n Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. Unauthorized use of these marks is strictly prohibited. 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 . Brand names: Dexferrum, INFeD Accessibility Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. 8.1 Pregnancy 4. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. 0000005917 00000 n For full access to this pdf, sign in to an existing account, or purchase an annual subscription. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. Take precautions to be prepared to treat potential allergic reactions. PMC 06\ zp#2j)kS \(nd+?5R . 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 [See USP Controlled Room Temperature]. . startxref 0000006695 00000 n 0000002294 00000 n a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) Excretion The stability of injectable medications after reconstitution is presented. [2:/T6*cz1"Jk&n#n[[TU Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates.

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