Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 We comply with the HONcode standard for trustworthy health information. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. National Library of Medicine 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. (See Special Populations under Pharmacokinetics.). The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Excess storage of iron and a syndrome similar to hemosiderosis possible when used for anemia not attributable to iron deficiency (e.g., those with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias). [Progress in drug technology in the years 1968 and 1969]. No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. xb```f``= @Q#3108-. The development and health benefits of breastfeeding should be considered along with the mothers clinical need for Infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition. and transmitted securely. Ferentino, Italy 03013, Distributed By: Iron Dextran Monograph for Professionals - Drugs.com The etiology of these reactions is not known. 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)]. The stability of Meropenemreconstituted in solution is influenced by the following factors: Storage temperature: The drug is stable for longer time in solutions stored at 4 to 5C than in solutions stored at 21 to 26C. (See PRECAUTIONS: General.) Following administration of Infed, circulating iron dextran is split by the cells of the reticuloendothelial system into its components of iron and dextran. The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. Infed: Package Insert / Prescribing Information - Drugs.com . 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. PLEASE READ THE. 0000013156 00000 n INFeD should not normally be given in the first four months of life. 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). 0000008504 00000 n INFeD (iron dextran injection), for intravenous or . Each monograph contains stability data, administration guidelines, and methods of preparation. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. Elimination Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. 12.2 Pharmacodynamics Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. 0000002275 00000 n 1989;23(4):197-207. doi: 10.1007/BF00451642. Epinephrine should be immediately available. *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH *Qp"Q!J Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. DOSAGE AND ADMINISTRATION 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. Therefore, administration of subsequent test doses during therapy should be considered. COMMENTARY Biological parenteral products ar - American Society of HHS Vulnerability Disclosure, Help government site. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. . d. Hemoglobin deficit HdTn0D HdTr0+(R^ 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). 1972;9:94-98. REFERENCES 0000027226 00000 n 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` Delayed Reactions For all medical inquiries contact: Your comment will be reviewed and published at the journal's discretion. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. LBW = Lean body weight in kg. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. $ 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. 0000004693 00000 n Before hO4,qv(8p]4SXs?_k^ '4["G!@` \ 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. For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Advise pregnant persons of the potential risk to the fetus. All Rights Reserved. 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 . infed stability after reconstitutionkneecap tattoo healing. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. the 6 time points after injection.15 A 94-subject rater-blinded randomized control study of EDP action potentials compared toxin used within 2 hours, 72 hours, 1, 2, 3, or 4 weeks after reconstitution; at 1 week after injection, the point of maximum effect, there was no difference in quantitative paralysis . 1985;14(2):83-95. doi: 10.1007/BF00434343. In vitro studies have shown that removal of iron dextran by dialysis is negligible. 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. . 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. 0000005691 00000 n For information on systemic interactions resulting from concomitant use, see Interactions. I. 0000011536 00000 n 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. <> A subsidiary of Watson Pharmaceuticals, Inc. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. Sv 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. official website and that any information you provide is encrypted Intravenous IV preparation and infusion guidelines - GlobalRPH Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. . PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan 1 0 obj Fetal/Neonatal Adverse Reactions 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; 1986;17(1):1-10. doi: 10.1007/BF00299858. Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. 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.