and transmitted securely. Risk of developing potentially life-threatening anaphylactic reactions. Known hypersensitivity to iron dextran or any ingredient in the formulation. 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. The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). PMC . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. 0000013156 00000 n Use with extreme caution in patients with serious impairment of hepatic function. endobj Int J Pharm Compd. Cardiac disorders: Cardiac arrest, tachycardia, bradycardia, arrhythmias. General considerations, the nitrosoureas and alkylating agents. Drug class: Iron Preparations V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= xref Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream Therefore, administration of subsequent test doses during therapy should be considered. Patients with Renal Impairment Fetal/Neonatal Adverse Reactions 0000002041 00000 n Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. 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. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Drug class: Iron products. Infed is a registered trademark of Allergan Sales, LLC. Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 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. DailyMed - INFED- iron dextran injection Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. Oxford University Press is a department of the University of Oxford. Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. 3 0 obj The test dose should be administered in the same recommended test site and by the same technique as described in the last paragraph of this section. During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. <> Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Bethesda, MD 20894, Web Policies '* xb```f``= @Q#3108-. This site needs JavaScript to work properly. The stability of injectable medications after reconstitution is presented. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. 0000004715 00000 n Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. [2:/T6*cz1"Jk&n#n[[TU . III. w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V Hypersensitivity Reactions Each days dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients. 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)]. 0000003091 00000 n 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? 0000027226 00000 n Careers. (See Iron, oral under Interactions.). 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. 88 0 obj<>stream Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Fatal reactions have also occurred in situations where the test dose was tolerated. 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]. HOW SUPPLIED PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan 0000011305 00000 n Assay methods, adriamycin and the other antitumour antibiotics. 4. 0000003913 00000 n No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. AHFS DI Essentials. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 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 . 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). Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. Data 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. 0000046285 00000 n This site needs JavaScript to work properly. Manifested as sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse; have resuscitation equipment and personnel trained in detection and treatment of anaphylactic-type reactions readily available during iron dextran administration. Disclaimer. 0000006734 00000 n . Therefore, administration of subsequent test doses during therapy should be considered. Generic name: iron dextran Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. 0000010567 00000 n Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. Increased Risk of Toxicity in Patients with Underlying Conditions Advise patients with pre-existing cardiovascular disease and rheumatoid arthritis that Infed administration may exacerbate symptoms and to contact their healthcare provider if any symptoms occur [see Warnings and Precautions (5.3)]. . government site. Administer only in a setting where resuscitation equipment and medications are available. % (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. 1989;23(4):197-207. doi: 10.1007/BF00451642. 0000011042 00000 n . The etiology of these reactions is not known. 0000035692 00000 n 5.2 Delayed Reactions 1 0 obj stream . *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH (See PRECAUTIONS: General.) Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 2001;5(1):75-7. Stability of aminophylline injection in three parenteral nutrient solutions. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. J Parenter Sci Technol. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Unable to load your collection due to an error, Unable to load your delegates due to an error. H|TMs6Wu*Q6i\l.` . 8.2 Lactation 0000008494 00000 n Brand and Other Names: INFeD, Dexferrum Classes: Iron Products Dosing & Uses AdultPediatric Dosage Forms & Strengths injectable solution 50mg (Fe)/mL Iron-deficiency Anemia 25-100 mg IV or deep. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. 0000007595 00000 n Am J Kid Dis. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. tran [6]. Four of the seven dilute solutions were stable after two months of storage. Protect from light. <> 0000010759 00000 n . Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). (See PRECAUTIONS: General.) Various studies involving intravenously administered 59Fe iron dextran to iron deficient subjects, some of whom had coexisting disease, have yielded half-life values ranging from 5 hours to more than 20 hours. Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Available for Android and iOS devices. . A.YGtT~Ud!$8 d|Ey[9l]^Z.d,{Ah>=1LfC6= Lc3I`hOf2!*sXk!dPz9.UZJe|6xsd_nMS]UYG4@GCj_'8m$7$U |_6%$yf . The total volume of Infed required for the treatment of iron replacement for blood loss is determined from an appropriate formula listed [see Dosage and Administration (2.3)]. MeSH 0000003224 00000 n Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron: Replacement iron (in mg) = Blood loss (in mL) x hematocrit, Example: Blood loss of 500 mL with 20% hematocrit. Clinical Considerations Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. FOIA All Rights Reserved. . 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. After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the bodys total iron stores. Following intramuscular injection, Infed is absorbed within 72 hours with any remaining iron absorbed over the ensuing 3 to 4 weeks. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. 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. Morristown, NJ 07962 USA. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. .0.34% This site complies with the HONcode standard for trust- worthy health information: verify here. Excretion Use with caution in patients with a history of clinically important allergies and/or asthma. 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. Thank you for submitting a comment on this article. The https:// ensures that you are connecting to the 0000024030 00000 n <> (See Boxed Warning.). 0000006695 00000 n J Pediatr Pharmacol Ther. It is not known if INFeD is safe and effective in children younger than 4 months of age. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. 0000002644 00000 n 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. 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). PDF Guidance for Addressing Shortages of Sterile Water for Injection and Distributed into breast milk, but only as trace amounts of unmetabolized iron dextran. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. 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. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. FOIA 0000002918 00000 n endobj 4 0 obj . Hatton RC, Portales IT, Finlay A, Ross EA. Please enable it to take advantage of the complete set of features! This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. 0000006673 00000 n Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. endstream endobj 55 0 obj<> endobj 56 0 obj<>stream The maximum daily dose of Infed should not exceed 2 mL. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. I. Would you like email updates of new search results? To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. 34 0 obj <> endobj 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. RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. 16.1 How Supplied It should not be used during the acute phase of infectious kidney disease. 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. 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. The site is secure. 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. 0000005669 00000 n sharing sensitive information, make sure youre on a federal The stability of injectable medications after reconstitution is presented. 0000007617 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. 0000001877 00000 n 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@> Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. 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. The 5 hour value was determined for 59Fe iron dextran from a study that used laboratory methods to separate the circulating 59Fe iron dextran from the transferrin bound 59Fe. Patheon Italia S.p.A. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. (See Cautions.). 1972;9:94-98. 0000009066 00000 n Written by ASHP. 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; 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. The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss. Metabolism [Progress in drug technology in the years 1968 and 1969]. . Question patients regarding any prior history of reactions to parenteral iron products. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. 0000014709 00000 n . 0000005917 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. 0000004693 00000 n Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Allergan USA, Inc.