The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. Administer the test dose at a gradual rate over at least 30 seconds. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. I. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. . Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. 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). The site is secure. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. If diluted, administer by IV infusion [off-label] over 16 hours. 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. For all medical inquiries contact: To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. 0000008504 00000 n LBW = Lean body weight in kg. 0000008737 00000 n 16.1 How Supplied Isoproterenol or similar beta-agonist agents may be required in these patients. 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. Note: Patients using beta-blocking agents may not respond adequately to epinephrine. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. Would you like email updates of new search results? 0000039715 00000 n Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. 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. Br Med J (Clin Res Ed). WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. All Rights Reserved. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. Medically reviewed by Drugs.com on Oct 25, 2022. Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. 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. rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! Medically reviewed by Drugs.com. (See Boxed Warning.). If there is no reaction after 1 hour continue. endobj 0000002019 00000 n INFeD may be used alone or with other medications. HHS Vulnerability Disclosure, Help Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. 16.2 Stability and Storage 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)]. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, Please check for further notifications by email. tran [6]. [Progress in drug technology in the years 1968 and 1969]. 0000005561 00000 n Increased Risk of Toxicity in Patients with Underlying Conditions endstream endobj 46 0 obj<>stream 0000030324 00000 n 0000011042 00000 n Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. Infed: Package Insert / Prescribing Information - Drugs.com Infed Dosage Guide - Drugs.com Advise patients that delayed reactions can occur and that these must be reported to their healthcare provider immediately [see Warnings and Precautions (5.2)]. 0000036781 00000 n Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. Fatal reactions have also occurred in situations where the test dose was tolerated. 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. Fetal/Neonatal Adverse Reactions . .12.0 g/dl, c. Iron content of hemoglobin . . 1989;23(4):197-207. doi: 10.1007/BF00451642. Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. Discontinue administration of any iron-containing products prior to administration of Infed. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. 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. 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. Int J Pharm Compd. Unable to load your collection due to an error, Unable to load your delegates due to an error. David McAuley, Pharm.D. Clipboard, Search History, and several other advanced features are temporarily unavailable. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. Question patients regarding any prior history of reactions to parenteral iron products. This site complies with the HONcode standard for trust- worthy health information: verify here. 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 Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test 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]. Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (14.8 g/dL Hbo)]+ (0.26 Wt) = total dosage of iron dextran injection (mL). (See Sensitivity Testing under Dosage and Administration.) .14.8 g/dl A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. 2. Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Based on: Desired Hb = the target Hb in g/dl. Administration Iron dextran is a Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. 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. Federal government websites often end in .gov or .mil. Absorption 7.1 Drug/Laboratory Test Interactions l Sm3G.E7=" r7/[^;q|= 0000040000 00000 n w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. TVFRk-ijJ>r$QK{\[8 `v,heF-ZQ4R70rj !sGE Iron storage parameters may improve prior to hematologic parameters. 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.]. 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 . and transmitted securely. 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. Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. % Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Observed Hb = the patients current hemoglobin in g/dl. Epinephrine should be immediately available. Fatal anaphylactic reactions are possible. endobj Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. Bookshelf 1-800-678-1605, Manufactured By: endobj It should be understood that these half-life values do not represent clearance of iron from the body. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK 0000005691 00000 n . 0000002803 00000 n Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. 5.1 Hypersensitivity Reactions 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)]. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Watson Pharma, Inc. 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. 0000003224 00000 n 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 . 0000004132 00000 n Before It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Gaithersburg, MD: Genzyme; August 2018. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. W = body weight in kg Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. Clinical Considerations Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* Alternatively, the total dose may be calculated using the formulas below: Adults and Children over 15 kg (33 lbs) Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW) Based on: 8600 Rockville Pike Infed is a registered trademark of Allergan Sales, LLC. 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. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. sharing sensitive information, make sure youre on a federal 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. Please enable it to take advantage of the complete set of features! INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. 4. 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. . . 0000010118 00000 n 0000002986 00000 n J Pediatr Pharmacol Ther. Calculate the Infed dose based upon Table 1 and formulas below. 0000005669 00000 n Postreconstitution Stability of Amoxicillin-Clavulanic Acid Suspensions Federal government websites often end in .gov or .mil. %PDF-1.3 % TRW3xs6's;W2YK8AAv4Qo~S ONW>dVN--sFhQe@ 0{7;;vmG+zW%Rmhh_}m?rjnY'0_i' C?U"-DA('[ . It should be recognized that iron storage may lag behind the appearance of normal blood morphology. 0000032198 00000 n Oral iron should be discontinued prior to administration of INFeD. 0000001071 00000 n ],kI#tp. 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. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Continue Infed until hemoglobin is within the normal range and iron stores are replete. SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. . 0000014709 00000 n NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y Do not exceed a total daily dose of 2 mL undiluted Infed. 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; Abstract. 8.4 Pediatric Use INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. Distributed into breast milk, but only as trace amounts of unmetabolized iron dextran. Discontinue oral iron therapy prior to initiation of iron dextran therapy. 34 55 . This site needs JavaScript to work properly. S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. 3. A subsidiary of Watson Pharmaceuticals, Inc. Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. 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. Figure 1. 0000009371 00000 n 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). Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. (See Cautions.). 1995; 26(2):327-330. Advise patients to consult their healthcare provider should they start to show symptoms of acute kidney infection as Infed should not be used [see Warnings and Precautions (5.3)].
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