infed stability after reconstitution

Dosage x&q}2(33",Y &HS4) IE][5MA0A8eT?g_>^J37_/>O?'_koJ?DE>k/~fhFh-hiQv?}{spq8[vwVZinj4i ~q;+~F[f*]WR_Lk.U}2W%hv`kO?n7gC8V.WR'GB}Y2&?|l=FLf5Q*>nm{rDY_cVk|#sZa_&_~N#vjAjqe_5x?n'j_|WlYU2RW[KK/$ All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). official website and that any information you provide is encrypted 0000046285 00000 n Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. . Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. 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. 12.2 Pharmacodynamics Copyright 2023, Selected Revisions November 4, 2013. N}F( 9N(i{:%NISD;%NIS*T1 If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. A subsidiary of Watson Pharmaceuticals, Inc. Before Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. 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. PLEASE READ THE. 0000010567 00000 n 0000003396 00000 n 0000003686 00000 n The product should be further diluted in a suitable diluent prior to infusion. endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream Abstract. Absorption Large doses of iron dextran (5 mL or more) have been reported to give a brown color to serum from a blood sample drawn 4 hours after administration. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. 5.4 Iron Overload Available as iron dextran; dosage expressed in terms of elemental iron. 0000003091 00000 n Copyright 1993-2021 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. Available for Android and iOS devices. .14.8 g/dl 0000008504 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. and transmitted securely. LBW = Lean body weight in kg. (Normal Hb for Children 15 kg or less is 12 g/dl). WARNING: RISK FOR ANAPHYLACTIC-TYPE REACTIONS 0000026943 00000 n 0000031965 00000 n 0000002696 00000 n Stability of aminophylline injection in three parenteral nutrient solutions. 0000008022 00000 n INFeD should not normally be given in the first four months of life. 0000002644 00000 n 1-800-678-1605, Manufactured By: Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. I. The https:// ensures that you are connecting to the 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. 0000035990 00000 n 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. . 0000010877 00000 n A test dose of 25 mg infused over 5 minutes should be given. 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. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. The stability of injectable medications after reconstitution is presented. Infed is a registered trademark of Allergan Sales, LLC. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. Anemia Associated with Chronic Renal Failure. Federal government websites often end in .gov or .mil. HR0~ The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). National Library of Medicine Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 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. %%EOF 2021 Allergan. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. 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. ],kI#tp. 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. Should be administered by qualified individuals with ready access to resuscitation equipment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction (e.g., epinephrine, or isoproterenol in patients receiving -adrenergic blocking agents). w:Z7LWT0 CIu:rz9;y| Nd'T 4'" \py?_%XySt[]O!8cf}Uhi6yf^r={qK"P-CspB_z%k6cCJbDKmE![V The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , %PDF-1.3 % Each monograph contains stability data, administration guidelines, and methods of preparation. 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. 0000001396 00000 n Br Med J (Clin Res Ed). 0000002275 00000 n 2 0 obj 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)]. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. 0000009983 00000 n Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. 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. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. The half-life of total iron, including both circulating and bound, is approximately 20 hours. hO4,qv(8p]4SXs?_k^ '4["G!@` \ startxref Continue Infed until hemoglobin is within the normal range and iron stores are replete. The maximum daily dose of Infed should not exceed 2 mL. 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. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. xref a. 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. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. The .gov means its official. TRW3xs6's;W2YK8AAv4Qo~S ONW>dVN--sFhQe@ 0{7;;vmG+zW%Rmhh_}m?rjnY'0_i' C?U"-DA('[ 16.1 How Supplied H|TMs6Wu*Q6i\l.` Available for Android and iOS devices. For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet 4. Do not freeze. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. Corrections in compilation of information on stability of injectable medications after reconstitution. Fatal reactions have also occurred in situations where the test dose was tolerated. 1995; 26(2):327-330. 0000035692 00000 n 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. 8.1 Pregnancy Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 1984 Mar;19(3):202, 207, 211-3. If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. Advise the patient to consult a healthcare provider before taking any other iron containing products as this may cause serious side effects [see Warnings and Precautions (5.4)]. . May increase risk for anaphylaxis with concomitant use, Bone scans using imaging agents labeled with technetium Tc 99m (diphosphonate), Dense, crescentic areas of activity along the contour of the iliac crest, visualized 16 days after IM administration of iron dextran, Possible reduced bone uptake, marked renal activity, and excessive blood pool and soft tissue accumulation, Therapeutic duplication; increased risk for iron toxicity, Serum iron determinations (especially colorimetric assays) may not be meaningful for 3 weeks following the administration of iron dextran, Serum ferritin concentrations peak approximately 79 days following an IV iron dextran dose and slowly return to baseline over a period of about 3 weeks, Bone marrow examination for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells, May cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium, Prolonged partial thromboplastin time following IV administration of iron dextran when the blood sample for the test is mixed with anticoagulant citrate dextrose solution but not sodium citrate solution, Blood typing and cross-matching unaffected. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: 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). 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). 0000001797 00000 n The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. endstream endobj 35 0 obj<> endobj 36 0 obj<> endobj 37 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 38 0 obj<> endobj 39 0 obj<> endobj 40 0 obj<> endobj 41 0 obj<> endobj 42 0 obj<> endobj 43 0 obj[/ICCBased 66 0 R] endobj 44 0 obj<> endobj 45 0 obj<>stream If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. Bethesda, MD 20894, Web Policies MeSH The stability of injectable medications after reconstitution is presented. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss . 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. . Factors contributing to the formula are shown below. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. 34 0 obj <> endobj . . 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: J Pain Palliat Care Pharmacother. Written by ASHP. DOSAGE AND ADMINISTRATION Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. 5.1 Hypersensitivity Reactions Cancer Chemother Pharmacol. 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. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. For all medical inquiries contact: 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)]. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. government site. 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. 2.1 Important Pre-Treatment Information III. Would you like email updates of new search results? 0000030324 00000 n Before ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. 2. Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. Administer only in a setting where resuscitation equipment and medications are available. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. Advise pregnant persons of the potential risk to the fetus. The etiology of these reactions is not known. . [Progress in drug technology in the years 1968 and 1969]. For information on systemic interactions resulting from concomitant use, see Interactions. 0000013156 00000 n Nephron. endobj . I. Figure 1. Niemiec PW Jr, Vanderveen TW, Hohenwarter MW, Gadsden RH Sr. Bullock L, Fitzgerald JF, Glick MR, Parks RB, Schnabel JG, Hancock BG. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. Curr Opin Clin Nutr Metab Care. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. 8.4 Pediatric Use Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. JLdddd0]`kig?yLm[}6:|Mm-g;b%&?,X,|&Y_}:|!'l%B%e]oJ\}v8l="[;`_#3B]v4ysnp6p3oQd+j_07(+g_Co;haE+1bk+|e>inBko686Jf?2o_>qfETmP@5(C7b$;HvqW!Vb(FNz& NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. The easiest-to-prepare dilute solution (iron dextran, benzyl alcohol, and sterile water for injection) was stable for three months; stability was greater when refrigerated. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Animal Data CONTRAINDICATIONS 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. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays.

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