The stability of injectable medications after reconstitution is presented. PDF Significance of Reconstitution Time and Other Physical Parameters for CAS number: 9004-66-4. 1989;23(4):197-207. doi: 10.1007/BF00451642. The product should be further diluted in a suitable diluent prior to infusion. Thank you for submitting a comment on this article. For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet 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. Metabolism Administer the test dose at a gradual rate over at least 30 seconds. N}F( 9N(i{:%NISD;%NIS*T1 0000002918 00000 n Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. 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. INFeD may be used alone or with other medications. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Sv The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. 5.1 Hypersensitivity Reactions rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. Total iron and free ferrous ion content of the preparations were measured for: (1) the dilute solutions at monthly intervals after up to three months of storage at room temperature and under refrigeration and (2) the parenteral nutrient solutions after 18 hours of storage at room temperature. PDF Vaccines with Diluents: How to Use Them - immunize.org PLEASE READ THE. Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. 8600 Rockville Pike . Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. Would you like email updates of new search results? A current package insert for the iron dextran product being used should always be reviewed, since these package inserts are periodically updated, and the product is currently made by more than one manufacturer. General disorders and administration site conditions: chest pain, chest tightness, weakness, malaise, febrile episodes, chills, shivering, sterile abscess, atrophy/fibrosis (intramuscular injection site), brown skin and/or underlying tissue discoloration (staining), soreness or pain at or near intramuscular injection sites, swelling, inflammation. The amount of vancomycin to treat an adult infection is superior to 1 g and so the volume administered can be higher than 100 mL. 0000046285 00000 n Before Bethesda, MD 20894, Web Policies Br Med J (Clin Res Ed). The site is secure. 12.1 Mechanism of Action Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: Take precautions to be prepared to treat potential allergic reactions. Risk of developing potentially life-threatening anaphylactic reactions. Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. 0000002986 00000 n Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. 0000035692 00000 n Watson Pharma, Inc. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK 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. 0000026747 00000 n [2:/T6*cz1"Jk&n#n[[TU Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. Each monograph contains stability data, administration guidelines, and methods of preparation. 8.4 Pediatric Use 88 0 obj<>stream . PDF INFeD See full prescribing information for complete boxed warning official website and that any information you provide is encrypted Your comment will be reviewed and published at the journal's discretion. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` 0000007316 00000 n 7.1 Drug/Laboratory Test Interactions *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH For full access to this pdf, sign in to an existing account, or purchase an annual subscription. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. Cancer Chemother Pharmacol. hO4,qv(8p]4SXs?_k^ '4["G!@` \ . I. J Pain Palliat Care Pharmacother. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias. 0000012898 00000 n Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. . 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: 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. No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. Severe adverse reactions including circulatory failure (severe hypotension, shock including in the context of anaphylactic reaction) may occur in pregnant persons with intravenous iron administration (such as Infed) which may have serious consequences on the fetus such as fetal bradycardia, especially during the second and third trimester. The need for chemical compatibility studies of subcutaneous medication combinations used in palliative care. Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. This site needs JavaScript to work properly. !m (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: Use with caution in patients with a history of clinically important allergies and/or asthma. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer Dilution Iron Dextran (imferon ) - GlobalRPH The half-life of free iron in the plasma circulation is approximately 5 hours. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. .14.8 g/dl 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. p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 Iron Overload Following administration of Infed, circulating iron dextran is split by the cells of the reticuloendothelial system into its components of iron and dextran. Infusion should then be stopped for 1 hour. It should not be used during the acute phase of infectious kidney disease. Please enable it to take advantage of the complete set of features! 6Ee^2+G8"c+TepPRb d_@ 0000002294 00000 n . 0000005917 00000 n LBW = Lean body weight in kg [A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage.] Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. . 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& 0000009066 00000 n Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. Specific Populations Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. Figure 1. endstream endobj 47 0 obj<>stream 0000012318 00000 n 0000010877 00000 n Data Clipboard, Search History, and several other advanced features are temporarily unavailable. Carcinogenesis KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 INFeD should not normally be given in the first four months of life. Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. Bullock L, Parks RB, Lampasona V, Mullins RE. 0000003686 00000 n Cancer Chemother Pharmacol. Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. 12.3 Pharmacokinetics 0000010567 00000 n INFeD belongs to a class of drugs called Iron Products. 0000026943 00000 n Blood volume . 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)]. Pregnancy Allergan PDF Storage and Reuse of Reconstituted Neuromodulators CAREFULLY BEFORE ACCESSING OR USING THIS SITE. 1984 Mar;19(3):202, 207, 211-3. endstream endobj 46 0 obj<>stream Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. (See Iron, oral under Interactions.). It should be understood that these half-life values do not represent clearance of iron from the body. Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. (5.1) [Progress in drug technology in the years 1968 and 1969]. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. Disclaimer. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. Administer only in a setting where resuscitation equipment and medications are available. 0000004098 00000 n Please check for further notifications by email. 1-800-678-1605, Manufactured By: Federal government websites often end in .gov or .mil. Brand names: Dexferrum, INFeD Dilute iron dextran formulation for addition to parenteral nutrient Continue Infed until hemoglobin is within the normal range and iron stores are replete. Observed Hb = the patients current hemoglobin in g/dl. (See DOSAGE AND ADMINISTRATION: Administration. 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. 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). Am J Kid Dis. Unauthorized use of these marks is strictly prohibited. 15 kg (33 lbs) or less . .65 mL/kg of body weight, b. 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. Allergan USA, Inc. DOSAGE FORMS AND STRENGTHS VIDAZA (azacitidine for injection) is supplied as lyophilized powder in 100 mg single-use vials. %PDF-1.3 % 16.1 How Supplied Oxford University Press is a department of the University of Oxford. Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). III. 0000015331 00000 n Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. In mice, rats, rabbits, and possibly hamsters, it has been demonstrated that these complexes may produce sarcoma following repeated administration of large or small doses of iron-carbohydrate complexes at a single injection site. (See PRECAUTIONS: General.) Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. Abstract. Excretion Madison, NJ 07940. Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. Infed (Iron Dextran): Uses, Dosage, Side Effects, Interactions - RxList 0000005019 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; INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. 0000002041 00000 n Available as iron dextran; dosage expressed in terms of elemental iron. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Dextran, a polyglucose, is either metabolized or excreted. 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. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. 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. General considerations, the nitrosoureas and alkylating agents. Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. The factors that affect the risk for anaphylactic-type reactions to iron dextran products are not fully known but limited clinical data suggest the risk may be increased among patients with a history of drug allergy or multiple drug allergies. . Patheon Italia S.p.A. Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. Indian J Anaesth. 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. <> 0000009983 00000 n PMC . Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. trailer << /Size 254 /Info 216 0 R /Root 219 0 R /Prev 331519 /ID[<618a70ff49b482af49be42cc5de1ac5d><4f4e9802b6496a1513efa6cfdffb7212>] >> startxref 0 %%EOF 219 0 obj << /Type /Catalog /Pages 213 0 R /Metadata 217 0 R /PageLabels 211 0 R >> endobj 252 0 obj << /S 769 /T 901 /L 982 /Filter /FlateDecode /Length 253 0 R >> stream Iron Dextran Monograph for Professionals - Drugs.com 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 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. In vitro studies have shown that removal of iron dextran by dialysis is negligible. DailyMed - INFED- iron dextran injection (Normal Hb for Children 15 kg or less is 12 g/dl). . 06\ zp#2j)kS \(nd+?5R Iron storage parameters may improve prior to hematologic parameters. 0000002072 00000 n Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy, Parenteral iron treatment should be administered only when, Milliliter Requirement of INFeD Based On Observed. 0000003708 00000 n HdTr0+(R^ FOIA The site is secure. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. A subsidiary of Watson Pharmaceuticals, Inc. . Four of the seven dilute solutions were stable after two months of storage. We comply with the HONcode standard for trustworthy health information. 8.2 Lactation 8600 Rockville Pike National Library of Medicine 0000046691 00000 n The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility ], Observed Hb = the patients current hemoglobin in g/dL. Risk Summary 0000003396 00000 n Nephron. DOSAGE AND ADMINISTRATION National Library of Medicine 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. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Ling J, Gupta VD. After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count. Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Medical Communications Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Based on: Desired Hb = the target Hb in g/dl. Risk Summary 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. Dosage form: injection 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. INFeD, Dexferrum (iron dextran complex) dosing, indications - Medscape Bonnie E. Kirschenbaum, M.S., Clifton J. Latiolais, Sc.D., Stability of injectable medications after reconstitution, American Journal of Hospital Pharmacy, Volume 33, Issue 8, 1 August 1976, Pages 767791, https://doi.org/10.1093/ajhp/33.8.767. 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. 0000013156 00000 n The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. Cancer Chemother Pharmacol. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. Do Not Copy, Distribute or otherwise Disseminate without express permission. 0000000016 00000 n Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. 0000037133 00000 n Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. PDF Guidance for Addressing Shortages of Sterile Water for Injection and Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. 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). Careers. PubMed PMID: 23981803. Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. S39(,``sS*|JmdcA#C-"J1GSNqH4r~INF!F!39$*Lcc$,4 (x((C!GvFL|N@2 xY@C`&6[lLf9YODqV,&$tbz*OJ%]. LBW = Lean body weight in kg. Delayed Reactions 1972;9:94-98. 0000004132 00000 n MeSH The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. CONTRAINDICATIONS 1986;17(1):1-10. doi: 10.1007/BF00299858. Advise pregnant persons of the potential risk to the fetus. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. Accessibility Clipboard, Search History, and several other advanced features are temporarily unavailable. 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.]. Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. Fetal/Neonatal Adverse Reactions 4GWVI~p`1x_7G|_Wz/ev5%b[~?w>ZG/*p%\/??w~=+ |O?~po>u|.@uM=Nvm_~~>\.%>?_mk+mp_{"ly"Y{JlqgIl#Y!Y@osLu]Mt=xx? Azacitidine - Vidaza - GlobalRPH 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. *Table values were calculated based on a normal adult hemoglobin of 14.8 g/dl for weights greater than 15 kg (33 lbs) and a hemoglobin of 12.0 g/dl for weights less than or equal to 15 kg (33 lbs). Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. 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. 0000009088 00000 n over 15 kg (33 lbs) . It is not known if INFeD is safe and effective in children younger than 4 months of age. Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. Stability of injectable medications after reconstitution
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