Bookshelf 0000027226 00000 n Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. 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; Observed Hb = the patients current hemoglobin in g/dl. MeSH Sv After reticuloendothelial cells separate iron from the iron dextran complex, iron becomes a part of the bodys total iron stores. Careers. Your comment will be reviewed and published at the journal's discretion. Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. LBW = Lean body weight in kg. trailer In vitro studies have shown that removal of iron dextran by dialysis is negligible. 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). SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. The stability of injectable medications after reconstitution is presented. . Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. Dosage form: injection Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. 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. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. Administer test dose prior to first therapeutic dose. W = body weight in kg Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. (See Anaphylaxis under Cautions.) 2 DOSAGE AND ADMINISTRATION Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. [s 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. Federal government websites often end in .gov or .mil. tran [6]. endstream endobj 47 0 obj<>stream Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. 12.3 Pharmacokinetics 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. 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. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. 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. 0 David McAuley, Pharm.D. %PDF-1.4 % Drug class: Iron products. e. Weight. 7.1 Drug/Laboratory Test Interactions 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. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. 3. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. 1 0 obj 0000026943 00000 n 0000010567 00000 n HHS Vulnerability Disclosure, Help For solution and drug compatibility information, see Compatibility under Stability. 0000008494 00000 n In patients with CKD receiving an ESA, administer sufficient iron to maintain selected targets of iron therapy (i.e., transferrin saturation and serum ferritin concentrations); periodically monitor these iron indices and use results (in conjunction with hemoglobin concentrations and ESA dosage) to guide iron therapy. HOW SUPPLIED m$K~*&S)j5-Df"F d (8-s)h#=xF9+47{%CDQ$EMDH7x$k"$>~ynvloopxfG? . 5. Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. General considerations, the nitrosoureas and alkylating agents. p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 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. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. 0000010855 00000 n stream "3#$-Irc8x=B_}>_W@HqAP!I`H9+.@F.ix;i1E]"EOQ4E7M9$PB em$ Ie2} %+}hIIU}E+rS_OENx(tF_)@nRAtZn#JHg221^m+U|"vy ]yakuU 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. Available for Android and iOS devices. 0000005019 00000 n . Copyright 2023, Selected Revisions November 4, 2013. 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)]. Use with caution in patients with a history of clinically important allergies and/or asthma. Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. Metabolism Advise pregnant persons of the potential risk to the fetus. 2.Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream 0000037133 00000 n Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. Infed (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. 0000003708 00000 n Fatal reactions have occurred following test dose and also in patients in whom test dose was tolerated. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Please enable it to take advantage of the complete set of features! 0000007316 00000 n 8600 Rockville Pike Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. Epinephrine should be immediately available. Bethesda, MD 20894, Web Policies Fatal anaphylactic reactions are possible. Please check for further notifications by email. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. It should not be used during the acute phase of infectious kidney disease. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. Stability of aminophylline injection in three parenteral nutrient solutions. II. ], Observed Hb = the patients current hemoglobin in g/dL. (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! 0000005561 00000 n 0000006734 00000 n These half-life values do not represent clearance of iron from the body. 0000031965 00000 n Unable to load your collection due to an error, Unable to load your delegates due to an error. The stability of injectable medications after reconstitution is presented. Serum ferritin may not be an accurate measure of body iron stores in patients on chronic dialysis. INFeD should not normally be given in the first four months of life. . 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. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss Four of the seven dilute solutions were stable after two months of storage. 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 . 0000001396 00000 n Alternatively, the total dose may be calculated using the formulas below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin (males and females) for body weight over 15 kg (33 lbs) is 14.8 g/dL. Trace amounts of unmetabolized iron dextran are present in human milk. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. 2025C; excursions permitted to 1530C. The pH of the solution is between 4.5 to 7.0. Allergan USA, Inc. DOSAGE AND ADMINISTRATION All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. Anemias not associated with iron deficiency. (See Special Populations under Pharmacokinetics.). 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` David McAuley, Pharm.D. z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Fetal/Neonatal Adverse Reactions Examination of the bone marrow for iron stores may not be meaningful for prolonged periods following iron dextran therapy because residual iron dextran may remain in the reticuloendothelial cells. . Use with extreme caution in patients with serious impairment of hepatic function. There have been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes. 0000035692 00000 n 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)]. 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. 0000002918 00000 n Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. 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)]. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. 4. 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. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. 0000006673 00000 n Last updated on Dec 1, 2022. Such reactions have been generally characterized by sudden onset of respiratory difficulty and/or cardiovascular collapse. INFeD belongs to a class of drugs called Iron Products. It should be understood that these half-life values do not represent clearance of iron from the body. The Summary of Product Characteristics (SmPC) recommends reconstituting a 1 g vial with 20 mL of water for injection (WFI), then diluting it in 100 mL of saline solution. Cancer Chemother Pharmacol. 0000008617 00000 n The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. INFeD (iron dextran injection), for intravenous or . 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. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). Pregnancy In doses 500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours. Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes, or sooner, it is recommended that a period of an hour or longer elapse before the remainder of the initial therapeutic dose is given. Delayed Reactions Distributed into breast milk, but only as trace amounts of unmetabolized iron dextran. Administer only in a setting where resuscitation equipment and medications are available. 12.2 Pharmacodynamics . 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility CAREFULLY BEFORE ACCESSING OR USING THIS SITE. Parenteral iron dextran therapy: a review. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. Iron Overload Dosage Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Unable to load your collection due to an error, Unable to load your delegates due to an error. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). endobj If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. The maximum daily dose of INFeD should not exceed 2 mL. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? !m 0000002909 00000 n Br Med J (Clin Res Ed). The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. 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 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. 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. . 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. Do Not Copy, Distribute or otherwise Disseminate without express permission. Disclaimer. 1986 Jul-Aug;40(4):142-63. xref INFeD (Iron Dextran Injection USP) containing 50 mg of elemental iron per mL, is available in 2 mL single dose amber vials (for intramuscular or intravenous use) in cartons of 10 (NDC 52544-931-02). Before Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. Animal Data Would you like email updates of new search results? sharing sensitive information, make sure youre on a federal Accessibility Clinical Considerations This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ Each mL contains the equivalent of 50 mg of elemental iron (as an iron dextran complex), approximately 0.9% sodium chloride, in water for injection. The site is secure. Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. Do not administer Infed to patients with evidence of iron overload. [See USP Controlled Room Temperature]. The half-life of total iron, including both circulating and bound, is approximately 20 hours. 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. 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. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. Stability and compatibility of histamine H2-receptor antagonists in parenteral nutrition mixtures. Anemia Associated with Chronic Renal Failure. HR0~ The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. I. 0000026302 00000 n For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. 2021 Allergan. 2001;5(1):75-7. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. Therefore, administration of subsequent test doses during therapy should be considered. 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. 0000013156 00000 n Patients with Renal Impairment This site needs JavaScript to work properly. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. Initial U.S. Approval: 1974 The animals used in these tests were not iron deficient. <> Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. Do not exceed a total daily dose of 2 mL undiluted Infed. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. 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. Infed is a registered trademark of Allergan Sales, LLC. . official website and that any information you provide is encrypted %%EOF Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. 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. CAS number: 9004-66-4. I1US99`^cc-G:>xzV5.tD8,D\>z;qxQ)bHV\c`BWNG ni*#gU4yv{J)!VMs12EJR4>43giIU?H(MlJW52 &&RBd2i%d)jUWfk$oQs=@a+~cl 0000003396 00000 n Administration Niemiec PW Jr, Vanderveen TW, Hohenwarter MW, Gadsden RH Sr. Bullock L, Fitzgerald JF, Glick MR, Parks RB, Schnabel JG, Hancock BG. 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. official website and that any information you provide is encrypted 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]. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. 4 0 obj Administer a test Infed dose prior to the first therapeutic dose. H|TMs6Wu*Q6i\l.` 1985;14(2):83-95. doi: 10.1007/BF00434343. Drug class: Iron Preparations 0000009538 00000 n 2. <> It is not known if INFeD is safe and effective in children younger than 4 months of age. N}F( 9N(i{:%NISD;%NIS*T1 Abstract. 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. CONTRAINDICATIONS Importance of informing patients of other important precautionary information. 0000004132 00000 n Medical Communications 0000014709 00000 n (5.3). 0000002986 00000 n REFERENCES There are two preparations of IV iron available; IV iron sucrose (Venofer) given as divided dosages, and low molecular weight iron dextran (CosmoFer) this can be given as divided dose or as a total dose infusion (CosmoFer may also be given intramuscularly). If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. 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? To avoid injection or leakage into subcutaneous tissue, use Z-track injection technique (i.e., firmly push aside subcutaneous tissue over the site of injection before inserting the needle). Fatal reactions have also occurred in situations where the test dose was tolerated. Calculate the Infed dose based upon Table 1 and formulas below. Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Iron Deficiency Anemia: Periodic hematologic determination (hemoglobin and hematocrit) is a simple and accurate technique for monitoring hematological response, and should be used as a guide in therapy. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. Hypersensitivity Reactions Risk Summary Prior to the first intravenous Infed therapeutic dose, administer an intravenous test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Patheon Italia S.p.A. . . 5.1 Hypersensitivity Reactions Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. Cancer Chemother Pharmacol. 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. Each monograph contains stability data, administration guidelines, and methods of preparation. The stability of injectable medications after reconstitution is presented. %PDF-1.3 What are the possible side effects of INFeD? 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$;HvqW!Vb(FNz& The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Allergan Oral iron should be discontinued prior to administration of INFeD. PMC 0000003091 00000 n Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. 0000004233 00000 n Ferentino, Italy 03013, Distributed By: HHS Vulnerability Disclosure, Help 0000002019 00000 n endobj Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. Increased Risk of Toxicity in Patients with Underlying Conditions Crosses the placenta and small amounts of iron apparently reach the fetus. Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site. 2.2 Recommended Dosage for Iron Deficiency Anemia Administer test dose by intended route of administration for therapeutic doses prior to initial therapeutic dose. If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. The https:// ensures that you are connecting to the 3. 5.4 Iron Overload Carcinogenesis Curr Opin Clin Nutr Metab Care. 0000040000 00000 n 2.4 Administration Risk of developing potentially life-threatening anaphylactic reactions. HlTM6(R;!$+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@> Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. During all Infed administrations, observe for signs or symptoms of anaphylactic-type reactions. The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. 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.]. (See Sensitivity Testing under Dosage and Administration.) 8600 Rockville Pike 1995; 26(2):327-330. An official website of the United States government. Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. . Disease-Associated Maternal and/or Embryo/Fetal Risk

Macbeth Act 1 Scene 7 Internal Conflict, Pendo Documentation, Rebranding Announcement Email Examples, Teamsters Local 399 Scholarship, Avengers: Endgame Writers Salary, Articles I