. Stability of injectable medications after reconstitution 3. 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)]. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. MeSH . Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. . 0000036781 00000 n 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. Gastrointestinal disorders: Abdominal pain, nausea, vomiting, diarrhea. FOIA 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. (See package insert for PRECAUTIONS: Pediatric Use), Alternatively the total dose may be calculated: 0000003686 00000 n Unauthorized use of these marks is strictly prohibited. p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 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. Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. 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. 5.1 Hypersensitivity Reactions Serum ferritin peaks approximately 7 to 9 days after an intravenous dose of Infed and returns to baseline after about 3 weeks. %%EOF Iron Overload 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 (IRON DEXTRAN COMPLEX) INJECTION SDS EFFECTIVE DATE: SEPTEMBER 24, 2018 PAGE 1 OF 8 SAFETY DATA SHEET Prepared to U.S. OSHA, CMA, ANSI, Canadian WHMIS Standards, European Union CLP EC 1272/2008 and the Global Harmonization Standard 1. official website and that any information you provide is encrypted NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. Therefore, administration of subsequent test doses during therapy should be considered. Clipboard, Search History, and several other advanced features are temporarily unavailable. 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. REFERENCES 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. 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. If diluted, administer by IV infusion [off-label] over 16 hours. 1985;14(2):83-95. doi: 10.1007/BF00434343. . HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 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). 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 . startxref 2025C; excursions permitted to 1530C. endobj Before Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. 16.2 Stability and Storage . Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? . 0000013156 00000 n 1995; 26(2):327-330. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. Such reactions may be immediate or delayed. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. 0000047340 00000 n endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream 0 HR0~ 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). We comply with the HONcode standard for trustworthy health information. Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. 5.3 Increased Risk of Toxicity in Patients with Underlying Conditions 0000026302 00000 n If there is no reaction after 1 hour continue. Parenteral iron dextran therapy: a review. 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. 12.1 Mechanism of Action This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. 0000005019 00000 n 0000030666 00000 n Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. "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 MeSH Infusion should then be stopped for 1 hour. This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. Disease-Associated Maternal and/or Embryo/Fetal Risk . The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. PDF Guidance for Addressing Shortages of Sterile Water for Injection and Figure 1. Evaluation of the stability of vancomycin solutions at concentrations 8.4 Pediatric Use Each monograph contains stability data, administration guidelines, and methods of preparation. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The maximum daily dose of INFeD should not exceed 2 mL. 218 0 obj << /Linearized 1 /O 220 /H [ 1168 873 ] /L 336009 /E 11783 /N 28 /T 331530 >> endobj xref 218 36 0000000016 00000 n Am J Kid Dis. 0000026747 00000 n 8.1 Pregnancy 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). 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. Hypersensitivity Reactions P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU 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. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. 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. Advise pregnant persons of the potential risk to the fetus. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Anemia Associated with Chronic Renal Failure. 0000035692 00000 n PMC Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. . Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. sharing sensitive information, make sure youre on a federal 0000006673 00000 n Postreconstitution Stability of Amoxicillin-Clavulanic Acid Suspensions Dilute iron dextran formulation for addition to parenteral nutrient Do not exceed a total daily dose of 2 mL undiluted Infed. Fatal reactions have been reported following the test dose of iron dextran and have also occurred in situations where the test dose was tolerated. 12.3 Pharmacokinetics %PDF-1.3 % F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' PDF Evaluation of the stability of vancomycin solutions at concentrations Package insert / product label endobj Please check for further notifications by email. Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ Unable to load your collection due to an error, Unable to load your delegates due to an error. Infed: Package Insert / Prescribing Information - Drugs.com (See Anaphylaxis under Cautions.) Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F). Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. The etiology of these reactions is not known. This site needs JavaScript to work properly. Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. Pregnancy Recommended formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL) for calculating total dosage of iron dextran injection (in mL): Use the following formula to calculate required total dosage of iron dextran injection (in mL): Infants weighing <5 kg (11 lbs): Maximum daily dosage is 25 mg of iron. [s Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. Ling J, Gupta VD. This site needs JavaScript to work properly. Corrections in compilation of information on stability of injectable medications after reconstitution. . I. Monitor response to therapy by evaluating hematologic parameters (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin). CONTRAINDICATIONS The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. 0000004715 00000 n PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan It is not known if INFeD is safe and effective in children younger than 4 months of age. Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. . official website and that any information you provide is encrypted Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. 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. Medically reviewed by Drugs.com. National Library of Medicine 0000010759 00000 n Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. 0000008494 00000 n Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. d. Hemoglobin deficit Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. 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. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. 12.2 Pharmacodynamics Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Assess baseline hematologic (hemoglobin and hematocrit) and iron storage parameters (serum iron, total iron binding capacity, and percent saturation of transferrin) to monitor response to therapy. Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. An official website of the United States government. Increases in hemoglobin are first noted after 1 week of iron sucrose administration [7]. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). H|TMs6Wu*Q6i\l.` Possible increased pathogenicity of certain microorganisms; not recommended for use during the acute phase of infectious renal disease. . Cancer Chemother Pharmacol. Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. N}F( 9N(i{:%NISD;%NIS*T1 Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. Risk of developing potentially life-threatening anaphylactic reactions. 0000003347 00000 n Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. Fatal reactions have also occurred in situations where the test dose was tolerated. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Take precautions to be prepared to treat potential allergic reactions. 3. Factors contributing to the formula are shown below. 0000007316 00000 n Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic ], Observed Hb = the patients current hemoglobin in g/dL. 8.2 Lactation 0000010005 00000 n HOW SUPPLIED 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. Advise patients with history of significant allergies and/or asthma to inform their healthcare provider as the risk of hypersensitivity reactions may be increased [see Warnings and Precautions (5.3)]. 0000009088 00000 n PDF 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE - Allergan Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. 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]. Careers. Question patients regarding any prior history of reactions to parenteral iron products. 0000046285 00000 n The pH of the solution is between 4.5 to 7.0. 0000002072 00000 n z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE . The animals used in these tests were not iron deficient. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. 0000032198 00000 n 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. SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. 0000013099 00000 n Fatal anaphylactic reactions are possible. ferrous sulfate, Venofer, Aranesp, epoetin alfa, Injectafer. 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.

Crumbl Cookies Locations In Mississippi, Dirty Farsi Phrases, Alaska Native Kuspuk, Property Plus Houses For Sale In Tonyrefail, Antique Standing Victrola Record Player, Articles I