0000002696 00000 n . The stability of injectable medications after reconstitution is presented. <<7815BA97DDE94C498B4A3154474182CA>]>> 0000011042 00000 n FOIA 0000006673 00000 n endstream endobj 57 0 obj<> endobj 58 0 obj<>stream 0000026943 00000 n (See Cautions.). . 0000009538 00000 n Br Med J (Clin Res Ed). If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). These half-life values do not represent clearance of iron from the body. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. 0000008022 00000 n xref Risk of developing potentially life-threatening anaphylactic reactions. endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream HHS Vulnerability Disclosure, Help 0000003708 00000 n 0000001396 00000 n Fatal reactions have been reported following the test dose of iron dextran injection. 0000009066 00000 n Dextran, a polyglucose, is either metabolized or excreted. The stability of injectable medications after reconstitution is presented. Similar effects were observed in mice and rats on administration of a single dose of 125 mg iron/kg. Oral and parenteral Iron Products - GlobalRPH Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to Infed. This site needs JavaScript to work properly. Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T 0000013948 00000 n DOSAGE AND ADMINISTRATION The maximum daily dose of Infed should not exceed 2 mL. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. This site complies with the HONcode standard for trust- worthy health information: verify here. 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). [s Therefore, administration of subsequent test doses during therapy should be considered. Such reactions may be immediate or delayed. 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. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. <> NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y 2.1 Important Pre-Treatment Information Calculate the Infed dose based upon Table 1 and formulas below. 1 INDICATIONS AND USAGE INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response . The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic Would you like email updates of new search results? 0000008504 00000 n stream 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 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)]. Excretion Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. 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). Known hypersensitivity to iron dextran or any ingredient in the formulation. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted. Anemia Associated with Chronic Renal Failure. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet, For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet. Risk Summary The half-life of free iron in the plasma circulation is approximately 5 hours. Package insert / product label Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Use the following formula to calculate required total iron dextran dosage in mL: 0.02 blood loss (in mL) hematocrit (expressed as a decimal fraction) = total dosage of iron dextran injection (mL). 1986 Jul-Aug;40(4):142-63. 88 0 obj<>stream Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Based on: Desired Hb = the target Hb in g/dl. Stability of injectable medications after reconstitution Federal government websites often end in .gov or .mil. 0000010567 00000 n PMC Would you like email updates of new search results? Although serum ferritin is usually a good guide to body iron stores, the correlation of body iron stores and serum ferritin may not be valid in patients on chronic renal dialysis who are also receiving iron dextran complex. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. The pH of the solution is between 4.5 to 7.0. 0000011536 00000 n 0000001071 00000 n Protect from light. e. Weight. The most common adverse reactions, including laboratory abnormalities, (20%) are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase,. 2021 Allergan. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. (See Iron, oral under Interactions.). V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. PDF HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPZELCA, periodically during The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Cancer Chemother Pharmacol. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. 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. To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss General Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. (See Sensitivity Testing under Dosage and Administration.) This revision is an update of: Latiolais CJ, Shoup LK and Thur MP: Stability of drugs after reconstitution, Am J Hosp Pharm 24:667-691 (Dec) 1967. . infed stability after reconstitutionkneecap tattoo healing. Ling J, Gupta VD. Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. 0000002294 00000 n (Normal Hb for Children 15 kg or less is 12 g/dl). Nervous system disorders: Convulsions, seizures, syncope, headache, unresponsiveness, paresthesia, dizziness, numbness, unconsciousness, altered taste. crobiological stability and recovery of the active drug after dilution or reconstitution should be evaluated during drug development to provide healthcare professionals with the necessary information about in-use stability. Sodium hydroxide and/or hydrochloric acid may have been used to adjust pH. 1984 Mar;19(3):202, 207, 211-3. Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. Infusion should then be stopped for 1 hour. . Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. <> The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. 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. 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. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Medical Communications If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. 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@> 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.
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