infed stability after reconstitution

The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic *`CRM-uxbpRvIfKHrt/E(#|oU,NRSiH INFeD belongs to a class of drugs called Iron Products. <<7815BA97DDE94C498B4A3154474182CA>]>> Allergan This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Specific Populations @['/=yWb7m$Hl%B0p`5s['9t YR=7lVnsuQ~ endobj Copyright 1993-2021 Injection: 100 mg/2 mL (50 mg/1 mL), dark brown, slightly viscous, sterile solution in single-dose vials. P'q<48}*@Z@"M~5`9r8iH5H Aok1Tv=Yh4DU Reports in the literature from countries outside the United States (in particular, New Zealand) have suggested that the use of intramuscular iron dextran in neonates has been associated with an increased incidence of gram-negative sepsis, primarily due to E. Coli. Reticulocyte count will increase in 3-4 days and peak in 7-10 days. 1986;17(1):1-10. doi: 10.1007/BF00299858. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. Iron dextran has been shown to be teratogenic and embryocidal in mice, rats, rabbits, dogs, and monkeys when given in doses of about 3 times the maximum human dose. In mice, rats, rabbits, and possibly hamsters, it has been demonstrated that these complexes may produce sarcoma following repeated administration of large or small doses of iron-carbohydrate complexes at a single injection site. %PDF-1.4 % Dosage form: injection Alternatively, the total dose may be calculated using the formulas below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin (males and females) for body weight over 15 kg (33 lbs) is 14.8 g/dL. a. V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Assay methods, adriamycin and the other antitumour antibiotics. 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]. Intravenous admixtures - preparation and infusion guidelines This reference contains standard dilutions including IV admixture drug concentration, infusion volumes, and infusion rates. 8600 Rockville Pike Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. These half-life values do not represent clearance of iron from the body. infed stability after reconstitutionkneecap tattoo healing. Bethesda, MD 20894, Web Policies 0000009066 00000 n The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. . For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet Delayed Reactions The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. Do Not Copy, Distribute or otherwise Disseminate without express permission. Serum iron, total iron binding capacity (TIBC) and percent saturation of transferrin are other important tests for detecting and monitoring the iron deficient state. . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Attached to this memorandum is a copy of a package insert for iron dextran (Infed). Each monograph contains stability data, administration guidelines, and methods of preparation. 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. The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. Increased Risk of Toxicity in Patients with Underlying Conditions 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. Four of the seven dilute solutions were stable after two months of storage. Iron Overload Such reactions may be immediate or delayed. 0000002072 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.] Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. rFsh4Js$[i =I.oF&G,6FLVs : :z!V VU55j}yMZN)!9~os6y;\Gc-b#`A`KKUq- `x9[nV&! Medically reviewed by Drugs.com on Oct 25, 2022. 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. J Pediatr Pharmacol Ther. [Progress in drug technology in the years 1968 and 1969]. Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` . This site complies with the HONcode standard for trust- worthy health information: verify here. . Data (See Boxed Warning.) 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. Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Disclaimer. (See DOSAGE AND ADMINISTRATION: Administration. All Rights Reserved. Infusion should then be stopped for 1 hour. . . Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. 0000003224 00000 n Oxford University Press is a department of the University of Oxford. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. 7.1 Drug/Laboratory Test Interactions Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. 0000011042 00000 n Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. Administer daily doses of no more than 2 mL of Infed until the total required dose is administered. For information on systemic interactions resulting from concomitant use, see Interactions. 0000018000 00000 n 2025C; excursions permitted to 1530C. 0000002918 00000 n Does not stimulate erythropoiesis nor does it correct hemoglobin disturbances not caused by iron deficiency. Package insert / product label 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). 0000046285 00000 n . 0000037133 00000 n %%EOF Factors contributing to the formula are shown below. Elimination If no manifestations of anaphylactic-type reactions occur after test dose, administer full therapeutic dose. 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. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). . 2 DOSAGE AND ADMINISTRATION Iron storage parameters may improve prior to hematologic parameters. We comply with the HONcode standard for trustworthy health information. 12.3 Pharmacokinetics 0000026302 00000 n Clinical Considerations We comply with the HONcode standard for trustworthy health information. 0000001877 00000 n . The stability of injectable medications after reconstitution is presented. Importance of informing patients of other important precautionary information. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. CONTRAINDICATIONS 5. 0000002909 00000 n fBw2e5/6k&Dd:/7(lc\s56l<6E'0$tumU? W@mZ_$3ZwE]^ Madison, NJ 07940. 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. 0000003396 00000 n MeSH Before . It should be recognized that iron storage may lag behind the appearance of normal blood morphology. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. This site needs JavaScript to work properly. (See PRECAUTIONS: General.) 06\ zp#2j)kS \(nd+?5R 5 0 obj Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. startxref Advise pregnant persons of the potential risk to the fetus. HdTr0+(R^ Accessibility . Anemias not associated with iron deficiency. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Parenteral iron dextran therapy: a review. Distribution Changes in serum ferritin levels represent the changes in calculated cellular non-heme iron levels. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. FOIA 0000009983 00000 n 1-800-678-1605, Manufactured By: Infed (iron dextran injection), for intravenous or intramuscular use Copyright 2023, Selected Revisions November 4, 2013. Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. III. 0000027226 00000 n Women's Bond NFT Collection This site needs JavaScript to work properly. (See Special Populations under Pharmacokinetics.). Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. . If no adverse reactions are observed, INFeD can be given according to the following schedule until the calculated total amount required has been reached. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. 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)]. Continue Infed until hemoglobin is within the normal range and iron stores are replete. 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. 0000003347 00000 n Niemiec PW Jr, Vanderveen TW, Hohenwarter MW, Gadsden RH Sr. Bullock L, Fitzgerald JF, Glick MR, Parks RB, Schnabel JG, Hancock BG. 5 If reconstituted vaccine is not used immediately or comes in a multidose vial, be sure to clearly mark the vial with the date and time the vaccine was reconstituted, maintain the product at 2-8C (36-46F); do not freeze, and use only within the time indicated on chart above. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. . 0000003746 00000 n . Seven formulations for dilute (50 mg/dl) iron dextran solutions and four parenteral nutrient solutions containing 100 mg/liter of iron dextran were prepared. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. (See Anaphylaxis under Cautions.) xref To avoid injection or leakage into the subcutaneous tissue, a Z-track technique (displacement of the skin laterally prior to injection) is recommended. CAREFULLY BEFORE ACCESSING OR USING THIS SITE. over 15 kg (33 lbs) . official website and that any information you provide is encrypted 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). %PDF-1.3 In vitro studies have shown that removal of iron dextran by dialysis is negligible. Cancer Chemother Pharmacol. 0000002644 00000 n The half-life of total iron, including both circulating and bound, is approximately 20 hours. What are the possible side effects of INFeD? Bookshelf 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. 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. PubMed PMID: 23981803. Clipboard, Search History, and several other advanced features are temporarily unavailable. Although there are significant variations in body build and weight distribution among males and females, the accompanying table and formula represent a convenient means for estimating the total iron required. A test dose of 25 mg infused over 5 minutes should be given. Your comment will be reviewed and published at the journal's discretion. 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& Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. All rights reserved. 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. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. 12.2 Pharmacodynamics 3. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. government site. Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. Clipboard, Search History, and several other advanced features are temporarily unavailable. . Before 0 $]: II. Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. Administer the test dose at a gradual rate over at least 30 seconds. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. Bullock L, Parks RB, Lampasona V, Mullins RE. 0000007617 00000 n 0000001396 00000 n This total iron requirement reflects the amount of iron needed to restore hemoglobin concentration to normal or near normal levels plus an additional allowance to provide adequate replenishment of iron stores in most individuals with moderately or severely reduced levels of hemoglobin. May also be given IM or slow IVP (1 ml/min x 2 min = 100 mg). . 8600 Rockville Pike <> After administration of iron dextran, evidence of a therapeutic response can be seen as an increase in the reticulocyte count. 0000035692 00000 n Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. (See Iron, oral under Interactions.). 1984 Mar;19(3):202, 207, 211-3. HdTn0D Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Administration [qsXBp^z\}L88l$ 6 v~\^bdQl=;GmC;c}_6u6bMUb#&YlKS;ii.HGaToD7Wg%.[vIo6y/tIiVool#8is?8dK Drug interactions involving Infed have not been studied. J Parenter Sci Technol. General The total volume of Infed required for the treatment of iron deficiency anemia is determined from Table 1 or the appropriate formula listed [see Dosage and Administration (2.2)]. Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. 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. F'T9CQU!haSuYn5yd)}^O:Cu) ^>?9#f+R' endstream endobj 57 0 obj<> endobj 58 0 obj<>stream . Federal government websites often end in .gov or .mil. 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. The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). Pregnancy 0000004098 00000 n 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)]. . Gaithersburg, MD: Genzyme; August 2018.

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