infed stability after reconstitution

The https:// ensures that you are connecting to the Risk Summary 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. . 0000004132 00000 n Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. The product should be further diluted in a suitable diluent prior to infusion. Iron Overload and transmitted securely. Bookshelf All Rights Reserved. Federal government websites often end in .gov or .mil. Administer only in a setting where resuscitation equipment and medications are available. 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). 0000013948 00000 n Bookshelf . a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) HR0~ 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). %PDF-1.4 % The adverse reactions are frequently delayed (1 to 2 days) reactions typified by one or more of the following symptoms: arthralgia, backache, chills, dizziness, moderate to high fever, headache, malaise, myalgia, nausea, and vomiting. Absorption Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. Do Not Copy, Distribute or otherwise Disseminate without express permission. and transmitted securely. Monitor for iron toxicity when Infed is used in patients with serious impairment of liver function. (See Anaphylaxis under Cautions.) The .gov means its official. Administer the test dose at a gradual rate over at least 30 seconds. 0000000016 00000 n . Available as iron dextran; dosage expressed in terms of elemental iron. If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. 0000031965 00000 n Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. (Normal Hb for Children 15 kg or less is 12 g/dl). e. Weight. 0000002696 00000 n Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? 15 kg (33 lbs) or less . Cancer Chemother Pharmacol. Abstract. . Cancer Chemother Pharmacol. Metabolism .12.0 g/dl, c. Iron content of hemoglobin . 5. The pH of the solution is between 4.5 to 7.0. MeSH %%EOF N}F( 9N(i{:%NISD;%NIS*T1 Oral iron should be discontinued prior to administration of INFeD. Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. 1 0 obj Such reactions may be immediate or delayed. Before This antibiotic is active against Gram-positive aerobic and anaerobic bacteria1 2 and is commonly used in hospitals to treat serious infections.3 4 Vancomycin has slow bactericidal time-dependent activity and can be administered by continuous or . (See Anaphylaxis under Cautions.) Dextran, a polyglucose, is either metabolized or excreted. hO4,qv(8p]4SXs?_k^ '4["G!@` \ 06\ zp#2j)kS \(nd+?5R . 3. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. Careers. Adverse reactions experienced following administration of Infed may exacerbate cardiovascular complications in patients with pre-existing cardiovascular disease. 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. Corrections in compilation of information on stability of injectable medications after reconstitution. Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. If there is no reaction after 1 hour continue. Careers. The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. (Usual adult dose: 0.5 mL of a 1:1000 solution, by subcutaneous or intramuscular injection.). <> CAS number: 9004-66-4. sharing sensitive information, make sure youre on a federal The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic endobj Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. official website and that any information you provide is encrypted After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. Ling J, Gupta VD. This site needs JavaScript to work properly. 2009;23(3):223-30. doi: 10.1080/15360280903098382. (8(YP VPRX_RY_ 4483%3(3XLLM|?|w! Parenteral iron administration may be associated with hypersensitivity reactions [see Warnings and Precautions (5.1)], which may have serious consequences, such as fetal bradycardia (see Clinical Considerations). 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). Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. Before . 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. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , Therefore, administration of subsequent test doses during therapy should be considered. Possible exacerbation of cardiovascular complications because of adverse effects of the drug in patients with preexisting cardiovascular disease. 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. 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. Removal of Iron Dextran by Hemodialysis: An In Vitro Study. No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. Infed (iron dextran injection USP) containing 50 mg of elemental iron per mL, is available as a dark brown, slightly viscous, sterile solution in 2 mL single-dose amber vials in cartons of 10 (NDC 0023-6082-10). . David McAuley, Pharm.D. endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. Discontinue administration of any iron-containing products prior to administration of Infed. 4 0 obj Distribution Based on: Desired Hb = the target Hb in g/dl. 0000036574 00000 n LBW = Lean body weight in kg. 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? <<7815BA97DDE94C498B4A3154474182CA>]>> Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. Copyright 2023, Selected Revisions November 4, 2013. For information on systemic interactions resulting from concomitant use, see Interactions. the 6 time points after injection.15 A 94-subject rater-blinded randomized control study of EDP action potentials compared toxin used within 2 hours, 72 hours, 1, 2, 3, or 4 weeks after reconstitution; at 1 week after injection, the point of maximum effect, there was no difference in quantitative paralysis . Intravenous Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAVENOUS TEST DOSE OF 0.5 mL. NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y 0000026943 00000 n Copyright 1993-2021 HHS Vulnerability Disclosure, Help Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Unwarranted therapy with parenteral iron will cause excess storage of iron with the consequent possibility of exogenous hemosiderosis. 0000012898 00000 n 0000003686 00000 n 34 0 obj <> endobj Administer test dose prior to administration of initial and subsequent therapeutic doses of the drug and observe patient closely. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. 0000006695 00000 n (See Boxed Warning.). 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$;HvqW!Vb(FNz& Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. sharing sensitive information, make sure youre on a federal 0000002644 00000 n The stability of dilute iron dextran formulations and of one formulation in parenteral nutrient solutions was studied. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. If undiluted, administer by slow IV injection at 50 mg/minute (1 mL/minute). x&q}2(33",Y &HS4) IE][5MA0A8eT?g_>^J37_/>O?'_koJ?DE>k/~fhFh-hiQv?}{spq8[vwVZinj4i ~q;+~F[f*]WR_Lk.U}2W%hv`kO?n7gC8V.WR'GB}Y2&?|l=FLf5Q*>nm{rDY_cVk|#sZa_&_~N#vjAjqe_5x?n'j_|WlYU2RW[KK/$ over 15 kg (33 lbs) . . The half-life of total iron, including both circulating and bound, is approximately 20 hours. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. 0000013156 00000 n Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. 1985;14(2):83-95. doi: 10.1007/BF00434343. 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. 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 to oral iron. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427.

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