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. . Fetal and maternal toxicity has been reported in monkeys at a total intravenous dose of 90 mg iron/kg over a 14 day period. Accessibility The stability of injectable medications after reconstitution is presented. 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. infed stability after reconstitution - womensbond.com This site complies with the HONcode standard for trust- worthy health information: verify here. PMC Infed is a registered trademark of Allergan Sales, LLC. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. Morristown, NJ 07962 USA. Federal government websites often end in .gov or .mil. PDF INFeD (IRON DEXTRAN INJECTION USP) Rx only Revised: September 2020 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. Excessive dosages of Infed may lead to accumulation of iron in storage sites potentially leading to hemosiderosis. government site. Before 3. Iron dextran also has been administered after dilution by IV infusion [off-label] (e.g., over 16 hours). <> 0000005561 00000 n 2.1 Important Pre-Treatment Information Generic name: iron dextran IV Iron Dextran Infusion Protocol | MedStar Health 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. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. The stability of injectable medications after reconstitution is presented. 0000001877 00000 n endstream endobj 47 0 obj<>stream 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. Treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. N}F( 9N(i{:%NISD;%NIS*T1 Fetal abnormalities in rats and dogs were observed at doses of 250 mg iron/kg and higher. %%EOF Risk Summary Epinephrine should be immediately available. 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. This site needs JavaScript to work properly. 4GWVI~p`1x_7G|_Wz/ev5%b[~?w>ZG/*p%\/??w~=+ |O?~po>u|.@uM=Nvm_~~>\.%>?_mk+mp_{"ly"Y{JlqgIl#Y!Y@osLu]Mt=xx? . Absorption Nephron. Manuel MA, Stewart WK, St. Clair Neill GD, Hutchinson F. Loss of Iron-Dextran through Cuprophane Membrane of a Disposable Coil Dialyser. Fatal reactions have occurred following a test dose of iron dextran and also in patients in whom the test dose was tolerated. Niemiec PW Jr, Vanderveen TW, Hohenwarter MW, Gadsden RH Sr. Bullock L, Fitzgerald JF, Glick MR, Parks RB, Schnabel JG, Hancock BG. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. "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 0000011042 00000 n 1986;17(1):1-10. doi: 10.1007/BF00299858. 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. 0000001396 00000 n PDF Vaccines with Diluents: How to Use Them - immunize.org Brand names: Dexferrum, INFeD PubMed PMID: 23981803. 0000012318 00000 n Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Carcinogenesis 0000026747 00000 n 0000037133 00000 n 1984 Mar;19(3):202, 207, 211-3. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions; can be immediate or delayed and vary widely in severity. (5.3). . Careers. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. 0000011305 00000 n TRW3xs6's;W2YK8AAv4Qo~S ONW>dVN--sFhQe@ 0{7;;vmG+zW%Rmhh_}m?rjnY'0_i' C?U"-DA('[ Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. Use of 5% dextrose injection instead of 0.9% sodium chloride injection may be associated with a higher incidence of local pain and phlebitis. [Progress in drug technology in the years 1968 and 1969]. 0000013948 00000 n "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D Postreconstitution Stability of Amoxicillin-Clavulanic Acid Suspensions NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. Data General considerations, the nitrosoureas and alkylating agents. NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. 0000002275 00000 n 0000003913 00000 n 2007 Jan;12(1):53-9. doi: 10.5863/1551-6776-12.1.53. Trace amounts of unmetabolized iron dextran are present in human milk. The site is secure. 12.2 Pharmacodynamics . Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Ferentino, Italy 03013, Distributed By: The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. Delayed Reactions (See PRECAUTIONS: General.) 3. 0000005917 00000 n Negligible amounts of iron are lost via the urinary or alimentary pathways after administration of iron dextran. (See Boxed Warning.). Parenteral iron dextran therapy: a review. Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. 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.