SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. tran [6]. 0000011536 00000 n Allergan This site complies with the HONcode standard for trust- worthy health information: verify here. Abstract. Brand and Other Names: INFeD, Dexferrum Classes: Iron Products Dosing & Uses AdultPediatric Dosage Forms & Strengths injectable solution 50mg (Fe)/mL Iron-deficiency Anemia 25-100 mg IV or deep. 5.3 Increased Risk of Toxicity in Patients with Underlying Conditions . 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. Prior to the first intravenous Infed therapeutic dose, administer an intravenous test dose of 0.5 mL [see BOXED WARNING and Warnings and Precautions (5.1)]. J Pediatr Pharmacol Ther. 1989;23(4):197-207. doi: 10.1007/BF00451642. Infed is not recommended for use in infants under 4 months of age [see Dosage and Administration (2.2)]. 0000011042 00000 n Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. trailer << /Size 254 /Info 216 0 R /Root 219 0 R /Prev 331519 /ID[<618a70ff49b482af49be42cc5de1ac5d><4f4e9802b6496a1513efa6cfdffb7212>] >> startxref 0 %%EOF 219 0 obj << /Type /Catalog /Pages 213 0 R /Metadata 217 0 R /PageLabels 211 0 R >> endobj 252 0 obj << /S 769 /T 901 /L 982 /Filter /FlateDecode /Length 253 0 R >> stream startxref 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.] . Animal Data 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. Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. . . Anemia Associated with Chronic Renal Failure, Hypersensitivity Reactions [see Warnings and Precautions (5.1)], Delayed Reactions [see Warnings and Precautions (5.2)], Increased Risk of Toxicity in Patients with Underlying Conditions [see Warnings and Precautions (5.3)], Iron Overload [see Warnings and Precautions (5.4)], Fetal bradycardia [see Use in Specific Populations (8.1)]. After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. INFeD may be used alone or with other medications. "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 . Patheon Italia S.p.A. <> 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)]. 2 0 obj The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. . endstream endobj 46 0 obj<>stream 0000008737 00000 n . 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. Fatal reactions have also occurred in situations where the test dose was tolerated. Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. 0000014709 00000 n Bethesda, MD 20894, Web Policies 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)]. 0000006673 00000 n Copyright 2023, Selected Revisions November 4, 2013. II. 0000003347 00000 n Iron Dextran (INFeD or DexFerrum ) INFeD and DexFerrum are iron dextran pro-ducts marketed in the United States. The product should be further diluted in a suitable diluent prior to infusion. endstream endobj 52 0 obj<> endobj 53 0 obj<> endobj 54 0 obj<>stream Known hypersensitivity to iron dextran or any ingredient in the formulation. 0000002909 00000 n Available for Android and iOS devices. Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. 0000005691 00000 n z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE Reticulocyte count will increase in 3-4 days and peak in 7-10 days. . . Delayed Reactions 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. <> 34 55 endstream endobj 55 0 obj<> endobj 56 0 obj<>stream Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. Careers. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. <> The pH of the solution is between 4.5 to 7.0. Epinephrine should be immediately available. The https:// ensures that you are connecting to the 0000003746 00000 n . . During all Infed administrations, observe patients for signs or symptoms of anaphylactic-type reactions. Absorption It should not be used during the acute phase of infectious kidney disease. (See Boxed Warning.) xb```f``= @Q#3108-. . Excreted in urine, bile, or feces, but only as trace amounts of unmetabolized iron dextran. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. 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. An official website of the United States government. Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. 8600 Rockville Pike Watson Pharma, Inc. 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. ~q`C34&rAd oG 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). 2010 Mar;54(2):95-103. doi: 10.4103/0019-5049.63637. Each days dose should not exceed 0.5 mL (25 mg of iron) for infants with body weight under 5 kg (11 lbs); 1 mL (50 mg of iron) for children with body weight under 10 kg (22 lbs); and 2 mL (100 mg of iron) for other patients. The animals used in these tests were not iron deficient. The https:// ensures that you are connecting to the Isoproterenol or similar beta-agonist agents may be required in these patients. "VIz h\["2[4p))zE.gggvY?D2$NB2+t*6-yEqK $iFV].o =6LyG)5"S t.?aA@pt4y!#4^R(3qCY#D In vitro studies have shown that removal of iron dextran by dialysis is negligible. Accessibility 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. INDICATIONS AND USAGE: Injectafer is indicated for the treatment of iron deficiency anemia in adult patients: >who have intolerance to oral iron or have had unsatisfactory response to oral iron; Stability of famotidine 20 and 40 mg/L and amino acids in total parenteral nutrient solutions. Copyright 1993-2021 8.4 Pediatric Use Infed Dose (in mL) = [Blood loss (in mL) x hematocrit] 50 mg/mL, Example: Blood loss of 500 mL with 20% hematocrit. 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. Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. 0000002918 00000 n 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 belongs to a class of drugs called Iron Products. sharing sensitive information, make sure youre on a federal Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. 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. Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. 0000009538 00000 n <> Medically reviewed by Drugs.com on Oct 25, 2022. The following adverse reactions associated with the use of Infed were identified in clinical studies or postmarketing reports. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. 0000001877 00000 n This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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 official website and that any information you provide is encrypted Thank you for submitting a comment on this article. 8600 Rockville Pike 0000004098 00000 n 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). 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 . Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. If diluted, administer by IV infusion [off-label] over 16 hours. 0000039715 00000 n 0000008617 00000 n FOIA 1984 Mar;19(3):202, 207, 211-3. There have been several reports in the literature describing tumors at the injection site in humans who had previously received intramuscular injections of iron-carbohydrate complexes. Following intramuscular administration, Infed is absorbed from the injection site into the capillaries and the lymphatic system. . The circulating iron is bound to the available protein moieties to form hemosiderin or ferritin, or to a lesser extent to transferrin. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Use with caution in patients with a history of clinically important allergies and/or asthma. Corrections in compilation of information on stability of injectable medications after reconstitution. over 15 kg (33 lbs) . Anemias not associated with iron deficiency. Do not freeze. The physicochemical and mi-crobiological qualities of biological products are functions of the aseptic Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. 0000007595 00000 n Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. N}F( 9N(i{:%NISD;%NIS*T1 The maximum daily dose of Infed should not exceed 2 mL. The onset is usually 24 to 48 hours after administration and symptoms generally subside within 3 to 4 days. Package insert / product label 1-800-678-1605, Manufactured By: The half-life of total iron, including both circulating and bound, is approximately 20 hours. Have resuscitation equipment and personnel trained in the detection and treatment of anaphylactic-type reactions readily available during Infed administration. Vascular disorders: Cyanosis, shock, hypertension, hypotension, flushing (flushing and hypotension may occur from too rapid injections by the intravenous route), local phlebitis at or near intravenous injection site. 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. 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. 0000009066 00000 n Individual doses of 2 mL or less may be given on a daily basis until the calculated total amount required has been reached. Manifested as sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse; have resuscitation equipment and personnel trained in detection and treatment of anaphylactic-type reactions readily available during iron dextran administration. 12.3 Pharmacokinetics A subsidiary of Watson Pharmaceuticals, Inc. 0000003913 00000 n Parenteral iron dextran therapy: a review. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. The site is secure. Unauthorized use of these marks is strictly prohibited. Large intravenous doses, such as used with total dose infusions (TDI), have been associated with an increased incidence of adverse reactions. HHS Vulnerability Disclosure, Help Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. Generic name: iron dextran Risk for anaphylaxis may be increased in patients with history of drug allergy or multiple drug allergies or with concomitant use of ACE inhibitors. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. (See Iron, oral under Interactions.). W = body weight in kg Would you like email updates of new search results? ), Epinephrine should be immediately available in the event of acute hypersensitivity reactions. Vancomycin hydrochloride is an antibiotic belonging to the glycopeptide family and acts by inhibiting the synthesis of the peptidoglycan wall. [s 0000030666 00000 n Unable to load your collection due to an error, Unable to load your delegates due to an error. . Anemia Associated with Chronic Renal Failure. Last updated on Dec 1, 2022. 0000003686 00000 n Bone scans involving 99m Tc-diphosphonate have been reported to show a dense, crescentic area of activity in the buttocks, following the contour of the iliac crest, 1 to 6 days after intramuscular injections of Infed. Do not mix with other drugs or add to parenteral nutrition solutions for IV infusion. Y-site compatibility of medications with parenteral nutrition. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. . 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). Hatton RC, Portales IT, Finlay A, Ross EA. 6FT2QHi!TlT\Gv8hoo6?y^Owm-2v\o**5b[ ,kDS@TzEr.2uTBs4PT>m231qSaLHh>` I. For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet 0000003396 00000 n Each monograph contains stability data, administration guidelines, and methods of preparation. 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. . Please check for further notifications by email. INFeD should not normally be given in the first four months of life. 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. Fatal reactions have been reported following the test dose of iron dextran injection. Unable to load your collection due to an error, Unable to load your delegates due to an error. Carcinogenesis % and transmitted securely. endobj 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. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. In iron-deficient patients, reticulocytosis may begin by the 4th day following an IV infusion of the total calculated dose of iron dextran and reaches a maximum by about the 10th day.