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PLEASE READ THE. Animal Data Copyright 1993-2021 !m The site is secure. 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. The chemical stability after reconstitution has been studied: the solution is physically and chemically stable for 48 hours at 25C. 0000007595 00000 n 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)]. (See Boxed Warning.). . NoPEF(djUMPU}ocl`<0yxk0R7?+9Ks,y Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. An official website of the United States government. 7.1 Drug/Laboratory Test Interactions 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. Metabolism 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. . HHS Vulnerability Disclosure, Help 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. . . Accessibility BILy@yK5] I(Y+ u YV ;bPqZ9~3oG RqK|"@k!/<9 .*JIr|R$ck4w8Szd*-qK"#AgFIyVsT`PtP_-tO=jq"~.^^2={nZU$ , Reticulocyte count will increase in 3-4 days and peak in 7-10 days. endstream endobj 48 0 obj<> endobj 49 0 obj<> endobj 50 0 obj<> endobj 51 0 obj<>stream official website and that any information you provide is encrypted Hbd`ab`ddpwwvL)IMN5405NKIa!#6= v`b`fd4/9(3=DA!YAR1%? (See PRECAUTIONS: General.) d. Hemoglobin deficit If diluted, administer by IV infusion [off-label] over 16 hours. Infed (iron dextran injection USP) is an iron replacement product provided as a dark brown, slightly viscous sterile liquid complex of ferric hydroxide and dextran for intravenous or intramuscular use. The amount of vancomycin to treat an adult infection is superior to 1 g and so the volume administered can be higher than 100 mL. Therefore, administration of subsequent test doses during therapy should be considered. 16.2 Stability and Storage (See Special Populations under Pharmacokinetics.). 1985;14(2):83-95. doi: 10.1007/BF00434343. RRd::||7?_EeYU2&*[-%yWU0J@eZZ+)_P2B A_`T 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. 5.2 Delayed Reactions Continue Infed until hemoglobin is within the normal range and iron stores are replete. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. The .gov means its official. General considerations, the nitrosoureas and alkylating agents. Risk Summary 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). .12.0 g/dl, c. Iron content of hemoglobin . 0000009066 00000 n SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING. 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 of frozen antibiotics. After administration of iron dextran complex, evidence of a therapeutic response can be seen in a few days as an increase in the reticulocyte count. 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; Recommended formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL) for calculating total dosage of iron dextran injection (in mL): Use the following formula to calculate required total dosage of iron dextran injection (in mL): Infants weighing <5 kg (11 lbs): Maximum daily dosage is 25 mg of iron. Curr Opin Clin Nutr Metab Care. Dosage form: injection It is not known if INFeD is safe and effective in children younger than 4 months of age. 0 $]: 0000009983 00000 n The stability of injectable medications after reconstitution is presented. 0000002441 00000 n Use only in patients in whom a clearly established indication for parenteral iron therapy exists, confirmed by appropriate clinical and laboratory tests. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 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. . Available for Android and iOS devices. 0000039715 00000 n 0000001071 00000 n Ferric carboxymaltose is a colloidal iron (III) hydroxide in complex with carboxymaltose, a carbohydrate polymer that releases iron. If there is no reaction after 1 hour continue. 2009;23(3):223-30. doi: 10.1080/15360280903098382. If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. 0000004715 00000 n Iron dextran preparations differ in chemical characteristics and may differ in clinical effects; manufacturers state that such preparations are not clinically interchangeable. HTP=0+21T !uC/OR@OwUl yakX2X#a;AFr=E!5#,Uyfl-D)@e !wGOCnGXO}>;WYQPdyJH{x4Wxm;Nys6;YH|J! Vhv Y-site compatibility of medications with parenteral nutrition. 0000010005 00000 n 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). 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)]. Increased Risk of Toxicity in Patients with Underlying Conditions 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Watson Pharma, Inc. Iron therapy in these patients should be directed toward replacement of the equivalent amount of iron represented in the blood loss. 4 0 obj Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. This site complies with the HONcode standard for trust- worthy health information: verify here. 0000002041 00000 n . 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. 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. 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). The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. [See USP Controlled Room Temperature]. 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. The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. 2009 Jan;14(1):48-56. doi: 10.5863/1551-6776-14.1.48. In doses 500 mg, iron dextran plasma concentrations decrease exponentially with a half-life of about 6 hours. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. 2 DOSAGE AND ADMINISTRATION 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. 2007 May;10(3):311-7. doi: 10.1097/MCO.0b013e3280ebb427. Allergan 34 0 obj <> endobj No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. '* endstream endobj 35 0 obj<> endobj 36 0 obj<> endobj 37 0 obj<>/Font<>/ProcSet[/PDF/Text]/ExtGState<>>> endobj 38 0 obj<> endobj 39 0 obj<> endobj 40 0 obj<> endobj 41 0 obj<> endobj 42 0 obj<> endobj 43 0 obj[/ICCBased 66 0 R] endobj 44 0 obj<> endobj 45 0 obj<>stream Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Do not administer Infed to patients with iron overload [see Warnings and Precautions (5.4)]. KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 Stability of cephapirin sodium admixtures after freezing and conventional or microwave thaw techniques. Administer undiluted by slow (50 mg/minute) IV injection; some preparations (i.e., INFeD) also are FDA-labeled for IM injection. xref 0000008022 00000 n . Iron Overload Pharmacists should emphasize the importance of adhering to the storage conditions listed on the label after the medication is reconstituted. The stability of injectable medications after reconstitution is presented. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. The animals used in these tests were not iron deficient. Clinical Considerations a Abciximab (reopro) Acetaminophen Acetazolamide (Diamox ) 0000009538 00000 n Administer a test Infed dose prior to the first therapeutic dose. Bookshelf 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]. Additionally, concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for reactions to an iron dextran product. 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. 0000047340 00000 n Hb```f`` l,/`"`FOB/r7}UL Advise pregnant persons of the potential risk to the fetus. Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. 0000003091 00000 n 0000002019 00000 n . 1989;23(4):197-207. doi: 10.1007/BF00451642. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. Infed Dosage Guide - Drugs.com Do not exceed a total daily dose of 2 mL undiluted Infed. Should be administered by qualified individuals with ready access to resuscitation equipment and appropriate agents for the treatment of a severe allergic or anaphylactic reaction (e.g., epinephrine, or isoproterenol in patients receiving -adrenergic blocking agents). Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 0000012149 00000 n Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. INFeD may be used alone or with other medications. 0000030666 00000 n Such iron overload is particularly apt to occur in patients with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias. Infed is not removed by hemodialysis [see Clinical Pharmacology (12.3)]. PMC A patients lean body weight (or actual body weight if less than lean body weight) should be utilized when determining dosage. FOIA INFeD should not normally be given in the first four months of life. 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). Allergan USA, Inc. Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. 0000002294 00000 n 0000002696 00000 n If patient is standing, administer IM injection in buttock of the leg opposite the patients weight-bearing leg; if supine, place patient in a lateral position with the injection site uppermost. Carcinogenesis Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. During administration of any iron dextran dose, observe for manifestations of anaphylactic-type reactions. To calculate a patient's weight in kg when lbs are known: Otherwise, the total dose may be calculated using the formula below: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x W + (0.26 x W), Desired Hb = the target hemoglobin in g/dL [Normal hemoglobin for children with body weight of 15 kg (33 lbs) or less is 12 g/dL.]. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). government site. 12.2 Pharmacodynamics % Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. 0000000016 00000 n 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. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Oxford University Press is a department of the University of Oxford. s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{ wQ&vYAv6bUd`l!k3X*4V. Dilute iron dextran formulation for addition to parenteral nutrient Dosage Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. Infed is a registered trademark of Allergan Sales, LLC. . 0000011305 00000 n The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). Gaithersburg, MD: Genzyme; August 2018. Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 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). Evaluation of the stability of vancomycin solutions at concentrations We comply with the HONcode standard for trustworthy health information.