Although anaphylactic reactions known to occur following INFeD administration are usually evident within a few minutes or sooner, it is recommended that at least an hour or longer elapse before the remainder of the initial therapeutic dose is given. Advise pregnant persons of the potential risk to the fetus. David McAuley, Pharm.D. . The circulating iron released from iron dextran, which is subject to physiological control, replenishes hemoglobin and depleted iron stores. 0000003224 00000 n Before Corrects the erythropoietic abnormalities that are due to a deficiency of iron. Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. Copyright 2021 GlobalRPH - Web Development by, IV Dilutions Medication Reference and Infusion Guidelines, Renal dosing for healthcare professionals, HONcode standard for trust- worthy health, 7 Natural Remedies for Rheumatoid Arthritis, How Prenatal Counseling Can Help You Through Pregnancy. Parenterally administered iron does not give a faster response compared to oral administration, therefore, the rate of recovery from anemia should be the same. For full access to this pdf, sign in to an existing account, or purchase an annual subscription. The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. . . 0000004132 00000 n For males: LBW = 50 kg + 2.3 kg for each inch of patients height over 5 feet %PDF-1.3 % PDF HIGHLIGHTS OF PRESCRIBING INFORMATION ZEPZELCA, periodically during Children weighing >15 kg (33 lbs): Use the following formula (where Wt = patient's weight in kg and Hbo = observed hemoglobin in g/dL): [0.0442 Wt (14.8 g/dL Hbo)]+ (0.26 Wt) = 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 of frozen antibiotics. . HHS Vulnerability Disclosure, Help Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. 0000046691 00000 n Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. 0000008022 00000 n endobj [See USP Controlled Room Temperature]. 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/$ Written by ASHP. 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. 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. All adult and pediatric patients receiving Infed require periodic monitoring of hematologic and iron parameters (hemoglobin, hematocrit, serum ferritin and transferrin saturation). . Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. Do not administer Infed to patients with evidence of iron overload. Excretion Unable to load your collection due to an error, Unable to load your delegates due to an error. Bookshelf Musculoskeletal and connective tissue disorders: Arthralgia, arthritis (may represent reactivation in patients with quiescent rheumatoid arthritis [see Warnings and Precautions (5.3)], myalgia, backache. Assay methods, adriamycin and the other antitumour antibiotics. Respiratory, thoracic and mediastinal disorders: Respiratory arrest, dyspnea, bronchospasm, wheezing. z6Y~]ZUkOR/R(;So__^41K}kf-#I{5mUirY@o"mkWbE 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. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. Azacitidine - Vidaza - GlobalRPH 2. '* Elimination 34 0 obj <> endobj PDF 1. IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE - Allergan Am J Kid Dis. The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. 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). Trace amounts of unmetabolized iron dextran are present in human milk. HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> Stability of acyclovir sodium after reconstitution in 0.9% sodium chloride inje ction and storage in polypropylene syringes for pediatric use. Iron dextran was stable in the four parenteral nutrient solutions after 18 hours of room-temperature storage. Question patients regarding any prior history of reactions to parenteral iron products. Infed Dosage Guide - Drugs.com Note: The table and accompanying formula are applicable for dosage determinations only in patients with iron deficiency anemia; they are not to be used for dosage determinations in patients requiring iron replacement for blood loss. INFeD is a prescription medicine used to treat the symptoms of Iron-deficiency Anemia. 0000003913 00000 n xb```f``= @Q#3108-. II. Children weighing 59 kg (1121 lbs): Maximum daily dosage is 50 mg of iron. Advise patients to inform their healthcare provider if any liver impairment is identified as this may cause iron toxicity. Fatal anaphylactic reactions are possible. 0000013099 00000 n Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. Madison, NJ 07940. 0000037133 00000 n 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). Excess storage of iron and a syndrome similar to hemosiderosis possible when used for anemia not attributable to iron deficiency (e.g., those with hemoglobinopathies and other refractory anemias that might be erroneously diagnosed as iron deficiency anemias). 2001;5(1):75-7. After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. Sensitivity (e.g., anaphylactoid or anaphylactic) reactions, including fatalities, have occurred following parenteral administration of iron dextran. 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). 3. . . Risk of developing potentially life-threatening anaphylactic reactions. 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. 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? After slow IV injection (given over 30 seconds for INFeD or 5 minutes for Dexferrum) or IM injection (INFeD) of 25 mg of iron (0.5 mL), observe for 1 hour for sensitivity reactions (see Anaphylaxis under Cautions) before administering the remaining portion of the initial dose. Recommended dosage for treatment of iron deficiency anemia also may be determined from a table; consult manufacturers labeling. . sharing sensitive information, make sure youre on a federal Children weighing 10 kg (22 lbs): Maximum daily dosage is 100 mg of iron. General considerations, the nitrosoureas and alkylating agents. H|TMs6Wu*Q6i\l.` If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Administer the test dose at a gradual rate over at least 30 seconds into the buttock. There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron: Replacement iron (in mg) = Blood loss (in mL) x hematocrit, Example: Blood loss of 500 mL with 20% hematocrit. . In patients with chronic kidney disease (CKD) on hemodialysis, IV iron superior to orally administered iron for increasing hemoglobin concentrations and/or minimizing dosage of an erythropoiesis-stimulating agent (ESA); the National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF-KDOQI) guidelines state that the IV route is preferred for iron administration in such patients. The maximum daily dose of INFeD should not exceed 2 mL. 2009;23(3):223-30. doi: 10.1080/15360280903098382. 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 . Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. 16.1 How Supplied 4. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. 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. Medically reviewed by Drugs.com on Oct 25, 2022. Such reactions may be immediate or delayed. Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. The maximum daily dose of Infed should not exceed 2 mL. 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. Administer only in a setting where resuscitation equipment and medications are available. Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Anaphylaxis and other hypersensitivity reactions have been reported after uneventful test doses as well as therapeutic doses of iron dextran injection. 5.3 Increased Risk of Toxicity in Patients with Underlying Conditions Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. 0000012898 00000 n Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). Reticulocyte count will increase in 3-4 days and peak in 7-10 days. Infed (iron dextran injection), for intravenous or intramuscular use 5.4 Iron Overload . IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: Continue Infed until hemoglobin is within the normal range and iron stores are replete. REFERENCES Available as iron dextran; dosage expressed in terms of elemental iron. Stability of injectable medications after reconstitution 0000001071 00000 n Concomitant use of angiotensin-converting enzyme inhibitor drugs may increase the risk for anaphylactic-type reactions to an iron dextran product. Drug class: Iron Preparations 3. 15 kg (33 lbs) or less . infed stability after reconstitutionkneecap tattoo healing. HdTn0D If diluted, administer by IV infusion [off-label] over 16 hours. Factors contributing to the formula are shown below. Varicella (Var) Measles, Mumps, Rubella (MMR) Measles, Mumps, Rubella, .65 mL/kg of body weight, b. . Specific Populations 0000046285 00000 n Discontinue oral iron therapy prior to initiation of iron dextran therapy. Fatal reactions have also occurred in situations where the test dose was tolerated. Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. 2 0 obj 4. Dextran, a polyglucose, is either metabolized or excreted. THE TEST DOSE SHOULD BE ADMINISTERED AT A GRADUAL RATE OVER AT LEAST 30 SECONDS. 0000010759 00000 n 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. Animal Data Use with caution in patients with a history of clinically important allergies and/or asthma. endobj HdTr0+(R^ 0000006734 00000 n For solution and drug compatibility information, see Compatibility under Stability. Abstract. 2.Intramuscular Injection - PRIOR TO RECEIVING THEIR FIRST INFeD THERAPEUTIC DOSE, ALL PATIENTS SHOULD BE GIVEN AN INTRAMUSCULAR TEST DOSE OF 0.5 mL. Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. . p?kh|*rB vg8Si*-T+/_VHEbT!AlK*3 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. Use Infed only in patients in whom clinical and laboratory investigations have established an iron deficient state not amenable to oral iron therapy. For all medical inquiries contact: 0000047340 00000 n INFeD should not normally be given in the first four months of life. Therapy, thus, should aim at not only replenishment of hemoglobin iron but iron stores as well. Morristown, NJ 07962 USA. Medical Communications 1-800-678-1605, Manufactured By: No consistent adverse fetal effects were observed in mice, rats, rabbits, dogs, and monkeys at doses of 50 mg iron/kg or less. We comply with the HONcode standard for trustworthy health information. Children 5 - 15 kg (11 - 33 lbs): See Dosage Table. 0000002294 00000 n The 20 hour value reflects a half-life determined by measuring total 59Fe, both circulating and bound. Disease-Associated Maternal and/or Embryo/Fetal Risk INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. 0000037333 00000 n Blood volume . Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia*. 0000009983 00000 n Infed (Iron Dextran): Uses, Dosage, Side Effects, Interactions - RxList 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 V]{iXn L2 Tv]OXSe` a l9@f `qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. Hb```f`` l,/`"`FOB/r7}UL This site needs JavaScript to work properly. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever the solution and container permit. The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). (See Iron, oral under Interactions.). 1989;23(4):197-207. doi: 10.1007/BF00451642. Risk for anaphylactic-type reactions to specific iron dextran preparations is not known and may vary. Dilute iron dextran formulation for addition to parenteral nutrient 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. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Elimination of iron from serum, including elimination half-life, does not correspond to clearance of the mineral from the body. 0000002275 00000 n Unauthorized use of these marks is strictly prohibited. The following clinically significant adverse reactions are described elsewhere in the labeling: Blood and lymphatic system disorders: Leukocytosis, lymphadenopathy. Int J Pharm Compd. 0000012318 00000 n 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. Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. 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; (See Special Populations under Pharmacokinetics.). 0000005019 00000 n 1 0 obj Accessibility Administer a test dose of Infed prior to administration of therapeutic dose [see Dosage and Administration (2.4)]. . 8600 Rockville Pike Carcinogenesis Protect from light. NOTE: Do not mix Infed with other medications or add to parenteral nutrition solutions for intravenous infusion. The stability of injectable medications after reconstitution is presented. . . [2:/T6*cz1"Jk&n#n[[TU An official website of the United States government. David McAuley, Pharm.D. Evaluation of the stability of vancomycin solutions at concentrations . The study suggests that addition of recommended daily doses of iron dextran to parenteral nutrient solutions creates no stability problems; however, further study of the effects of temperature, pH, light, and storage time are recommended. (See PRECAUTIONS: General.) <> 0000026943 00000 n 0000005669 00000 n Disclaimer. 0000009088 00000 n 0000000016 00000 n 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. . 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 . endstream endobj 57 0 obj<> endobj 58 0 obj<>stream Corrections in compilation of information on stability of injectable medications after reconstitution. Each monograph contains stability data, administration guidelines, and methods of preparation. 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. IV Iron Dextran Infusion Protocol | MedStar Health . The stability of injectable medications after reconstitution is presented. 0000008504 00000 n PDF VACCINE PREPARATION AND ADMINISTRATION (Post in Vaccine Prep - Michigan Cancer Chemother Pharmacol. 0000036781 00000 n 0000002918 00000 n Calculate the Infed dose based upon the formula below which is based upon the approximate amount of blood loss and pretreatment hematocrit. . Normal hemoglobin (males and females) Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. 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. Delay administration of the initial therapeutic Infed dose until 1 hour or more after the test dose. Antimetabolites, tubulin-binding agents, platinum drugs, amsacrine, L-asparaginase, interferons, steroids and other miscellaneous antitumor agents. Advise the patient to consult a healthcare provider before taking any other iron containing products as this may cause serious side effects [see Warnings and Precautions (5.4)]. Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. PDF Protocol for the use of Intravenous Iron Dextran (CosmoFer Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. Do not freeze. The total amount of INFeD required for the treatment of iron deficiency anemia or iron replacement for blood loss is determined from the table or appropriate formula (See Dosage). BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. <> Dosage . The pH of the solution is between 4.5 to 7.0. 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 . 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. It should be remembered that iron deficiency anemia will not appear until essentially all iron stores have been depleted.
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