%PDF-1.3 If no signs or symptoms of anaphylactic-type reactions follow the test dose, administer the full therapeutic Infed dose. 0000007595 00000 n
Infed is a registered trademark of Allergan Sales, LLC. Skin and subcutaneous disorders: Urticaria, pruritus, purpura, rash, sweating. Patients with a history of significant allergies and/or asthma may have an increased risk of hypersensitivity reactions [see Dosage and Administration (5.1)]. 0000003746 00000 n
official website and that any information you provide is encrypted (See Special Populations under Pharmacokinetics.). sharing sensitive information, make sure youre on a federal Risk of developing potentially life-threatening anaphylactic reactions. National Library of Medicine Possible increased incidence of gram-negative sepsis; not recommended for use in infants <4 months of age. J Pediatr Pharmacol Ther. MeSH Solution Stability: VIDAZA reconstituted for intravenous administration may be stored at 25C (77F), but administration must be completed within 1 hour of reconstitution. 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). (See Cautions.). 0000036781 00000 n
KAAtAP%$ 1GvuK h|Sqm!5x:9>{HBBL9x`:}R/{H$\SRH'yVf3g1EG5=p2a[\K5E:/mV: T1 1984 Mar;19(3):202, 207, 211-3. 0000003913 00000 n
Oral iron should be discontinued prior to administration of INFeD. General considerations, the nitrosoureas and alkylating agents. '* Stability of ranitidine hydrochloride and amino acids in parenteral nutrient solutions. (See Boxed Warning.). INFeD is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Therefore, administration of subsequent test doses during therapy should be considered. The site is secure. Hb```f`` l,/`"`FOB/r7}UL Cancer Chemother Pharmacol. . 0000003347 00000 n
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Copyright 2023, Selected Revisions November 4, 2013. Iron Overload 0000002041 00000 n
III. 15 kg (33 lbs) or less . This revision is an update of: Latiolais CJ, Shoup LK and Thur MP: Stability of drugs after reconstitution, Am J Hosp Pharm 24:667-691 (Dec) 1967. J Pediatr Pharmacol Ther. 8600 Rockville Pike Observe patients for at least one hour after the test dose before administering the remainder of the initial therapeutic dose. Infed may cause falsely elevated values of serum bilirubin and falsely decreased values of serum calcium. Development and operation of a pharmacy-based intravenous cytotoxic reconstitution service. x&q}2(33",Y
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~q;+~F[f*]WR_Lk.U}2W%hv`kO?n7gC8V.WR'GB}Y2&?|l=FLf5Q*>nm{rDY_cVk|#sZa_&_~N#vjAjqe_5x?n'j_|WlYU2RW[KK/$ If no adverse reactions are observed, Infed can be given according to the following schedule until the calculated total required dose has been reached. 1995; 26(2):327-330. 0000030666 00000 n
Ferric hydroxide or ferric oxyhydroxide in a complex with partially hydrolyzed low molecular weight dextran. Women's Bond NFT Collection Distributed into milk (as traces of unmetabolized iron dextran); use with caution in nursing women. Department of Pharmacy, Ohio State University Hospitals, Columhus 43210. The table and formula described under I.Iron Deficiency Anemia are not applicable for simple iron replacement values. . Infed is contraindicated in patients who have demonstrated a previous hypersensitivity to iron dextran [see Warnings and Precautions (5.1)]. 0000026302 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. 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. 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)]. Fetal/Neonatal Adverse Reactions Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of Infed. 1986 Jul-Aug;40(4):142-63. $ HdTn0D Alternatively the total dose may be calculated: Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW). I. Metabolism Parenteral iron dextran therapy: a review. )U!$5X3/9 ($5EO1'G!X! l Sm3G.E7="
r7/[^;q|= . IDENTIFICATION OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY UNDERTAKING TRADE/MATERIAL NAME: 0000011305 00000 n
The intramuscular injection of iron-carbohydrate complexes may be associated with an increased risk of carcinogenesis. Each monograph contains stability data, administration guidelines, and methods of preparation. Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration. If the patient is standing, he/she should be bearing his/her weight on the leg opposite the injection site, or if in bed, he/she should be in the lateral position with injection site uppermost. Search for other works by this author on: Copyright 1976, American Society of Hospital Pharmacists, Inc. All rights reserved. Possible risk of carcinogenesis associated with IM administration of iron-carbohydrate complexes. V]{iXn L2 Tv]OXSe` a
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`qY+W^Fau/j#3KG"rZ,1pKe"1$W0!#>xr}L=T|&~pu ZUtk&q %= If a hypersensitivity reaction occurs with the test dose, manage medically and do not administer further doses of Infed. Serum iron determinations (especially by colorimetric assays) may not be meaningful for 3 weeks following the administration of Infed. 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. 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.
The PubMed wordmark and PubMed logo are registered trademarks of the U.S. Department of Health and Human Services (HHS). 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. If hypersensitivity reactions occur during administration, stop Infed immediately and manage reaction medically. Medically reviewed by Drugs.com on Oct 25, 2022. 0000031965 00000 n
A subsidiary of Watson Pharmaceuticals, Inc. Protect from light. . REFERENCES Patients with a history of drug allergy or multiple drug allergies may be at increased risk of anaphylactic-type reactions to iron dextran. startxref
J Parenter Sci Technol. For females: LBW = 45.5 kg + 2.3 kg for each inch of patients height over 5 feet There are risks to the pregnant person and fetus associated with untreated iron deficiency anemia in pregnancy (see Clinical Considerations). After reconstitution with 19 ml water for injections, the product contains 10 mg/ml voriconazole and 160 mg/ml SBECD. 1972;9:94-98. Each mL of iron dextran injection is equivalent of 50 mg of elemental iron. 0000004715 00000 n
. . 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). Clinical Considerations Intravenous or intramuscular injections of INFeD are indicated for treatment of patients with documented iron deficiency in whom oral administration is unsatisfactory or impossible.. Iron Replacement for Blood Loss: Some individuals sustain blood losses on an intermittent or repetitive basis. 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. 0000018000 00000 n
Infed is given undiluted at a slow gradual rate not to exceed 50 mg (1 mL) per minute. Therefore, administration of subsequent test doses during therapy should be considered. Y-site compatibility of medications with parenteral nutrition. Cancer Chemother Pharmacol. The pH of the solution is between 4.5 to 7.0. %%EOF
To calculate a patient's weight in kg when lbs are known: 2.3 Recommended Dosage of Iron Replacement for Blood Loss INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. . Six different dialyzer membranes were investigated (polysulfone, cuprophane, cellulose acetate, cellulose triacetate, polymethylmethacrylate and polyacrylonitrile), including those considered high efficiency and high flux. Data sources include IBM Watson Micromedex (updated 2 Apr 2023), Cerner Multum (updated 17 Apr 2023), ASHP (updated 10 Apr 2023) and others. HlTM6(R;!$+g}4h*I:-~`wIg;g5#I:X3Gs3dlg7E%~KyV0=^z@X,/%OE9oCz?=P%!XYUX8]hMW;2m%}?={ Pov5J%3LaA@a9"099^eiqk5r#ZH34`&`Eaj,@6kbBQ(BPt"`32n'OV4=:yOM2hf}"V@> Absorbed very slowly from subcutaneous tissue; stains skin for up to 2 years if the drug is deposited in this tissue. HHS Vulnerability Disclosure, Help Do not exceed a total daily dose of 2 mL undiluted Infed. The formula shown below is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron: Replacement iron (in mg) = Blood loss (in mL) x hematocrit, Example: Blood loss of 500 mL with 20% hematocrit. s sw?s4 rA,Pg_F\6IV5fbZW[Xo3tvR>el#Fd+9#Q|M-:bp6(-Ua7y3|b'O1:B`#Q)oTdQ~} B7&y"p$dKHo$zqx)|{JOj?aaZ=*#s}#;{
wQ&vYAv6bUd`l!k3X*4V. 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. 1983 Jan 1;286(6358):32-6. doi: 10.1136/bmj.286.6358.32. 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.]. Written by ASHP. Clipboard, Search History, and several other advanced features are temporarily unavailable. . Chemical and physical bases determining the instability and incompatibility of formulated injectable drugs. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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. This site complies with the HONcode standard for trust- worthy health information: verify here. Available data from postmarketing reports with iron dextran use in pregnancy are insufficient to assess the risk of major birth defects or miscarriage. Accessibility 0000009371 00000 n
Increased Risk of Toxicity in Patients with Underlying Conditions 7.1 Drug/Laboratory Test Interactions Pregnancy Improper storage conditions after reconstitution will lead to the administration of a subtherapeutic medication and will eventually lead to treatment failure and antibiotic resistance. 0000006734 00000 n
Stability of solutions of antineoplastic agents during preparation and storage for in vitro assays. Lumizyme (Alglocosidase Alfa) [Personal Communication] MIS 1-1277662768. . <> 1 INDICATIONS AND USAGE 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 . 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)]. 12.2 Pharmacodynamics 0000008022 00000 n
Systemic exposure to iron dextran may be increased. Possible fever and exacerbation or reactivation of joint pain and swelling with IV administration in patients with rheumatoid arthritis; use with extreme caution. 0000004132 00000 n
Advise pregnant persons about the risk of hypersensitivity reactions which may have serious consequences for the fetus [see Use in Specific Populations (8.1)]. 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. PMC Patients with rheumatoid arthritis may have an acute exacerbation of joint pain and swelling following the administration of INFeD. NOTE: Do not mix INFeD with other medications or add to parenteral nutrition solutions for intravenous infusion. We comply with the HONcode standard for trustworthy health information. Table 1: Total Infed Requirement for Hemoglobin Restoration and Iron Stores Replacement in Patients with Iron Deficiency Anemia* Alternatively, the total dose may be calculated using the formulas below: Adults and Children over 15 kg (33 lbs) Dose (mL) = 0.0442 (Desired Hb - Observed Hb) x LBW + (0.26 x LBW) Based on: 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. 0000010567 00000 n
. Excretion All Rights Reserved. The extent of risk for anaphylactic-type reactions following exposure to any specific iron dextran product is unknown and may vary among the products. Store at 20-25C (68-77F) [See USP Controlled Room Temperature]. The maximum daily dose of INFeD should not exceed 2 mL. . Administer a test dose of Infed prior to the first therapeutic dose [see Dosage and Administration (2.4)]. 0000046285 00000 n
0000011536 00000 n
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. 0000013948 00000 n
The formula is based on the approximation that 1 mL of normocytic, normochromic red cells contains 1 mg of elemental iron. 0000001396 00000 n
0000003686 00000 n
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d_@ . 4. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. Disease-Associated Maternal and/or Embryo/Fetal Risk Anaphylactic-type reactions, including fatalities, have been reported following the parenteral administration of iron dextran injection. INFeD should be used with caution in individuals with histories of significant allergies and/or asthma. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER. <<7815BA97DDE94C498B4A3154474182CA>]>>
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. Mr}~sK8Beo3dzSJ&LrOUTO 4%4I :, Trq3@b !Fa`G"@mjxY9Y2|az$G!,vj: The development and health benefits of breastfeeding should be considered along with the mothers clinical need for Infed in addition to any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.
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