trace elements (Rx)

Brand and Other Names:Tralement
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection

  • 1mL/vial
  • Each mL contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg

Parenteral nutrition

Indicated in adults as a source of zinc, copper, manganese, and selenium for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated

≥50 kg

  • Each mL provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg
  • 1 mL per day added to PN
  • Not recommended for patients who may require a lower dosage of one or more of the individual trace elements

Dosage Modifications

Hepatic impairment

  • Patients with cholestasis, biliary dysfunction, or cirrhosis: Monitor hepatic and biliary function during long-term administration; if a patient develops signs or symptoms of hepatic or biliary dysfunction during use, obtain serum concentrations of copper and ceruloplasmin as well as manganese whole blood concentrations
  • Consider using individual trace element products in patients with hepatic and/or biliary dysfunction

Dosing Considerations

Monitoring parameters

  • Monitor serum zinc, copper, and selenium concentrations and manganese whole blood concentrations during long-term administration of PN
  • Trace elements concentrations may vary depending on the assay used and the laboratory reference range
  • Collection, processing, and storage of the blood samples should be performed according to the laboratory’s sample requirements for analysis

Dosage Forms & Strengths

injection

  • 1mL/vial
  • Each mL contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg

Parenteral nutrition

Indicated in adult and pediatric patients weighing at least 10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition (PN) when oral or enteral nutrition is not possible, insufficient, or contraindicated

<10 kg: Not recommended

10-49 kg

  • 10-19 kg: 0.2 mL (zinc 600 mcg, copper 60 mcg, manganese 11 mcg , selenium 12 mcg) per day
  • 20-29 kg: 0.4 mL (zinc 1,200 mcg, copper 120 mcg, manganese 22 mcg , selenium 24 mcg) per day
  • 30-39 kg: 0.6 mL (zinc 1,800 mcg, copper 1800 mcg, manganese 33 mcg , selenium 36 mcg) per day
  • 40-49 kg: 0.8 mL (zinc 2,400 mcg, copper 240 mcg, manganese 11 mcg , selenium 12 mcg) per day
  • Dosage of zinc (in heavier patients in some weight bands), copper or selenium
    • Additional supplementation using single trace element products may be needed for these patients
    • For complete dosing information see table in the full prescribing information
≥50 kg
  • Each mL provides zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg
  • 1 mL per day added to PN
  • Not recommended for patients who may require a lower dosage of one or more of the individual trace elements
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Interactions

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            Adverse Effects

            Frequency Not Defined

            With other components of parenteral nutrition solutions

            • Pulmonary embolism due to pulmonary vascular precipitates
            • Vein damage and thrombosis
            • Aluminum toxicity

            Use of trace elements administered parenterally or by other routes of administration H4 Neurologic toxicity with manganese

            • Hepatic accumulation of copper and manganese
            • Hypersensitivity reactions with zinc and copper
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            Warnings

            Contraindications

            Hypersensitivity to zinc or copper

            Cautions

            Solutions with osmolarity of 900 mOsmol/L or more must be infused through a central catheter

            Monitor for clinical signs and symptoms of neurotoxicity, whole blood manganese concentrations and liver function tests in patients receiving long-term administration; discontinue trace elements and consider brain magnetic resonance imaging (MRI) if toxicity suspected

            Hepatic accumulation of copper and manganese reported; assess for development of hepatic or biliary dysfunction; monitor concentrations of copper and manganese in patients with cholestasis, biliary dysfunction or cirrhosis receiving trace elements long-term

            Aluminum toxicity may occur; increased risk in patients with renal impairment, including preterm infants

            Monitor blood zinc, copper, manganese, and selenium concentrations, fluid and electrolyte status, serum osmolarity, blood glucose, liver and kidney function, blood count and coagulation parameters

            Hypersensitivity reactions with zinc and copper may occur; if reactions occur, discontinue trace elements and initiate appropriate medical treatment

            Pulmonary embolism due to pulmonary vascular precipitates

            • Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress have been reported in patients receiving parenteral nutrition
            • Cause of precipitate formation has not been determined in all cases; however, in some fatal cases, pulmonary emboli occurred as a result of calcium phosphate precipitates
            • If signs of pulmonary distress occur, stop the parenteral nutrition infusion and initiate a medical evaluation
            • Periodically inspect for precipitates in the solution, the infusion set, and catheter
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            Pregnancy & Lactation

            Pregnancy

            Administration of the recommended dose in PN is not expected to cause major birth defects, miscarriage, or adverse maternal or fetal outcomes

            Deficiency of trace elements may result in adverse pregnancy and fetal outcomes

            Animal reproduction studies have not been conducted with trace elements

            Clinical considerations

            • Deficiencies of trace elements, including zinc, copper, manganese, and selenium are associated with adverse pregnancy and fetal outcomes
            • Pregnant females have an increased metabolic demand for trace elements
            • Consider PN if a pregnant female’s nutritional requirements cannot be fulfilled by oral or enteral intake

            Lactation

            Zinc, copper, manganese, and selenium are present in human milk

            Administration of the approved recommended dose in PN is not expected to cause harm to a breastfed infant

            There is no information on the effects of zinc sulfate, cupric sulfate, manganese sulfate, or selenious acid on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Zinc

            • Zinc functions as a cofactor of various enzymes including DNA polymerases, RNA polymerases, alcohol dehydrogenase, and alkaline phosphatases
            • Coordinator of protein structural folding that interacts with a variety of proteins, lipids, and nucleic acids

            Copper

            • Copper is a cofactor for many metalloenzymes acting as an oxidase to achieve reduction of molecular oxygen

            Manganese

            • Manganese is essential for the normal catalytic activity of several metalloenzymes including manganese superoxide dismutase, arginase, glutamine synthetase, phosphoenolpyruvate decarboxylase, and pyruvate carboxylase
            • Contributes to the normal function of several other enzyme families including the oxidoreductases, transferases, hydrolases, lyases, isomerases, and ligases

            Selenium

            • Selenious acid is converted in vivo to hydrogen selenide via glutathione-involved electron reductions. Hydrogen selenide acts as a selenium pool to form selenoproteins which include, but are not limited to, glutathione peroxidase, iodothyronine deiodinase, peroxidase, and thioredoxins

            Distribution

            Protein bound

            • Zinc: ~80% of serum zinc is bound to albumin and the remainder to α-2­ macroglobulin and amino acids
            • Copper: 7% (plasma); ~93% (liver)
            • Selenium: 85% (4-6 hr); 95% (24 hr)
            • Manganese: Bound to albumin and beta1-globulin

            Elimination

            Excretion

            • Copper: Excreted in bile and into the gastrointestinal tract where it is not reabsorbed; also eliminated through the kidney
            • Manganese: Found in human bile suggesting biliary excretion
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            Administration

            IV Preparation

            Supplied as a single-dose vial for admixture use only

            Must be transfer to a separate parenteral nutrition container, diluted and used as an admixture in PN solution

            Add to PN solution in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area)

            Use aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients

            Inspect vials and PN for particulate matter before admixing, after admixing, and prior to administration

            Transfer to PN container after the admixture of amino acids, dextrose, lipid emulsion (if added), and electrolytes solutions is prepared

            Additives may be incompatible; evaluate all additions to PN container for compatibility and stability of the resulting preparation

            An interaction may occur between cupric ion and ascorbic acid; therefore, add multivitamin additives to the admixed PN solution shortly before infusion

            Inspect final PN solution to ensure that precipitates have not formed during mixing or addition on additives; emulsion has not separated, if lipid emulsion has been added

            Separation of the emulsion can be visibly identified by a yellowish streaking or the accumulation of yellowish droplets in the admixed emulsion

            Discard if any precipitates are observed

            IV Administration

            Not for direct IV infusion

            Final PN solution is for IV infusion into a central or peripheral vein; choice of a central or peripheral venous route should depend on the osmolarity of the final infusate

            Infuse solutions with osmolarity ≥900 mOsmol/L through a central catheter

            Storage

            Single-dose vial

            Vial closure is not made with natural rubber latex

            Store at 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)

            PN solutions containing trace elements

            Use promptly after mixing

            If not, refrigerate at 2-8ºC (36-46ºF) and limited to a period of no longer than 9 days

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            Formulary

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.