Dosing & Uses
Dosage Forms & Strengths
injection (Tralement)
- 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 (Tralement)
- 1mL/vial
- Each mL contains zinc 3 mg, copper 0.3 mg, manganese 55 mcg, and selenium 60 mcg
injection (Multrys)
- 1mL/vial
- Each mL contains zinc 1000 mcg, copper 60 mcg, manganese 3 mcg, and selenium 6 mcg
Parenteral nutrition
Tralement
- 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 180 mcg, manganese 33 mcg, selenium 36 mcg) per day
- 40-49 kg: 0.8 mL (zinc 2,400 mcg, copper 240 mcg, manganese 44 mcg, selenium 48 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
Multrys
- Indicated in neonates and infants weighing <10 kg as a source of zinc, copper, manganese, and selenium for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated
-
<10 kg
- 0.6-0.8 kg: 0.2 mL (zinc 200 mcg, copper 12 mcg, manganese 0.6 mcg, selenium 1.2 mcg) per day
- 0.9-1.1 kg: 0.3 mL (zinc 300 mcg, copper 18 mcg, manganese 0.9 mcg, selenium 1.8 mcg) per day
- 1.2-1.4 kg: 0.4 mL (zinc 400 mcg, copper 24 mcg, manganese 1.2 mcg, selenium 2.4 mcg) per day
- 1.5-1.7 kg: 0.5 mL (zinc 500 mcg, copper 30 mcg, manganese 1.5 mcg, selenium 3 mcg) per day
- 1.8-2 kg: 0.6 mL (zinc 600 mcg, copper 36 mcg, manganese 1.8 mcg, selenium 3.6 mcg) per day
- 2.1-2.3 kg: 0.7 mL (zinc 700 mcg, copper 42 mcg, manganese 2.1 mcg, selenium 4.2 mcg) per day
- 2.4-2.6 kg: 0.8 mL (zinc 800 mcg, copper 48 mcg, manganese 2.4 mcg, selenium 4.8 mcg) per day
- 2.7-2.9 kg: 0.9 mL (zinc 900 mcg, copper 54 mcg, manganese 2.7 mcg, selenium 5.4 mcg) per day
- 3-9.9 kg: 1 mL (zinc 1000 mcg, copper 60 mcg, manganese 3 mcg, selenium 6 mcg) per day
-
Additional trace elements supplementation
- Add additional trace elements to parenteral and/or enteral routes of administration
- <3 kg: No recommended daily dosage of zinc provided; add zinc sulfate to provide total daily dose (TDD) of 400 mcg/kg/day
- 0.4-9.9 kg: No recommended daily dosage of copper or selenium provided
- Copper: TDD of 20 mcg/kg/day
- Selenium: TDD of 2 mcg/kg/day
Dosing Considerations
Monitoring parameters
- Monitor zinc, copper, and selenium serum concentrations and manganese whole blood concentrations during long-term administration
- Trace element concentrations may vary depending on assay used and laboratory reference range
- Perform collection, processing, and storage of blood samples according to the laboratory’s sample requirements for analysis
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (0)
Minor (0)
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
- Neurologic toxicity with manganese
- Hepatic accumulation of copper and manganese
- Hypersensitivity reactions with zinc and copper
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
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.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
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
Vials
- 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)
Admixture
- 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
- After removal from refrigeration, use promptly and complete infusion within 24 hr
- Discard any remaining admixture
- Protect from light
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