Trace Elements

Trace Elements is a fixed-combination medication 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.

• Trace Elements are available under the following different brand names: Tralement, Multrys.

Common side effects of Trace Elements include:

• nausea
• vomiting
• gastric irritation
• deterioration of nerves
• headache
• insomnia
• irritability
• mood changes
• sleep disturbances
• weight gain
• anemia
• low platelet count
• gout-like symptoms
• metallic taste
• fever
• diarrhea
• itching
• acne
• thyroid suppression
• joint pain

Serious side effects of Trace Elements include:

• hives
• rash 
• itching 
• dizziness 
• trouble breathing 
• chest pain
• swelling
• toxicity from having too many Trace Elements in the body: fever, skin flushing, nausea, diarrhea, stomach pain, tremors (shaking), movement problems, changes in mood or memory, confusion, seizures

Rare side effects of Trace Elements include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injection (Tralement)

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

Injection (Multrys)

• 1 mL/vial
  • Each mL contains zinc 1000 mcg, copper 60 mcg, manganese 3 mcg

Parenteral nutrition (PN)

Adult dosage

• Weighing 50 kg and more
  • 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

Pediatric dosage

Tralement

• Weighing less than 10 kg: Not recommended
• Weighing between 10 to 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 the table in the full prescribing information
• Weighing 50 kg and more
  • 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

• Weighing less than 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
• Weighing less than 3 kg: No recommended daily dosage of zinc provided; add zinc sulfate to provide a 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

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Trace Elements have severe interactions with no other drugs
• Trace Elements have serious interactions with no other drugs
• Trace Elements have moderate interactions with no other drugs
• Trace Elements have minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity to zinc or copper

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Trace Elements?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Trace Elements?”

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 because 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 the catheter

Pregnancy and Lactation

• 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 women have an increased metabolic demand for Trace Elements
  • Consider PN if a pregnant woman'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