Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Injection, solution:
Addamel N: Chromium 1 mcg, copper 0.13 mg, fluoride 0.095 mg, iodide 0.013 mg, iron 0.11 mg, manganese 0.027 mg, molybdenum 1.9 mcg, selenium, 3.2 mcg, and zinc 0.65 mg per 1 mL (20 mL [DSC])
Multitrace-4: Chromium 4 mcg, copper 0.4 mg, manganese 0.1 mg, and zinc 1 mg per 1 mL (10 mL) [contains aluminum, benzyl alcohol]
Multitrace-4 Concentrate: Chromium 10 mcg, copper 1 mg, manganese 0.5 mg, and zinc 5 mg per 1 mL (1 mL) [contains aluminum]; chromium 10 mcg, copper 1 mg, manganese 0.5 mg, and zinc 5 mg per 1 mL (10 mL) [contains benzyl alcohol]
Multitrace-4 Neonatal: Chromium 0.85 mcg, copper 0.1 mg, manganese 0.025 mg, and zinc 1.5 mg per 1 mL (2 mL) [contains aluminum]
Multitrace-5: Chromium 4 mcg, copper 0.4 mg, manganese 0.1 mg, selenium 20 mcg, and zinc 1 mg per 1 mL (10 mL) [contains aluminum, benzyl alcohol]
Multitrace-5 Concentrate: Chromium 10 mcg, copper 1 mg, manganese 0.5 mg, selenium 60 mcg, and zinc 5 mg per 1 mL (1 mL) [contains aluminum]; chromium 10 mcg, copper 1 mg, manganese 0.5 mg, selenium 60 mcg, and zinc 5 mg per 1 mL (10 mL) [contains benzyl alcohol]
Trace Elements 4 Pediatric: Chromium 1 mcg, copper 0.1 mg, manganese 0.03 mg, and zinc 0.5 mg per 1 mL (10 mL) [contains aluminum, benzyl alcohol]
Injection, solution [preservative free]:
Multitrace-4 Pediatric: Chromium 1 mcg, copper 0.1 mg, manganese 0.025 mg, and zinc 1 mg per 1 mL (3 mL) [contains aluminum]
Pharmacology
Mechanism of Action
Chromium: Helps to maintain normal glucose metabolism and peripheral nerve function and prevents development of impaired glucose tolerance, ataxia, peripheral neuropathy, and a confusional state similar to mild/moderate hepatic encephalopathy.
Copper: Cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin; also helps maintain normal rates of red and white blood cell formation and prevents development of leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency.
Manganese: Activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase and prevents development of nausea and vomiting, weight loss, dermatitis, and changes in growth and hair color.
Selenium: Protects cell components from oxidative damage due to peroxides produced in cellular metabolism and prevents development of muscle pain and tenderness.
Zinc: Facilitates wound healing, helps maintain normal growth rates, normal skin hydration and senses of taste and smell and prevents development of parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly.
Pharmacokinetics/Pharmacodynamics
Excretion
Chromium: Urine and bile
Copper: Feces
Manganese: Feces (primarily); ancillary routes via pancreatic secretions or reabsorption into the intestinal lumen
Selenium: Urine, feces
Zinc: Urine, feces
Use: Labeled Indications
Trace metal supplement for total parenteral nutrition: Prevent and correct trace metal deficiencies as a supplement to IV total parenteral nutrition (TPN).
Contraindications
Administration of undiluted solutions by direct injection into a peripheral vein.
Dosage and Administration
Dosing: Adult
Trace metal supplement for TPN: IV:
Manufacturer labeling:
Chromium: 10 to 15 mcg/day (20 mcg/day with intestinal fluid loss)
Copper: 500 to 1,500 mcg/day
Manganese: 150 to 800 mcg/day
Selenium: 20 to 40 mcg/day
Zinc: 2.5 to 4 mg/day. Consider an additional 2 mg/day for acute catabolic states; with fluid loss from the small bowel, an additional 12.2 mg/L of small bowel fluid lost, or an additional 17.1 mg/kg of stool or ileostomy output is recommended.
ASPEN Guidelines (Mirtallo 2004):
Chromium: 10 to 15 mcg/day
Copper: 300 to 500 mcg/day
Manganese: 60 to 100 mcg/day
Selenium: 20 to 60 mcg/day
Zinc: 2.5 to 5 mg/day
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Parenteral nutrition; maintenance requirements: Infants, Children, and Adolescents: IV: As an additive to parenteral nutrition solution; see individual agents (chromium, copper, manganese, and zinc) (ASPEN [Vanek 2012])
Administration
For IV use only. Must be diluted prior to use and infused as component of parenteral nutrition or parenteral solutions. Do not administer undiluted solutions by direct injection into a peripheral vein.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Warnings/Precautions
Disease-related concerns:
- GI malfunction: Consider reduction in dosage or deletion of selenium in patients with GI malfunction.
- Hepatic impairment: Copper and manganese may accumulate in severe hepatic impairment and/or biliary obstruction; consider reduction in dosage or deletion of copper and manganese in patients with severe hepatic impairment or biliary obstruction.
- Renal impairment: Use with caution in patients with renal impairment; metals may accumulate in renal failure. Consider reduction in dosage or deletion of selenium in patients with renal impairment.
Dosage form specific issues:
- Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.
Other warnings/precautions:
- Aluminum toxicity: Contains aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or in patients with renal impairment. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses.
- Overdose potential: Multiple trace metal solutions present a risk of overdosage when the need for one trace element is appreciably higher than for others in the formulation; utilization of individual trace metal solutions may be needed.
Monitoring Parameters
Periodically monitor plasma zinc, copper, manganese, chromium and selenium, with more frequent monitoring in patients receiving more than the usual dose.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Refer to individual elements for requirements in pregnancy.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
