Tralement Injection

Tralement is a combination of zinc, copper, manganese and selenium, which are trace elements necessary for various physiological functions.^[1][2] This injection may be used as a supplement for those who require parenteral nutrition to maintain adequate levels of these trace elements.^[1] Zinc plays a role in immune function, protein synthesis, wound healing, DNA synthesis and cell division^[3]. Copper is important for the metabolism of iron and the maintenance of the immune system.^[4] Manganese is involved in bone formation, blood clotting and the immune system.^[5] Selenium may help as an antioxidant and may help prevent cell damage, support thyroid function and play a role in the immune system.^[6]

Tralement injections may be used to prevent and treat deficiencies of these trace elements in patients receiving parenteral nutrition.^[1] The proper balance of these elements is crucial, as both deficiencies and excesses can lead to significant health issues.^[2] Zinc deficiency may result in impaired immune function and delayed wound healing, while excess zinc may cause copper deficiency.^[3] Copper deficiency may lead to anemia and bone issues, whereas excess copper can cause toxicity.^[4] Manganese deficiency is rare but may affect bone health and metabolism, while excess manganese can be neurotoxic.^[5] Selenium deficiency may cause thyroid dysfunction, while excess selenium may lead to selenosis, a condition causing gastrointestinal upsets and hair loss.^[6][7]

Tralement should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

Warnings: Copper and Manganese are eliminated via the bile. In patients with severe liver dysfunction and/or biliary tract obstruction, decreasing or omitting copper and manganese supplements entirely may be necessary.

This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

Precautions: Before administering Tralement in TPN solutions, the physician must assess the metabolic requirements for trace elements and disease state of the patient. Frequent determinations of serum levels of the various trace elements are suggested as a guideline for adjusting the dosage or completely omitting the solution. ZINC is eliminated via the intestine and kidneys. The possibility of retention should be considered in patients with malfunctioning excretory routes. COPPER and MANGANESE are eliminated via the bile, therefore the possibility of retention of these elements should be considered in patients with biliary obstruction. Ancillary routes of MANGANESE excretion, however, include pancreatic juice, or reabsorption into the lumen of duodenum, jejunum, or ileum.

As SELENIUM is eliminated in urine and feces, SELENIUM supplements may be adjusted, reduced or omitted in renal dysfunction and/or gastrointestinal malfunction. In patients receiving blood transfusions, contribution from such transfusions should also be considered. Frequent selenium plasma level determinations are suggested as a guideline.

In animals, SELENIUM has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium, and arsenic.

The amounts of ZINC, COPPER, MANGANESE and SELENIUM in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.

Overdosage: Symptoms of ZINC overdosage resulting from oral ingestion of Zinc Sulfate in large amounts have resulted in death. Symptoms included nausea, vomiting, dehydration, electrolyte imbalances, dizziness, abdominal pain, lethargy and incoordination. Single intravenous doses of 1 to 2mg zinc/kg bodyweight have been given to adult leukemic patients without toxic manifestations. Normal plasma levels for Zinc vary from approximately 88 to 112 mcg/100 mL. Plasma levels sufficient to produce symptoms of toxic manifestations are not known. Calcium supplements may confer a protective effect against Zinc toxicity.

Symptoms of COPPER toxicity reported in literature include prostration, behavior change, diarrhea, progressive marasmus, hypotonia, photophobia and peripheral edema. D-penicillamine has been reported effective as an antidote.

MANGANESE toxicity has not been reported in patients receiving TPN. Neither have reports of manganese toxicity from excessive intake in foods and/or beverages been published.

Chronic toxicity in humans resulting from exposure to SELENIUM in industrial environments, intake of foods grown in seleniferous soils, use of selenium contaminated water, and application of cosmetics containing selenium has been reported in literature. Toxicity symptoms include hair loss, weakened nails, dermatitis, dental defects, gastrointestinal disorders, nervousness, mental depression, metallic taste, vomiting, and garlic odor of breath and sweat. Acute poisoning due to ingestion of large amounts of selenium compounds has resulted in death with histopathological changes including fulminating peripheral vascular collapse, internal vascular congestion, diffusely hemorrhagic, congested and edematous lungs, brick-red color gastric mucosa. The death was preceded by coma. No effective antidote to selenium poisoning in humans is known. Animal studies have shown casein and linseed oil in feeds, reduced glutathione, arsenic, magnesium sulfate, and bromobenzene to afford limited protection.

Teratogenic effects. Pregnancy Category C: SELENIUM at high dose levels (15-30mcg/egg) has been reported to have adverse embryological effects among chickens. There are however no adequate and well-controlled studies in pregnant women. Tralement should be used during pregnancy only if potential benefit justifies the potential risk to the fetus.

Presence of SELENIUM in placenta and umbilical cord blood has been reported in humans.

Store this medication at 68°F to 77°F (20°C to 25°C) and away from heat, moisture and light. Keep all medicine out of the reach of children. Throw away any unused medicine after the beyond use date. Do not flush unused medications or pour down a sink or drain.

1. Drugs.com. “Tralement (Trace Elements Injection 4).” Available at: https://www.drugs.com/pro/tralement.html
2. National Research Council (US) Committee on Diet and Health. (1989). Trace Elements. In Diet and Health: Implications for Reducing Chronic Disease Risk. Washington (DC): National Academies Press (US). Retrieved from https://www.ncbi.nlm.nih.gov/books/NBK218751/.
3. National Institutes of Health (NIH). “Zinc – Fact Sheet for Health Professionals.” Available at: https://ods.od.nih.gov/factsheets/Zinc-HealthProfessional/
4. National Institutes of Health (NIH). “Copper – Fact Sheet for Health Professionals.” Available at: https://ods.od.nih.gov/factsheets/Copper-HealthProfessional/
5. National Institutes of Health (NIH). “Manganese – Fact Sheet for Health Professionals.” Available at: https://ods.od.nih.gov/factsheets/Manganese-HealthProfessional/
6. National Institutes of Health (NIH). “Selenium – Fact Sheet for Health Professionals.” Available at: https://ods.od.nih.gov/factsheets/Selenium-HealthProfessional/
7. Linus Pauling Institute, Oregon State University. “Selenium.” Available at: https://lpi.oregonstate.edu/mic/minerals/selenium