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Trace Metal 5 Combination
MULTITRACE™ - 5 CONCENTRATE (TRACE ELEMENTS INJECTION 5, USP) is a sterile nonpyrogenic CONCENTRATED solution containing five Trace Elements for use as an additive for Total Parenteral Nutrition (TPN).
The 10 mL Multiple Dose Vial contains 0.9% Benzyl Alcohol as an antimicrobial
preservative.
Zinc has been identified as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and senses of taste and smell. Providing zinc during TPN prevents development of the following deficiency symptoms: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly. At plasma levels below 20 mcg zinc/100 mL, dermatitis followed by alopecia has been reported for TPN patients. Copper is essential as a cofactor for serum ceruloplasmin, and oxidase necessary for proper formation of the iron carrier protein, transferrin. Copper also helps maintain normal rates of red and white blood cell formation. Scorbutic type bone changes seen in infants fed exclusively with copper- poor cow’s milk are believed due to decreased activity of ascorbate oxidase, a cuproenzyme. Providing copper during TPN prevents development of the following deficiency symptoms: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency. Manganese is an activator for enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. Providing manganese during TPN prevents development of the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis, and changes in growth and color of hair. Chromium (trivalent) is party of glucose tolerance factor, and activator of insulin-mediated reactions. Chromium helps to maintain normal glucose metabolism and peripheral nerve function. Providing chromium during TPN prevents development of the following deficiency symptoms: impaired glucose tolerance, ataxia, peripheral neuropathy and a confusional state similar to mild/moderate hepatic encephalopathy. Selenium is party of glutathione peroxidase which protects cell components from oxidative damage due to peroxides produced in cellular metabolism. Prolonged TPN support in humans has resulted in selenium deficiency symptoms
which include muscle pain and tenderness. The symptoms have been reported
to respond to supplementation of TPN solutions with selenium.
This formulation is indicated for use as a supplement to intravenous solutions given for TPN. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, selenium and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.
Each mL of the solution provides Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, and Selenium 60 mcg. The suggested dosage ranges for the five trace elements are: Zinc: For the metabolically stable adult receiving TPN, the suggested intravenous dosage level is 2.5 to 4 mg zinc/day. An additional 2 mg zinc/day is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid loss, or an additional 17.1 mg zinc/kg of stool or ileostomy output is recommended. Frequent monitoring of zinc blood levels is suggested for patients receiving more than the usual maintenance dosage level of zinc. Normal plasma levels for zinc vary from approximately 88 to 112 mcg/10 mL. For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day is suggested. Copper: For the metabolically stable adult receiving TPN, the suggested additive dosage level is 0.5 to 1.5 mg copper/day. For pediatric patients, the suggested additive dosage level is 20 mcg copper/kg/day. The normal plasma range for copper is approximately 80 to 160 mcg/100 mL. Manganese: For the metabolically stable adult receiving TPN, the suggested additive dosage level for manganese is 0.15 mg to 0.8 mg/day. For pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended. Chromium: For the metabolically stable adult receiving TPN, the suggested additive dosage level is 10 to 15 mcg chromium/day. The metabolically stable adult with intestinal fluid loss may require 20 mcg chromium/day, with frequent monitoring of blood levels as a guideline for subsequent administration. For pediatric patients, the suggested additive dosage level is 0.14 to 0.20 mcg/kg/day. Selenium: For metabolically stable adults receiving TPN, the suggested additive dosage level is 20 to 40 mcg selenium/day. For pediatric patients, the suggested additive dosage level is 3 mcg/kg/day. In adults, selenium deficiency states resulting from long term TPN support, selenium as selenomethionine or selenious acid, administered intravenously at 100 mcg/day for a period of 24 and 31 days, respectively, has been reported to reverse deficiency symptoms without toxicity. The normal whole blood range for selenium is approximately 10 to 37 mcg/100 mL. Periodic monitoring of plasma levels of Zinc, Copper, Manganese, Chromium and Selenium is suggested as a guideline for administration. Aseptic addition of the solution to the TPN solution under laminar wflow hood is recommended. The trace elements present in the solution are physically compatible with the electrolytes and vitamins usually present in the amino acid/dextrose solution used for TPN. Parenteral drug products should be inspected visually for particulate matter and discoloration, whenever solution and container permit. Store at controlled room temperature between 15°- 30° C( 59°- 86° F). Avoid excessive heat. HOW SUPPLIED MULTITRACE™ - 5 CONCENTRATE (TRACE ELEMENTS INJECTION 5, USP)
CAUTION: Federal (USA) law prohibits dispensing without prescription.
The amounts of Zinc, Copper, Manganese, Chromium 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.
No information provided.
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.
Before administering MULTITRACE™ - 5 CONCENTRATE 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 kidneys, therefore the possibility of Zinc retention should be considered in patients with renal dysfunction. 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. In assessing the contribution of Chromium supplements to maintenance of normal glucose homeostasis, consideration should be given to the possibility that the patient may be diabetic, in which case oral or intravenous antidiabetic medication may be indicated. As Selenium is eliminated in urine and feces, Selenium supplements may be adjusted, reduced or omitted in renal disfunction 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. Pregnancy Teratogenic Effects -Pregnancy Category C: Selenium at high dose levels (15-30 mcg/egg) has been reported to have adverse embryological effects among chickens. There are however no adequate and well-controlled studies in pregnant women. MULTITRACE™ - 5 CONCENTRATE 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.
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