Multitrace-5 Concentrate Injection
Each dose contains: Zinc Sulfate Heptahydrate; Cupric Sulfate Pentahydrate; Manganese Sulfate Monohydrate; Chromic Chloride Hexahydrate; Selenious Acid; and Water. The pH of the solution may have been adjusted with Sulfuric Acid. A 10mL Multiple Dose Vial contains Benzyl Alcohol as an antimicrobial preservative.
Zinc serves as a cofactor for over 70 different enzymes, including alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. In this role, zinc promotes wound healing, regulates growth rates, and contributes to skin hydration, taste, and smell.
Providing zinc during TPN prevents the following deficiency symptoms: Parakeratosis, hypogeusia, anorexia, dysosmia, geophagia, hypogonadism, growth retardation and hepatosplenomegaly. At plasma levels below 20mcg zinc/100mL, dermatitis and alopecia have been reported for TPN patients.
Copper is a cofactor for serum ceruloplasmin, which is necessary for proper formation of the iron carrier protein, transferrin. Copper also regulates rates of red and white blood cell formation. Scorbutic type bone changes seen in infants fed exclusively with copper-poor cow's milk may be due to decreased activity of ascorbate oxidase, a cuproenzyme.
Providing copper during TPN prevents the following deficiencies: leukopenia, neutropenia, anemia, depressed ceruloplasmin levels, impaired transferrin formation and secondary iron deficiency.
Manganese activates enzymes such as polysaccharide polymerase, liver arginase, cholinesterase and pyruvate carboxylase. Providing manganese during TPN prevents the following deficiency symptoms: nausea and vomiting, weight loss, dermatitis, and changes in growth and color of hair.
Chromium (trivalent) is part of glucose tolerance factor, an activator of insulin-mediated reactions.. Chromium supports glucose metabolism and peripheral nerve function.
Providing chromium during TPN prevents the following deficiency symptoms: impaired glucose tolerance, ataxia, peripheral neuropathy and a confused state similar to mild hepatic encephalopathy.
Selenium is part of glutathione peroxidase which protects cells from oxidative damage due to peroxides produced during cellular metabolism.
Prolonged TPN in humans has resulted in selenium deficiency symptoms including muscle pain and tenderness.
Intravenous Administration: Dilute in a compatible diluent prior to administration. Compatible diluents include Dextrose 5%, Dextrose 10%, 0.9% Sodium Chloride (Normal Saline or NS), 0.45% Sodium Chloride (half-Normal Saline), Lactated Ringer's (LR), Dextrose/Saline combinations or Dextrose/LR solutions. For intermittent IV infusion: Add to a large volume of diluent and infuse slowly (manufacturer recommendations). A faster rate of infusion and less diluent have been used in clinical trials. A pharmacokinetic modeling study reported the administration of intravenous vitamin C (doses up to 1.25 gram IV) at a rate of 250 mg/min IV to healthy volunteers.13 Another study reported the infusion of 3 g of vitamin C infused IV over 10 minutes (rate: 300 mg/min IV) without deleterious effects on monitoring parameters such as the ECG.14 For continuous IV infusion: When used for the reduction of fluid resuscitation requirements in severely burned patients, a 25 mg/mL concentration was compounded in LR solution and administered at a rate of 66 mg/kg/hr.
To avoid infusion phlebitis, multitrace-5 concentrate solution should not be given undiluted by direct injection into a peripheral vein.
Warnings: Copper and Manganese are eliminated via the bile. Manganese supplements may need to be omitted for patients with severe liver dysfunction and/or biliary tract obstruction.
This product contains aluminum, which may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature.
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 that may cause central nervous system and bone toxicity.
Before administering this 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 can be used to guide the dosage or end the treatment. Zinc is eliminated via the intestine and kidneys. Retention may occur in patients with compromised excretory routes. Copper and manganese are eliminated via the bile, so these treatments should be avoided in patients with biliary obstruction.
Before providing chromium supplements, the patient should be assessed for diabetes, in which case oral or intravenous antidiabetic medication may be indicated.
Selenium is eliminated in urine and feces, and should be adjusted, reduced or omitted in patients with renal dysfunction or gastrointestinal malfunction, or those receiving blood transfusions. Frequent selenium plasma level determinations are suggested as a guideline.
Selenium may enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium, and arsenic.
Multitrace elements in Pregnancy Category C: SELENIUM at high dose levels (15-30mcg/egg) has been reported to have adverse embryological effects among chickens. No adequate studies exist in pregnant women. This concentrate should be used during pregnancy only if potential benefit justifies risk to the fetus.
The amounts of zinc, copper, manganese, chromium and selenium in the solution are small, and toxicity symptoms due to these trace elements are unlikely to occur.
Zinc overdosage resulting from oral ingestion of Zinc Sulfate in large amounts may result in death. Symptoms include 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. Plasma levels sufficient to produce symptoms of toxic manifestations are not known. Calcium supplements may protect against zinc toxicity.
Copper toxicity symptoms 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.
Chromium toxicity symptoms include nausea, vomiting, ulcers of gastrointestinal tract, renal and hepatic damage, and abnormalities of the central nervous system culminating in convulsions and coma. Trivalent Chromium administered by IV to TPN patients has been shown to be nontoxic when given at dosage levels up to 250 mcg/day for two consecutive weeks.
Chronic selenium toxicity resulting from exposure in industrial environments, 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. Poisoning due to ingestion 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 offer limited protection.