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Multitrace-5
Overview
What is Multitrace-5?
MULTITRACE- 5 CONCENTRATE (TRACE ELEMENTS INJECTION 5, USP) is a sterile nonpyrogenic solution containing five Trace Elements for use as an additive for Total Parenteral Nutrition (TPN).
Each mL Contains: Zinc Sulfate Heptahydrate 22 mg (equivalent to 5 mg Zinc); Cupric Sulfate Pentahydrate 3.93 mg (equivalent to 1 mg Copper); Manganese Sulfate Monohydrate 1.54 mg (equivalent to 0.5 mg Manganese); Chromic Chloride Hexahydrate 51.3 mcg (equivalent to 10 mcg Chromium); Selenious Acid 98 mcg (equivalent to 60 mcg Selenium); and Water for Injection q.s. pH of the solution may have been adjusted with Sulfuric Acid. The 10 mL Multiple Dose Vial contains 0.9% Benzyl Alcohol as an antimicrobial preservative.
What does Multitrace-5 look like?
What are the available doses of Multitrace-5?
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What should I talk to my health care provider before I take Multitrace-5?
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How should I use Multitrace-5?
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 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
:
MANGANESE
:
CHROMIUM
:
SELENIUM
:
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 flow 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 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
What interacts with Multitrace-5?
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What are the warnings of Multitrace-5?
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What are the precautions of Multitrace-5?
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What are the side effects of Multitrace-5?
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What should I look out for while using Multitrace-5?
MULTITRACE- 5 should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.
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 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
What might happen if I take too much Multitrace-5?
Symptoms of 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 2 mg 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 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
Symptoms of toxicity 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 intravenously to TPN patients has been shown to be nontoxic when given at dosage levels up to 250 mcg/day for two consecutive weeks.
Chronic toxicity in humans resulting from exposure to 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.
How should I store and handle Multitrace-5?
Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].Dispense in a well-closed container as defined in the USP.Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09MULTITRACE- 5 (TRACE ELEMENTS INJECTION 5, USP)Each mL provides: Zinc 5 mg, Copper 1 mg, Manganese 0.5 mg, Chromium 10 mcg, Selenium 60 mcg.NDC 0517-8201-25 1 mL Single Dose Vial Packaged in boxes of 25NDC 0517-8210-25 10 mL Multiple Dose Vial* Packaged in boxes of 25*The 10 mL multiple dose vial contains 0.9% benzyl alcohol as an antimicrobial preservative.AMERICAN REGENT, INC. SHIRLEY, NY 11967IN8201Rev. 01/09
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ZINC
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
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
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
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
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.
Non-Clinical Toxicology
MULTITRACE- 5 should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.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 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
studies were conducted to investigate the potential of gabapentin to inhibit the major cytochrome P450 enzymes (CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4) that mediate drug and xenobiotic metabolism using isoform selective marker substrates and human liver microsomal preparations. Only at the highest concentration tested (171 µg/mL; 1 mM) was a slight degree of inhibition (14%-30%) of isoform CYP2A6 observed. No inhibition of any of the other isoforms tested was observed at gabapentin concentrations up to 171 µg/mL (approximately 15 times the C at 3600 mg/day).
Gabapentin is not appreciably metabolized nor does it interfere with the metabolism of commonly coadministered antiepileptic drugs.
The drug interaction data described in this section were obtained from studies involving healthy adults and adult patients with epilepsy.
Before administering MULTITRACE- 5 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. is eliminated via the intestine and kidneys. The possibility of retention should be considered in patients with malfunctioning excretory routes. and 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 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 is eliminated in urine and feces, 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, has been reported to enhance the action of Vitamin E and decrease the toxicity of mercury, cadmium, and arsenic.
The amounts of and in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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