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Trace Elements 4
Overview
What is Multitrace -4 Pediatric?
MULTITRACE
- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)
Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg and Chromium 1 mcg. Each mL contains: Zinc Sulfate Heptahydrate 4.39 mg (equivalent to 1 mg Zinc); Cupric Sulfate Pentahydrate 0.4 mg (equivalent to 0.1 mg Copper); Manganese Sulfate Monohydrate 77 mcg (equivalent to 25 mcg Manganese); Chromic Chloride Hexahydrate 5.12 mcg (equivalent to 1 mcg Chromium); and Water for Injection, q.s. pH of the solution may have been adjusted with sulfuric acid and/or sodium hydroxide. Preservative Free.
What does Multitrace -4 Pediatric look like?
What are the available doses of Multitrace -4 Pediatric?
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What should I talk to my health care provider before I take Multitrace -4 Pediatric?
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How should I use Multitrace -4 Pediatric?
This formulation is indicated for use as a supplement to intravenous solutions given for TPN for children up to 11 years of age. Administration of the solution in TPN solutions helps to maintain plasma levels of zinc, copper, manganese, and chromium and to prevent depletion of endogenous stores of these trace elements and subsequent deficiency symptoms.
Each mL of the solution provides Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg, and is administered intravenously only after dilution to a minimum of 1:200. The suggested dosage ranges for the four trace elements are:
ZINC
:
COPPER
:
MANGANESE
:
CHROMIUM
:
Periodic monitoring of plasma levels of Zinc, Copper, Manganese, and Chromium is suggested as a guideline for administration.
Aseptic addition of the solution to the TPN solution under a 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 -4 Pediatric?
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What are the warnings of Multitrace -4 Pediatric?
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What are the precautions of Multitrace -4 Pediatric?
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What are the side effects of Multitrace -4 Pediatric?
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What should I look out for while using Multitrace -4 Pediatric?
MULTITRACE
- 4 PEDIATRIC
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 -4 Pediatric?
Symptoms of overdose 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 body weight have been given to adult leukemia 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 and 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.
How should I store and handle Multitrace -4 Pediatric?
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- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11MULTITRACE- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11MULTITRACE- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11MULTITRACE- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11MULTITRACE- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11MULTITRACE- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11MULTITRACE- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11MULTITRACE- 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP)Each mL provides: Zinc 1 mg, Copper 0.1 mg, Manganese 25 mcg, and Chromium 1 mcg.NDC 0517-9203-25 3 mL Single Dose Vial Packaged in boxes of 25AMERICANREGENT, INC.SHIRLEY, NY 11967IN9203Rev. 1/11
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.
Non-Clinical Toxicology
MULTITRACE- 4 PEDIATRIC
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 mcg/mL; 1 mM) was a slight degree of inhibition (14% to 30%) of isoform CYP2A6 observed. No inhibition of any of the other isoforms tested was observed at gabapentin concentrations up to 171 mcg/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 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 the retention of these elements should be considered in patients with biliary obstruction. Ancillary routes of 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.
The amounts of 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/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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