Multitrace -4 Pediatric 5.12 ug/mL
Trace Elements 4 · INJECTION, SOLUTION, CONCENTRATE · American Regent, Inc.
Multitrace-4 Pediatric is an intravenous injection containing trace elements that is used to supplement nutrition in pediatric patients who cannot eat or absorb nutrients normally. This medication provides essential minerals like zinc, copper, manganese, and chromium that the body needs to function properly.
Key Facts
- Brand Name
- Multitrace -4 Pediatric
- Generic Name
- Trace Elements 4
- NDC Code (Product)
0517-9203- Manufacturer
- American Regent, Inc.
- Strength
- 5.12 ug/mL
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Route
- INTRAVENOUS
- Marketing Status
- Marketing Start
- 12/09/1993
Recall History
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 : For full term infants and children, 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 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 pediatric patients, a dosage level of 2 to 10 mcg manganese/kg/day is recommended. CHROMIUM : For pediatric patients, the suggested additive dosage level is 0.14 to 0.20 mcg/kg/day. Periodic monitoring of plasma levels of Zinc, Copper, Manganese, and Chromium is suggested as a guideline for administration. Aseptic addition of MULTITRACE® - 4 PEDIATRIC to parenteral nutrition solutions under a laminar flow hood is recommended. The trace elements present in MULTITRACE® - 4 PEDIATRIC are physically compatible with the electrolytes and vitamins usually presen…
Warnings
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 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.
Contraindications
CONTRAINDICATIONS MULTITRACE ® - 4 PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.
Adverse Reactions
ADVERSE REACTIONS The amounts of ZINC, COPPER, MANGANESE, AND CHROMIUM in the solution are very small and toxicity symptoms due to these trace elements at suggested dosage levels are considered unlikely to occur.
Frequently Asked Questions
What is Multitrace -4 Pediatric used for?
Multitrace-4 Pediatric is an intravenous injection containing trace elements that is used to supplement nutrition in pediatric patients who cannot eat or absorb nutrients normally. This medication provides essential minerals like zinc, copper, manganese, and chromium that the body needs to function properly.
Is Multitrace -4 Pediatric a controlled substance?
Multitrace -4 Pediatric is not classified as a controlled substance by the DEA.
What is the generic name for Multitrace -4 Pediatric?
The generic name for Multitrace -4 Pediatric is Trace Elements 4. There are no other listed brand versions of Trace Elements 4.
What is the NDC code for Multitrace -4 Pediatric 5.12 ug/mL?
The NDC (National Drug Code) for Multitrace -4 Pediatric 5.12 ug/mL is 0517-9203, listed by American Regent, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)