Multitrace-5 20.5 ug/mL
Trace Elements 5 · INJECTION, SOLUTION · American Regent, Inc.
Multitrace-5 is a injection, solution containing trace elements 5 at 20.5 ug/mL, taken intravenous. Manufactured by American Regent, Inc..
Key Facts
- Brand Name
- Multitrace-5
- Generic Name
- Trace Elements 5
- NDC Code (Product)
0517-8510- Manufacturer
- American Regent, Inc.
- Strength
- 20.5 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Marketing Start
- 02/17/1994
Recall History
South Coast Specialty Compounding, Inc.
Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
Beacon Hill Medical Pharmacy, P.C.
Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance
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. 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Each mL of the solution provides Zinc 1 mg, Copper 0.4 mg, Manganese 0.1 mg, Chromium 4 mcg, and Selenium 20 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 lost, 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/100 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 cop…
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 ® - 5 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, 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.
Frequently Asked Questions
What is Multitrace-5 used for?
Multitrace-5 contains Trace Elements 5. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Multitrace-5 a controlled substance?
Multitrace-5 is not classified as a controlled substance by the DEA.
What is the generic name for Multitrace-5?
The generic name for Multitrace-5 is Trace Elements 5. There are no other listed brand versions of Trace Elements 5.
What is the NDC code for Multitrace-5 20.5 ug/mL?
The NDC (National Drug Code) for Multitrace-5 20.5 ug/mL is 0517-8510, 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)