Trace Elements 4
FDA Drug Information • Also known as: Multitrace -4 Pediatric
- Brand Names
- Multitrace -4 Pediatric
- Route
- INTRAVENOUS
- Dosage Form
- INJECTION, SOLUTION, CONCENTRATE
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION MULTITRACE ® - 4 PEDIATRIC (TRACE ELEMENTS INJECTION 4, USP) is a sterile, nonpyrogenic solution containing four Trace Elements for use as an additive for Total Parenteral Nutrition (TPN). 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 Is Trace Elements 4 Used For?
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 and 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 present in parenteral nutrition formulations. Do not directly mix ascorbic acid injection with copper or selenium containing parenteral products in the same syringe or vial, as this admixture may cause the formation of an insoluble precipitate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, 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).
Side Effects (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.
Warnings and Precautions
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.
Pregnancy and Breastfeeding
Pregnancy Teratogenic Effects Pregnancy Category C: Safety for use in pregnancy has not been established. Use of MULTITRACE ® - 4 PEDIATRIC in women of childbearing potential requires that anticipated benefits be weighed against possible hazards.
Overdosage
OVERDOSAGE Symptoms of ZINC 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 COPPER 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 toxicity has not been reported in patients receiving TPN. Neither have reports of manganese toxicity from excessive intake in foods and/or beverages been published. Symptoms of CHROMIUM 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 Supplied
HOW SUPPLIED 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 25 AMERICAN REGENT, INC. SHIRLEY, NY 11967 IN9203 Rev. 8/18
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.