Trace Elements 4

Brand Names: Multitrace -4 Pediatric

Drug Class: General Prescription

Overview

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.

Mechanism of Action

CLINICAL PHARMACOLOGY ZINC has been identified as a cofactor for over 70 different enzymes, including carbonic anhydrase, alkaline phosphatase, lactic dehydrogenase and both RNA and DNA polymerase. Zinc facilitates wound healing, helps maintain normal growth rates, normal skin hydration and senses of taste and smell. 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 is essential as a cofactor for serum ceruloplasmin, an oxidase necessary for proper formation of the iron carrier protein, transferrin.

Indications

  • 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.

Common Doses

  • 1 mg
  • 0.1 mg
  • 25 mcg
  • 1 mcg

Dosage

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.

Contraindications

  • CONTRAINDICATIONS MULTITRACE ® - 4 PEDIATRIC should not be given undiluted by direct injection into a peripheral vein because of the potential of infusion phlebitis.

Side Effects

  • 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.

Interactions

  • No major interactions listed on the FDA label. Always consult a healthcare professional.