Chromic chloride, cupric sulfate, manganese sulfate, and zinc sulfate heptahydrate

FDA label, American Regent, Inc., intravenous, effective 2019-04-25. Full label on DailyMed

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Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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.

Preparation and administration

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Your numbers for chromic chloride, cupric sulfate, manganese sulfate, and zinc sulfate heptahydrate. Take vial strength, diluent, and limits from the label below.

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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.

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).

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 lactation

Pregnancy

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.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

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