Chromic Chloride

FDA Drug Profile — Chromium

Drug Details

Generic Name
Chromic Chloride
Brand Names
Chromium
Application Number
NDA018961
Sponsor
Hospira, Inc.
NDC Codes
2
Dosage Forms
INJECTION, SOLUTION, INJECTION
Routes
INTRAVENOUS
Active Ingredients
CHROMIC CHLORIDE

Indications and Usage

INDICATIONS AND USAGE Chromic Chloride Injection is indicated for use as a supplement to intravenous solutions given for total parenteral nutrition (TPN). Administration helps to maintain chromium serum levels and to prevent depletion of endogenous stores and subsequent deficiency symptoms.

Warnings

WARNINGS Direct intramuscular or intravenous injection of Chromic Chloride Injection is contraindicated, as the acidic pH of the solution may cause considerable tissue irritation. Severe kidney disease may make it necessary to reduce or omit chromium and zinc doses because these elements are primarily eliminated in the urine. WARNING: 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.